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 claim amendments filed on 10 May 2026.
Claims 1-17, 36 and 41-42 are cancelled.
Claim 18 has been amended.
Claims 43-45 have been added.
Claims 18-35, 37-40 and 43-45 are presented for examination herein to the extent that the respiratory pathogen infection is coronavirus, e.g., applicant’s elected species.
Objections and/or Rejections Withdrawn
The objection of claim 41 is withdrawn in view of the claim amendments filed 10 May 2026.
The rejection of claims 18-26, 31-35, 37-40 and 43 under 35 U.S.C. 103(a) 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), WENSLEY (US 2014/0144429 A1, cited in PTO-892 mailed 07 November 2023) and ECK (US 9,717,683; cited in PTO-892 mailed 07 November 2023) as evidenced by the instant specification, is withdrawn in view of the claim amendments filed 10 May 2026.
The rejection of claims 27 under 35 U.S.C. 103(a) 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of GHOWEBA (US 2021/0322464 A1, effective filing date of 20 April 2020, cited in PTO-892 mailed 07 November 2023), is withdrawn in view of the claim amendments filed 10 May 2026.
The rejection of claim 28 under 35 U.S.C. 103(a) 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37-40 and 43 above, and further in view of GOODRICH (US 2003/0077264 A1, cited in PTO-892 mailed 07 November 2023), is withdrawn in view of the claim amendments filed 10 May 2026.
The rejection of claims 29-30 under 35 U.S.C. 103(a) 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37-40 and 43 above, and further in view of SOMMADOSSI (US 10,874,687; cited in PTO-892 mailed 07 November 2023), is withdrawn in view of the claim amendments filed 10 May 2026.
The rejection of claim 32 under 35 U.S.C. 103(a) 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), is withdrawn in view of the claim amendments filed 10 May 2026.
The rejection of claims 43 and 45 under 35 U.S.C. 103(a) 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), is withdrawn in view of the claim amendments filed 10 May 2026.
New Grounds of Rejection
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 18-35 and 37 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. This is a new matter rejection. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 18, upon which claims 19-35 and 37 depend, has been amended to include the recitation “prepared by optimizing the alliinase enzyme reaction in propylene glycol to achieve maximum catalytic yield of allicin”. A review of the instant specification, yields no disclosure of steps that needs to occur for this optimization (e.g., is it limited to the steps in the examples or something more). Thus, because the instant specification does not disclose steps that provide optimization of the alliinase enzyme reaction in propylene glycol to achieve maximum catalytic yield of allicin, the recitation of “prepared by optimizing the alliinase enzyme reaction in propylene glycol to achieve maximum catalytic yield of allicin” constitutes new matter.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 18-35 and 37 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 18 recites “the allicin liquid mixture” and “the alliinase enzyme reaction in propylene glycol” in lines 8-9. There is insufficient antecedent basis for this limitation in the claim.
Claim 18 recites “prepared by optimizing the alliinase enzyme reaction in propylene glycol to achieve maximum catalytic yield of allicin” which renders claims 18-35 and 37 indefinite because it is unclear what steps would involve such a broad disclosure of “optimizing the alliinase enzyme reaction” and what steps would not.
Rejections Maintained
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.
Rejections Modified and Maintained
Claims 18-26, 31-35, 37-40 and 44 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. Hirshberg does not specifically teach that the liquid mixture is heated to about 35°C. The deficiencies are made up for by the teachings of Glick, Wensley and Eck.
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]).
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 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, including allicin generated alliin and enzyme alliinase (e.g., alliinase enzyme reaction), 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 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, 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; and 4) Eck teaches application of heat can change a composition and teaches administration by inhalation without the use of application of heat over 50°C, wherein the formulation comprises active dissolved in one or more pharmaceutically and inhalation acceptable propellants, in the present of one or more pharmaceutically and inhalation acceptable co-solvents including propylene glycol, glycerol and mixtures thereof. 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]). Eck teaches 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
Regarding the recitation of “optimizing the alliinase enzyme reaction in propylene glycol to achieve maximum catalytic yield of allicin and the viscosity stabilization with glycerol to produce a stable suspension having a multi-year shelf life at room temperature” and “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, Wensley and Eck (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]). Wensley teaches that one or more carriers including glycerin and propylene glycol can stabilize the active (paragraph [0096]). Thus, the disclosure of Hirshberg and the teachings of Glick, Wensley and Eck (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, including allicin generated alliin and enzyme alliinase (e.g., alliinase enzyme reaction), 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., alliinase enzyme reaction in propylene glycol achieve maximum catalytic yield of allicin, glycerol provides viscosity stabilization that produce a stable suspension having a multi-year shelf life at room temperature, 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, 31-35, 37-40 and 44 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, including allicin generated alliin and enzyme alliinase (e.g., alliinase enzyme reaction), a glutathione (GSH) precursor, and selenocysteine as actives 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 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, 31-35, 37-40 and 44 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 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, including allicin generated alliin and enzyme alliinase (e.g., alliinase enzyme reaction), 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; and wherein the concentration 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, 31-35, 37-40 and 44 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 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 losartan and allicin, including allicin generated alliin and enzyme alliinase (e.g., alliinase enzyme reaction), as an actives 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 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]).
Claims 43 and 45 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, 31-35, 37-40 and 44 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 43, 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 45, 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 on page 1 that no ADS is required and that a provisional application is properly incorporated by reference in the instant specification is legally sufficient under MPEP 211.03 and 37 CFR 1.57/1.78. Applicant argues that applicant’s commercial product “Aero AV” later called “AllicinV”, which fully embodies the claimed subject matter, was placed into public use and commerce in the United States beginning in late July 2019. Applicant argues that a prior public disclosure published 24 March 2020 which expressly references the provisional as “patent pending 62,993,481” and describes the claimed vapor/aerosol formulation. Applicant argues the declaration under 37 CFR 1.130(b) establishes that the cited references are disqualified as prior art under 35 U.S.C. 102(b)(1)(B) and 102(b)(2)(B).
Applicant's arguments filed on 10 May 2026 have been fully considered but they are not persuasive. In response, the priority date cannot be decided by and needs to go through the Office of Petitions. 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.
Applicant argues that the declaration under 37 CFR 1.132 presents objective indicia of nonobviousness, including commercial success, unexpected results, and long-felt need.
Applicant's arguments filed on 10 May 2026 have been fully considered but they are not persuasive. In response, no evidence has been provided for the alleged commercial success that shows a nexus between the claimed invention and the evidence of commercial success. Regarding the unexpected results, Wensley teaches that one or more carriers including glycerin and propylene glycol can stabilize the active in a composition that is heated (paragraph [0096]). Therefore, it is expected that including glycerin and propylene glycol would provide a stable active at room temperature. Regarding the long-felt need, the relevance of long-felt need and the failure of others to the issue of obviousness depends on several factors, first, the need must have been a persistent one that was recognized by those of ordinary skill in the art. Second, the long-felt need must not have been satisfied by another before the invention by applicant. Third, the invention must in fact satisfy the long-felt need. See MPEP 716.04. The evidence of long-felt need at least fails to meet the second factor because the issue has been satisfied by Hirshberg (e.g., treatment for viral respiratory infection including SARS (e.g., coronavirus) by administering a composition comprising allicin).
Applicant argues that Hirshberg reference does not anticipate claims 38-39 or 43, because Hirshberg discloses only minced garlic inhalation that yields about 4% allicin and expires within approximately one hour. Applicant argues that, in contrast, applicants product that comprises optimized alliinase reaction in propylene glycol + glycerol stabilization, result in a stable suspension having a multi-year room temperature shelf life.
Applicant's arguments filed on 10 May 2026 have been fully considered but they are not persuasive. In response, claims 38-39 and 43 only recites a “method for treating a respiratory infection in a patient in need thereof, comprising administering to the patient a therapeutically effective amount of allicin or an allicin derivative”. The method of claims 38-39 does not recite administration of a composition comprising propylene glycol or glycerol. 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). Therefore, the method of claims 38-39 is anticipated by Hirshberg.
Thus, for the reasons of record and for the reasons presented above claims 18-35, 37-40 and 43-45 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN P NGUYEN whose telephone number is (571)270-5877. The examiner can normally be reached Monday-Friday 10am-6pm EST.
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/JOHN P NGUYEN/
Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600
