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 .
Election/Restrictions
Claims 23, 28, 34, 37, 40, 42-43, 46, 50, 52, 54 and 58 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/07/25.
Accordingly, elected claims 1-2, 6-7, 12-13, 20 and 22 are under examination on the merits.
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 1-2, 6-7, 12-13, 20 and 22 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. 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 1 is drawn to a method of treatment or prevention of a disease state or a condition associated with or characterized by acute viral respiratory disease in a subject. However, Specification does not provide a definition or list of disease states or conditions associated with acute viral respiratory disses. It is known that viral respiratory disease can lead to major health conditions including cardiovascular diseases, lung diseases, kidney diseases, neurological diseases, etc. The specification not only does not mention which conditions are associated with respiratory disease, does not provide any evidence or support that an administration of a composition comprising hypochlorous acid can treat or prevent such conditions.
Claims 1-2, 6, 12-13, 20 and 22 are rejected for reciting a method of treatment… by administration of a composition comprising hypochlorous acid to the subject. The step of administration includes all routes of administration inlcudi8ng topical, ophthalmic, otic, oral, injection, etc. The Specification fails to provide support that Applicants have performed or envisioned any routes of administration other than by nebulizer or metered dose inhaler.
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 7 and 12 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 7 is drawn to a method of claim 1 wherein the solution is administered by a nebulizer, a metered dose inhaler or a combination thereof. The claim is indefinite because it is not clear how an administration can be performed by a combination of a nebulizer and a metered dose inhaler. The Specification states “Any suitable method can be used for administering the solution to the subject. In one embodiment, the solution may be administered as a steam or a spray or by aerosolization, nebulization, or atomization. In such embodiments, the solution is inhaled by the subject”.
Claim 12 is indefinite for reciting that a therapeutically effective amount of the solution of claim 1 is about 5 mL. This is indefinite because 5 mL appears to be the volume of the solution dispensed/administered. However, the said 5 mL amount of the solution also contains an amount of a carrier and possibly other active agents and inert excipients. Since claim 1 does not indicate the concentration of hypochlorous acid in the solution, the recitation of a 5 mL solution as the effective amount is indefinite and at best it is arbitrary.
Claim Interpretation
Claim 1 is directed to a method of treatment or prevention of a disease…. . The Specification defines “prevention” as “The terms “prevention,” “prevent,” “preventing,” “suppression,” “suppress,” and “suppressing”, as used herein, refer to a course of action (such as implanting a medical device) initiated prior to the onset of a clinical manifestation of a disease state or condition so as to prevent or reduce such clinical manifestation of the disease state or condition. Such preventing and suppressing need not be absolute to be useful (See [0012] of the published Spec).
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 6, 13 and 22, 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 § 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 6, 20 and 22 are rejected under 35 U.S.C. 102(a)(1) (a)(2) as being anticipated by Najafi et al (US 2008/0279963).
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 0.1 ppm to about 1,000 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 1-2, 6).
Regarding claims 1, 20 and 22, 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 claims 1-2, 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]).
Claims 1-2, 6, 20 and 22 are rejected under 35 U.S.C. 102(a)(1) (a)(2) as being anticipated by Morrow (5,622,848).
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 1-2, 6, 20 and 22).
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 limitations of claims 1-2).
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) (meeting limitations of claims 1, 20 and 22).
Claims 1-2, 6-7, 20 and 22 are rejected under 35 U.S.C. 102(a)(1) (a)(2) as being anticipated by Northey (US 2012026904).
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 claim 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 7, 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 1-2, 20 and 22, 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 2, 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]).
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 1-2, 6-7, 12-13, 20 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Northey (US 2012026904) in view of RU 2707505.
Teachings of Northey are delineated above and incorporated herein.
Northey discloses administration of a solution comprising hypochlorous acid to a subject such as via nebulization, but is silent with regard to the milliliter limitation of claim 12 and dosing interval of claim 13. 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 claims 12-13, 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, 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.
Claims 1-2, 6-7, 12-13, 20 and 22 are rejected.
Claims 23, 28, 34, 37, 40, 42-43, 46, 50, 52, 54 and 58 are withdrawn.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue X. Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Mina Haghighatian/
Mina Haghighatian
Primary Examiner
Art Unit 1616