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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 25 September 2025 has been entered.
Status of Claims
Receipt is acknowledged of the claim amendments filed on 25 September 2025.
Claim 18 has been amended.
Claims 1-17 and 36 are cancelled.
Claims 38-42 have been added. There are two claims numbered 41. Applicant will have to cancel the second claim 41, add it as new claim 43, and amend the dependency of each claim accordingly.
Claims 18-35 and 37-43 are presented for examination herein to the extent that the respiratory pathogen infection is coronavirus, e.g., applicant’s elected species.
Claim Objections
The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not).
Misnumbered claim 41 (e.g., second claim 41) is renumbered to claim 43.
Rejections 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.
Claims 18-26, 31, 33-35, 37-40 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over SHEKH (“In silico allicin induced S-thioallylation of SARS-CoV-2 main protease”, JOURNAL OF SULFUR CHEMISTRY, pages 1-12, published online 2020 Sep 16) in view of GLICK (US 10,980,756; filed 31 March 2020; claims benefit of provisional application No. 62/990,414, filed 16 March 2020) and WENSLEY (US 2014/0144429 A1, cited in PTO-892 mailed 07 November 2023) as evidenced by the instant specification.
Shekh is primarily directed towards results indicating that allicin causes dual S-thioallylation of SARS-CoV-2 Mpro which may be of interest for treatment and attenuation of ongoing coronavirus infection (abstract).
Regarding claims 18, 23, 25, 34, 38-40, Shekh discloses that active site of SARS-CoV-2 main protease that cleaves eleven sites of long polyprotein to release functional proteins required for assembly/replication of coronavirus contains cysteine free thiol (page 11, first paragraph). Shekh discloses that allicin has proven medicinal properties including antiviral and antimicrobial activity, contains reactive thiosulfinate which can cause protein S-thioallyllation (page 11, first paragraph). Shekh disclose that allicin causes dual S-thioallylation of Cys-145 and solvent-exposed Cys-85/Cys-156 residue of SARS-CoV-2 Mpro thereby acts as a potent inhibitor of SARS-CoV-2 Mpro (page 11, first paragraph). Shekh discloses that the multi-faceted roles of allicin as a booster of immune system and covalent inhibitor of coronavirus protease may be useful in treating COVID-19 infection (e.g., coronavirus/SARS-CoV/homology with SARS-CoV) (page 11, first paragraph). Thus, from the disclosure of Shekh it would have been prima facie obvious for one of ordinary skill in the art to administer allicin as an active to treat COVID-19 infection in light of the disclosure of Shekh.
Shekh does not specifically teach that the allicin is in a liquid mixture that comprises propylene glycol and glycerol, aerosolizing the liquid mixture, and inhaling the aerosolized liquid mixture into the patient’s respiratory tract to contact a pathogen in the respiratory tract. The deficiency is made up for by the teachings of Glick and Wensley.
Glick is primarily directed towards compounds and compositions that are useful in method of treating coronavirus infections in a subject in need thereof (abstract).
Regarding claims 18, 26 and 38, Glick teaches that SARS-CoV causes Severe Acute Respiratory Syndrome (SARS) (column 1, lines 48-49). Glick teaches a method for treating COVID-19 (e.g., coronavirus/SARS-CoV/homology with SARS-CoV) in a subject in need thereof, comprising administering an effective amount of a compound (column 2, lines 29-32). Glick teaches local administration of the compound at a desired area of treatment including lower respiratory tract, e.g., lungs, significantly reduces the likelihood that a patient will experience systemic toxicities (column 6, lines 34-39). Glick teaches that respiratory administration via inhalation of the compound to a subject more efficiently produces a local concentration at a site where treatment is need including the lower respiratory tract (e.g., lungs) of a respiratory infection associated with COVID-19. The foregoing can be achieved using a lower dosage with a reduced particle size of the compound (paragraph bridging columns 6 and 7). Glick teaches including delivery to the peripheral lung regions including the alveoli (column 69, lines 23-26).
Wensley is primarily directed towards method, devices, systems for delivering one or more compounds to a subject by inhalation of a liquid formulation that is vaporized into aerosol particles (abstract and paragraph [0015]).
Regarding claims 18, 25-26, 31 and 43, Wensley teaches an aerosol generating device for generating an aerosol from a liquid formulation (paragraph [0008]). Wensley teaches that the liquid formulation is vaporized into aerosol particles (e.g. aerosolizing liquid mixture) (paragraph [0015]). Wensley teaches that the aerosol is delivered to the lung of the user of the device (paragraph [0013]). Wensley teaches that the liquid formulation comprises a pharmaceutically active agent and a carrier that includes propylene glycol (paragraphs [0014] and [0041]). Wensley teaches delivery to the deep lung including alveoli of the subject (paragraph [0096]). Wensley teaches that one or more carriers including glycerin and propylene glycol can stabilize the active (paragraph [0096]). Wensley teaches that the carrier can be a mixture of including propylene glycol and glycerol (paragraph [0124]). Wensley teaches that suitable drug agents in the method and devices include antibiotic and anti-infective agents (paragraph [0225]).
Regarding claim 33, Wensley teaches that doses of liquid agent are held in a safe dose cartridge (e.g. vaporizer cartridge) (paragraph [0143]). Wensley teaches that dose cartridge (e.g. vaporizer cartridge) comprises a heater element (paragraph [0145]).
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 Covid-19 (e.g., coronavirus/SARS-CoV/homology with SARS-CoV) by administration via inhalation (e.g., deliver and contact a composition to the respiratory tract) of an aerosolized liquid mixture composition comprising allicin as an active and carriers including propylene glycol and glycerol. The person of ordinary skill in the art would have been motivated to make those modifications because: 1) Shekh discloses that allicin may be useful in treating COVID-19 infection (e.g., coronavirus/SARS-CoV/homology with SARS-CoV) due to the multi-faceted roles of allicin as a booster of immune system and covalent inhibitor of coronavirus protease, 2) Glick teaches that desired area for delivery of an active to treat COVID-19 is the lungs by inhalation, and 3) Wensley teaches that compositions for administration by inhalation that delivers a drug to the lungs, wherein the composition includes an active and a carrier including propylene glycol and glycerol which may help stabilize the active, and wherein drugs include anti-infective agents further including antivirals. The person of ordinary skill in the art would have reasonably expected success because Shekh discloses that allicin has proven medicinal properties including antiviral and antimicrobial activity, contains reactive thiosulfinate which can cause protein S-thioallyllation (page 11, first paragraph). Shekh disclose that allicin causes dual S-thioallylation of Cys-145 and solvent-exposed Cys-85/Cys-156 residue of SARS-CoV-2 Mpro thereby acts as a potent inhibitor of SARS-CoV-2 Mpro (page 11, first paragraph). Shekh discloses that the multi-faceted roles of allicin as a booster of immune system and covalent inhibitor of coronavirus protease may be useful in treating COVID-19 infection (e.g., coronavirus/SARS-CoV/homology with SARS-CoV) (page 11, first paragraph). Glick teaches that SARS-CoV causes Severe Acute Respiratory Syndrome (SARS) (column 1, lines 48-49). Glick teaches a method for treating COVID-19 (e.g., coronavirus/SARS-CoV/homology with SARS-CoV) in a subject in need thereof, comprising administering an effective amount of a compound (column 2, lines 29-32). Glick teaches local administration of the compound at a desired area of treatment including lower respiratory tract, e.g., lungs, significantly reduces the likelihood that a patient will experience systemic toxicities (column 6, lines 34-39). Glick teaches that respiratory administration via inhalation of the compound to a subject more efficiently produces a local concentration at a site where treatment is need including the lower respiratory tract (e.g., lungs) of a respiratory infection associated with COVID-19. The foregoing can be achieved using a lower dosage with a reduced particle size of the compound (paragraph bridging columns 6 and 7). Glick teaches including delivery to the peripheral lung regions including the alveoli (column 69, lines 23-26). Wensley teaches that the liquid formulation comprises a pharmaceutically active agent and a carrier that includes propylene glycol (paragraphs [0014] and [0041]). Wensley teaches delivery to the deep lung including alveoli of the subject (paragraph [0096]). Wensley teaches that one or more carriers including glycerin and propylene glycol can stabilize the active (paragraph [0096]). Wensley teaches that the carrier can be a mixture of including propylene glycol and glycerol (paragraph [0124]). Wensley teaches that suitable drug agents in the method and devices include antibiotic and anti-infective agents (paragraph [0225]).
Regarding the recitation of “allicin disrupts the formation of one or more disulfide bridges of a pathogen protein” (e.g., claim 18), claims 19-22, 24, 35 and 37, in light of the disclosure of Shekh and the teachings of Glick and Wensley (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 Covid-19 (e.g., coronavirus/SARS-CoV/homology with SARS-CoV) by administration via inhalation (e.g., deliver and contact a composition to the respiratory tract) of an aerosolized liquid mixture composition comprising allicin as an active and carriers including propylene glycol and glycerol. As evidenced by the instant specification, 2PSP (e.g., allicin) prevents proper folding of proteins of N-CoV which disables the ability of the protein to bind to ACE2 (paragraph [0044]). Thus, the disclosure of Shekh and the teachings of Glick and Wensley (described above) renders prima facie obvious a method of treating Covid-19 (e.g., coronavirus/SARS-CoV) comprising administration through inhalation of an aerosol comprising allicin as an active and carriers including mixture of including propylene glycol and glycerol; wherein the aerosol is generated from a liquid formulation comprising allicin, propylene glycol and glycerol; which is the same as the instantly claimed method, therefore, necessarily has the same characteristics, e.g., disrupts or impedes the formation of one or more disulfide bridges of a pathogen protein including a spike or envelope protein of coronavirus (e.g., claim 18 and 24), disrupts the formation of one or more disulfide bridges of coronavirus by impairing the ability of the coronavirus to bind to ACE2 (e.g., claims 19-20), cause misfolding of the coronavirus protein (e.g., claim 21), causes reduction in survival of the coronavirus (e.g., claim 22), cause misfolding of the angiotensin-converting enzyme 2 (ACE2) which results in lowered blood pressure (e.g., claim 35), and heat shock of the human body increases the enthalpy of the proteins involved in coronavirus replication such that protein folding is easier to destabilize (e.g., claim 37).
Applicant is reminded that “[t]he fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious.” Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979) (Claims were directed to grooved carbon disc brakes wherein the grooves were provided to vent steam or vapor during a braking action. A prior art reference taught noncarbon disc brakes which were grooved for the purpose of cooling the faces of the braking members and eliminating dust. The court held the prior art references when combined would overcome the problems of dust and overheating solved by the prior art and would inherently overcome the steam or vapor cause of the problem relied upon for patentability by applicants. Granting a patent on the discovery of an unknown but inherent function (here venting steam or vapor) “would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art.” 596 F.2d at 1022, 201 USPQ at 661.); In re Baxter Travenol Labs., 952 F.2d 388, 21 USPQ2d 1281 (Fed. Cir. 1991).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Shekh in view of Glick and Wensley as evidenced by the instant specification as applied to claims 18-26, 31, 33-35, 37-40 and 43 above, and further in view of GHOWEBA (US 2021/0322464 A1, effective filing date of 20 April 2020, cited in PTO-892 mailed 07 November 2023).
Shekh, Glick and Wensley do not specifically teach that liquid mixture further comprises selenocysteine. The deficiency is made up for by the teachings of Ghoweba.
Ghoweba is primarily directed towards methods of treatment and prevention of COVID-19 (abstract).
Regarding claim 27, Ghoweba teaches treatment for COVID-19 comprising administering at least a molecule containing selenium (paragraphs [0003], [0009] and [0019]). Ghoweba teaches that selenium containing molecule, or compound or drug that is suitable for use as the molecule containing selenium includes selenocysteine (paragraph [0035]).
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 Covid-19 (e.g., coronavirus/SARS-CoV/homology with SARS-CoV) by administration via inhalation (e.g., deliver and contact a composition to the respiratory tract) of an aerosolized liquid mixture composition comprising allicin and selenocysteine as actives and carriers including propylene glycol and glycerol. The person of ordinary skill in the art would have been motivated to make those modifications because molecule containing selenium including selenocysteine can be used to treat COVID-19, as taught by Ghoweba, which one of ordinary skill in the art would add to a composition comprising allicin that is administered for the same treatment of treating COVID-19 and expected the composition which includes two actives, allicin and selenocysteine, for treating COVID-19 to be able to treat COVID-19 when administered to a patient with COVID-19. Applicant is reminded that "[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose ....[T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Exparte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious). The person of ordinary skill in the art would have reasonably expected success because Shekh discloses that the multi-faceted roles of allicin as a booster of immune system and covalent inhibitor of coronavirus protease may be useful in treating COVID-19 infection (e.g., coronavirus/SARS-CoV/homology with SARS-CoV) (page 11, first paragraph). Ghoweba teaches treatment for COVID-19 comprising administering at least a molecule containing selenium (paragraphs [0003], [0009] and [0019]). Ghoweba teaches that selenium containing molecule, or compound or drug that is suitable for use as the molecule containing selenium includes selenocysteine (paragraph [0035]).
Claims 28 is rejected under 35 U.S.C. 103 as being unpatentable over Shekh in view of Glick and Wensley as evidenced by the instant specification as applied to claims 18-26, 31, 33-35, 37-40 and 43above, and further in view of GOODRICH (US 2003/0077264 A1, cited in PTO-892 mailed 07 November 2023).
Shekh, Glick and Wensley do not specifically teach that the amount of the allicin in the liquid mixture is about 0.27 mg/ml or about 0.3 mg/ml. The deficiency is made up for by the teachings of Goodrich.
Goodrich is primarily directed towards composition selected from the group consisting of garlic extract, allicin, other microorganism-growth-inhibiting compounds derived from garlic, and analogs and derivatives of allicin and said other compounds, in an amount effective to inhibit growth of at least one selected microorganism which is a bacterium, virus, fungus or parasite (abstract).
Regarding claim 28, Goodrich teaches that allicin has been shown to exhibit including antiviral activity (paragraphs [0009] and [0029]). Goodrich teaches allicin present in concentrations sufficient to inhibit the growth of at least a microorganism including from about 10 µg/ml to the solubility of the compound in solution, and preferably up to about 3000 µg/ml (e.g., from about 0.01 mg/ml up to 3mg/ml) (paragraph [0026]).
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 Covid-19 (e.g., coronavirus/SARS-CoV/homology with SARS-CoV) by administration via inhalation (e.g., deliver and contact a composition to the respiratory tract) of an aerosolized liquid mixture composition comprising allicin as an active and carriers including propylene glycol and glycerol; and wherein the concentration of allicin or derivatives of allicin is from about 10 µg/ml and including up to about 3000 µg/ml (e.g., from about 0.01 mg/ml up to 3mg/ml). The person of ordinary skill in the art would have been motivated to make those modifications because Goodrich teaches that concentrations of allicin that is sufficient to provide inhibition of the growth of at least a microorganism including virus of from about 10 µg/ml and including up to about 3000 µg/ml (e.g., from about 0.01 mg/ml up to 3mg/ml), which one of ordinary skill in the art would use to optimize the amount of allicin, which is a result-effective parameter, in order to obtain sufficient inhibition of growth of covid-19. The person of ordinary skill in the art would have reasonably expected success because Goodrich teaches that allicin has been shown to exhibit including antiviral activity (paragraphs [0009] and [0029]). Goodrich teaches allicin present in concentrations sufficient to inhibit the growth of at least a microorganism including from about 10 µg/ml to the solubility of the compound in solution, and preferably up to about 3000 µg/ml (e.g., from about 0.01 mg/ml up to 3mg/ml) (paragraph [0026]).
Claims 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over Shekh in view of Glick and Wensley as evidenced by the instant specification as applied to claims 18-26, 31, 33-35, 37-40 and 43 above, and further in view of SOMMADOSSI (US 10,874,687; cited in PTO-892 mailed 07 November 2023).
Shekh, Glick and Wensley do not specifically teach that the liquid further comprises an angiotensin type II receptor blocker (ARB). The deficiency is made up for by the teachings of Sommadossi.
Sommadossi is primarily directed towards a composition for treatment of COVID-19 (abstract).
Regarding claims 29-30, Sommadossi teaches that additional drugs that may be used in the treatment of a COVID patient include losartan (e.g., angiotensin type II receptor blocker) (column 68, lines 62-65). As evidenced by the instant specification, losartan bind the complex of ARB 135 and ACE2 134 when the dimer reaches the surface of the cell before the ACE2 receptor 134 is separated on the surface of the lung cell (paragraph [0053]).
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 Covid-19 (e.g., coronavirus/SARS-CoV/homology with SARS-CoV) by administration via inhalation (e.g., deliver and contact a composition to the respiratory tract) of an aerosolized liquid mixture composition comprising allicin and losartan as actives and carriers including propylene glycol and glycerol. The person of ordinary skill in the art would have been motivated to make those modifications because Sommadossi teaches that other drugs for treatment of COVID-19 include losartan which one of ordinary skill in the art would add as an additional COVID-19 treating drug in a composition that is administered to treat COVID-19. The person of ordinary skill in the art would have reasonably expected success because Sommadossi teaches that additional drugs that may be used in the treatment of a COVID patient include losartan (e.g., angiotensin type II receptor blocker) (column 68, lines 62-65). As evidenced by the instant specification, losartan bind the complex of ARB 135 and ACE2 134 when the dimer reaches the surface of the cell before the ACE2 receptor 134 is separated on the surface of the lung cell (paragraph [0053]).
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Shekh in view of Glick and Wensley as evidenced by the instant specification as applied to claims 18-26, 31, 33-35, 37-40 and 43 above, and further in view of ECK (US 9,717,683; cited in PTO-892 mailed 07 November 2023).
Shekh, Glick and Wensley do not specifically teach that the liquid mixture is heated to about 35°C. The deficiency is made up for by the teachings of Eck.
Eck is primarily directed towards administration of a formulation by inhalation without using heat greater than 50°C (abstract and column 1, lines 17-27).
Regarding claim 32, Eck teaches that application of heat can change a composition (column 1, lines 46-49). Eck teaches administration by inhalation without the use of application of heat over 50°C (column 2, lines 53-57). Eck teaches administration of a formulation comprising active dissolved in one or more pharmaceutically and inhalation acceptable propellants, in the present of one or more pharmaceutically and inhalation acceptable co-solvents, which formulation is delivered by inhalation via a metered dose inhaler device without the need for heating over 50°C (column 3, lines 12-23). Eck teaches that co-solvents including propylene glycol, glycerol and mixtures thereof (column 6, lines 59-64). Eck teaches that heating of including not exceeding 35°C (column 7, lines 26-28, 42-44).
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 Covid-19 (e.g., coronavirus/SARS-CoV/homology with SARS-CoV) by administration via inhalation (e.g., deliver and contact a composition to the respiratory tract) of an aerosolized liquid mixture composition comprising allicin as an active and carriers including propylene glycol and glycerol; wherein the administration via inhalation is without the use of heating of exceeding including not exceeding 35°C. The person of ordinary skill in the art would have been motivated to make those modifications to avoid any potential of changing a composition administered by inhalation by application of heat of including over 35°C by administration of a composition in the form of a liquid formulation that includes the allicin as an active, one or more propellants and co-solvents including mixture of including propylene glycol and glycerol which does not require heating of above including 35°C. The person of ordinary skill in the art would have reasonably expected success because Eck teaches that application of heat can change a composition (column 1, lines 46-49). Eck teaches administration by inhalation without the use of application of heat over 50°C (column 2, lines 53-57). Eck teaches administration of a formulation comprising active dissolved in one or more pharmaceutically and inhalation acceptable propellants, in the present of one or more pharmaceutically and inhalation acceptable co-solvents, which formulation is delivered by inhalation via a metered dose inhaler device without the need for heating over 50°C (column 3, lines 12-23). Eck teaches that co-solvents including propylene glycol, glycerol and mixtures thereof (column 6, lines 59-64). Eck teaches that heating of including not exceeding 35°C (column 7, lines 26-28, 42-44).
New Grounds of Rejection
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 38-39 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by HIRSHBERG (WO 2009/022347 A2, publication date of 19 February 2009).
Regarding instant claims 38-39, Hirshberg discloses administration by inhaling of allicin vapors to the lungs to treat including infections caused by virus (page 2, lines 4-12). Hirshberg discloses treatment of respiratory and other infections by inhaling vapors that contain allicin (page 5, lines 24-30). Hirshberg discloses using the method to cure including influenza, pneumonia, SARS, sore throat and asthma caused by fungi in the lungs (claim 14 of Hirshberg).
Thus, the disclosure of Hirshberg anticipates claims 38-39 and 43.
Claim 41-42 are rejected under 35 U.S.C. 103 as being unpatentable over Shekh in view of Glick and Wensley as evidenced by the instant specification as applied to claims 18-26, 31, 33-35, 37-40 and 43 above, and further in view of JIANG (CN 102807517 A, publication date of 05 December 2012).
Shekh, Glick and Wensley do not specifically teach that that the allicin is an allicin derivative having the formula:
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. The deficiency is made up for by the teachings of Jiang.
Jiang is primarily directed towards synthesizing allicin derivative with efficient disinfection effect (abstract of the English translation of Jiang).
Regarding claim 41, Jiang teaches allicin derivative with a formula including:
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, wherein R1 and R2 can be the same and is including a C4 alkene (e.g., includes but-2-ene) (paragraph [0001] of the English translation).
Regarding claim 42, Glick teaches local administration of the compound at a desired area of treatment including lower respiratory tract, e.g., lungs, significantly reduces the likelihood that a patient will experience systemic toxicities (column 6, lines 34-39). Glick teaches that respiratory administration via inhalation of the compound to a subject more efficiently produces a local concentration at a site where treatment is need including the lower respiratory tract (e.g., lungs) of a respiratory infection associated with COVID-19. The foregoing can be achieved using a lower dosage with a reduced particle size of the compound (paragraph bridging columns 6 and 7). Glick teaches including delivery to the peripheral lung regions including the alveoli (column 69, lines 23-26).
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 Covid-19 (e.g., coronavirus/SARS-CoV/homology with SARS-CoV) by administration via inhalation (e.g., deliver and contact a composition to the respiratory tract) of an aerosolized liquid mixture composition comprising an allicin derivative as an active and carriers including propylene glycol and glycerol, wherein the allicin derivative has the formula
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, wherein R1 and R2 can be the same and is including a C4 alkene (e.g., genus that includes but-2-ene). The person of ordinary skill in the art would have been motivated to make those modifications because the allicin derivatives of Jiang, that have a formula
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, wherein R1 and R2 can be the same and is including a C4 alkene (e.g., genus that includes but-2-ene), have efficient disinfection effects, has similar structures to allicin and would be expected to have similar effects to allicin when administered to treat coronavirus including COVID-19. The person of ordinary skill in the art would have reasonably expected success because Jiang teaches allicin derivative with a formula including:
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, wherein R1 and R2 can be the same and is including a C4 alkene (e.g., includes but-2-ene) (paragraph [0001] of the English translation).
Claim Rejections - 35 USC § 103
Claims 18-26, 31, 33-35, 37-40 and 43 above are rejected under 35 U.S.C. 103 as being unpatentable over HIRSHBERG (WO 2009/022347 A2, publication date of 19 February 2009) in view of GLICK (US 10,980,756; filed 31 March 2020; claims benefit of provisional application No. 62/990,414, filed 16 March 2020) and WENSLEY (US 2014/0144429 A1, cited in PTO-892 mailed 07 November 2023) as evidenced by the instant specification.
Applicant is reminded that although a claimed invention can be obvious but not anticipated, it “cannot have been anticipated and not have been obvious.” In re Fracalossi, 681 F.2d 792, 794 [215 USPQ 569] (CCPA 1982) (emphasis added). Indeed, this court has repeatedly emphasized that “a disclosure that anticipates … also renders the claim invalid under §103, for anticipation is the epitome of obviousness.” Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 [220 USPQ 193] (Fed. Cir. 1983).
Hirshberg is primarily directed towards method and device to prevent and cure body diseases caused by infection factors including virus by inhaling vapors containing allicin (abstract and see entire document).
Regarding claims 18, 23, 26 and 38-39, Hirshberg discloses administration by inhaling of allicin vapors to the lungs to treat including infections caused by virus (page 2, lines 4-12). Hirshberg discloses treatment of respiratory and other infections by inhaling vapors that contain allicin (page 5, lines 24-30). Hirshberg discloses allicin produced that is semi-synthetic; first, its precursor, alliin, is chemically synthesized, then a modified form of the natural enzyme, alliinase, converts it into pure allicin (page 8, lines 3-5). Hirshberg discloses that scientific studies made on allicin proved it is highly effective against many kinds of infection virus and this give reason to believe allicin can cure SARS (e.g., Severe Acute Respiratory Syndrome (respiratory pathogen infection)) (paragraph bridging pages 11 and 12).
Hirshberg does not specifically teach a liquid mixture comprising the allicin with propylene glycol and glycerol, aerosolizing the liquid mixture, and inhaling the aerosolized liquid mixture into the patient’s respiratory tract to contact a pathogen in the respiratory tract. The deficiencies are made up for by the teachings of Glick and Wensley.
Glick is primarily directed towards compounds and compositions that are useful in method of treating coronavirus infections in a subject in need thereof (abstract).
Regarding claims 18, 26, 38, 40 and 43, Glick teaches that SARS-CoV causes Severe Acute Respiratory Syndrome (SARS) (column 1, lines 48-49). Glick teaches a method for treating COVID-19 (e.g., coronavirus/SARS-CoV/homology with SARS-CoV) in a subject in need thereof, comprising administering an effective amount of a compound (column 2, lines 29-32). Glick teaches local administration of the compound at a desired area of treatment including lower respiratory tract, e.g., lungs, significantly reduces the likelihood that a patient will experience systemic toxicities (column 6, lines 34-39). Glick teaches that respiratory administration via inhalation of the compound to a subject more efficiently produces a local concentration at a site where treatment is needed including the lower respiratory tract (e.g., lungs) of a respiratory infection associated with COVID-19. The foregoing can be achieved using a lower dosage with a reduced particle size of the compound (paragraph bridging columns 6 and 7). Glick teaches including delivery to the peripheral lung regions including the alveoli (column 69, lines 23-26).
Wensley is primarily directed towards method, devices, systems for delivering one or more compounds to a subject by inhalation of a liquid formulation that is vaporized into aerosol particles (abstract and paragraph [0015]).
Regarding claims 18, 25-26, 31 and 42-43, Wensley teaches an aerosol generating device for generating an aerosol from a liquid formulation (paragraph [0008]). Wensley teaches that the liquid formulation is vaporized into aerosol particles (e.g. aerosolizing liquid mixture) (paragraph [0015]). Wensley teaches that the aerosol is delivered to the lung of the user of the device (paragraph [0013]). Wensley teaches that the liquid formulation comprises a pharmaceutically active agent and a carrier that includes propylene glycol (paragraphs [0014] and [0041]). Wensley teaches delivery to the deep lung including alveoli of the subject (paragraph [0096]). Wensley teaches that one or more carriers including glycerin and propylene glycol can stabilize the active (paragraph [0096]). Wensley teaches that the carrier can be a mixture of including propylene glycol and glycerol (paragraph [0124]). Wensley teaches that suitable drug agents in the method and devices include antibiotic and anti-infective agents (paragraph [0225]).
Regarding claim 33, Wensley teaches that doses of liquid agent are held in a safe dose cartridge (e.g. vaporizer cartridge) (paragraph [0143]). Wensley teaches that dose cartridge (e.g. vaporizer cartridge) comprises a heater element (paragraph [0145]).
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 coronavirus including Covid-19 caused by SARS-COV2 (e.g., coronavirus/SARS-CoV/homology with SARS-CoV) by administration via inhalation (e.g., deliver and contact a composition to the respiratory tract) of an aerosolized liquid mixture composition comprising allicin as an active and carriers including propylene glycol and glycerol. The person of ordinary skill in the art would have been motivated to make those modifications because: 1) Hirshberg discloses inhalation of allicin to treat including SARS (e.g., coronavirus caused by SARS-CoV), 2) Glick teaches that desired area for delivery of an active to treat coronavirus infection including COVID-19 in the lungs by inhalation, and 3) Wensley teaches that compositions for administration by inhalation that delivers a drug to the lungs, wherein the composition includes an active and a carrier including propylene glycol and glycerol which may help stabilize the active, and wherein drugs include anti-infective agents further including antivirals. The person of ordinary skill in the art would have reasonably expected success because Hirshberg discloses administration by inhaling of allicin vapors to the lungs to treat including infections caused by virus (page 2, lines 4-12). Hirshberg discloses treatment of respiratory and other infections by inhaling vapors that contain allicin (page 5, lines 24-30). Hirshberg discloses allicin produced that is semi-synthetic; first, its precursor, alliin, is chemically synthesized, then a modified form of the natural enzyme, alliinase, converts it into pure allicin (page 8, lines 3-5). Hirshberg discloses that scientific studies made on allicin proved it is highly effective against many kinds of infection virus and this give reason to believe allicin can cure SARS (e.g., Severe Acute Respiratory Syndrome (respiratory pathogen infection)) (paragraph bridging pages 11 and 12). Glick teaches that SARS-CoV causes Severe Acute Respiratory Syndrome (SARS) (column 1, lines 48-49). Glick teaches a method for treating COVID-19 (e.g., coronavirus/SARS-CoV/homology with SARS-CoV) in a subject in need thereof, comprising administering an effective amount of a compound (column 2, lines 29-32). Glick teaches local administration of the compound at a desired area of treatment including lower respiratory tract, e.g., lungs, significantly reduces the likelihood that a patient will experience systemic toxicities (column 6, lines 34-39). Glick teaches that respiratory administration via inhalation of the compound to a subject more efficiently produces a local concentration at a site where treatment is need including the lower respiratory tract (e.g., lungs) of a respiratory infection associated with COVID-19. The foregoing can be achieved using a lower dosage with a reduced particle size of the compound (paragraph bridging columns 6 and 7). Glick teaches including delivery to the peripheral lung regions including the alveoli (column 69, lines 23-26). Wensley teaches that the liquid formulation comprises a pharmaceutically active agent and a carrier that includes propylene glycol (paragraphs [0014] and [0041]). Wensley teaches delivery to the deep lung including alveoli of the subject (paragraph [0096]). Wensley teaches that one or more carriers including glycerin and propylene glycol can stabilize the active (paragraph [0096]). Wensley teaches that the carrier can be a mixture of including propylene glycol and glycerol (paragraph [0124]). Wensley teaches that suitable drug agents in the method and devices include antibiotic and anti-infective agents (paragraph [0225]).
Regarding the recitation of “allicin disrupts the formation of one or more disulfide bridges of a pathogen protein” (e.g., claim 18), claims 19-22, 24, 35 and 37, in light of the disclosure of Hirshberg and the teachings of Glick and Wensley (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 coronavirus including Covid-19 (e.g., coronavirus/SARS-CoV/homology with SARS-CoV) by administration via inhalation (e.g., deliver and contact a composition to the respiratory tract) of an aerosolized liquid mixture composition comprising allicin as an active and carriers including propylene glycol and glycerol. Hirshberg discloses that allicin modifies sulfhydryl groups in enzymes and block the enzymes (page 7, lines 14-30). As evidenced by the instant specification, 2PSP (e.g., allicin) prevents proper folding of proteins of N-CoV which disables the ability of the protein to bind to ACE2 (paragraph [0044]). Thus, the disclosure of Hirshberg and the teachings of Glick and Wensley (described above) renders prima facie obvious a method of treating including Covid-19 (e.g., coronavirus/SARS-CoV) comprising administration through inhalation of an aerosol comprising allicin as an active and carriers including mixture of including propylene glycol and glycerol; wherein the aerosol is generated from a liquid formulation comprising allicin, propylene glycol and glycerol; which is the same as the instantly claimed method, therefore, necessarily has the same characteristics, e.g., disrupts or impedes the formation of one or more disulfide bridges of a pathogen protein including a spike or envelope protein of coronavirus (e.g., claim 18 and 24), disrupts the formation of one or more disulfide bridges of coronavirus by impairing the ability of the coronavirus to bind to ACE2 (e.g., claims 19-20), cause misfolding of the coronavirus protein (e.g., claim 21), causes reduction in survival of the coronavirus (e.g., claim 22), cause misfolding of the angiotensin-converting enzyme 2 (ACE2) which results in lowered blood pressure (e.g., claim 35), and heat shock of the human body increases the enthalpy of the proteins involved in coronavirus replication such that protein folding is easier to destabilize (e.g., claim 37).
Applicant is reminded that “[t]he fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious.” Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979) (Claims were directed to grooved carbon disc brakes wherein the grooves were provided to vent steam or vapor during a braking action. A prior art reference taught noncarbon disc brakes which were grooved for the purpose of cooling the faces of the braking members and eliminating dust. The court held the prior art references when combined would overcome the problems of dust and overheating solved by the prior art and would inherently overcome the steam or vapor cause of the problem relied upon for patentability by applicants. Granting a patent on the discovery of an unknown but inherent function (here venting steam or vapor) “would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art.” 596 F.2d at 1022, 201 USPQ at 661.); In re Baxter Travenol Labs., 952 F.2d 388, 21 USPQ2d 1281 (Fed. Cir. 1991).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Hirshberg in view of Glick and Wensley as evidenced by the instant specification as applied to claims 18-26, 31, 33-35, 37-40 and 43 above, and further in view of CRUM (US 2016/0101079 A1, publication date of 14 April 2016).
Hirshberg, Glick and Wensley do not specifically teach that liquid mixture further comprises selenocysteine. The deficiency is made up for by the teachings of Crum.
Crum is primarily directed towards composition for therapy of viral diseases (abstract).
Regarding claim 27, Crum teaches a method for treatment of viruses and viral diseases including SARS (e.g., coronavirus) (paragraph [0052]). Crum teaches a composition comprising a glutathione (GSH) precursor and a selenium source (paragraph [0107]). Crum teaches that selenium source includes selenocysteine (paragraph [0138]).
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 Covid-19 (e.g., coronavirus/SARS-CoV/homology with SARS-CoV) by administration via inhalation (e.g., deliver and contact a composition to the respiratory tract) of an aerosolized liquid mixture composition comprising allicin, a glutathione (GSH) precursor, and selenocysteine as actives and carriers including propylene glycol and glycerol. The person of ordinary skill in the art would have been motivated to make those modifications because a composition comprising a glutathione (GSH) precursor and a selenium source including selenocysteine can be used to treat SARS, as taught by Crum, which one of ordinary skill in the art would add to a composition comprising allicin that is administered for the same treatment of treating coronavirus and applied it to treat including COVID-19 and expected the composition which includes two actives, allicin and selenocysteine, for treat coronavirus to be able to treat another coronavirus including COVID-19 when administered to a patient with COVID-19. Applicant is reminded that "[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose ....[T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Exparte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious). The person of ordinary skill in the art would have reasonably expected success because Crum teaches a method for treatment of viruses and viral diseases including SARS (e.g., coronavirus) (paragraph [0052]). Crum teaches a composition comprising a glutathione (GSH) precursor and a selenium source (paragraph [0107]). Crum teaches that selenium source includes selenocysteine (paragraph [0138]).
Claims 28 is rejected under 35 U.S.C. 103 as being unpatentable over Hirshberg in view of Glick and Wensley as evidenced by the instant specification as applied to claims 18-26, 31, 33-35, 37-40 and 43 above, and further in view of GOODRICH (US 2003/0077264 A1, cited in PTO-892 mailed 07 November 2023).
Hirshberg, Glick and Wensley do not specifically teach that the amount of the allicin in the liquid mixture is about 0.27 mg/ml or about 0.3 mg/ml. The deficiency is made up for by the teachings of Goodrich.
Goodrich is primarily directed towards composition selected from the group consisting of garlic extract, allicin, other microorganism-growth-inhibiting compounds derived from garlic, and analogs and derivatives of allicin and said other compounds, in an amount effective to inhibit growth of at least one selected microorganism which is a bacterium, virus, fungus or parasite (abstract).
Regarding claim 28, Goodrich teaches that allicin has been shown to exhibit including antiviral activity (paragraphs [0009] and [0029]). Goodrich teaches allicin present in concentrations sufficient to inhibit the growth of at least a microorganism including from about 10 µg/ml to the solubility of the compound in solution, and preferably up to about 3000 µg/ml (e.g., from about 0.01 mg/ml up to 3mg/ml) (paragraph [0026]).
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 Covid-19 (e.g., coronavirus/SARS-CoV/homology with SARS-CoV) by administration via inhalation (e.g., deliver and contact a composition to the respiratory tract) of an aerosolized liquid mixture composition comprising allicin as an active and carriers including propylene glycol and glycerol; and wherein the concentration of allicin or derivatives of allicin is from about 10 µg/ml and including up to about 3000 µg/ml (e.g., from about 0.01 mg/ml up to 3mg/ml). The person of ordinary skill in the art would have been motivated to make those modifications because Goodrich teaches that concentrations of allicin that is sufficient to provide inhibition of the growth of at least a microorganism including virus of from about 10 µg/ml and including up to about 3000 µg/ml (e.g., from about 0.01 mg/ml up to 3mg/ml), which one of ordinary skill in the art would use to optimize the amount of allicin, which is a result-effective parameter, in order to obtain sufficient inhibition of growth of covid-19. The person of ordinary skill in the art would have reasonably expected success because Goodrich teaches that allicin has been shown to exhibit including antiviral activity (paragraphs [0009] and [0029]). Goodrich teaches allicin present in concentrations sufficient to inhibit the growth of at least a microorganism including from about 10 µg/ml to the solubility of the compound in solution, and preferably up to about 3000 µg/ml (e.g., from about 0.01 mg/ml up to 3mg/ml) (paragraph [0026]).
Claims 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over Hirshberg in view of Glick and Wensley as evidenced by the instant specification as applied to claims 18-26, 31, 33-35, 37-40 and 43 above, and further in view of OLSEN (US 2004/0259934 A1, publication date of 23 December 2004).
Hirshberg, Glick and Wensley do not specifically teach that the liquid further comprises an angiotensin type II receptor blocker (ARB). The deficiency is made up for by the teachings of Olsen.
Olsen is primarily directed towards treatment of coronavirus (abstract).
Regarding claims 29-30, Olsen teaches therapeutically effective amount of active against coronavirus includes an angiotensin II receptor blocker including losartan (paragraph [0115]). As evidenced by the instant specification, losartan bind the complex of ARB 135 and ACE2 134 when the dimer reaches the surface of the cell before the ACE2 receptor 134 is separated on the surface of the lung cell (paragraph [0053]).
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 Covid-19 (e.g., coronavirus/SARS-CoV/homology with SARS-CoV) by administration via inhalation (e.g., deliver and contact a composition to the respiratory tract) of an aerosolized liquid mixture composition comprising allicin and losartan as actives and carriers including propylene glycol and glycerol. The person of ordinary skill in the art would have been motivated to make those modifications because Sommadossi teaches that other drugs for treatment of COVID-19 include losartan which one of ordinary skill in the art would add as an additional COVID-19 treating drug in a composition that is administered to treat COVID-19. The person of ordinary skill in the art would have reasonably expected success because Olsen teaches therapeutically effective amount of active against coronavirus includes an angiotensin II receptor blocker including losartan (paragraph [0115]). As evidenced by the instant specification, losartan bind the complex of ARB 135 and ACE2 134 when the dimer reaches the surface of the cell before the ACE2 receptor 134 is separated on the surface of the lung cell (paragraph [0053]).
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Hirshberg in view of Glick and Wensley as evidenced by the instant specification as applied to claims 18-26, 31, 33-35, 37-40 and -43 above, and further in view of ECK (US 9,717,683; patent date of 01 August 2017; cited in PTO-892 mailed 07 November 2023).
Hirshberg, Glick and Wensley do not specifically teach that the liquid mixture is heated to about 35°C. The deficiency is made up for by the teachings of Eck.
Eck is primarily directed towards administration of a formulation by inhalation without using heat greater than 50°C (abstract and column 1, lines 17-27).
Regarding claim 32, Eck teaches that application of heat can change a composition (column 1, lines 46-49). Eck teaches administration by inhalation without the use of application of heat over 50°C (column 2, lines 53-57). Eck teaches administration of a formulation comprising active dissolved in one or more pharmaceutically and inhalation acceptable propellants, in the present of one or more pharmaceutically and inhalation acceptable co-solvents, which formulation is delivered by inhalation via a metered dose inhaler device without the need for heating over 50°C (column 3, lines 12-23). Eck teaches that co-solvents including propylene glycol, glycerol and mixtures thereof (column 6, lines 59-64). Eck teaches that heating of including not exceeding 35°C (column 7, lines 26-28, 42-44).
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 Covid-19 (e.g., coronavirus/SARS-CoV/homology with SARS-CoV) by administration via inhalation (e.g., deliver and contact a composition to the respiratory tract) of an aerosolized liquid mixture composition comprising allicin as an active and carriers including propylene glycol and glycerol; wherein the administration via inhalation is without the use of heating of exceeding including not exceeding 35°C. The person of ordinary skill in the art would have been motivated to make those modifications to avoid any potential of changing a composition administered by inhalation by application of heat of including over 35°C by administration of a composition in the form of a liquid formulation that includes the allicin as an active, one or more propellants and co-solvents including mixture of including propylene glycol and glycerol which does not require heating of above including 35°C. The person of ordinary skill in the art would have reasonably expected success because Eck teaches that application of heat can change a composition (column 1, lines 46-49). Eck teaches administration by inhalation without the use of application of heat over 50°C (column 2, lines 53-57). Eck teaches administration of a formulation comprising active dissolved in one or more pharmaceutically and inhalation acceptable propellants, in the present of one or more pharmaceutically and inhalation acceptable co-solvents, which formulation is delivered by inhalation via a metered dose inhaler device without the need for heating over 50°C (column 3, lines 12-23). Eck teaches that co-solvents including propylene glycol, glycerol and mixtures thereof (column 6, lines 59-64). Eck teaches that heating of including not exceeding 35°C (column 7, lines 26-28, 42-44).
Claims 41-42 are rejected under 35 U.S.C. 103 as being unpatentable over Hirshberg in view of Glick and Wensley as evidenced by the instant specification as applied to claims 18-26, 31, 33-35, 37-40 and 43 above, and further in view of JIANG (CN 102807517 A, publication date of 05 December 2012).
Hirshberg, Glick and Wensley do not specifically teach that that the allicin is an allicin derivative having the formula:
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. The deficiency is made up for by the teachings of Jiang.
Jiang is primarily directed towards synthesizing allicin derivative with efficient disinfection effect (abstract of the English translation of Jiang).
Regarding claim 41, Jiang teaches allicin derivative with a formula including:
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, wherein R1 and R2 can be the same and is including a C4 alkene (e.g., includes but-2-ene) (paragraph [0001] of the English translation).
Regarding claim 42, Glick teaches local administration of the compound at a desired area of treatment including lower respiratory tract, e.g., lungs, significantly reduces the likelihood that a patient will experience systemic toxicities (column 6, lines 34-39). Glick teaches that respiratory administration via inhalation of the compound to a subject more efficiently produces a local concentration at a site where treatment is needed including the lower respiratory tract (e.g., lungs) of a respiratory infection associated with COVID-19. The foregoing can be achieved using a lower dosage with a reduced particle size of the compound (paragraph bridging columns 6 and 7). Glick teaches including delivery to the peripheral lung regions including the alveoli (column 69, lines 23-26).
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 coronavirus including Covid-19 caused by SARS-COV2 (e.g., coronavirus/SARS-CoV/homology with SARS-CoV) by administration via inhalation (e.g., deliver and contact a composition to the respiratory tract) of an aerosolized liquid mixture composition comprising an allicin derivative as an active and carriers including propylene glycol and glycerol, wherein the allicin derivative has the formula
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, wherein R1 and R2 can be the same and is including a C4 alkene (e.g., genus that includes but-2-ene). The person of ordinary skill in the art would have been motivated to make those modifications because the allicin derivatives of Jiang, that have a formula
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, wherein R1 and R2 can be the same and is including a C4 alkene (e.g., genus that includes but-2-ene), have efficient disinfection effects, has similar structures to allicin and would be expected to have similar effects to allicin when administered to treat coronavirus including COVID-19. The person of ordinary skill in the art would have reasonably expected success because Jiang teaches allicin derivative with a formula including:
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, wherein R1 and R2 can be the same and is including a C4 alkene (e.g., includes but-2-ene) (paragraph [0001] of the English translation).
Response to Arguments
Applicant argues that when the instant priority date to the March 23, 2020 Provisional Application Number 62/993,481 is corrected, the Shekh and Glick references will not be prior art because both were filed or published after March 23, 2020.
Applicant's arguments filed on 25 September 2025 have been fully considered but they are not persuasive. In response, as stated in the Petition Decision mailed 22 October 2025 Applicant has not filed a corrected ADS that clearly indicate that the instant application number 17/210,366 claims benefit of provisional Application No. 62/993,481. Thus, a proper benefit claim was not timely provided in the ADS and a proper benefit claim under 35 U.S.C. 119(e) was not timely made. It is pointed out that Glick claims benefit of provisional application No. 62/990,414, filed 16 March 2020. The rejection above over Shekh in view of Glick and Wensley (described above) is maintained.
Thus, for the reasons of record and for the reasons presented above claims 18-35 and 37-43 are rejected under 35 U.S.C. 103(a).
Conclusion and Correspondence
No claims are allowed.
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/JOHN P NGUYEN/
Examiner, Art Unit 1619
/ANNA R FALKOWITZ/
Primary Examiner, Art Unit 1600