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 .
Receipt is acknowledged of Amendments and Remarks filed on 04/29/26. Claims 1 and 6 have been amended, claims 2, 7, 12-13 and 22 have been canceled and no new claims have been added. Accordingly, elected claims 1, 6 and 20 remain under examination on the merits. Claims 23, 28, 34, 37, 40, 42-43, 46, 50, 52, 54 and 58 remain withdrawn.
Rejections and/or objections not reiterated from the previous Office Action are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Claim Interpretation
Claim 1 recites the concentration of hypochlorous acid in the solution in terms of 250 ppm. According to the Specification this is interpreted as a concentration of 0.025%. The term “substantially free of sodium hypochlorite” in claim 6 is a relative term. This term is interpreted according to the definition in the Spec as ““pure hypochlorous acid” generally refers to a solution of hypochlorous acid that is substantially free of impurities ….. including sodium hypochlorite …. comprising less than 10%” (See [0022]).
In claims 1 and 6, the term “or” means only one option has to be present.
In claim 20, the recitation of “wherein the solution is nontoxic to biological tissue” is the property of the composition and does not further limit the scope of claim 1.
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, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 6 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Najafi et al (US 2008/0279963) in view of Burd (US 20200281969) and RU 2707505.
Najafi et al teach a method for the treatment of a medical condition selected from the groups consisting of disinfection or decontamination of open wounds and burns, promotion of wound healing, in a patient in need of such treatment comprising: applying to a treatment site an effective amount of a stable aqueous physiologically balanced, ionized solution comprising an acidic solution of hypohalous acid with a concentration from about 10 ppm to about 200 ppm; a halide comprising salt, the halide comprising salt is sodium chloride at a concentration of about four-tenth to slightly higher than full strength of normal or isotonic saline solution, said solution having a pH range from about 3.0 to about 4.0, an original reduction potential (ORP) at room temperature ranging from about +600 mV to about +1200 mV. Preferably the halogen is chlorine, i.e. hypochlorous acid (See abstract, [0023], Table 2, [0085] and claims 1 and 52-54) (meeting limitations of claims 1 and 6).
Regarding claims 1 and 20 , Najafi et al teach that the use of said acidic salt solutions has been instrumental in healing a number of patients with deep wounds as well as treatment of various medical conditions such as promoting wound healing, reduction of pathogens in open wounds, reduction of pathogens in pulmonary infections, reduction of infectious load in organs for transplantation, treatment of biofilm for cystic fibrosis and related diseases, treatment of viral infections, etc, (See [0156] and [0200]-[0201]).
Regarding claim 1, Najafi et al further teach that a method of reduction of pathogens in pulmonary infections, wherein the said solution is used for the reduction of pathogens in pulmonary infections, for example, various viral or bacterial infections are effectively treated with the said solution. Non-limited examples of infections that may be effectively treated using the said solution include anthrax spores present in the lungs, and the reduction of pneumonia causing bacteria in the lungs, including strep bacteria and the like (See [0170]).
It is also disclosed that the antimicrobial properties of the solutions have been tested against many organisms, including Escherichia coli, Listeria monocytogenes, Staphylococcus aureus, methicillin-resistant S. aureus (MRSA), Pseudomonas aeruginosa, Lactobacillus, yeast, vancomycin-resistant enterococcus, molds, and spores, including spores of anthrax (See [0032]).
Najafi et al discloses administration of a solution comprising hypochlorous acid to a subject for treatment of pulmonary infections such as various viral or bacterial infections, but is silent with regard to the administration of the solution by nebulization or metered dose inhaler or dosing interval. These limitations are well known in the art as taught by Burd and RU ‘505.
Burd teaches a method of treating disease states associated with bacteria, a virus, comprising a respiratory and internal delivery of hypochlorous acid (HOCl) via a nebulizer, an aerosolizer, etc (See abstract).
Regarding claims 1 and 20, Burd teaches that applications of aqueous solutions containing approximately 30-2500 ppm (0.003% to 0.25%) HOCl are used as antimicrobial agents (See [0014]). The said agent delivery systems in which the antiseptic agent is administered via a pulmonary route as a treatment of infectious diseases caused by microbial or viral agents. Because the inhalation process gives a more direct access to the target organ/cavity than more traditional routes (e.g., topical, oral, intravenous, etc.), the pulmonary administration of HOCl used to inhibit bacterial growth provides a therapeutic approach that may help avoid reduce antimicrobial resistance while alleviating the disease symptoms. For example, upper respiratory tract infections caused by one or more bacterial or viral pathogens such as bronchitis, lung infections, etc, may be treated by a pulmonary administration of an agent, such as HOCl (See [0020]). Burd discloses that a solution of HOCl may be delivered via the pulmonary route via a number pulmonary delivery devices, including a nebulizer, an aerosolizer, or any other such pulmonary delivery device (See [0021]). It is further disclosed that a condition associated with acute respiratory tract infection may be treated by administering HOCl solution by a pulmonary delivery method (See [0044]).
RU ‘505 teach that more than 30% of cases of acute respiratory viral infections are complicated by bacterial infections. In modern health care, the problem of acquiring infections, including the upper and lower respiratory tract, during hospitalization in hospital is very acute, due to the nosocomial nature of infectious complications (See page 1, last para of provided English translation).
Regarding claim 1, RU ‘505 teaches a method of treating bacterial infections of the respiratory tract, including prescribing drug therapy with the drug according to indications through a nebulizer, including administering via a compressor nebulizer for inhalation therapy, a selected bacteriophage in a volume of 5 ml from a container for medicines of a compressor nebulizer. The spraying time was 1, 3, 5, 10 min, and wherein inhalation is performed three times during the day for 10 days (See page 3, 4th para, and claim 1).
It would have been prima facie obvious to a person of ordinary skilled in the art at the time the invention was made given the teachings of Najafi et al on administration of an antimicrobial solution comprising hypochlorous acid to treat various viral infections including respiratory viral infections to have looked in the art for suggestions on the delivery devices and dosage intervals as taught by Burd and RU ‘505 with a reasonable expectation of success. It would have been obvious to do so because to follow Najafi et al’s method, it would be necessary to use the appropriate delivery device including nebulizer and to know or get suggestions on the dosing regimen. Thus, one of ordinary skill in the art would have arrived at the instant invention by following the teachings of the art.
In other words, the claims would have been obvious because the technique for improving a particular formulation was part of the ordinary capabilities of a person of ordinary skill in the art, in view of the teaching of the technique for improvement in other situations.
Claims 1 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Morrow (5,622,848) in view of RU 2707505 and Burd (US 20200281969).
Morrow teaches a microbicidal solution for in vivo and in vitro treatment of microbial infections. The solution comprises an electrolyzed saline containing regulated amounts of ozone and active chlorine species, wherein the active chlorine species content is between about 5 and 300 ppm and a pH range from 7.2-7.6. The active chlorine species comprises free chlorine, hypochlorous acid, and the hypochlorite ion, as measured by a chlorine selective electrode. The solution is preferably utilized at an isotonic saline concentration, and may be adjusted with hypertonic saline. The solution may be used for in vitro treatment of infected whole blood, blood cells, or plasma to reduce contamination, and may be used in the treatment of fluids infected with HIV, hepatitis, and other viral, bacterial, and fungal agents. The solution may also be administered to warm-blooded animals, including humans, by intravenous injection or other modes, for similar purposes (See abstract and entire disclosure) (meeting limitations of claims 1 and 20).
Morrow teaches that the said solution may be effective in treating infections caused by Epstein-Barr virus, hepatitis A, B or C virus, rhinovirus, rubeola virus, rubella virus, influenza viruses, parainfluenza viruses, herpes simplex viruses, Varicella-zoster viruses, adenoviruses, respiratory syncytial viruses, alphaviruses, superficial and systemic infections, etc, (See Col. 3, lines 30-59 and claim 2). (meeting claims 1 and 20).
Morrow discloses that the said solutions are nontoxic to cells and can be administered before, concurrent with or after the electrolyzed saline and may be administered intravenously, parenterally or, in some cases, orally (See Col.6, lines 20-29).
Morrow discloses administration of a solution comprising hypochlorous acid to a subject for treatment of respiratory viral infections, but is silent with regard to the administration of the solution by nebulization or metered dose inhaler or dosing interval. These limitations are well known in the art as taught by Burd and RU ‘505.
Burd and RU ‘505’s teachings are delineated above and incorporated herein.
It would have been prima facie obvious to a person of ordinary skilled in the art at the time the invention was made given the teachings of Morrow on administration of microbial solution comprising hypochlorous acid to treat various viral infections including respiratory viral infections to have looked in the art for suggestions on the delivery devices and dosage intervals as taught by Burd and RU ‘505 with a reasonable expectation of success. It would have been obvious to do so because to follow Morrow’s method, it would be necessary to use the appropriate delivery device including nebulizer and to know or get suggestions on the dosing regimen. Thus, one of ordinary skill in the art would have arrived at the instant invention by following the teachings of the art.
In other words, the claims would have been obvious because the technique for improving a particular formulation was part of the ordinary capabilities of a person of ordinary skill in the art, in view of the teaching of the technique for improvement in other situations.
Claims 1, 6 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Northey (US 2012026904) in view of RU 2707505.
Northey teach low pH antimicrobial solutions comprising hypochlorous acid, water, and, optionally, a buffer, with a pH from about 4 to about 6 and useful for treating impaired or damaged tissue and for disinfecting surfaces (See abstract) (meeting limitations of claims 1 and 6).
Regarding claims 1 and 6, it is disclosed that the said solution comprises hypochlorous acid in an amount from about 5 mg/L to about 200 mg/L (an amount of 25 mg/L is equivalent to 0.025%) (See [0011] and claims 1-3). Free chlorine typically includes hypochlorous acid (HClO), hypochlorite ions (ClO−), dissolved chlorine gas (Cl2), and other radical chlorine species (See [0014]).
Regarding claims 1 and 6, it is disclosed that the said low pH antimicrobial solution can be administered as a steam or a spray, or by aerosolization, nebulization or atomization, so as to contact the impaired or damaged tissue with the solution. When the said low pH antimicrobial solution is administered by aerosolization, nebulization or atomization, it is preferably administered in the form of droplets having a diameter in the range of from about 1 micron to about 10 microns. Methods and devices, which are useful for aerosolization, nebulization and atomization, are well known in the art (See [0026]- [0027]).
Regarding claims 1 and 20, Northey teaches a method of treating tissues which have been impaired or damaged by non-surgical means, wherein the said low pH antimicrobial solution can be used to treat one or more burns, cuts, abrasions, ulcers, puncture wounds, combinations thereof, and the like. The said method also can be used for treating impaired or damaged tissue, which is infected, or tissue impaired or damaged due to infection. Such infection can be caused by one or more infectious pathogens, one or more microorganisms including viruses, bacteria, fungi, and combinations thereof (See [0021] and [0029]-[0030]).
Furthermore, regarding claims 1 and 6, it is disclosed that the viruses can include, one or more viruses selected from the group consisting of adenoviruses, human immunodeficiency virus (HIV), rhinoviruses, flu viruses (e.g., influenza A), hepatitis (e.g., hepatitis A), coronavirus (responsible for Severe Acute Respiratory Syndrome (SARS)), rotavirus, respiratory syncytial virus, herpes simplex virus, varicella zoster virus, rubella virus, and other susceptible viruses (See [0031]).
Northey discloses administration of a solution comprising hypochlorous acid to a subject such as via nebulization, but is silent with regard to the dosing interval of claim 1. These limitations are well known in the art as taught by RU ‘505.
RU ‘505 teach that more than 30% of cases of acute respiratory viral infections are complicated by bacterial infections. In modern health care, the problem of acquiring infections, including the upper and lower respiratory tract, during hospitalization in hospital is very acute, due to the nosocomial nature of infectious complications (See page 1, last para of provided English translation).
Regarding claim 1, RU ‘505 teaches a method of treating bacterial infections of the respiratory tract, including prescribing drug therapy with the drug according to indications through a nebulizer, including administering via a compressor nebulizer for inhalation therapy, a selected bacteriophage in a volume of 5 ml from a container for medicines of a compressor nebulizer. The spraying time was 1, 3, 5, 10 min, and wherein inhalation is performed three times during the day for 10 days (See page 3, 4th para, and claim 1).
It would have been prima facie obvious to a person of ordinary skilled in the art at the time the invention was made given the teachings of Northey on administration of an antimicrobial solution to the respiratory system via a nebulizer to have looked in the art for suggestions on the volume of the solution and dosing regimen, as taught by RU ‘505 with a reasonable expectation of success. It would have been obvious to do so because to follow Northey’s method, it would be necessary to know the amount of a solution that can be effectively administered via a nebulizer and also to get suggestions on the dosing regimen. Thus, one of ordinary skill in the art would have arrived at the instant invention by following the teachings of the art.
In other words, the claims would have been obvious because the technique for improving a particular formulation was part of the ordinary capabilities of a person of ordinary skill in the art, in view of the teaching of the technique for improvement in other situations.
Response to Arguments
Applicant's arguments filed 04/29/26 have been fully considered but they are not persuasive.
Applicant’s amendments to the claims have necessitated modified grounds of rejections. Applicant’s arguments so far as they pertain to the maintained references and rejections are discussed below.
Applicant’s first argument is regarding the rejection of claims under obviousness over Northey and RU ‘505. Applicant argues that “Claim 1 as amended is not rendered obvious by the combination of Northey with RU '505. ….. In this case, there is no motivation to combine Northey and RU '505 to render Claim 1 obvious as amended. Claim 1 as amended is directed to treatment of an acute viral respiratory disease. The Office Action asserts that Northey is directed to use of hypochlorous acid as an antimicrobial solution. However, RU '505 is directed to use of hypochlorous acid an antibacterial treatment in a disclosed concentration and administration frequency, not an antiviral treatment. See Non-Final Office Action, at 11. Therefore, a person of ordinary skill in the art and knowledge of Northey would not be motivated to apply the teachings of RU '505 (for antibacterial treatments) when attempting to determine an appropriate effective therapeutic amount for treatment of a viral disease with an expectation of success” (See Remarks, page 7).
The argument is not found persuasive. Both Northey and RU ‘505 teach that hypochlorous acid is known to act as antimicrobial and antiviral agent. This is also well known in the art as taught by other references of record, Najafi et al and Morrow and as disclosed in the Instant Specification. Thus, one of ordinary skill in the art is more than motivated to incorporate the dosing regimen of RU ‘505 in the method and compositions of Northey with a reasonable expectation of success. It is also noted that claim 1 recites that the solution is administered for a period of 1 to 15 minute. The duration of administration by a nebulizer device or metered dose inhaler is typically determined and disclosed by the device and not the formulation. Furthermore, Northey’s formulation would necessarily be administered at least 1 times a day, reading on the next limitation of claim 1, even without incorporating RU ‘505’s disclosure.
Therefore, claims 1, 6 and 20 are properly rendered obvious by Northey and RU ‘505.
Claims 1, 6 and 20 remain rejected.
Claims 23, 28, 34, 37, 40, 42-43, 46, 50, 52, 54 and 58 are withdrawn.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mina Haghighatian whose telephone number is (571)272-0615. The examiner can normally be reached M-F, 7-5 EST.
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/Mina Haghighatian/
Mina Haghighatian
Primary Examiner
Art Unit 1616
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