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 .
Claims 1-20 have been presented for examination on the merits.
Priority
This Application is a continuation of Application No. 16/926,199 filed on 07/10/2020 and now Patent No. 12,115,250, which claims priority to provisional application no. 62/873,516 filed on 07/12/2019.
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 5, 7, 16 and 19 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.
Claims 7 and 19 are indefinite for reciting that the fungal infection is associated with one or more fungi selected from …. Pneumocystis and Pneumocystis jirovecii. This is indefinite because claims 7 and 19 depend on claims 1 and 18, respectively, which require that the infection is not caused by Pneumocystis. Thus, it is not clear how the fungal infection is associated with Pneumocystis when it is not caused by Pneumocystis.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 5 and 16 recite the broad recitation Mycobacteria, and the claims also recite tobramycin-resistant Pseudomonas and Pseudomonas aeruginosa which are the narrower statement of the range/limitation; claims 7 and 19 recite the broad recitation Aspergillus, and the claims also recite Aspergillus niger which is the narrower statement of the range/limitation; claims 7 and 19 recite the broad recitation Fusarium, and the claims also recite Fusarium solani complex, which is the narrower statement of the range/limitation; claims 7 and 19 recite the broad recitation Pneumocystis, and the claims also recite Pneumocystis jirovecii, which is the narrower statement of the range/limitation; claims 7 and 19 recite the broad recitation Cryptococcus, and the claims also recite Cryptococcus neoformans and Cryptococcus gatti, which are the narrower statement of the range/limitation; claims 7 and 19 recite the broad recitation Candida, and the claims also recite Candida albicans, which is the narrower statement of the range/limitation.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.
Claims are directed to a method of treating a respiratory infection, comprising administering a treatment composition….. with the proviso that the respiratory infection is not caused by methicillin-resistant Staphylococcus aureus or Pneumocystis. It is noted that methicillin-resistant Staphylococcus aureus is a bacterium and Pneumocystis is a fungus. Thus, when the infection is a viral infection, this proviso does not apply; when the infection is bacterium Pneumocystis is not relevant and when the infection is a fungal infection Staphylococcus aureus is irrelevant.
Applicant’s claims
Claim 1 is directed to a method for treating a respiratory infection, comprising:
administering a treatment composition to a patient in need thereof via inhalation into the patient's lungs, with the proviso that the respiratory infection is not caused by methicillin-resistant Staphylococcus aureus or Pneumocystis, wherein the treatment composition comprises nonionic, ground state, spherical silver nanoparticles having a mean diameter in a range of about 1 nm to about 40 nm and a particle size distribution such that at least 99% of the silver nanoparticles have a diameter within 30% of the mean diameter, wherein the nanoparticles are non-crystalline with no external edges or bond angles, and a carrier formulated for administration via inhalation; and the treatment composition treating the respiratory infection by the silver nanoparticles killing or deactivating microbes associated with the respiratory infection without the release of silver ions.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-6, 8 and 10-18 are rejected under 35 U.S.C. 103 as being unpatentable over Tarbet et al (US 20160287631) or Tarbet et al (US 20180078580) in view of Gillis (US 20040176312) and Pompilio et al (Frontiers in microbiology).
Tarbet et al ‘631 teach stabilized multi-component antimicrobial compositions for treating tissue diseases, infections or conditions including metal nanoparticles, and a stabilizing agent, wherein the diseases, infections or conditions are caused by microbial infections, such as bacteria, viral, and/or fungal infections (See abstract).
The said metal nanoparticles can comprise at least one metal selected from the group consisting of gold, platinum, silver, etc, mixtures thereof, and alloys thereof. The said metal nanoparticles can comprise or consist essentially of nonionic, ground state metal nanoparticles (See [0018]-[0019] and [0043]-[0044]).
Tarbet et al disclose a method of preventing or reducing the severity or occurrence of a tissue disease or infection comprises: (1) applying treatment composition comprising a carrier and metal nanoparticles onto a treatment area, and (2) the treatment composition killing or deactivating microbes present at or coming into contact with the treatment area (See [0023]).
The treatment composition is administered by inhalation to the respiratory tissue (See [0024]).
Tarbet et al disclose that tissue diseases or infections caused by bacterial infection and susceptible to treatment using the said compositions and methods include infections caused by staphylococcus bacteria, streptococcus bacteria, methicillin-resistant staphylococcus aureus (MRSA), etc (See [0037] and claim 20).
It is also disclosed that the said spherical-shaped metal nanoparticles can have a diameter of about 40 nm or less, about 35 nm or less, etc. The said spherical-shaped nanoparticles can have a particle size distribution such that at least 99% of the nanoparticles have a diameter within 30% of the mean diameter of the nanoparticles, or within 20% of the mean diameter, or within 10% of the mean diameter (See [0045]-[0046]).
Tarbet et al further disclose that “In the particular case of silver (Ag) nanoparticles, the interaction of the silver (Ag) nanoparticle(s) within a microbe has been demonstrated to be particularly lethal without the need to rely on the production of silver ions (Ag+) to provide the desired antimicrobial effects, as is typically the case with conventional colloidal silver compositions. The ability of silver (Ag) nanoparticles to provide effective microbial control without any significant release of toxic silver ions (Ag+) into the surrounding environment is a substantial advancement in the art” (See [0058]).
Exemplary carriers for nasal or pulmonary aerosol or inhalation administration (e.g., for treating a respiratory MRSA infection or pneumonia) include solutions in saline which can contain, for example, benzyl alcohol or other suitable preservatives, absorption promoters to enhance bioavailability, and/or other solubilizing or wetting or dispersing agents, such as glycerin, a naturally occurring phosphatide (e.g., lecithin), polysaccharides and polysaccharide-like compounds (e.g. dextran sulfate); etc. The said nanoparticles and additional stabilizing agents and/or carriers can be formulated as dry powders (e.g., powders useful for administering with dry powder inhalers) (See [0084]).
Exemplary aerosols useful for nasal and/or inhalation administration can include a vaporizable propellant, water, alcohol, propylene glycol, and polyethylene glycols and may be provided as sprays in a form of solution, suspension, or emulsion capable of forming a fine mist for administration, and in some embodiments, may include saline (See [0085]).
Tarbet et al further disclose that the said nanoparticle composition may contain about 0.5 ppm to about 100 ppm of metal nanoparticles by weight (See [0082]).
Tarbet et al ‘580’s teachings are the same as above.
Tarbet et al lack a teaching on other bacteria, viruses and fungi causing infections, or infection comprising biofilm. However, these are known in the art as taught as taught by Gillis and Pompilio et al.
Gillis teach treating infections by silver nanoparticles (See [0003], [0036] and [0042]). The conditions that can be treated with the metal-containing material include, for example, bacterial conditions, microbial conditions, biofilm conditions, fungal conditions, viral conditions, etc. Such conditions can be associated with, for example, one or more fungi, viruses and/or bacteria. In general, the location of the condition to be treated corresponds to the type of condition to be treated (See [0049]).
Gillis teach that the condition can be a respiratory condition (e.g., a bacterial respiratory condition, a biofilm respiratory condition, a microbial respiratory condition, an inflammatory respiratory condition, a fungal respiratory condition, a viral respiratory condition, etc. Examples of respiratory conditions include asthma, emphysema, bronchitis, pneumonia, and cystic fibrosis. In general, the treatment of respiratory conditions involves contacting the metal-containing material with the area of the respiratory system having the condition. Areas of the respiratory system include, for example, the oral cavity, the nasal cavity, and the lungs. As an example, certain respiratory conditions can be treated by inhaling a free-standing powder of the metal-containing material (e.g., with a dry powder inhaler). As another example, certain respiratory conditions can be treated by inhaling an aerosol containing the metal-containing material (e.g., with an inhaler) (See [0051]).
A solution containing the material can be formed into an aerosol (e.g., an aerosol prepared by a mechanical mister, such as a spray bottle or a nebulizer), and the aerosol can be contacted with the subject using an appropriate device (e.g., a hand- held inhaler, a nebulizer, etc,) (See [0099]).
Gillis teach that the methods of contacting metal containing material can include one or more of injection or inhalation (e.g., inhalation of a dry powder, inhalation of an aerosol) (See [0110]).
Gillis discloses that in one example silver solutions were prepared and placed in an ultrasonic nebulizer to combat cultures containing Pseudomonas aeruginosa and Staphylococcus aureus (See [0191]-[0192] and [0198]).
Furthermore, Gillis teach that the nebulized nanocrystalline silver reduced bacterial colonization in Pseudomonas infected lungs reduced injury as determined by gross pathology (consolidation, hemorrhage, edema) in Pseudomonas infected lungs. Further, the nanocrystalline silver delivered by aerosol reduced pulmonary inflammation (primarily PMN infiltration) in Pseudomonas infected lungs compared to tobramycin (IM) (See [0264]-[0265]).
Pompilio et al teach silver nanoparticles (AgNPs) formulation evaluated in vitro against Pseudomonas aeruginosa, Burkholderia cepacia, Stenotrophomonas maltophilia, and Staphylococcus aureus strains from cystic fibrosis (CF) patients. AgNPs were particularly active against P. aeruginosa and B. cepacia planktonic cells by a rapid, bactericidal and concentration-dependent effect. AgNPs showed to be particularly effective against P. aeruginosa and S. aureus biofilm causing a viability reduction ranging from 50% (1×MIC) to >99.9% (4×MIC). Compared to tobramycin, AgNPs showed comparable, or even better, activity against planktonic and biofilm P. aeruginosa cells. Our silver-based formulation might be an alternative to antibiotics in CF patients (See abstract).
Pompilio et al state that cystic fibrosis patients are prone to chronic infection of the respiratory tract, which ultimately leads to pulmonary failure, the primary cause of death in this patient population. CF patients have a peculiar set of bacterial pathogens that are frequently acquired in an age-dependent sequence. Staphylococcus aureus and Pseudomonas aeruginosa are the most prevalent respiratory pathogens, respectively, in younger and adult CF patients. Other pathogens, such as Burkholderia cepacia complex and Stenotrophomonas maltophilia, are less frequently recovered but particularly troublesome in these patients due to their multidrug-resistant phenotypes and can cause a severe decline in lung function. Most of CF pathogens also are highly adapted to the CF pulmonary environment, and one of the key strategic adaptation mechanisms includes the formation of biofilms, cellular aggregations embedded in EPS to protect bacteria from the antibiotic therapy and host immunity. This scenario is further complicated by the evidence that at the site of infection pathogens grow in highly viscous sputum whose composition affects both delivery and functionality of antibiotics (See Introduction).
It is further stated that in vitro and in vivo studies reported no toxic effect against lung epithelial cells up to 100 μg/ml. The aerosolized silver nanoaerosols (20 nm diameter) resulted in no functional and structural alterations of the epithelia. The high efficiency in killing activity is probably due to the accumulation of NPs embedded in the biofilm, and to their inability to agglomerate thus make them more efficient in penetrating into the different extent of biofilm. The size cut-off for optimal penetration into P. aeruginosa biofilm clusters was previously located around 100–130 nm and this is consistent with our results since the mean diameter of AgNPs we used was about 44 nm (See page 9, 2nd para).
It is disclosed that “As a whole, the morphological changes we observed at microscopic observation support the potential use of AgNPs as adjuvant also in the antibiotic therapy of biofilm-related infections, since NPs might: (i) increase the antibiotic susceptibility of drug-resistant cells by enhancing the membrane permeability to the antibiotic, and (ii) favor the antibiotic penetration through biofilm without being sequestered by EPS (See page 9, 2nd col.).
Pompilio et al state that “Using NPs as an antibacterial agent is a new and talented approach that has many advantages in comparison to conventional antimicrobial agents, such as low cost and simple NPs preparation, easy penetration into the bacterial cell or through matrix of biofilm communities due to NPs small dimensions, less time to kill bacteria, and lower probability to develop resistance due to the multiple and simultaneous mechanisms of NPs action. Beside fighting bacterial resistance NPs can also act as a “medium and carrier” of antibiotics. The use of AgNPs combined with antimicrobial agents might help reduce the NP toxic potential, to avoid the potential for development of resistance and, above all, strongly enhance the microbicidal effect of antibiotics against both planktonic and biofilm cells” (See Page 9, 2nd Col, last para).
It would have been prima facie obvious to a person of ordinary skilled in the art at the time the invention was made to have combined the teachings of Gillis and Pompilio et al with that of Tarbet et al to arrive at the instant invention. It would have been obvious to do so because Tarbet et al teach stabilized antimicrobial compositions for treating respiratory infections by inhalation, the compositions comprising nonionic ground state, spherical silver nanoparticles and a carrier for killing or deactivating microbes in the respiratory tissue. The infections may have been caused by staphylococcus bacteria or streptococcus bacteria. Gillis teach administration of silver nanoparticles for treating infections associated with respiratory infections including cystic fibrosis and wherein the infections may have been caused by Pseudomonas aeruginosa or Staphylococcus aureus. Gillis further teach that the said silver nanoparticles are effective in treating various infections caused by bacteria, fungi or viruses. Gillis also teach administration of the silver containing formulations to a patient’s lung via aerosolizers including dry powder inhalers and ultrasonic nebulizers, spray mists, etc. Pompilio et al disclose the typical infections in a cystic fibrosis patient which are typically caused by Staphylococcus aureus and Pseudomonas aeruginosa, the effect of administering silver nanoparticles to treat said infections and their ability to penetrate the viscous sputum and thick matrix of biofilm. Accordingly, one of ordinary skill in the art would have been motivated to have administered Tarbet et al’s formulations for treating respiratory infections caused by bacteria, viruses or fungi, including those involved in cystic fibrosis with a recommended device and a reasonable expectation of success.
The claims would have been obvious because a person of ordinary skill has good reasons to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.
Regarding the limitation in claims 1, 15 and 18, “with the proviso that the respiratory infection is not caused by methicillin-resistant Staphylococcus aureus or Pneumocystis”, it is noted that Tarbet et al teach that the infections may have been caused by staphylococcus bacteria or streptococcus bacteria. Thus, Tarbet et al disclose embodiments wherein the infection is not caused by methicillin-resistant Staphylococcus aureus or Pneumocystis, meeting this proviso.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Niedermeyer (US 20160081346) in view of Gillis (US 20040176312), Chen et al (Inhibitory effects of silver nanoparticles against adenovirus type 3 in vitro) and Nasrollahi et al (Antifungal activity of silver nanoparticles on some fungi).
Niedermeyer teach antimicrobial compositions for killing or deactivating microbes, such as viruses, bacteria, or fungi, include metal nanoparticles, a carrier, and a plurality of metal nanoparticles. The nanoparticles can be selected to have a particle size and particle size distribution to selectively and preferentially kill one of a virus, a bacterium, or a fungus. Antibacterial compositions can include nanoparticles having a particle size of 3-14 nm. Exemplary methods of killing or deactivating microbes include: (1) applying an antimicrobial composition to a substrate containing microbes, and (2) the antimicrobial composition killing or deactivating the microbes (See abstract and claims 17 and 20).
The said metal nanoparticles can comprise at least one metal selected from the group consisting of gold, platinum, silver, etc, mixtures thereof, and alloys thereof (See [0024] and [0050]).
Niedermeyer teach that metal nanoparticles are dispersed within or contained on or within a carrier that can be applied onto or into a substrate containing a microbe. The carrier can be a liquid, gel or solid. The antimicrobial compositions can be formulated to selectively and preferentially kill one or more specific microbes (See [0039]).
The said metal nanoparticles may comprise or consist essentially of nonionic, ground state metal nanoparticles including spherical-shaped metal nanoparticles which can have a diameter of about 40 nm or less, about 35 nm or less, or about 20 nm or less. The said spherical-shaped nanoparticles can have a particle size distribution such that at least 99% of the nanoparticles have a diameter within 30% of the mean diameter of the nanoparticles, or within 20% of the mean diameter, or within 10% of the mean diameter (See [0042], [0044]-[0045] and claims 4-6).
It is disclosed that, nonionic metal nanoparticles useful for making antimicrobial compositions comprise spherical nanoparticles, preferably spherical-shaped metal nanoparticles having a solid core. The term "spherical-shaped metal nanoparticles" refers to nanoparticles that are made from one or more metals, preferably nonionic, ground state metals, having only internal bond angles and no external edges or bond angles. In this way, the spherical nanoparticles are highly resistant to ionization, highly stable, and highly resistance to agglomeration. Such nanoparticles can exhibit a high zeta-potential, which permits the spherical nanoparticles to remain dispersed within a polar solvent without a surfactant, which is a surprising and expected result (See [0043]).
Furthermore, Niedermeyer discloses that “In the particular case of silver (Ag) nanoparticles, the interaction of the silver (Ag) nanoparticle(s) within a microbe has been demonstrated to be particularly lethal without the need to rely on the production of silver ions (Ag+) to provide the desired antimicrobial effects, as is typically the case with conventional colloidal silver compositions. The ability of silver (Ag) nanoparticles to provide effective microbial control without any significant release of toxic silver ions (Ag+) into the surrounding environment is a substantial advancement in the art” (See [0057]).
Exemplary carriers for nasal or pulmonary aerosol or inhalation administration include solutions in saline which can contain, for example, benzyl alcohol or other suitable preservatives, absorption promoters to enhance bioavailability, and/or other solubilizing or wetting or dispersing agents, such as glycerin, a naturally occurring phosphatide (e.g., lecithin). The nanoparticles and additional stabilizing agents and/or carriers are formulated as dry powders (e.g., powders useful for administering with dry powder inhalers) (See [0072]).
Exemplary aerosols useful for nasal and/or inhalation administration include a vaporizable propellant, water, alcohol, propylene glycol, and polyethylene glycols. inhalation administration, are provided as sprays which may be provided as a solution, suspension, or emulsion capable of forming a fine mist for administration, and in some embodiments, may include saline and/or be isotonic (See [0073]).
Examples of stabilizing agents include alcohols (e.g., ethanol, propanol, butanol, etc.), amine compounds (e.g., mono-, di-, or tri-ethanol amine), carbohydrates (e.g., sucrose, fructose), etc, (See [0080]).
The said antimicrobial composition may contain about 10 ppb (parts per billion) to about 100 ppm (parts per million) by weight of the antimicrobial composition, or about 3 ppm to about 20 ppm metal nanoparticles by weight of the antimicrobial composition (See [0077]).
Niedermeyer lack a teaching on specific bacteria, fungi and virsuses causing infections, or infection comprising biofilm. However, these are known in the art as taught by Gillis, Chen et al and Nasrollahi et al.
Gillis’s teachings are delineated above and incorporated herein.
Chen et al teach that adenoviruses are associated with respiratory, ocular, or gastrointestinal disease. With various species and high morbidity, adenoviruses are increasingly recognized as significant viral pathogen among pediatric and immunocompromised patients. The present study indicates silver nanoparticles exhibit remarkably inhibitory effects on adenovirus type 3 (Ad3) in vitro, which suggests silver nanoparticles could be a potential antiviral agent for inhibiting Ad3 infection (See abstract).
Chen et al state that it is reported that silver nanoparticles are virucidal against the human immunodeficiency virus by interacting with gp120 glycoprotein subunit, against hepatitis B virus by impacting with double strand DNA or binding with the viral particles, against respiratory syncytial virus by interfering with viral attachment (See Page 470, 2nd col).
Chen et al conclude that, this study clarifies silver nanoparticles have remarkably inhibitory effects on Ad3 in vitro for the first time. Silver nanoparticles could reduce CPE induced by Ad3, increase the viability and decrease the viral fluorescence intensity in Ad3 infected Hela cells. The reasons for these inhibitory effects are possibly due to directly damaging to Ad3 structure and associated with interaction effect on Ad3 DNA (See Page 477, conclusion).
Nasrollahi et al disclose an investigation into the antifungal effects of silver nanoparticles (Ag-Nps) on Candida albicans (ATCC 5027), Saccharomyces cerevisiae (ATCC 5027). Investigating method by using Minimum Inhibitory Concentration (MIC) technique, some of drugs including amphotericin B, fluconazole and synthesized Ag-Nps have been obtained on the fungi and the changes on membrane reactions of yeasts have been elucidated by Scanning Electron Microscopy (SEM). The present study indicates Ag-Nps has considerable antifungal activity comparison with other antifungal drugs (See Abstract).
Nasrollahi et al teach that “In particular, because of the recent advances in research on metal nanoparticles, Ag-Nps have received special attention as a possible antimicrobial agent. It has been known that silver and its compounds have strong inhibitory and bactericidal effects as well as a broad spectrum of antimicrobial activities for bacteria, fungi, and virus since ancient times. Compared with other metals, silver exhibits higher toxicity to microorganisms while it exhibits lower toxicity to mammalian cells. Lately, the recent advances in researches on metal nanoparticles appear to revive the use of Ag-Nps for antimicrobial applications” (See introduction, 2nd para).
Nasrollahi et al disclose that the antifungal activity of Ag-NPs against Candida albicans, Saccharomyces cerevisiae as models for fungi was investigated and Ag-NPs has been used as a comparable antifungal drug by antifungal drugs like amphotericin B, fluconazole. Ag-NPs exhibited a potent antifungal activity against fungal strains tested.
The conclusion is that “the effect of amphotericin B is more than to fluconazole, and Ag-NPs have more potent effect than to amphotericin B and fluconazole, on Saccharomyces cerevisiae, Candida albicans. This fact is true about both MIC50 and MIC90, because when the number of MIC is low, the drugs have more lethal characteristics. So, we can substitute the chemical drugs with Ag-NPs to treat disease” (See pages 235-236).
It would have been prima facie obvious to a person of ordinary skilled in the art at the time the invention was made to have combined the teachings of Gillis, Chen et al and Nasrollahi et al with that of Niedermeyer to arrive at the instant invention. It would have been obvious to do so because Niedermeyer teach stabilized antimicrobial compositions for treating respiratory infections by inhalation, the compositions comprising nonionic ground state, spherical silver nanoparticles and a carrier for killing or deactivating microbes in the respiratory tissue. The microbes may be one or more of a virus, fungi or bacteria.
Gillis teach administration of silver nanoparticles for treating infections associated with respiratory infections including cystic fibrosis and wherein the infections may have been caused by Pseudomonas aeruginosa or Staphylococcus aureus. Gillis further teach that the said silver nanoparticles are effective in treating various infections caused by bacteria, fungi or viruses. Gillis also teach administration of the silver containing formulations to a patient’s lung via aerosolizers including dry powder inhalers and ultrasonic nebulizers, spray mists, etc. Gillis additionally teach that the said method of treatment is effective against infections in a biofilm.
Chen et al teach that that silver nanoparticles are effective against adenoviruses and Nasrollahi et al teach that silver nanoparticles are effective against fungi including candida albicans and Saccharomyces cerevisiae. Thus, one of ordinary skill in the art having possession of all references would have readily recognized that the antimicrobial compositions and methods of Niedermeyer and those by Gillis, can be effective in treating respiratory infections caused by bacteria such as Pseudomonas aeruginosa; viruses such as adenoviruses or fungi such as candida albicans.
The claims would have been obvious because a person of ordinary skill has good reasons to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-5 and 10-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,115,250. Although the claims at issue are not identical, they are not patentably distinct from each other because the examined claims would have been obvious over the reference claims.
Examined claims and reference claims are drawn to a method of treating a (bacterial) respiratory infection, comprising administering by inhalation to the patient’s lung a composition comprising nonionic, ground state spherical silver nanoparticles. The differences are minor including reference claims limiting the patient population to those with cystic fibrosis. However, the examined claims encompass patients with or without cystic fibrosis. Also, reference claims 1 and 14 include a list of bacteria which have been included in depending claims of the examined claim set.
Thus, the differences and modifications between examined claims and reference claims are obvious variants and are not palatably distinct.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,115,250 in view of Gillis (US 20040176312), Chen et al (Inhibitory effects of silver nanoparticles against adenovirus type 3 in vitro) and Nasrollahi et al (Antifungal activity of silver nanoparticles on some fungi).
An obviousness-type double patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims because the examined claims would have been obvious over the reference claims in view of Gillis, Chen et al and Nasrollahi et al.
Examined claims and reference claims are drawn to a method of treating a (bacterial) respiratory infection, comprising administering by inhalation to the patient’s lung a composition comprising nonionic, ground state spherical silver nanoparticles. The differences are minor including reference claims limiting the patient population to those with cystic fibrosis. However, the examined claims encompass patients with or without cystic fibrosis. Also, reference claims 1 and 14 include a list of bacteria which have been included in depending claims of the examined claim set.
The other difference between the recited claims of the instant application and the reference claims is that reference claims do not include infections caused by virus and fungi or the listed viruses and fungi. However, this modification would have been obvious to one of ordinary skill in the art in view of Gillis, Chen et al and Nasrollahi et al. Gillis teaches administering the claimed silver nanoparticles with a carrier to the respiratory system via inhalation, wherein the said composition and method are effective in combating cultures containing bacteria such as Pseudomonas aeruginosa and Staphylococcus aureus, viruses and fungi. Chen et al and Nasrollahi et al also teach the effectiveness of silver nanoparticles on infections caused by viruses such as adenoviruses and fungi such as candida albicans.
Accordingly, it would have been obvious to one of ordinary skill in the art to have administered the reference claimed composition in a method of treating respiratory infection via inhalation for infections caused by bacteria, viruses and/or fungi with a reasonable expectation of success.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Looper et al (WO 2014190097).
Looper et al teach compositions and methods comprising (i) a polyamine compound and (ii) a silver substance with antimicrobial activity and dispersing activity against a variety of bacterial strains capable of forming biofilms. Metallic silver, including colloidal silver and silver nanoparticles can be used in the said compositions and methods (See [0002] and [0098]).
The silver substances can include elemental silver, colloidal silver, or nanoparticulate silver with an average particle size of from 1 nm to 100 nm (See [0223]). The said silver substances are used in concentrations ranging from about 0.01 ppm to about 1,000 ppm, for example from about 1 to about 500 ppm, or from 30 to 60 ppm (See [0224]).
Looper et al disclose that the said compound or composition can be incorporated into pharmaceutical compositions comprising a pharmaceutically acceptable carrier including solvents, binders, dispersion media, a buffer solution, one or more amino acids, an essential-to-human amino acid, one or more carbohydrates, etc, (See [0321]-[0324]).
Looper et al disclose that a pharmaceutical composition containing the silver substance and the polyamine compound can be formulated to be compatible with its intended route of administration as known by those of ordinary skill in the art. Examples of routes of administration include parenteral and inhalation. Solutions or suspensions can include a sterile diluent such as water for injection, saline solution, buffers such as acetates, citrates or phosphates, etc, (See [0331] and [0326]).
For administration by inhalation, the silver substance and the polyamine compound can be delivered in the form of an aerosol spray from pressured container or dispenser that contains a suitable propellant, or a nebulizer (See [0335]).
Looper et al disclose that the subject in need of treatment can be one afflicted with one or more of the infections or disorders including biofilm-associated conditions such as cystic fibrosis. The biofilm-related disorder such as pneumonia, cystic fibrosis, etc, or infection and combinations thereof are caused by bacteria of the genus Acinetobacter, Burkholderia, Pseudomonas, Staphylococcus, Streptococcus, etc. Subjects with cystic fibrosis display an accumulation of biofilm in the lungs and digestive tract (See [0311]-[0313]).
The said silver substance may be used to treat bacteria including strains that are resistant to conventional antibiotics, mycobacteria, enveloped viruses, fungi and even transformed or cancerous cells (See [0292]).
The said compounds, compositions, and methods can be used to kill, disperse, treat, reduce biofilms, or prevent or inhibit biofilm formation. In exemplary methods, the biofilms are formed by biofilm- forming bacteria. The bacteria can be a gram- negative bacterial species or a gram-positive bacterial species including Burkholderia cepacia Escherichia (such as Escherichia coli), etc, (See [0294]).
Chin et al (US 20140186290).
Chin et al teach compositions and methods to disperse mucin and/or actin using nanoparticles wherein the average diameter of the nanoparticles is less than about 1000 nm (See abstract). Increased mucin production can occur in lung diseases such as asthma, bronchitis, COPD or cystic fibrosis (CF). The compositions and methods of nanoparticles provided herein, avoid the need for drugs, chemicals or enzymes which are conventionally used to disperse the mucin (See [0007]).
The said composition is the combination of an active agent with a carrier, inert or active such as saline or water, making the composition suitable for diagnostic or therapeutic use in vitro, in vivo or ex vivo (See [0038]).
Chin et al state that "mucus" refers to the mixtures of different types of mucins, actins, DNA or other glycol-proteins that form the hydrated layer on the surface of various tissues, such as the eyes, respiratory tracts, reproductive tracts, etc. (See [0043]).
The said nanoparticles can be solid colloidal particles ranging in size from 1 to 1000 nm, such as less than about 20 nm, or alternatively less than about 25 nm, or alternatively less than about 30 nm, etc, (See [0047]).
Chin et al also disclose that in diseases such as cystic fibrosis, airway secretions are a primary factor in respiratory dysfunction and ultimately contribute to the death of individuals with the disease. The secretions have been characterized as thick and highly viscous. As such, they are difficult to expectorate and contribute to reduced lung volumes and expiratory flow rates. Cystic fibrosis patients are further characterized as having chronic infections of pseudomonas aeruginosa where despite antibiotic therapy, efficacy of treatment with aminoglycoside antibiotics is reduced (See [0058]-[0059]).
The administration of the said composition can be in the form of a single unit dose of inhalation or multiple inhalations or doses. Suitable devices for a delivery of the said composition comprising a nanoparticle include nebulizers, small particle aerosol generators, metered-dose inhalers, inhalers with a propellant, and the like devices. An exemplary nebulizer includes an Acorn II jet nebulizer (See [0041], [0081]-[0083] and [0109]).
Claims 1-20 are rejected.
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/Mina Haghighatian/
Mina Haghighatian
Primary Examiner
Art Unit 1616
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