DETAILED ACTION
This Office Action is in response to the election/restriction response, filed on July 15, 2026. Primary Examiner acknowledges Claims 10-14 and 20-28 are pending in this application, with Claims 1-9 and 15-19 having been cancelled.
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
Applicant’s election without traverse of Group I, Claims 10-14 and 20-28, in the reply filed on July 15, 2026 is acknowledged.
Specification
The disclosure is objected to because of the following informalities:
In Para 0314, the term “itraconazole” is repeated twice. It appears perhaps this a typographical error. Appropriate correction is required.
Claim Objections
Claim 28 is objected to because of the following informalities:
Specifically, Claim 28, Line 4 recites the limitation “itraconazole” is repeated twice. It appears perhaps this a typographical error. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 27 and 28 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.
Specifically, Claim 27, Line 1 recites the limitation “antimicrobial”; however, this limitation appears to lack antecedent basis in the claims. It appears this recitation should be “antimicrobial agent” to be consistent with the parentage within Claim 10 which recites “antimicrobial agent” in Lines 5 and 6. Appropriate correction and clarification is required.
Specifically, Claim 28, Line 1 recites the limitation “antimicrobial”; however, this limitation appears to lack antecedent basis in the claims. It appears this recitation should be “antimicrobial agent” to be consistent with the parentage within Claim 10 which recites “antimicrobial agent” in Lines 5 and 6. Appropriate correction and clarification is required.
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 10-14 and 20-28 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Miller (2007/0086954).
As to Claim 10, Miller discloses a method of treating a subject having a medical condition associated with a pathogenic microorganism (“Methods for suppressing, killing, and inhibiting pathogenic cells, such as microorganisms associated with a respiratory infection within the respiratory tract of an animal are described. Methods include the step of exposing the pathogenic cells to an effective amount of nitric oxide, such as through inhalation of nitric oxide gas, in combination with traditional respiratory infection agents, such as antibiotics.” Abstract; “In all aspects of the invention, the nitric oxide source, such as gaseous nitric oxide may be used in combination with traditional respiratory infection agents, such as antibiotics. … The combination of gaseous nitric oxide and respiratory infection agents is anticipated to give synergistic effects in the treatment of respiratory infections. The combination is anticipated to give synergistic effects in killing and inhibiting bacterial cells, parasites and fungi associated with respiratory infections.” Para 0014; “The nitric oxide source, such as gaseous nitric oxide may be used in combination with traditional respiratory infection agents, such as antibiotics. … The combination of gaseous nitric oxide and respiratory infection agents is anticipated to give synergistic effects in the treatment of respiratory infections. The combination is anticipated to give synergistic effects in killing and inhibiting bacterial cells, parasites and fungi associated with respiratory infections.” Para 0062; “Respiratory infection agents may be administered orally, intravenously, through inhalation or any other traditional method of administration to the animal or patient. These agents may be delivered before, after or concurrently with the gaseous nitric oxide. In addition to the administration of the gaseous nitric oxide, one or more respiratory infection agents may be administered to the patient. … Respiratory infection agents include antibiotics and other respiratory tract aids and remedies.” Paras 0063-0064), the method comprising:
i) topically administering to said subject a potentiating effective amount of gaseous nitric oxide (gNO) (“Methods include the step of exposing the pathogenic cells to an effective amount of nitric oxide, such as through inhalation of nitric oxide gas, in combination with traditional respiratory infection agents, such as antibiotics.” Abstract: “Preferably, the pathogenic cells are exposed to a gas or a gas is delivered to the respiratory tract of the animal being treated, wherein the gas is comprised of the nitric oxide source. More preferably, the pathogenic cells are exposed to a gas comprised of nitric oxide. For instance, the gas may be comprised of oxygen and nitric oxide for delivery by the inhalation route to the respiratory tract of the animal being treated.” Para 0021; “The nitric oxide source, such as gaseous nitric oxide may be used in combination with traditional respiratory infection agents, such as antibiotics. … The combination of gaseous nitric oxide and respiratory infection agents is anticipated to give synergistic effects in the treatment of respiratory infections. The combination is anticipated to give synergistic effects in killing and inhibiting bacterial cells, parasites and fungi associated with respiratory infections.” Para 0062); and
ii) administering to said subject a therapeutically effective amount of an antimicrobial agent, wherein said antimicrobial agent is other than said gNO (“Methods include the step of exposing the pathogenic cells to an effective amount of nitric oxide, such as through inhalation of nitric oxide gas, in combination with traditional respiratory infection agents, such as antibiotics.” Abstract; “Respiratory infection agents may be administered orally, intravenously, through inhalation or any other traditional method of administration to the animal or patient. These agents may be delivered before, after or concurrently with the gaseous nitric oxide. In addition to the administration of the gaseous nitric oxide, one or more respiratory infection agents may be administered to the patient. … Respiratory infection agents include antibiotics and other respiratory tract aids and remedies.” Paras 0063-0064).
As to Claim 11, Miller discloses the potentiating effective amount is lower than a therapeutically effective amount of said gNO with respect to said pathogenic microorganism (e.g. “M. tuberculosis” – “a multidrug-resistant (isoniazid and rifampin) wild strain of M. tuberculosis” Para 0037, “A MULTIDRUG- RESISTANT WILD STRAIN OF M. TUBERCULOSIS” Para 0041 - Table 2, “a multidrug-resistant wild strain of M. tuberculosis” Para 0042, “a multidrug-resistant (isoniazid and rifampin) wild strain of M. tuberculosis” Para 0044; “methicillin-resistant S. aureus” – “methicillin-resistant S. aureus” Para 0048, “methicillin-resistant Staphylococcus aureus” Para 0067, “methicillin-resistant Staphylococcus aureus (MRSA)” Para 0067; “vancomycin-resistant Enterococcus faecium (VREF)” – “vancomycin-resistant Enterococcus faecium (VREF)” Para 0067; and “methicillin-resistant … Streptococcus pyogenes” – “methicillin-resistant … Streptococcus pyogenes” Para 0067).
Explicitly, Miller discloses “Although in the preferred embodiments of the various aspects of the invention, any effective amount of nitric oxide may be used, the concentration of the nitric oxide in the gas is preferably at least about 25 parts per million. Further, the concentration of the nitric oxide in the gas is more than about 100 parts per million, such as about 160 ppm to 250 ppm.” (Para 0022). As shown in Table 1 under Para 0039, the exposure of gNO to the “M. tuberculosis” at lower PPMs was less effective to kill the pathogenic microorganism for the same amount of time as compared to the higher PPMs; whilst, lower times at the same PPM was less effective to kill the pathogenic microorganism as compared to higher times. Thus, the therapeutically effective dosage to effectively kill the pathogenic microorganism is a balancing of both PPM and time.
Returning to the claims, in the case of 24 hours exposure, it is noted that the application of a potentiating effective amount of 25 PPMs only yielded approximately a 34% kill (66+/- 4); while the exposure at 90 PPMs is a more therapeutically effective amount yielding approximately an 85% kill (15+/-3). Hence, 25 PPMs does not meet the LD50 and thus cannot be a considered a therapeutically effective amount. Thus, the application of gNO for 24 hours at 25 PPM is a potentiating effective amount that is lower than a therapeutically effective amount such as 90 PPM.
As to Claim 12, Miller discloses the potentiating effective amount (e.g. 25 PPM at 24 hours) is lower than 1 MIC unit of gNO (a therapeutically effective amount – e.g. 90 PPM at 24 hours) with respect to the pathogenic microorganism (e.g. “M. tuberculosis” – “a multidrug-resistant (isoniazid and rifampin) wild strain of M. tuberculosis” Para 0037, “A MULTIDRUG- RESISTANT WILD STRAIN OF M. TUBERCULOSIS” Para 0041 - Table 2, “a multidrug-resistant wild strain of M. tuberculosis” Para 0042, “a multidrug-resistant (isoniazid and rifampin) wild strain of M. tuberculosis” Para 0044; “methicillin-resistant S. aureus” – “methicillin-resistant S. aureus” Para 0048, “methicillin-resistant Staphylococcus aureus” Para 0067, “methicillin-resistant Staphylococcus aureus (MRSA)” Para 0067; “vancomycin-resistant Enterococcus faecium (VREF)” – “vancomycin-resistant Enterococcus faecium (VREF)” Para 0067; and “methicillin-resistant … Streptococcus pyogenes” – “methicillin-resistant … Streptococcus pyogenes” Para 0067).
Explicitly, Miller discloses “Although in the preferred embodiments of the various aspects of the invention, any effective amount of nitric oxide may be used, the concentration of the nitric oxide in the gas is preferably at least about 25 parts per million. Further, the concentration of the nitric oxide in the gas is more than about 100 parts per million, such as about 160 ppm to 250 ppm.” (Para 0022). As shown in Table 1 under Para 0039, the exposure of gNO to the “M. tuberculosis” at lower PPMs was less effective to kill the pathogenic microorganism for the same amount of time as compared to the higher PPMs; whilst, lower times at the same PPM was less effective to kill the pathogenic microorganism as compared to higher times. Thus, the therapeutically effective dosage to effectively kill the pathogenic microorganism is a balancing of both PPM and time.
Returning to the claims, in the case of 24 hours exposure, it is noted that the application of a potentiating effective amount of 25 PPMs only yielded approximately a 34% kill (66+/- 4); while the exposure at 90 PPMs is a more therapeutically effective amount yielding approximately an 85% kill (15+/-3). Hence, 25 PPMs does not meet the LD50 and thus cannot be a considered a therapeutically effective amount. As 90 PPMs at 24 hours meets the LD50, this value is a potential therapeutically effective amount which could represent 1 MIC. Thus, the value of 25 PPM is less than approximately 1/3 MIC of 90 PPMs (expressly 0.27 MIC = 25/90 PPM).
As to Claim 13, Miller discloses said pathogenic microorganism (e.g. “M. tuberculosis” – “a multidrug-resistant (isoniazid and rifampin) wild strain of M. tuberculosis” Para 0037, “A MULTIDRUG- RESISTANT WILD STRAIN OF M. TUBERCULOSIS” Para 0041 - Table 2, “a multidrug-resistant wild strain of M. tuberculosis” Para 0042, “a multidrug-resistant (isoniazid and rifampin) wild strain of M. tuberculosis” Para 0044; “methicillin-resistant S. aureus” – “methicillin-resistant S. aureus” Para 0048, “methicillin-resistant Staphylococcus aureus” Para 0067, “methicillin-resistant Staphylococcus aureus (MRSA)” Para 0067; “vancomycin-resistant Enterococcus faecium (VREF)” – “vancomycin-resistant Enterococcus faecium (VREF)” Para 0067; and “methicillin-resistant … Streptococcus pyogenes” – “methicillin-resistant … Streptococcus pyogenes” Para 0067) exhibits a resistance (“Preferably, antibiotics used to treat severe infections or resistant bacteria may be respiratory infection agents.” Para 0067) to said antimicrobial agent prior to said administering said potentiating effective amount of gNO. Each of the aforementioned pathogenic microorganisms have the denotation of “resistant” in their nomenclature because they have been pre-established to be strains of pathogenic organisms which have a historical and well known resistance that is established within the medical field. Consequently, when the patient presents with any of these known resistant strains of pathogenic organisms, e.g. MRSA in a hospital setting, the healthcare provider knows which antibiotics have been deemed ineffective for the treatment of that pathogenic organism, and thus will choose another class of antibiotic which maybe more effective to quickly and effectively subdue the pathogenic organism and its infection of the patient.
As to Claim 14, Miller discloses the antimicrobial agent (e.g. “isoniazid and rifampin” – “a multidrug-resistant (isoniazid and rifampin) wild strain of M. tuberculosis” Para 0037, “a multidrug-resistant (isoniazid and rifampin) wild strain of M. tuberculosis” Para 0044; “methicillin-resistant” – “methicillin-resistant S. aureus” Para 0048, “methicillin-resistant Staphylococcus aureus” Para 0067, “methicillin-resistant Staphylococcus aureus (MRSA)” Para 0067, “methicillin-resistant … Streptococcus pyogenes” Para 0067; “vancomycin-resistant” – “vancomycin-resistant Enterococcus faecium (VREF)” Para 0067) is inactive when used against said pathogenic microorganism (e.g. “M. tuberculosis” – “a multidrug-resistant (isoniazid and rifampin) wild strain of M. tuberculosis” Para 0037, “A MULTIDRUG- RESISTANT WILD STRAIN OF M. TUBERCULOSIS” Para 0041 - Table 2, “a multidrug-resistant wild strain of M. tuberculosis” Para 0042, “a multidrug-resistant (isoniazid and rifampin) wild strain of M. tuberculosis” Para 0044; “methicillin-resistant S. aureus” – “methicillin-resistant S. aureus” Para 0048, “methicillin-resistant Staphylococcus aureus” Para 0067, “methicillin-resistant Staphylococcus aureus (MRSA)” Para 0067; “vancomycin-resistant Enterococcus faecium (VREF)” – “vancomycin-resistant Enterococcus faecium (VREF)” Para 0067; and “methicillin-resistant … Streptococcus pyogenes” – “methicillin-resistant … Streptococcus pyogenes” Para 0067).
As to Claim 20, Miller discloses the i) topically administering to said subject a potentiating effective amount of gaseous nitric oxide (gNO) is affected prior to (“Respiratory infection agents may be administered orally, intravenously, through inhalation or any other traditional method of administration to the animal or patient. These agents may be delivered before, after or concurrently with the gaseous nitric oxide. In addition to the administration of the gaseous nitric oxide, one or more respiratory infection agents may be administered to the patient. … Respiratory infection agents include antibiotics and other respiratory tract aids and remedies.” Paras 0063-0064) ii) administering to said subject a therapeutically effective amount of an antimicrobial agent, wherein said antimicrobial agent is other than said gNO.
As to Claim 21, Miller discloses the i) topically administering to said subject a potentiating effective amount of gaseous nitric oxide (gNO) is affected concomitantly with (“Respiratory infection agents may be administered orally, intravenously, through inhalation or any other traditional method of administration to the animal or patient. These agents may be delivered before, after or concurrently with the gaseous nitric oxide. In addition to the administration of the gaseous nitric oxide, one or more respiratory infection agents may be administered to the patient. … Respiratory infection agents include antibiotics and other respiratory tract aids and remedies.” Paras 0063-0064) ii) administering to said subject a therapeutically effective amount of an antimicrobial agent, wherein said antimicrobial agent is other than said gNO.
As to Claim 22, Miller discloses ii) administering to said subject a therapeutically effective amount of an antimicrobial agent, wherein said antimicrobial agent is other than said gNO is affected prior to (“Respiratory infection agents may be administered orally, intravenously, through inhalation or any other traditional method of administration to the animal or patient. These agents may be delivered before, after or concurrently with the gaseous nitric oxide. In addition to the administration of the gaseous nitric oxide, one or more respiratory infection agents may be administered to the patient. … Respiratory infection agents include antibiotics and other respiratory tract aids and remedies.” Paras 0063-0064) i) topically administering to said subject a potentiating effective amount of gaseous nitric oxide (gNO).
As to Claim 23, Miller discloses the pathogenic microorganism (e.g. “M. tuberculosis” – “a multidrug-resistant (isoniazid and rifampin) wild strain of M. tuberculosis” Para 0037, “A MULTIDRUG- RESISTANT WILD STRAIN OF M. TUBERCULOSIS” Para 0041 - Table 2, “a multidrug-resistant wild strain of M. tuberculosis” Para 0042, “a multidrug-resistant (isoniazid and rifampin) wild strain of M. tuberculosis” Para 0044; “methicillin-resistant S. aureus” – “methicillin-resistant S. aureus” Para 0048, “methicillin-resistant Staphylococcus aureus” Para 0067, “methicillin-resistant Staphylococcus aureus (MRSA)” Para 0067; “vancomycin-resistant Enterococcus faecium (VREF)” – “vancomycin-resistant Enterococcus faecium (VREF)” Para 0067; and “methicillin-resistant … Streptococcus pyogenes” – “methicillin-resistant … Streptococcus pyogenes” Para 0067) is selected from one or more of gram-negative bacteria, gram-positive bacteria, eubacteria, archaebacteria, eukaryotic organisms, yeast, fungi, algae, protozoa, and other parasites.
It is noted that each of the following pathogenic microorganism are historically well-known whereby “M. tuberculosis” is a pathogenic bacteria, “S. aureus” is a gram-positive bacteria, “E. faecium” is a gram-positive bacteria; “S. pyogenes” is a gram-positive bacteria.
Should Applicant respectfully disagree it is noted the further limiting of Claim 23 by its dependency of Claim 24 includes each of “M. tuberculosis”, “S. aureus”, and genus of “S. pyogenes” – Streptococcus. Thus, the recitation of each of “M. tuberculosis”, “S. aureus”, and genus of “S. pyogenes” – Streptococcus in Claim 24 affirms the type of pathogenic microorganism is selected from one or more of gram-negative bacteria, gram-positive bacteria, eubacteria, archaebacteria, eukaryotic organisms, yeast, fungi, algae, protozoa, and other parasites.
Thus, several pathogenic microorganism are disclosed by Miller to meet this Markush grouping.
As to Claim 24, Miller discloses the pathogenic microorganism (e.g. “M. tuberculosis” – “a multidrug-resistant (isoniazid and rifampin) wild strain of M. tuberculosis” Para 0037, “A MULTIDRUG- RESISTANT WILD STRAIN OF M. TUBERCULOSIS” Para 0041 - Table 2, “a multidrug-resistant wild strain of M. tuberculosis” Para 0042, “a multidrug-resistant (isoniazid and rifampin) wild strain of M. tuberculosis” Para 0044; “methicillin-resistant S. aureus” – “methicillin-resistant S. aureus” Para 0048, “methicillin-resistant Staphylococcus aureus” Para 0067, “methicillin-resistant Staphylococcus aureus (MRSA)” Para 0067; “vancomycin-resistant Enterococcus faecium (VREF)” – “vancomycin-resistant Enterococcus faecium (VREF)” Para 0067; and “methicillin-resistant … Streptococcus pyogenes” – “methicillin-resistant … Streptococcus pyogenes” Para 0067) is selected from one or more of “M. tuberculosis”, “S. aureus”, and genus of “S. pyogenes” – Streptococcus.
Additionally, it is noted Miller also discloses “Enterobacter sp.” – “Enterobacter aerogenes” (Para 0048) a species of Enterobacter; “Acinetobacter baumanii” (Para 0048) a species of “Acinetobacter”; “Klebsiella pneumoniae” (Para 0048); and “Stenotrophomonas maltophilia” (Para 0048).
Thus, several pathogenic microorganism are disclosed by Miller to meet this Markush grouping.
As to Claim 25, Miller discloses the pathogenic microorganism (e.g. “M. tuberculosis” – “a multidrug-resistant (isoniazid and rifampin) wild strain of M. tuberculosis” Para 0037, “A MULTIDRUG- RESISTANT WILD STRAIN OF M. TUBERCULOSIS” Para 0041 - Table 2, “a multidrug-resistant wild strain of M. tuberculosis” Para 0042, “a multidrug-resistant (isoniazid and rifampin) wild strain of M. tuberculosis” Para 0044; “methicillin-resistant S. aureus” – “methicillin-resistant S. aureus” Para 0048, “methicillin-resistant Staphylococcus aureus” Para 0067, “methicillin-resistant Staphylococcus aureus (MRSA)” Para 0067; “vancomycin-resistant Enterococcus faecium (VREF)” – “vancomycin-resistant Enterococcus faecium (VREF)” Para 0067; and “methicillin-resistant … Streptococcus pyogenes” – “methicillin-resistant … Streptococcus pyogenes” Para 0067; “Enterobacter sp.” – “Enterobacter aerogenes” (Para 0048) a species of Enterobacter; “Acinetobacter baumanii” (Para 0048) a species of “Acinetobacter”; “Klebsiella pneumoniae” (Para 0048); and “Stenotrophomonas maltophilia” (Para 0048)) is a bacteria and the medical condition is a bacterial infection.
It is noted that each of the following pathogenic microorganism are historically well-known whereby “M. tuberculosis” is a pathogenic bacteria, “S. aureus” is a gram-positive bacteria, “E. faecium” is a gram-positive bacteria; “S. pyogenes” is a gram-positive bacteria; “Enterobacter aerogenes” is a gram-negative bacteria (currently known as “Klebsiella aerogenes”); “Acinetobacter baumanii” [sic: “Acinetobacter baumannii”] is a gram-negative bacteria; “Klebsiella pneumoniae” is a gram-negative bacteria; “Stenotrophomonas maltophilia” is a gram-negative bacteria.
Thus, several pathogenic microorganism are disclosed by Miller to meet this Markush grouping to include “gram-negative bacterial infections” from any of “Enterobacter aerogenes” “Acinetobacter baumanii” “Klebsiella pneumoniae” or “Stenotrophomonas maltophilia”, “gram-positive bacterial infections” from any of “S. aureus” “E. faecium” or “S. pyogenes”, “Klebsiella infections” from “Klebsiella pneumoniae” or the new name for “Enterobacter aerogenes” - “Klebsiella aerogenes”, “Mycobacterium infections” from “M. tuberculosis”, “pneumonia” from “Klebsiella pneumoniae”, “Staphylococcal infections” from “S. aureus”; “Streptococcal infections” from “S. pyogenes”, and Tuberculosis from “M. tuberculosis”.
As to Claim 26, Miller discloses the pathogenic microorganism is a fungi, and the medical condition is a fungal infection (“fungal” / “fungi” – “As well, in a preferred embodiment, the present invention relates to the use of nitric oxide in a gaseous form (NO) in the treatment of fungal, parasitic and bacterial infections …” Para 0004; “Preferably, as discussed further below, the present invention relates to the novel use of inhaled nitric oxide gas as an agent for killing bacterial cells, parasites and fungi in the treatment of respiratory infections.” Para 0009; “However, the pathogenic cells are preferably pathogenic microorganisms, including but not limited to pathogenic bacteria, pathogenic parasites and pathogenic fungi.” Para 0013; “The combination is anticipated to give synergistic effects in killing and inhibiting bacterial cells, parasites and fungi associated with respiratory infections.” Para 0014; “The combination is anticipated to give synergistic effects in killing and inhibiting bacterial cells, parasites and fungi associated with respiratory infections.” Para 0062) in which the fungal infection is endemic and/or opportunistic.
As to Claim 27, Miller discloses the antimicrobial agent (“Examples of known antibiotics that have been used to treat respiratory infections include, but are not limited to, ample spectrum penicillins, such as amoxicillin, ampicillin, and bacampicillin, penicillins and beta lactamase inhibitors, such as benzylpenicillin, cloxacillin, methicillin, nafcillin, and cephalosporins, such as cefadrocil, cefazolin, cephalexin, cephalothin, cefaclor, cefamandol [sic: cefamandole], cefonicid, loracerbef, cefdinir, ceftibuten, cefoperazone, and cefepime, macrolide and lincosamines, such as azithromycin, clarithromycin, clindamycin, and dirithromycin, quinolones and fluoroquinolones, such as cinoxacin, ciprofloxacin, enoxacin, gatifloxacin, levoflaxacin, moxifloxacin, and trovafloxican, carbepenems, such as impienem-cilastatin and meropenem, monobactams, such as aztreonam, aminoglycosides, such as amikacin, gentamicin, kanamycin, neomycin, streptomycin, and tobramycin, glycopeptides, such as teicoplanin and vancomycin, tetracyclines, such as democlocycline, doxycycline, and tetracycline, sulfonamides, such as mafenide, silver sulfadiazine, sulfacetamide, trimethoprime-sulfamethoxazole, and sulfamethizole, rifampin, such as rifabutin, rifamphin, and rifapentine, oxazolidonones, such as linezolid, streptogramins, such as quinopristin+dalfopristin, bacitracin, chloramphenicol, methenamine, nitrofurantoin.” Para 0065; “Respiratory infection agents also include the compounds of isoniazid, rifampin, pyrazinamine, ethambutol, rifabutin, rifapentine, streptomycin, cycloserine, p-Aminosalicylic acid, ethionamide, amikacin, kanamycin, capreomycin, levofloxcin, moxifloxican, gatifloxacin, erythromycin, clarithromycin, roxithromycin, azithromycin, penicillin, amoxicillin, amoxicillin and clavulanate, cefuroxime, celixime, cephalexin, Sulfamethoxazole and Trimethoprim, Erythromycin and Sulfisoxazole, enrofloxacin, ciprofloxacin, oxytetracycline, and ampicillin.” Para 0066; and “Preferably, antibiotics used to treat severe infections or resistant bacteria may be respiratory infection agents. These include streptogramins, such as Synercid (quinupristin and dalfopristin), which has been indicated for use in treating vancomycin-resistant enterococcus faecium (VREF) infections, and skin and soft-tissue infections caused by methicillin-resistant Staphylococcus aureus or Streptococcus pyogenes. Zyvox (linezolid), an antibacterial drug to treat infections associated with vancomycin-resistant Enterococcus faecium (VREF), including cases with bloodstream infection. Zyvox is used also for treatment of hospital-acquired pneumonia and complicated skin and skin structure infections, including cases due to methicillin-resistant Staphylococcus aureus (MRSA). In addition, it is used for treatment of community-acquired pneumonia and uncomplicated skin and skin structure infections.” Para 0067).
The bolded antimicrobial agents are shared in both Claims 27 and 28; whilst the underlined antimicrobial agents are only found in Claim 27.
As to Claim 28, Miller discloses the antimicrobial agent (“Examples of known antibiotics that have been used to treat respiratory infections include, but are not limited to, ample spectrum penicillins, such as amoxicillin, ampicillin, and bacampicillin, penicillins and beta lactamase inhibitors, such as benzylpenicillin, cloxacillin, methicillin, nafcillin, and cephalosporins, such as cefadrocil, cefazolin, cephalexin, cephalothin, cefaclor, cefamandol [sic: cefamandole], cefonicid, loracerbef, cefdinir, ceftibuten, cefoperazone, and cefepime, macrolide and lincosamines, such as azithromycin, clarithromycin, clindamycin, and dirithromycin, quinolones and fluoroquinolones, such as cinoxacin, ciprofloxacin, enoxacin, gatifloxacin, levoflaxacin, moxifloxacin, and trovafloxican, carbepenems, such as impienem-cilastatin and meropenem, monobactams, such as aztreonam, aminoglycosides, such as amikacin, gentamicin, kanamycin, neomycin, streptomycin, and tobramycin, glycopeptides, such as teicoplanin and vancomycin, tetracyclines, such as democlocycline, doxycycline, and tetracycline, sulfonamides, such as mafenide, silver sulfadiazine, sulfacetamide, trimethoprime-sulfamethoxazole, and sulfamethizole, rifampin, such as rifabutin, rifamphin, and rifapentine, oxazolidonones, such as linezolid, streptogramins, such as quinopristin+dalfopristin, bacitracin, chloramphenicol, methenamine, nitrofurantoin.” Para 0065; “Respiratory infection agents also include the compounds of isoniazid, rifampin, pyrazinamine, ethambutol, rifabutin, rifapentine, streptomycin, cycloserine, p-Aminosalicylic acid, ethionamide, amikacin, kanamycin, capreomycin, levofloxcin, moxifloxican, gatifloxacin, erythromycin, clarithromycin, roxithromycin, azithromycin, penicillin, amoxicillin, amoxicillin and clavulanate, cefuroxime, celixime, cephalexin, Sulfamethoxazole and Trimethoprim, Erythromycin and Sulfisoxazole, enrofloxacin, ciprofloxacin, oxytetracycline, and ampicillin.” Para 0066; and “Preferably, antibiotics used to treat severe infections or resistant bacteria may be respiratory infection agents. These include streptogramins, such as Synercid (quinupristin and dalfopristin), which has been indicated for use in treating vancomycin-resistant enterococcus faecium (VREF) infections, and skin and soft-tissue infections caused by methicillin-resistant Staphylococcus aureus or Streptococcus pyogenes. Zyvox (linezolid), an antibacterial drug to treat infections associated with vancomycin-resistant Enterococcus faecium (VREF), including cases with bloodstream infection. Zyvox is used also for treatment of hospital-acquired pneumonia and complicated skin and skin structure infections, including cases due to methicillin-resistant Staphylococcus aureus (MRSA). In addition, it is used for treatment of community-acquired pneumonia and uncomplicated skin and skin structure infections.” Para 0067).
The bolded antimicrobial agents are shared in both Claims 27 and 28; whilst the underlined antimicrobial agents are only found in Claim 28.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 10-14 and 20-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,890,421.
Although the claims at issue are not identical, they are not patentably distinct from each other because instant independent claim, Claim 10, is merely broader than patent claim, Claim 1. It is clear that all of the elements of the instant claims are found in the patent claims. The difference lies in the fact that the patent claims include many more elements and is thus much more specific. Thus, the invention of the patent claims is in effect a “species” of the “generic” invention of the instant claims. It has been held that the “generic” invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the instant claims are anticipated by the patent claims they are not patentably distinct.
Instant Application – 18391989
Differences Underlined
Similarities Italicized
Patent - 11,890,421
Differences Underlined
Similarities Italicized
10. (Previously Presented) A method of treating a subject having a medical condition associated with a pathogenic microorganism, the method comprising:
(i) topically administering to said subject a potentiating effective amount of gaseous nitric oxide (gNO); and
(ii) administering to said subject a therapeutically effective amount of an antimicrobial agent, wherein said antimicrobial agent is other than said gNO.
1. A method of treating a subject having a medical condition associated with a pathogenic microorganism, the method comprising:
(i) administering to said subject a potentiating effective amount of nitric oxide by inhalation; and
(ii) administering to said subject a therapeutically effective amount of an antimicrobial agent, wherein said antimicrobial agent is other than said nitric oxide, and wherein said antimicrobial agent is inactive when used alone against said pathogenic microorganism.
11. (Previously Presented) The method of claim 10, wherein
said potentiating effective amount is lower than a therapeutically effective amount of said gNO with respect to said pathogenic microorganism.
2. The method of claim 1, wherein
said potentiating effective amount is lower than a therapeutically effective amount of said nitric oxide with respect to said pathogenic microorganism.
12. (Previously Presented) The method of claim 11, wherein
said potentiating effective amount is lower than 1 MIC unit of gNO with respect to said pathogenic microorganism.
3. The method of claim 2, wherein
said potentiating effective amount is lower than 1 MIC unit of nitric oxide with respect to said pathogenic microorganism.
13. (Previously Presented) The method of claim 10, wherein
said pathogenic microorganism exhibits a resistance to said antimicrobial agent prior to said administering said potentiating effective amount of gNO.
4. The method of claim 1, wherein
said pathogenic microorganism exhibits a resistance to said antimicrobial agent prior to said administering said potentiating effective amount of nitric oxide.
14. (Previously Presented) The method of claim 10, wherein said antimicrobial agent is inactive when used against said pathogenic microorganism.
Excerpt from Claim 1:
“…wherein said antimicrobial agent is inactive when used alone against said pathogenic microorganism.”
20. (Previously Presented) The method of claim 10, wherein (i) is affected prior to (ii).
5. The method of claim 1,
wherein (i) is affected prior to (ii).
21. (Previously Presented) The method of claim 10,
wherein (i) is affected concomitantly with (ii).
6. The method of claim 1,
wherein (i) is affected concomitantly with (ii).
22. (Previously Presented) The method of claim 10, wherein (ii) is affected prior to (i).
7. The method of claim 1,
wherein (ii) is affected prior to (i).
23. (Previously Presented) The method of claim 10,
wherein the pathogenic microorganism is selected from one or more of gram-negative bacteria, gram-positive bacteria, eubacteria, archaebacteria, eukaryotic organisms, yeast, fungi, algae, protozoa, and other parasites.
8. The method of claim 1,
wherein the pathogenic microorganism is selected from one or more of gram-negative bacteria, gram-positive bacteria, eubacteria, archaebacteria, eukaryotic organisms, yeast, fungi, algae, protozoa, and other parasites.
24. (Previously Presented) The method of claim 23, wherein the pathogenic microorganism is
selected from one or more of Plasmodium falciparum and related malaria-causing protozoan parasites, Acanthamoeb, Aeromonas hydrophila, Anisakis and related worms, Serracia sp., Enterobacter sp., Acinetobacter sp., Acinetobacter baumanii, Ascaris lumbricoides, Bacillus cereus, Brevundimonas diminuta, Campylobacter jejuni, Clostridium botulinum, Clostridium peifringens, Cryptosporidium parvum, Cyclospora cayetanensis, Diphyllobothrium, Entamoeba histolytica, Escherichia coli, Eustrongylides, Giardia lamblia, Klebsiella pneumoniae, Listeria monocytogenes, Nanophyetus, Mycobacterium smegmatis, Mycobacterium tuberculosis, Mycobacterium avium intracellularae, Plesiomonas shigelloides, Proteus mirabilis, Pseudomonas aeruginosa, Salmonella, Serratia odorifera, Shigella, Staphylococcus aureus, Stenotrophomonas maltophilia, Streptococcus, Trichuris trichiura, Vibrio cholerae, Vibrio parahaemolyticus, Vibrio vulnifzcus, Yersinia enterocolitica, Yersinia pseudotuberculosis and Yersinia kristensenii.
9. The method of claim 8, wherein the pathogenic microorganism is
selected from one or more of Plasmodium falciparum and related malaria-causing protozoan parasites, Acanthamoeb, Aeromonas hydrophila, Anisakis and related worms, Serracia sp., Enterobacter sp., Acinetobacter sp., Acinetobacter baumanii, Ascaris lumbricoides, Bacillus cereus, Brevundimonas diminuta, Campylobacter jejuni, Clostridium botulinum, Clostridium perfringens, Cryptosporidium parvum, Cyclospora cayetanensis, Diphyllobothrium, Entamoeba histolytica, Escherichia coli, Eustrongylides, Giardia lamblia, Klebsiella pneumoniae, Listeria monocytogenes, Nanophyetus, Mycobacterium smegmatis, Mycobacterium tuberculosis, Mycobacterium avium intracellularae, Plesiomonas shigelloides, Proteus mirabilis, Pseudomonas aeruginosa, Salmonella, Serratia odorifera, Shigella, Staphylococcus aureus, Stenotrophomonas maltophilia, Streptococcus, Trichuris trichiura, Vibrio cholerae, Vibrio parahaemolyticus, Vibrio vulnificus, Yersinia enterocolitica, Yersinia pseudotuberculosis and Yersinia kristensenii.
25. (Previously Presented) The method of claims 10, wherein the
pathogenic microorganism is a bacteria, and the medical condition is a bacterial infection selected from one or more of actinomycosis, anthrax, aspergillosis, bacteremia, bacterial skin diseases, bartonella infections, botulism, brucellosis, burkholderia infections, campylobacter infections, candidiasis, cat-scratch disease, chlamydia infections, cholera, clostridium infections, coccidioidomycosis, cryptococcosis, dermatomycoses, diphtheria, ehrlichiosis, epidemic louse borne typhus, Escherichia coli infections, fusobacterium infections, gangrene, general infections, general mycoses, gonorrhea, gram-negative bacterial infections, gram-positive bacterial infections, histoplasmosis, impetigo, klebsiella infections, legionellosis, leprosy, leptospirosis, listeria infections, lyme disease, malaria, maduromycosis, melioidosis, mycobacterium infections, mycoplasma infections, necrotizing fasciitis, nocardia infections, onychomycosis, omithosis, pneumococcal infections, pneumonia, pseudomonas infections, Q fever, rat-bite fever, relapsing fever, rheumatic fever, rickettsia infections, Rocky-mountain spotted fever, salmonella infections, scarlet fever, scrub typhus, sepsis, sexually transmitted bacterial diseases, staphylococcal infections, streptococcal infections, surgical site infection, tetanus, tickborne diseases, tuberculosis, tularemia, typhoid fever, urinary tract infection, vibrio infections, yaws, yersinia infections, Yersinia pestis plague, zoonoses and zygomycosis.
10. The method of claim 1, wherein the
pathogenic microorganism is a bacteria, and the medical condition is a bacterial infection selected from one or more of actinomycosis, anthrax, aspergillosis, bacteremia, bacterial skin diseases, bartonella infections, botulism, brucellosis, burkholderia infections, campylobacter infections, candidiasis, cat-scratch disease, chlamydia infections, cholera, clostridium infections, coccidioidomycosis, cryptococcosis, dermatomycoses, diphtheria, ehrlichiosis, epidemic louse borne typhus, Escherichia coli infections, fusobacterium infections, gangrene, general infections, general mycoses, gonorrhea, gram-negative bacterial infections, gram-positive bacterial infections, histoplasmosis, impetigo, klebsiella infections, legionellosis, leprosy, leptospirosis, listeria infections, lyme disease, malaria, maduromycosis, melioidosis, mycobacterium infections, mycoplasma infections, necrotizing fasciitis, nocardia infections, onychomycosis, omithosis, pneumococcal infections, pneumonia, pseudomonas infections, Q fever, rat-bite fever, relapsing fever, rheumatic fever, rickettsia infections, Rocky-mountain spotted fever, salmonella infections, scarlet fever, scrub typhus, sepsis, sexually transmitted bacterial diseases, staphylococcal infections, streptococcal infections, surgical site infection, tetanus, tickborne diseases, tuberculosis, tularemia, typhoid fever, urinary tract infection, vibrio infections, yaws, yersinia infections, Yersinia pestis plague, zoonoses and zygomycosis.
26. (Previously Presented) The method of claim 10, wherein the
pathogenic microorganism is a fungi, and the medical condition is a fungal infection selected from one or more of endemic fungal infections, opportunistic fungal infections, histoplasmosis histoplasma associated with capsulatum, coccidioidomycosis associated with coccidioides immitis, blastomycosis blastomyces associated with dermatitidis, paracoccidioidomycosis paracoccidioides associated with brasiliensis, candidiasis associated with candida spp., aspergillosis associated with aspergillus spp., mucormycosis associated with mucor spp., infections associated with absidia, infections associated with rhizopus spp., and cryptococcosis associated with Cryptococcus neoformans.
11. The method of claim 1, wherein the
pathogenic microorganism is a fungi, and the medical condition is a fungal infection selected from one or more of endemic fungal infections, opportunistic fungal infections, histoplasmosis histoplasma associated with capsulatum, coccidioidomycosis associated with coccidioides immitis, blastomycosis blastomyces associated with dermatitidis, paracoccidioidomycosis paracoccidioides associated with brasiliensis, candidiasis associated with candida spp., aspergillosis associated with aspergillus spp., mucormycosis associated with mucor spp., infections associated with absidia, infections associated with rhizopus spp., and cryptococcosis associated with Cryptococcus neoformans.
27. (Previously Presented) The method of claim 10, wherein the
antimicrobial is selected from one or more of mandelic acid, 2,4-dichlorobenzenemethanol,
4-[bis( ethylthio )methyl]-2- methoxyphenol, 4-epitetracycline, 4-hexylresorcinol, 5, 12-dihydro-5, 7, 12, 14- tetrazapentacen, 5-chlorocarvacrol, 8-hydroxyquinoline, acetarsol, acetylkitasamycin, acriflavin, alatrofloxacin, ambazon, amfomycin, amikacin, amikacin sulfate, aminoacridine, aminosalicylate calcium, aminosalicylate sodium, aminosalicylic acid, ammoniumsulfobituminat, amorolfin, amoxicillin, amoxicillin sodium, amoxicillin trihydrate, amoxicillin-potassium clavulanate combination, amphotericin B, ampicillin, ampicillin sodium, ampicillin trihydrate, ampicillin-sulbactam, apalcillin, arbekacin, aspoxicillin, astromicin, astromicin sulfate, avermycin, azanidazole, azidamfenicol, azidocillin, azithromycin, azlocillin, aztreonam, bacampicillin, bacitracin, bacitracin zmc, bekanamycin, benzalkonium, benzethonium chloride, benzoxonium chloride, berberine hydrochloride, biapenem, bibrocathol, biclotymol, bifonazole, bismuth subsalicylate, bleomycin antibiotic complex, bleomycin hydrochloride, bleomycin sulfate, brodimoprim, bromochlorosalicylanilide, bronopol, broxyquinolin, butenafine, butenafine hydrochloride, butoconazol, calcium undecylenate, candicidin antibiotic complex, capreomycin, carbenicillin, carbenicillin disodium, carfecillin, carindacillin, carumonam, carzinophilin, caspofungin acetate, cefacetril, cefaclor, cefadroxil, cefalexin, cefalexin hydrochloride, cefalexin sodium, cefaloglycin, cefaloridine, cefalotin, cefalotin sodium, cefamandole, cefamandole nafate, cefamandole sodium, cefapirin, cefapirin sodium, cefatrizine, cefatrizine propylene glycol, cefazedone, cefazedone sodium salt, cefazolin, cefazolin sodium, cefbuperazone, cefbuperazone sodium, cefcapene, cefcapene pivoxil hydrochloride, cefdinir, cefditoren, cefditoren pivoxil, cefepime, cefepime hydrochloride, cefetamet, cefetamet pivoxil, cefixime, cefmenoxime, cefmetazole, cefinetazole sodium, cefininox, cefminox sodium, cefmolexin, cefodizime, cefodizime sodium, cefonicid, cefonicid sodium, cefoperazone, cefoperazone sodium, ceforanide, cefoselis sulfate, cefotaxime, cefotaxime sodium, cefotetan, cefotetan disodium, cefotiam, cefotiam hexetil hydrochloride, cefotiam hydrochloride, cefoxitin, cefoxitin sodium, cefozopran hydrochloride, cefpiramide, cefpiramide sodium, cefpirome, cefpirome sulfate, cefpodoxime, cefpodoxime proxetil, cefprozil, cefquinome, cefradine, cefroxadine, cefsulodin, ceftazidime, cefteram, cefteram pivoxil, ceftezole, ceftibuten, ceftizoxime, ceftizoxime sodium, ceftriaxone, ceftriaxone sodium, cefuroxime, cefuroxime axetil, cefuroxime sodium, cetalkonium chloride, cetrimide, cetrimonium, cetylpyridinium, chloramine T, chloramphenicol, chloramphenicol palmitate, chloramphenicol succinate sodium, chlorhexidine, chlormidazole, chlormidazole hydrochloride, chloroxylenol, chlorphenesin, chlorquinaldol, chlortetracycline, chlortetracycline hydrochloride, ciclacillin, ciclopirox, cinoxacin, ciprofloxacin, ciprofloxacin hydrochloride, citric acid, clarithromycin, clavulanate potassium, clavulanate sodium, clavulanic acid, clindamycin, clindamycin hydrochloride, clindamycin palmitate hydrochloride, clindamycin phosphate, clioquinol, cloconazole, cloconazole monohydrochloride, clofazimine, clofoctol, clometocillin, clomocycline, clotrimazol, cloxacillin, cloxacillin sodium, colistin, colistin sodium methanesulfonate, colistin sulfate, cycloserine, dactinomycin, danofloxacin, dapsone, daptomycin, daunorubicin, DDT, demeclocycline, demeclocycline hydrochloride, dequalinium, dibekacin, dibekacin sulfate, dibrompropamidine, dichlorophene, dicloxacillin, dicloxacillin sodium, didecyldimethylammonium chloride, dihydrostreptomycin, dihydrostreptomycin sulfate, diiodohydroxyquinolin, dimetridazole, dipyrithione, dirithromycin, DL-menthol, D-menthol, dodecyltriphenylphosphonium bromide, doxorubicin, doxorubicin hydrochloride, doxycycline, doxycycline hydrochloride, econazole, econazole nitrate, enilconazole, enoxacin, enrofloxacin, eosine, epicillin, ertapenem sodium, erythromycin, erythromycin estolate, erythromycin ethyl succinate, erythromycin lactobionate, erythromycin stearate, ethacridine, ethacridine lactate, ethambutol, ethanoic acid, ethionamide, ethyl alcohol, eugenol, exalamide, faropenem, fenticonazole, fenticonazole nitrate, fezatione, fleroxacin, flomoxef, flomoxef sodium, florfenicol, flucloxacillin, flucloxacillin magnesium, flucloxacillin sodium, fluconazole, flucytosine, flumequine, flurithromycin, flutrimazole, fosfomycin, fosfomycin calcium, fosfomycin sodium, framycetin, framycetin sulphate, furagin, furazolidone, fusafungin, fusidic acid, fusidic acid sodium salt, gatifloxacin, gemifloxacin, gentamicin antibiotic complex, gentamicin cla, gentamycin sulfate, glutaraldehyde, gramicidin, grepafloxacin, griseofulvin, halazon, haloprogine, hetacillin, hetacillin potassium, hexachlorophene, hexamidine, hexetidine, hydrargaphene, hydroquinone, hygromycin, imipenem, isepamicin, isepamicin sulfate, isoconazole, isoconazole nitrate, isoniazid, isopropanol, itraconazole, josamycin, josamycin propionate, kanamycin, kanamycin sulphate, ketoconazole, kitasamycin, lactic acid, lanoconazole, lenampicillin, leucomycin Al, leucomycin A13, leucomycin A4, leucomycin AS, leucomycin A6, leucomycin A7, leucomycin A8, leucomycin A9, levofloxacin, lincomycin, lincomycin hydrochloride, linezolid, liranaftate, 1- menthol, lomefloxacin, lomefloxacin hydrochloride, loracarbef, lymecyclin, lysozyme, mafenide acetate, magnesium monoperoxophthalate hexahydrate, mecetronium ethylsulfate, mecillinam, meclocycline, meclocycline sulfosalicylate, mepartricin, merbromin, meropenem, metalkonium chloride, metampicillin, methacycline, methenamin, methyl salicylate, methylbenzethonium chloride, methylrosanilinium chloride, meticillin, meticillin sodium, metronidazole, metronidazole benzoate, mezlocillin, mezlocillin sodium, miconazole, miconazole nitrate, micronomicin, micronomicin sulfate, midecamycin, minocycline, minocycline hydrochloride, miocamycin, miristalkonium chloride, mitomycin c, monensin, monensin sodium, morinamide, moxalactam, moxalactam disodium, moxifloxacin, mupirocin, mupirocin calcium, nadifloxacin, nafcillin, nafcillin sodium, naftifine, nalidixic acid, natamycin, neomycin a, neomycin antibiotic complex, neomycin C, neomycin sulfate, neticonazole, netilmicin, netilmicin sulfate, nifuratel, nifuroxazide, nifurtoinol, nifurzide, nimorazole, niridazole, nitrofurantoin, nitrofurazone, nitroxolin, norfloxacin, novobiocin, nystatin antibiotic complex, octenidine, ofloxacin, oleandomycin, omoconazol, orbifloxacin, omidazole, ortho-phenylphenol, oxacillin, oxacillinsodium, oxiconazole, oxiconazole nitrate, oxoferin, oxolinic acid, oxychlorosene, oxytetracycline, oxytetracycline calcium, oxytetracycline hydrochloride, pampenem, paromomycm, paromomycm sulfate, pazufloxacine, pefloxacin, pefloxacin mesylate, penamecillin, penicillin G, penicillin G potassium, penicillin G sodium, penicillin V, penicillin V calcium, penicillin V potassium, pentamidine, pentamidine diisetionate, pentamidine mesilas, pentamycin, phenethicillin, phenol, phenoxyethanol, phenylmercuriborat, PHMB, phthalylsulfathiazole, picloxydin, pipemidic acid, piperacillin, piperacillin sodium, pipercillin sodium - tazobactam sodium, piromidic acid, pivampicillin, pivcefalexin, pivmecillinam, pivmecillinam hydrochloride, policresulen, polymyxin antibiotic complex, polymyxin B, polymyxin B sulfate, polymyxin Bl, polynoxylin, povidone-iodine, propamidin, propenidazole, propicillin, propicillin potassium, propionic acid, prothionamide, protiofate, pyrazinamide, pyrimethamine, pyridomycin, pyrithion, pyrrolnitrin, quinoline, quinupristin-dalfopristin, resorcinol, ribostamycin, ribostamycin sulfate, rifabutin, rifampicin, rifamycin, rifapentine, rifaximin, ritiometan, rokitamycin, rolitetracycline, rosoxacin, roxithromycin, rufloxacin, salicylic acid, secnidazol, selenium disulphide, sertaconazole, sertaconazole nitrate, siccanin, sisomicin, sisomicin sulfate, sodium thiosulfate, sparfloxacin, spectinomycin, spectinomycin hydrochloride, spiramycin antibiotic complex, spiramycin b, streptomycin, streptomycin sulphate, succinylsulfathiazole, sulbactam, sulbactam sodium, sulbenicillin disodium, sulbentin, sulconazole, sulconazole nitrate, sulfabenzamide, sulfacarbamide, sulfacetamide, sulfacetamide sodium, sulfachlorpyridazine, sulfadiazine, sulfadiazine silver, sulfadiazine sodium, sulfadicramide, sulfadimethoxine, sulfadoxine, sulfaguanidine, sulfalene, sulfamazone, sulfamerazine, sulfamethazine, sulfamethazine sodium, sulfamethizole, sulfamethoxazole, sulfamethoxazol-trimethoprim, sulfamethoxypyridazine, sulfamonomethoxine, sulfamoxol, sulfanilamide, sulfaperine, sulfaphenazol, sulfapyridine, sulfaquinoxaline, sulfasuccinamide, sulfathiazole, sulfathiourea, sulfatolamide, sulfatriazin, sulfisomidine, sulfisoxazole, sulfisoxazole acetyl, sulfonamides, sultamicillin, sultamicillin tosilate, tacrolimus, talampicillin 15 hydrochloride, teicoplanin A2 complex, teicoplanin A2-1, teicoplanin A2-2, teicoplanin A2-3, teicoplanin A2-4, teicoplanin A2-5, teicoplanin A3, teicoplanin antibiotic complex, telithromycin, temafloxacin, temocillin, tenoic acid, terbinafine, terconazole, terizidone, tetracycline, tetracycline hydrochloride, tetracycline metaphosphate, tetramethylthiuram monosulfide, tetroxoprim, thiabendazole, thiamphenicol, thiaphenicol glycinate hydrochloride, 20 thiomersal, thiram, thymol, tibezonium iodide, ticarcillin, ticarcillin-clavulanic acid mixture, ticarcillin disodium, ticarcillin monosodium, tilbroquinol, tilmicosin, tinidazole, tioconazole, tobramycin, tobramycin sulfate, tolciclate, tolindate, tolnaftate, toloconium metilsulfat, toltrazuril, tosufloxacin, triclocarban, triclosan, trimethoprim, trimethoprim sulfate, triphenylstibinsulfide, troleandomycin, trovafloxacin, tylosin, tyrothricin, undecoylium chloride, undecylenic acid, vancomycin, vancomycin hydrochloride, viomycin, virginiamycin antibiotic complex, voriconazol, xantocillin, xibomol and zinc undecylenate.
12. The method of claim 1, wherein the
antimicrobial is selected from one or more of mandelic acid, 2,4-dichlorobenzenemethanol,
4-[bis(ethylthio)methyl]-2-methoxyphenol,
4-epitetracycline, 4-hexylresorcinol, 5, 12-dihydro-5, 7, 12, 14-tetrazapentacen, 5-chlorocarvacrol, 8-hydroxyquinoline, acetarsol, acetylkitasamycin, acriflavin, alatrofloxacin, ambazon, amfomycin, amikacin, amikacin sulfate, aminoacridine, aminosalicylate calcium, aminosalicylate sodium, aminosalicylic acid, ammoniumsulfobituminat, amorolfin, amoxicillin, amoxicillin sodium, amoxicillin trihydrate, amoxicillin-potassium clavulanate combination, amphotericin B, ampicillin, ampicillin sodium, ampicillin trihydrate, ampicillin-sulbactam, apalcillin, arbekacin, aspoxicillin, astromicin, astromicin sulfate, avermycin, azanidazole, azidamfenicol, azidocillin, azithromycin, azlocillin, aztreonam, bacampicillin, bacitracin, bacitracin zmc, bekanamycin, benzalkonium, benzethonium chloride, benzoxonium chloride, berberine
hydrochloride, biapenem, bibrocathol, biclotymol, bifonazole, bismuth subsalicylate, bleomycin antibiotic complex, bleomycin hydrochloride, bleomycin sulfate, brodimoprim, bromochlorosalicylanilide, bronopol, broxyquinolin, butenafine, butenafine hydrochloride, butoconazol, calcium undecylenate, candicidin antibiotic complex, capreomycin, carbenicillin, carbenicillin disodium, carfecillin, carindacillin, carumonam, carzinophilin, caspofungin acetate, cefacetril, cefaclor, cefadroxil, cefalexin, cefalexin hydrochloride, cefalexin sodium, cefaloglycin, cefaloridine, cefalotin, cefalotin sodium, cefamandole, cefamandole nafate, cefamandole sodium, cefapirin, cefapirin sodium, cefatrizine, cefatrizine propylene glycol, cefazedone, cefazedone sodium salt, cefazolin, cefazolin sodium, cefbuperazone, cefbuperazone sodium, cefcapene, cefcapene pivoxil hydrochloride, cefdinir, cefditoren, cefditoren pivoxil, cefepime, cefepime hydrochloride, cefetamet, cefetamet pivoxil, cefixime, cefmenoxime, cefmetazole, cefinetazole sodium, cefininox, cefminox sodium, cefmolexin, cefodizime, cefodizime sodium, cefonicid, cefonicid sodium, cefoperazone, cefoperazone sodium, ceforanide, cefoselis sulfate, cefotaxime, cefotaxime sodium, cefotetan, cefotetan disodium, cefotiam, cefotiam hexetil hydrochloride, cefotiam hydrochloride, cefoxitin, cefoxitin sodium, cefozopran hydrochloride, cefpiramide, cefpiramide sodium, cefpirome, cefpirome sulfate, cefpodoxime, cefpodoxime proxetil, cefprozil, cefquinome, cefradine, cefroxadine, cefsulodin, ceftazidime, cefteram, cefteram pivoxil, ceftezole, ceftibuten, ceftizoxime, ceftizoxime sodium, ceftriaxone, ceftriaxone sodium, cefuroxime, cefuroxime axetil, cefuroxime sodium, cetalkonium chloride, cetrimide, cetrimonium, cetylpyridinium, chloramine T, chloramphenicol, chloramphenicol palmitate, chloramphenicol succinate sodium, chlorhexidine, chlormidazole, chlormidazole hydrochloride, chloroxylenol, chlorphenesin, chlorquinaldol, chlortetracycline, chlortetracycline hydrochloride, ciclacillin, ciclopirox, cinoxacin, ciprofloxacin, ciprofloxacin hydrochloride, citric acid, clarithromycin, clavulanate potassium, clavulanate sodium, clavulanic acid, clindamycin, clindamycin hydrochloride, clindamycin palmitate hydrochloride, clindamycin phosphate, clioquinol, cloconazole, cloconazole monohydrochloride, clofazimine, clofoctol, clometocillin, clomocycline, clotrimazol, cloxacillin, cloxacillin sodium, colistin, colistin sodium methanesulfonate, colistin sulfate, cycloserine, dactinomycin, danofloxacin, dapsone, daptomycin, daunorubicin, DDT, demeclocycline, demeclocycline hydrochloride, dequalinium, dibekacin, dibekacin sulfate, dibrompropamidine, dichlorophene, dicloxacillin, dicloxacillin sodium, didecyldimethylammonium chloride, dihydrostreptomycin, dihydrostreptomycin sulfate, diiodohydroxyquinolin, dimetridazole, dipyrithione, dirithromycin, DL-menthol, D-menthol, dodecyltriphenylphosphonium bromide, doxorubicin, doxorubicin hydrochloride, doxycycline, doxycycline hydrochloride, econazole, econazole nitrate, enilconazole, enoxacin, enrofloxacin, eosine, epicillin, ertapenem sodium, erythromycin, erythromycin estolate, erythromycin ethyl succinate, erythromycin lactobionate, erythromycin stearate, ethacridine, ethacridine lactate, ethambutol, ethanoic acid, ethionamide, ethyl alcohol, eugenol, exalamide, faropenem, fenticonazole, fenticonazole nitrate, fezatione, fleroxacin, flomoxef, flomoxef sodium, florfenicol, flucloxacillin, flucloxacillin magnesium, flucloxacillin sodium, fluconazole, flucytosine, flumequine, flurithromycin, flutrimazole, fosfomycin, fosfomycin calcium, fosfomycin sodium, framycetin, framycetin sulphate, furagin, furazolidone, fusafungin, fusidic acid, fusidic acid sodium salt, gatifloxacin, gemifloxacin, gentamicin antibiotic complex, gentamicin cla, gentamycin sulfate, glutaraldehyde, gramicidin, grepafloxacin, griseofulvin, halazon, haloprogine, hetacillin, hetacillin potassium, hexachlorophene, hexamidine, hexetidine, hydrargaphene, hydroquinone, hygromycin, imipenem, isepamicin, isepamicin sulfate, isoconazole, isoconazole nitrate, isoniazid, isopropanol, itraconazole, josamycin, josamycin propionate, kanamycin, kanamycin sulphate, ketoconazole, kitasamycin, lactic acid, lanoconazole, lenampicillin, leucomycin A1, leucomycin A13, leucomycin A4, leucomycin AS, leucomycin A6, leucomycin A7, leucomycin A8, leucomycin A9, levofloxacin, lincomycin, lincomycin hydrochloride, linezolid, liranaftate, 1-menthol, lomefloxacin, lomefloxacin hydrochloride, loracarbef, lymecyclin, lysozyme, mafenide acetate, magnesium monoperoxophthalate hexahydrate, mecetronium ethylsulfate, mecillinam, meclocycline, meclocycline sulfosalicylate, mepartricin, merbromin, meropenem, metalkonium chloride, metampicillin, methacycline, methenamin, methyl salicylate, methylbenzethonium chloride, methylrosanilinium chloride, meticillin, meticillin sodium, metronidazole, metronidazole benzoate, mezlocillin, mezlocillin sodium, miconazole, miconazole nitrate, micronomicin, micronomicin sulfate, midecamycin, minocycline, minocycline hydrochloride, miocamycin, miristalkonium chloride, mitomycin c, monensin, monensin sodium, morinamide, moxalactam, moxalactam disodium, moxifloxacin, mupirocin, mupirocin calcium, nadifloxacin, nafcillin, nafcillin sodium, naftifine, nalidixic acid, natamycin, neomycin a, neomycin antibiotic complex, neomycin C, neomycin sulfate, neticonazole, netilmicin, netilmicin sulfate, nifuratel, nifuroxazide, nifurtoinol, nifurzide, nimorazole, niridazole, nitrofurantoin, nitrofurazone, nitroxolin, norfloxacin, novobiocin, nystatin antibiotic complex, octenidine, ofloxacin, oleandomycin, omoconazol, orbifloxacin, omidazole, ortho-phenylphenol, oxacillin, oxacillinsodium, oxiconazole, oxiconazole nitrate, oxoferin, oxolinic acid, oxychlorosene, oxytetracycline, oxytetracycline calcium, oxytetracycline hydrochloride, pampenem, paromomycm, paromomycm sulfate, pazufloxacine, pefloxacin, pefloxacin mesylate, penamecillin, penicillin G, penicillin G potassium, penicillin G sodium, penicillin V, penicillin V calcium, penicillin V potassium, pentamidine, pentamidine diisetionate, pentamidine mesilas, pentamycin, phenethicillin, phenol, phenoxyethanol, phenylmercuriborat, PHMB, phthalylsulfathiazole, picloxydin, pipemidic acid, piperacillin, piperacillin sodium, pipercillin sodium-tazobactam sodium, piromidic acid, pivampicillin, pivcefalexin, pivmecillinam, pivmecillinam hydrochloride, policresulen, polymyxin antibiotic complex, polymyxin B, polymyxin B sulfate, polymyxin Bl, polynoxylin, povidone-iodine, propamidin, propenidazole, propicillin, propicillin potassium, propionic acid, prothionamide, protiofate, pyrazinamide, pyrimethamine, pyridomycin, pyrithion, pyrrolnitrin, quinoline, quinupristin-dalfopristin, resorcinol, ribostamycin, ribostamycin sulfate, rifabutin, rifampicin, rifamycin, rifapentine, rifaximin, ritiometan, rokitamycin, rolitetracycline, rosoxacin, roxithromycin, rufloxacin, salicylic acid, secnidazol, selenium disulphide, sertaconazole, sertaconazole nitrate, siccanin, sisomicin, sisomicin sulfate, sodium thiosulfate, sparfloxacin, spectinomycin, spectinomycin hydrochloride, spiramycin antibiotic complex, spiramycin b, streptomycin, streptomycin sulphate, succinylsulfathiazole, sulbactam, sulbactam sodium, sulbenicillin disodium, sulbentin, sulconazole, sulconazole nitrate, sulfabenzamide, sulfacarbamide, sulfacetamide, sulfacetamide sodium, sulfachlorpyridazine, sulfadiazine, sulfadiazine silver, sulfadiazine sodium, sulfadicramide, sulfadimethoxine, sulfadoxine, sulfaguanidine, sulfalene, sulfamazone, sulfamerazine, sulfamethazine, sulfamethazine sodium, sulfamethizole, sulfamethoxazole, sulfamethoxazol-trimethoprim, sulfamethoxypyridazine, sulfamonomethoxine, sulfamoxol, sulfanilamide, sulfaperine, sulfaphenazol, sulfapyridine, sulfaquinoxaline, sulfasuccinamide, sulfathiazole, sulfathiourea, sulfatolamide, sulfatriazin, sulfisomidine, sulfisoxazole, sulfisoxazole acetyl, sulfonamides, sultamicillin, sultamicillin tosilate, tacrolimus, talampicillin 15 hydrochloride, teicoplanin A2 complex, teicoplanin A2-1, teicoplanin A2-2, teicoplanin A2-3, teicoplanin A2-4, teicoplanin A2-5, teicoplanin A3, teicoplanin antibiotic complex, telithromycin, temafloxacin, temocillin, tenoic acid, terbinafine, terconazole, terizidone, tetracycline, tetracycline hydrochloride, tetracycline metaphosphate, tetramethylthiuram monosulfide, tetroxoprim, thiabendazole, thiamphenicol, thiaphenicol glycinate hydrochloride, 20 thiomersal, thiram, thymol, tibezonium iodide, ticarcillin, ticarcillin-clavulanic acid mixture, ticarcillin disodium, ticarcillin monosodium, tilbroquinol, tilmicosin, tinidazole, tioconazole, tobramycin, tobramycin sulfate, tolciclate, tolindate, tolnaftate, toloconium metilsulfat, toltrazuril, tosufloxacin, triclocarban, triclosan, trimethoprim, trimethoprim sulfate, triphenylstibinsulfide, troleandomycin, trovafloxacin, tylosin, tyrothricin, undecoylium chloride, undecylenic acid, vancomycin, vancomycin hydrochloride, viomycin, virginiamycin antibiotic complex, voriconazol, xantocillin, xibomol and zinc undecylenate.
28. (Previously Presented) The method of claim 10 wherein the
antimicrobial is selected from one or more of polyenes, amphotericin B, liposomal amphotericin, nystatin, and pimaricin; azoles, fluconazole, itraconazole, ketoconazole, itraconazole, voriconazole, posaconazole, anidulafungin, caspofungin, micafungin, allylamines, naftifine, binafine, amorolfine, 5-fluorocytosine, amoxicillin, amoxicillin sodium, amoxicillin trihydrate, amoxicillin-potassium clavulanate combination, aztreonam, azithromycin, azlocillin, clofazimine, cloxacillin, cloxacillin sodium, dicloxacillin, cefdinir, cefditoren, cefditoren pivoxil, cefepime, cefepime hydrochloride, colistin, colistin sodium methanesulfonate, colistin sulfate, clarithromycin, cefprozil, cefaclor, cefuroxime, cefuroxime axetil, cefuroxime sodium, dicloxacillin sodium, amikacin, amikacin sulfate, flucloxacillin, flucloxacillin magnesium, flucloxacillin sodium, doxycycline, doxycycline hydrochloride, imipenem, levofloxacin, linezolid, minocycline, minocycline hydrochloride, mezlocillin, mezlocillin sodium, nafcillin, nafcillin sodium, oxacillin, piperacillin, penicillin G, ciprofloxacin, ciprofloxacin hydrochloride, erythromycin, sulfisoxazole, sulfisoxazole acetyl, sulfamethoxazole, sulfamethoxazol-trimethoprim, tazobactam, tazobactam sodium, tetracycline, tobramycin, tobramycin sulfate, ticarcillin, ticarcillin-clavulanic acid mixture, ticarcillin disodium, ticarcillin monosodium, gentamicin, vancomycin and methicillin.
13. The method of claim 1 wherein the
antimicrobial is selected from one or more of polyenes, amphotericin B, liposomal amphotericin, nystatin, and pimaricin; azoles, fluconazole, itraconazole, ketoconazole, itraconazole, voriconazole, posaconazole, anidulafungin, caspofungin, micafungin, allylamines, naftifine, binafine, amorolfine, 5-fluorocytosine, amoxicillin, amoxicillin sodium, amoxicillin trihydrate, amoxicillin-potassium clavulanate combination, aztreonam, azithromycin, azlocillin, clofazimine, cloxacillin, cloxacillin sodium, dicloxacillin, cefdinir, cefditoren, cefditoren pivoxil, cefepime, cefepime hydrochloride, colistin, colistin sodium methanesulfonate, colistin sulfate, clarithromycin, cefprozil, cefaclor, cefuroxime, cefuroxime axetil, cefuroxime sodium, dicloxacillin sodium, amikacin, amikacin sulfate, flucloxacillin, flucloxacillin magnesium, flucloxacillin sodium, doxycycline, doxycycline hydrochloride, imipenem, levofloxacin, linezolid, minocycline, minocycline hydrochloride, mezlocillin, mezlocillin sodium, nafcillin, nafcillin sodium, oxacillin, piperacillin, penicillin G, ciprofloxacin, ciprofloxacin hydrochloride, erythromycin, sulfisoxazole, sulfisoxazole acetyl, sulfamethoxazole, sulfamethoxazol-trimethoprim, tazobactam, tazobactam sodium, tetracycline, tobramycin, tobramycin sulfate, ticarcillin, ticarcillin-clavulanic acid mixture, ticarcillin disodium, ticarcillin monosodium, gentamicin, vancomycin and methicillin.
Regarding the instant limitation of “topically administering … gaseous nitric oxide” as compared to the patent claim’s “administering … of nitric oxide by inhalation”, the term “topical administration” involves applying medications directly to the skin or mucous membranes to achieve localized therapeutic effects. The nose and/or mouth of the user is a mucous membrane thus the administering of the gaseous nitric oxide to the nose and/or mouth is inhalation a form of topical delivery of medication to the user. Hence, the term “topical” is a “generic” administration type; whilst, “inhalation” is a specific / ”species” administration type. As previously stated, the “generic” invention is “anticipated” by the “species”. Thus, the instant claims are anticipated by the patent claims and are not patentably distinct from the patent claims.
Claims 10, 20-22, 27, and 28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-15 of U.S. Patent No. 12,274,830.
Although the claims at issue are not identical, they are not patentably distinct from each other because instant independent claim, Claim 10, is merely broader than patent claim, Claim 10. It is clear that all of the elements of the instant claims are found in the patent claims. The difference lies in the fact that the patent claims include many more elements and is thus much more specific. Thus, the invention of the patent claims is in effect a “species” of the “generic” invention of the instant claims. It has been held that the “generic” invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the instant claims are anticipated by the patent claims they are not patentably distinct.
Instant Application – 18391989
Differences Underlined
Similarities Italicized
Patent - 12,274,830
Differences Underlined
Similarities Italicized
10. (Previously Presented) A method of treating a subject having a medical condition associated with a pathogenic microorganism, the method comprising:
(i) topically administering to said subject a potentiating effective amount of gaseous nitric oxide (gNO); and
(ii) administering to said subject a therapeutically effective amount of an antimicrobial agent, wherein said antimicrobial agent is other than said gNO.
1. A method of delivering gaseous nitric oxide (gNO) to a patient in need thereof, the method comprising
administering, by intermittent inhalation, 200 ppm to 320 ppm gNO for 10 to 45 minutes 2 to 5 times per day to provide a therapeutic amount of gNO wherein the therapeutic amount is a nitric oxide-load (NO load) of 300 ppm-hrs to 900 ppm-hrs of gNO per day over a period of at least 14 days; wherein the patient has a condition associated with a pathogenic microorganism; wherein the pathogenic microorganism is non-tuberculous mycobacteria (NTM); and wherein the therapeutic amount of gNO results in a reduction of a bacterial load of the NTM.
AND
10. The method according to claim 1, wherein an antimicrobial agent is administered in combination with gNO.
11. (Previously Presented) The method of claim 10, wherein said potentiating effective amount is lower than a therapeutically effective amount of said gNO with respect to said pathogenic microorganism.
12. (Previously Presented) The method of claim 11, wherein said potentiating effective amount is lower than 1 MIC unit of gNO with respect to said pathogenic microorganism.
13. (Previously Presented) The method of claim 10, wherein said pathogenic microorganism exhibits a resistance to said antimicrobial agent prior to said administering said potentiating effective amount of gNO.
14. (Previously Presented) The method of claim 10, wherein said antimicrobial agent is inactive when used against said pathogenic microorganism.
20. (Previously Presented) The method of claim 10,
wherein (i) is affected prior to (ii).
15. The method according to claim 10,
wherein the antimicrobial agent is administered after gNO.
21. (Previously Presented) The method of claim 10,
wherein (i) is affected concomitantly with (ii).
14. The method according to claim 10,
wherein the antimicrobial agent is administered concomitantly with gNO.
22. (Previously Presented) The method of claim 10,
wherein (ii) is affected prior to (i).
13. The method according to claim 10,
wherein the antimicrobial agent is administered prior to gNO.
23. (Previously Presented) The method of claim 10, wherein the pathogenic microorganism is selected from one or more of gram-negative bacteria, gram-positive bacteria, eubacteria, archaebacteria, eukaryotic organisms, yeast, fungi, algae, protozoa, and other parasites.
24. (Previously Presented) The method of claim 23, wherein the pathogenic microorganism is selected from one or more of Plasmodium falciparum and related malaria-causing protozoan parasites, Acanthamoeb, Aeromonas hydrophila, Anisakis and related worms, Serracia sp., Enterobacter sp., Acinetobacter sp., Acinetobacter baumanii, Ascaris lumbricoides, Bacillus cereus, Brevundimonas diminuta, Campylobacter jejuni, Clostridium botulinum, Clostridium peifringens, Cryptosporidium parvum, Cyclospora cayetanensis, Diphyllobothrium, Entamoeba histolytica, Escherichia coli, Eustrongylides, Giardia lamblia, Klebsiella pneumoniae, Listeria monocytogenes, Nanophyetus, Mycobacterium smegmatis, Mycobacterium tuberculosis, Mycobacterium avium intracellularae, Plesiomonas shigelloides, Proteus mirabilis, Pseudomonas aeruginosa, Salmonella, Serratia odorifera, Shigella, Staphylococcus aureus, Stenotrophomonas maltophilia, Streptococcus, Trichuris trichiura, Vibrio cholerae, Vibrio parahaemolyticus, Vibrio vulnifzcus, Yersinia enterocolitica, Yersinia pseudotuberculosis and Yersinia kristensenii.
25. (Previously Presented) The method of claims 10, wherein the pathogenic microorganism is a bacteria, and the medical condition is a bacterial infection selected from one or more of actinomycosis, anthrax, aspergillosis, bacteremia, bacterial skin diseases, bartonella infections, botulism, brucellosis, burkholderia infections, campylobacter infections, candidiasis, cat-scratch disease, chlamydia infections, cholera, clostridium infections, coccidioidomycosis, cryptococcosis, dermatomycoses, diphtheria, ehrlichiosis, epidemic louse borne typhus, Escherichia coli infections, fusobacterium infections, gangrene, general infections, general mycoses, gonorrhea, gram-negative bacterial infections, gram-positive bacterial infections, histoplasmosis, impetigo, klebsiella infections, legionellosis, leprosy, leptospirosis, listeria infections, lyme disease, malaria, maduromycosis, melioidosis, mycobacterium infections, mycoplasma infections, necrotizing fasciitis, nocardia infections, onychomycosis, omithosis, pneumococcal infections, pneumonia, pseudomonas infections, Q fever, rat-bite fever, relapsing fever, rheumatic fever, rickettsia infections, Rocky-mountain spotted fever, salmonella infections, scarlet fever, scrub typhus, sepsis, sexually transmitted bacterial diseases, staphylococcal infections, streptococcal infections, surgical site infection, tetanus, tickborne diseases, tuberculosis, tularemia, typhoid fever, urinary tract infection, vibrio infections, yaws, yersinia infections, Yersinia pestis plague, zoonoses and zygomycosis.
26. (Previously Presented) The method of claim 10, wherein the pathogenic microorganism is a fungi, and the medical condition is a fungal infection selected from one or more of endemic fungal infections, opportunistic fungal infections, histoplasmosis histoplasma associated with capsulatum, coccidioidomycosis associated with coccidioides immitis, blastomycosis blastomyces associated with dermatitidis, paracoccidioidomycosis paracoccidioides associated with brasiliensis, candidiasis associated with candida spp., aspergillosis associated with aspergillus spp., mucormycosis associated with mucor spp., infections associated with absidia, infections associated with rhizopus spp., and cryptococcosis associated with Cryptococcus neoformans.
27. (Previously Presented) The method of claim 10, wherein the
antimicrobial is selected from one or more of mandelic acid, 2,4-dichlorobenzenemethanol,
4-[bis( ethylthio )methyl]-2- methoxyphenol, 4-epitetracycline, 4-hexylresorcinol, 5, 12-dihydro-5, 7, 12, 14- tetrazapentacen, 5-chlorocarvacrol, 8-hydroxyquinoline, acetarsol, acetylkitasamycin, acriflavin, alatrofloxacin, ambazon, amfomycin, amikacin, amikacin sulfate, aminoacridine, aminosalicylate calcium, aminosalicylate sodium, aminosalicylic acid, ammoniumsulfobituminat, amorolfin, amoxicillin, amoxicillin sodium, amoxicillin trihydrate, amoxicillin-potassium clavulanate combination, amphotericin B, ampicillin, ampicillin sodium, ampicillin trihydrate, ampicillin-sulbactam, apalcillin, arbekacin, aspoxicillin, astromicin, astromicin sulfate, avermycin, azanidazole, azidamfenicol, azidocillin, azithromycin, azlocillin, aztreonam, bacampicillin, bacitracin, bacitracin zmc, bekanamycin, benzalkonium, benzethonium chloride, benzoxonium chloride, berberine hydrochloride, biapenem, bibrocathol, biclotymol, bifonazole, bismuth subsalicylate, bleomycin antibiotic complex, bleomycin hydrochloride, bleomycin sulfate, brodimoprim, bromochlorosalicylanilide, bronopol, broxyquinolin, butenafine, butenafine hydrochloride, butoconazol, calcium undecylenate, candicidin antibiotic complex, capreomycin, carbenicillin, carbenicillin disodium, carfecillin, carindacillin, carumonam, carzinophilin, caspofungin acetate, cefacetril, cefaclor, cefadroxil, cefalexin, cefalexin hydrochloride, cefalexin sodium, cefaloglycin, cefaloridine, cefalotin, cefalotin sodium, cefamandole, cefamandole nafate, cefamandole sodium, cefapirin, cefapirin sodium, cefatrizine, cefatrizine propylene glycol, cefazedone, cefazedone sodium salt, cefazolin, cefazolin sodium, cefbuperazone, cefbuperazone sodium, cefcapene, cefcapene pivoxil hydrochloride, cefdinir, cefditoren, cefditoren pivoxil, cefepime, cefepime hydrochloride, cefetamet, cefetamet pivoxil, cefixime, cefmenoxime, cefmetazole, cefinetazole sodium, cefininox, cefminox sodium, cefmolexin, cefodizime, cefodizime sodium, cefonicid, cefonicid sodium, cefoperazone, cefoperazone sodium, ceforanide, cefoselis sulfate, cefotaxime, cefotaxime sodium, cefotetan, cefotetan disodium, cefotiam, cefotiam hexetil hydrochloride, cefotiam hydrochloride, cefoxitin, cefoxitin sodium, cefozopran hydrochloride, cefpiramide, cefpiramide sodium, cefpirome, cefpirome sulfate, cefpodoxime, cefpodoxime proxetil, cefprozil, cefquinome, cefradine, cefroxadine, cefsulodin, ceftazidime, cefteram, cefteram pivoxil, ceftezole, ceftibuten, ceftizoxime, ceftizoxime sodium, ceftriaxone, ceftriaxone sodium, cefuroxime, cefuroxime axetil, cefuroxime sodium, cetalkonium chloride, cetrimide, cetrimonium, cetylpyridinium, chloramine T, chloramphenicol, chloramphenicol palmitate, chloramphenicol succinate sodium, chlorhexidine, chlormidazole, chlormidazole hydrochloride, chloroxylenol, chlorphenesin, chlorquinaldol, chlortetracycline, chlortetracycline hydrochloride, ciclacillin, ciclopirox, cinoxacin, ciprofloxacin, ciprofloxacin hydrochloride, citric acid, clarithromycin, clavulanate potassium, clavulanate sodium, clavulanic acid, clindamycin, clindamycin hydrochloride, clindamycin palmitate hydrochloride, clindamycin phosphate, clioquinol, cloconazole, cloconazole monohydrochloride, clofazimine, clofoctol, clometocillin, clomocycline, clotrimazol, cloxacillin, cloxacillin sodium, colistin, colistin sodium methanesulfonate, colistin sulfate, cycloserine, dactinomycin, danofloxacin, dapsone, daptomycin, daunorubicin, DDT, demeclocycline, demeclocycline hydrochloride, dequalinium, dibekacin, dibekacin sulfate, dibrompropamidine, dichlorophene, dicloxacillin, dicloxacillin sodium, didecyldimethylammonium chloride, dihydrostreptomycin, dihydrostreptomycin sulfate, diiodohydroxyquinolin, dimetridazole, dipyrithione, dirithromycin, DL-menthol, D-menthol, dodecyltriphenylphosphonium bromide, doxorubicin, doxorubicin hydrochloride, doxycycline, doxycycline hydrochloride, econazole, econazole nitrate, enilconazole, enoxacin, enrofloxacin, eosine, epicillin, ertapenem sodium, erythromycin, erythromycin estolate, erythromycin ethyl succinate, erythromycin lactobionate, erythromycin stearate, ethacridine, ethacridine lactate, ethambutol, ethanoic acid, ethionamide, ethyl alcohol, eugenol, exalamide, faropenem, fenticonazole, fenticonazole nitrate, fezatione, fleroxacin, flomoxef, flomoxef sodium, florfenicol, flucloxacillin, flucloxacillin magnesium, flucloxacillin sodium, fluconazole, flucytosine, flumequine, flurithromycin, flutrimazole, fosfomycin, fosfomycin calcium, fosfomycin sodium, framycetin, framycetin sulphate, furagin, furazolidone, fusafungin, fusidic acid, fusidic acid sodium salt, gatifloxacin, gemifloxacin, gentamicin antibiotic complex, gentamicin cla, gentamycin sulfate, glutaraldehyde, gramicidin, grepafloxacin, griseofulvin, halazon, haloprogine, hetacillin, hetacillin potassium, hexachlorophene, hexamidine, hexetidine, hydrargaphene, hydroquinone, hygromycin, imipenem, isepamicin, isepamicin sulfate, isoconazole, isoconazole nitrate, isoniazid, isopropanol, itraconazole, josamycin, josamycin propionate, kanamycin, kanamycin sulphate, ketoconazole, kitasamycin, lactic acid, lanoconazole, lenampicillin, leucomycin Al, leucomycin A13, leucomycin A4, leucomycin AS, leucomycin A6, leucomycin A7, leucomycin A8, leucomycin A9, levofloxacin, lincomycin, lincomycin hydrochloride, linezolid, liranaftate, 1- menthol, lomefloxacin, lomefloxacin hydrochloride, loracarbef, lymecyclin, lysozyme, mafenide acetate, magnesium monoperoxophthalate hexahydrate, mecetronium ethylsulfate, mecillinam, meclocycline, meclocycline sulfosalicylate, mepartricin, merbromin, meropenem, metalkonium chloride, metampicillin, methacycline, methenamin, methyl salicylate, methylbenzethonium chloride, methylrosanilinium chloride, meticillin, meticillin sodium, metronidazole, metronidazole benzoate, mezlocillin, mezlocillin sodium, miconazole, miconazole nitrate, micronomicin, micronomicin sulfate, midecamycin, minocycline, minocycline hydrochloride, miocamycin, miristalkonium chloride, mitomycin c, monensin, monensin sodium, morinamide, moxalactam, moxalactam disodium, moxifloxacin, mupirocin, mupirocin calcium, nadifloxacin, nafcillin, nafcillin sodium, naftifine, nalidixic acid, natamycin, neomycin a, neomycin antibiotic complex, neomycin C, neomycin sulfate, neticonazole, netilmicin, netilmicin sulfate, nifuratel, nifuroxazide, nifurtoinol, nifurzide, nimorazole, niridazole, nitrofurantoin, nitrofurazone, nitroxolin, norfloxacin, novobiocin, nystatin antibiotic complex, octenidine, ofloxacin, oleandomycin, omoconazol, orbifloxacin, omidazole, ortho-phenylphenol, oxacillin, oxacillinsodium, oxiconazole, oxiconazole nitrate, oxoferin, oxolinic acid, oxychlorosene, oxytetracycline, oxytetracycline calcium, oxytetracycline hydrochloride, pampenem, paromomycm, paromomycm sulfate, pazufloxacine, pefloxacin, pefloxacin mesylate, penamecillin, penicillin G, penicillin G potassium, penicillin G sodium, penicillin V, penicillin V calcium, penicillin V potassium, pentamidine, pentamidine diisetionate, pentamidine mesilas, pentamycin, phenethicillin, phenol, phenoxyethanol, phenylmercuriborat, PHMB, phthalylsulfathiazole, picloxydin, pipemidic acid, piperacillin, piperacillin sodium, pipercillin sodium - tazobactam sodium, piromidic acid, pivampicillin, pivcefalexin, pivmecillinam, pivmecillinam hydrochloride, policresulen, polymyxin antibiotic complex, polymyxin B, polymyxin B sulfate, polymyxin Bl, polynoxylin, povidone-iodine, propamidin, propenidazole, propicillin, propicillin potassium, propionic acid, prothionamide, protiofate, pyrazinamide, pyrimethamine, pyridomycin, pyrithion, pyrrolnitrin, quinoline, quinupristin-dalfopristin, resorcinol, ribostamycin, ribostamycin sulfate, rifabutin, rifampicin, rifamycin, rifapentine, rifaximin, ritiometan, rokitamycin, rolitetracycline, rosoxacin, roxithromycin, rufloxacin, salicylic acid, secnidazol, selenium disulphide, sertaconazole, sertaconazole nitrate, siccanin, sisomicin, sisomicin sulfate, sodium thiosulfate, sparfloxacin, spectinomycin, spectinomycin hydrochloride, spiramycin antibiotic complex, spiramycin b, streptomycin, streptomycin sulphate, succinylsulfathiazole, sulbactam, sulbactam sodium, sulbenicillin disodium, sulbentin, sulconazole, sulconazole nitrate, sulfabenzamide, sulfacarbamide, sulfacetamide, sulfacetamide sodium, sulfachlorpyridazine, sulfadiazine, sulfadiazine silver, sulfadiazine sodium, sulfadicramide, sulfadimethoxine, sulfadoxine, sulfaguanidine, sulfalene, sulfamazone, sulfamerazine, sulfamethazine, sulfamethazine sodium, sulfamethizole, sulfamethoxazole, sulfamethoxazol-trimethoprim, sulfamethoxypyridazine, sulfamonomethoxine, sulfamoxol, sulfanilamide, sulfaperine, sulfaphenazol, sulfapyridine, sulfaquinoxaline, sulfasuccinamide, sulfathiazole, sulfathiourea, sulfatolamide, sulfatriazin, sulfisomidine, sulfisoxazole, sulfisoxazole acetyl, sulfonamides, sultamicillin, sultamicillin tosilate, tacrolimus, talampicillin 15 hydrochloride, teicoplanin A2 complex, teicoplanin A2-1, teicoplanin A2-2, teicoplanin A2-3, teicoplanin A2-4, teicoplanin A2-5, teicoplanin A3, teicoplanin antibiotic complex, telithromycin, temafloxacin, temocillin, tenoic acid, terbinafine, terconazole, terizidone, tetracycline, tetracycline hydrochloride, tetracycline metaphosphate, tetramethylthiuram monosulfide, tetroxoprim, thiabendazole, thiamphenicol, thiaphenicol glycinate hydrochloride, 20 thiomersal, thiram, thymol, tibezonium iodide, ticarcillin, ticarcillin-clavulanic acid mixture, ticarcillin disodium, ticarcillin monosodium, tilbroquinol, tilmicosin, tinidazole, tioconazole, tobramycin, tobramycin sulfate, tolciclate, tolindate, tolnaftate, toloconium metilsulfat, toltrazuril, tosufloxacin, triclocarban, triclosan, trimethoprim, trimethoprim sulfate, triphenylstibinsulfide, troleandomycin, trovafloxacin, tylosin, tyrothricin, undecoylium chloride, undecylenic acid, vancomycin, vancomycin hydrochloride, viomycin, virginiamycin antibiotic complex, voriconazol, xantocillin, xibomol and zinc undecylenate.
11. The method according to claim 10, wherein the
antimicrobial agent is selected from one or more of mandelic acid, 2,4-dichlorobenzenemethanol,
4-[bis(ethylthio)methyl]-2-methoxyphenol, 4-epitetracycline, 4-hexylresorcinol, 5, 12-dihydro-5,7,12,14-tetrazapentacen, 5-chlorocarvacrol, 8-hydroxyquinoline, acetarsol, acetylkitasamycin, acriflavin, alatrofloxacin, ambazon, amfomycin, amikacin, amikacin sulfate, aminoacridine, aminosalicylate calcium, aminosalicylate sodium, aminosalicylic acid, ammoniumsulfobituminat, amorolfin, amoxicillin, amoxicillin sodium, amoxicillin trihydrate, amoxicillin-potassium clavulanate combination, amphotericin B, ampicillin, ampicillin sodium, ampicillin trihydrate, ampicillin-sulbactam, apalcillin, arbekacin, aspoxicillin, astromicin, astromicin sulfate, avermycin, azanidazole, azidamfenicol, azidocillin, azithromycin, azlocillin, aztreonam, bacampicillin, bacitracin, bacitracin zmc, bekanamycin,
benzalkonium, benzethonium chloride, benzoxonium chloride, berberine hydrochloride, biapenem, bibrocathol, biclotymol, bifonazole, bismuth subsalicylate, bleomycin antibiotic complex, bleomycin hydrochloride, bleomycin sulfate, brodimoprim, bromochlorosalicylanilide, bronopol, broxyquinolin, butenafine, butenafine hydrochloride, butoconazol, calcium undecylenate, candicidin antibiotic complex, capreomycin, carbenicillin, carbenicillin disodium, carfecillin, carindacillin, carumonam, carzinophilin, caspofungin acetate, cefacetril, cefaclor, cefadroxil, cefalexin, cefalexin hydrochloride, cefalexin sodium, cefaloglycin, cefaloridine, cefalotin, cefalotin sodium, cefamandole, cefamandole nafate, cefamandole sodium, cefapirin, cefapirin sodium, cefatrizine, cefatrizine propylene glycol, cefazedone, cefazedone sodium salt, cefazolin, cefazolin sodium, cefbuperazone, cefbuperazone sodium, cefcapene, cefcapene pivoxil hydrochloride, cefdinir, cefditoren, cefditoren pivoxil, cefepime, cefepime hydrochloride, cefetamet, cefetamet pivoxil, cefixime, cefmenoxime, cefmetazole, cefinetazole sodium, cefininox, cefminox sodium, cefmolexin, cefodizime, cefodizime sodium, cefonicid, cefonicid sodium, cefoperazone, cefoperazone sodium, ceforanide, cefoselis sulfate, cefotaxime, cefotaxime sodium, cefotetan, cefotetan disodium, cefotiam, cefotiam hexetil hydrochloride, cefotiam hydrochloride, cefoxitin, cefoxitin sodium, cefozopran hydrochloride, cefpiramide, cefpiramide sodium, cefpirome, cefpirome sulfate, cefpodoxime, cefpodoxime proxetil, cefprozil, cefquinome, cefradine, cefroxadine, cefsulodin, ceftazidime, cefteram, cefteram pivoxil, ceftezole, ceftibuten, ceftizoxime, ceftizoxime sodium, ceftriaxone, ceftriaxone sodium, cefuroxime, cefuroxime axetil, cefuroxime sodium, cetalkonium chloride, cetrimide, cetrimonium, cetylpyridinium, chloramine T, chloramphenicol, chloramphenicol palmitate, chloramphenicol succinate sodium, chlorhexidine, chlormidazole, chlormidazole hydrochloride, chloroxylenol, chlorphenesin, chlorquinaldol, chlortetracycline, chlortetracycline hydrochloride, ciclacillin, ciclopirox, cinoxacin, ciprofloxacin, ciprofloxacin hydrochloride, citric acid, clarithromycin, clavulanate potassium, clavulanate sodium, clavulanic acid, clindamycin, clindamycin hydrochloride, clindamycin palmitate hydrochloride, clindamycin phosphate, clioquinol, cloconazole, cloconazole monohydrochloride, clofazimine, clofoctol, clometocillin, clomocycline, clotrimazol, cloxacillin, cloxacillin sodium, colistin, colistin sodium methanesulfonate, colistin sulfate, cycloserine, dactinomycin, danofloxacin, dapsone, daptomycin, daunorubicin, DDT, demeclocycline, demeclocycline hydrochloride, dequalinium, dibekacin, dibekacin sulfate, dibrompropamidine, dichlorophene, dicloxacillin, dicloxacillin sodium, didecyldimethylammonium chloride, dihydrostreptomycin, dihydrostreptomycin sulfate, diiodohydroxyquinolin, dimetridazole, dipyrithione, dirithromycin, DL-menthol, D-menthol, dodecyltriphenylphosphonium bromide, doxorubicin, doxorubicin hydrochloride, doxycycline, doxycycline hydrochloride, econazole, econazole nitrate, enilconazole, enoxacin, enrofloxacin, eosine, epicillin, ertapenem sodium, erythromycin, erythromycin estolate, erythromycin ethyl succinate, erythromycin lactobionate, erythromycin stearate, ethacridine, ethacridine lactate, ethambutol, ethanoic acid, ethionamide, ethyl alcohol, eugenol, exalamide, faropenem, fenticonazole, fenticonazole nitrate, fezatione, fleroxacin, flomoxef, flomoxef sodium, florfenicol, flucloxacillin, flucloxacillin magnesium, flucloxacillin sodium, fluconazole, flucytosine, flumequine, flurithromycin, flutrimazole, fosfomycin, fosfomycin calcium, fosfomycin sodium, framycetin, framycetin sulphate, furagin, furazolidone, fusafungin, fusidic acid, fusidic acid sodium salt, gatifloxacin, gemifloxacin, gentamicin antibiotic complex, gentamicin cla, gentamycin sulfate, glutaraldehyde, gramicidin, grepafloxacin, griseofulvin, halazon, haloprogine, hetacillin, hetacillin potassium, hexachlorophene, hexamidine, hexetidine, hydrargaphene, hydroquinone, hygromycin, imipenem, isepamicin, isepamicin sulfate, isoconazole, isoconazole nitrate, isoniazid, isopropanol, itraconazole, josamycin, josamycin propionate, kanamycin, kanamycin sulphate, ketoconazole, kitasamycin, lactic acid, lanoconazole, lenampicillin, leucomycin A1, leucomycin A13, leucomycin A4, leucomycin AS, leucomycin A6, leucomycin A7, leucomycin A8, leucomycin A9, levofloxacin, lincomycin, lincomycin hydrochloride, linezolid, liranaftate, 1-menthol, lomefloxacin, lomefloxacin hydrochloride, loracarbef, lymecyclin, lysozyme, mafenide acetate, magnesium monoperoxophthalate hexahydrate, mecetronium ethylsulfate, mecillinam, meclocycline, meclocycline sulfosalicylate, mepartricin, merbromin, meropenem, metalkonium chloride, metampicillin, methacycline, methenamin, methyl salicylate, methylbenzethonium chloride, methylrosanilinium chloride, meticillin, meticillin sodium, metronidazole, metronidazole benzoate, mezlocillin, mezlocillin sodium, miconazole, miconazole nitrate, micronomicin, micronomicin sulfate, midecamycin, minocycline, minocycline hydrochloride, miocamycin, miristalkonium chloride, mitomycin c, monensin, monensin sodium, morinamide, moxalactam, moxalactam disodium, moxifloxacin, mupirocin, mupirocin calcium, nadifloxacin, nafcillin, nafcillin sodium, naftifine, nalidixic acid, natamycin, neomycin a, neomycin antibiotic complex, neomycin C, neomycin sulfate, neticonazole, netilmicin, netilmicin sulfate, nifuratel, nifuroxazide, nifurtoinol, nifurzide, nimorazole, niridazole, nitrofurantoin, nitrofurazone, nitroxolin, norfloxacin, novobiocin, nystatin antibiotic complex, octenidine, ofloxacin, oleandomycin, omoconazol, orbifloxacin, omidazole, ortho-phenylphenol, oxacillin, oxacillinsodium, oxiconazole, oxiconazole nitrate, oxoferin, oxolinic acid, oxychlorosene, oxytetracycline, oxytetracycline calcium, oxytetracycline hydrochloride, pampenem, paromomycm, paromomycm sulfate, pazufloxacine, pefloxacin, pefloxacin mesylate, penamecillin, penicillin G, penicillin G potassium, penicillin G sodium, penicillin V, penicillin V calcium, penicillin V potassium, pentamidine, pentamidine diisetionate, pentamidine mesilas, pentamycin, phenethicillin, phenol, phenoxyethanol, phenylmercuriborat, PHMB, phthalylsulfathiazole, picloxydin, pipemidic acid, piperacillin, piperacillin sodium, pipercillin sodium-tazobactam sodium, piromidic acid, pivampicillin, pivcefalexin, pivmecillinam, pivmecillinam hydrochloride, policresulen, polymyxin antibiotic complex, polymyxin B, polymyxin B sulfate, polymyxin Bl, polynoxylin, povidone-iodine, propamidin, propenidazole, propicillin, propicillin potassium, propionic acid, prothionamide, protiofate, pyrazinamide, pyrimethamine, pyridomycin, pyrithion, pyrrolnitrin, quinoline, quinupristin-dalfopristin, resorcinol, ribostamycin, ribostamycin sulfate, rifabutin, rifampicin, rifamycin, rifapentine, rifaximin, ritiometan, rokitamycin, rolitetracycline, rosoxacin, roxithromycin, rufloxacin, salicylic acid, secnidazol, selenium disulphide, sertaconazole, sertaconazole nitrate, siccanin, sisomicin, sisomicin sulfate, sodium thiosulfate, sparfloxacin, spectinomycin, spectinomycin hydrochloride, spiramycin antibiotic complex, spiramycin b, streptomycin, streptomycin sulphate, succinylsulfathiazole, sulbactam, sulbactam sodium, sulbenicillin disodium, sulbentin, sulconazole, sulconazole nitrate, sulfabenzamide, sulfacarbamide, sulfacetamide, sulfacetamide sodium, sulfachlorpyridazine, sulfadiazine, sulfadiazine silver, sulfadiazine sodium, sulfadicramide, sulfadimethoxine, sulfadoxine, sulfaguanidine, sulfalene, sulfamazone, sulfamerazine, sulfamethazine, sulfamethazine sodium, sulfamethizole, sulfamethoxazole, sulfamethoxazol-trimethoprim, sulfamethoxypyridazine, sulfamonomethoxine, sulfamoxol, sulfanilamide, sulfaperine, sulfaphenazol, sulfapyridine, sulfaquinoxaline, sulfasuccinamide, sulfathiazole, sulfathiourea, sulfatolamide, sulfatriazin, sulfisomidine, sulfisoxazole, sulfisoxazole acetyl, sulfonamides, sultamicillin, sultamicillin tosilate, tacrolimus, talampicillin 15 hydrochloride, teicoplanin A2 complex, teicoplanin A2-1, teicoplanin A2-2, teicoplanin A2-3, teicoplanin A2-4, teicoplanin A2-5, teicoplanin A3, teicoplanin antibiotic complex, telithromycin, temafloxacin, temocillin, tenoic acid, terbinafine, terconazole, terizidone, tetracycline, tetracycline hydrochloride, tetracycline metaphosphate, tetramethylthiuram monosulfide, tetroxoprim, thiabendazole, thiamphenicol, thiaphenicol glycinate hydrochloride, 20 thiomersal, thiram, thymol, tibezonium iodide, ticarcillin, ticarcillin-clavulanic acid mixture, ticarcillin disodium, ticarcillin monosodium, tilbroquinol, tilmicosin, tinidazole, tioconazole, tobramycin, tobramycin sulfate, tolciclate, tolindate, tolnaftate, toloconium metilsulfat, toltrazuril, tosufloxacin, triclocarban, triclosan, trimethoprim, trimethoprim sulfate, triphenylstibinsulfide, troleandomycin, trovafloxacin, tylosin, tyrothricin, undecoylium chloride, undecylenic acid, vancomycin, vancomycin hydrochloride, viomycin, virginiamycin antibiotic complex, voriconazol, xantocillin, xibomol and zinc undecylenate.
28. (Previously Presented) The method of claim 10 wherein the
antimicrobial is selected from one or more of polyenes, amphotericin B, liposomal amphotericin, nystatin, and pimaricin; azoles, fluconazole, itraconazole, ketoconazole, itraconazole, voriconazole, posaconazole, anidulafungin, caspofungin, micafungin, allylamines, naftifine, binafine, amorolfine, 5-fluorocytosine, amoxicillin, amoxicillin sodium, amoxicillin trihydrate, amoxicillin-potassium clavulanate combination, aztreonam, azithromycin, azlocillin, clofazimine, cloxacillin, cloxacillin sodium, dicloxacillin, cefdinir, cefditoren, cefditoren pivoxil, cefepime, cefepime hydrochloride, colistin, colistin sodium methanesulfonate, colistin sulfate, clarithromycin, cefprozil, cefaclor, cefuroxime, cefuroxime axetil, cefuroxime sodium, dicloxacillin sodium, amikacin, amikacin sulfate, flucloxacillin, flucloxacillin magnesium, flucloxacillin sodium, doxycycline, doxycycline hydrochloride, imipenem, levofloxacin, linezolid, minocycline, minocycline hydrochloride, mezlocillin, mezlocillin sodium, nafcillin, nafcillin sodium, oxacillin, piperacillin, penicillin G, ciprofloxacin, ciprofloxacin hydrochloride, erythromycin, sulfisoxazole, sulfisoxazole acetyl, sulfamethoxazole, sulfamethoxazol-trimethoprim, tazobactam, tazobactam sodium, tetracycline, tobramycin, tobramycin sulfate, ticarcillin, ticarcillin-clavulanic acid mixture, ticarcillin disodium, ticarcillin monosodium, gentamicin, vancomycin and methicillin.
12. The method according to claim 10, wherein the
antimicrobial agent is selected from one or more of polyenes, amphotericin B, liposomal amphotericin, nystatin, and pimaricin; azoles, fluconazole, itraconazole, ketoconazole, itraconazole, voriconazole, posaconazole, anidulafungin, caspofungin, micafungin, allylamines, naftifine, binafine, amorolfine, 5-fluorocytosine, amoxicillin, amoxicillin sodium, amoxicillin trihydrate, amoxicillin-potassium clavulanate combination, aztreonam, azithromycin, azlocillin, clofazimine, cloxacillin, cloxacillin sodium, dicloxacillin, cefdinir, cefditoren, cefditoren pivoxil, cefepime, cefepime hydrochloride, colistin, colistin sodium methanesulfonate, colistin sulfate, clarithromycin, cefprozil, cefaclor, cefuroxime, cefuroxime axetil, cefuroxime sodium, dicloxacillin sodium, amikacin, amikacin sulfate, flucloxacillin, flucloxacillin magnesium, flucloxacillin sodium, doxycycline, doxycycline hydrochloride, imipenem, levofloxacin, linezolid, minocycline, minocycline hydrochloride, mezlocillin, mezlocillin sodium, nafcillin, nafcillin sodium, oxacillin, piperacillin, penicillin G, ciprofloxacin, ciprofloxacin hydrochloride, erythromycin, sulfisoxazole, sulfisoxazole acetyl, sulfamethoxazole, sulfamethoxazol-trimethoprim, tazobactam, tazobactam sodium, tetracycline, tobramycin, tobramycin sulfate, ticarcillin, ticarcillin-clavulanic acid mixture, ticarcillin disodium, ticarcillin monosodium, gentamicin, vancomycin and methicillin.
Regarding the instant limitation of “topically administering … gaseous nitric oxide” as compared to the patent claim’s “delivering gaseous nitric oxide … by intermittent inhalation”, the term “topical administration” involves applying medications directly to the skin or mucous membranes to achieve localized therapeutic effects. The nose and/or mouth of the user is a mucous membrane thus the administering of the gaseous nitric oxide to the nose and/or mouth is inhalation a form of topical delivery of medication to the user. Hence, the term “topical” is a “generic” administration type; whilst, “inhalation” is a specific / ”species” administration type. As previously stated, the “generic” invention is “anticipated” by the “species”. Thus, the instant claims are anticipated by the patent claims and are not patentably distinct from the patent claims.
Regarding the instant limitation “potentiating effective amount” as compared to the patent claim’s “therapeutic amount”, the term “potentiating effective” is a precursor to “therapeutic”. Simply put, a “potentiating effective” is the first steps of a treatment protocol to being the amelioration process, e.g. reduction in infection growth, while the “therapeutic” is the next step of a treatment protocol achieve the desired resolution, e.g. elimination of infection completely. Hence, the term “potentiating effective” is a “generic” treatment type; whilst, “therapeutic” is a specific / ”species” treatment type. As previously stated, the “generic” invention is “anticipated” by the “species”. Thus, the instant claims are anticipated by the patent claims and are not patentably distinct from the patent claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Av-Gay et al. (WO 2013/132498 A2) shares a common applicant/inventor with the instant application and appears to disclose the treatment of a pathogenic microorganism with gaseous nitric oxide whereby the “inhalation of gaseous nitric oxide (gNO) has been shown to be a highly effective broad-spectrum antimicrobial therapy” (Para 0107) and considers the concept of “Concomitant medication (i.e. antibiotics or steroids)” (Para 0454) in the form of antibiotics; yet, does not expressly disclose the antibiotic/antimicrobial agent is different from the gNO.
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ANNETTE FREDRICKA DIXON
Primary Examiner
Art Unit 3782
/Annette Dixon/Primary Examiner, Art Unit 3785
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