DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Receipt is acknowledged of Amendments and Remarks filed on 04/16/26. Claims 5, 8-11, 14-15 have been amended, claim 6 has been canceled and new claims 51-52 have been added. Accordingly, claims 5, 7-15, 43-47 and 50-52 are pending and under examination on the merits.
Specification has also been Amended.
Rejections and/or objections not reiterated from the previous Office Action are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed on 03/13/23.
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 8-11 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 8-11 recite the limitation "unit dose " in the method of claim 5. There is insufficient antecedent basis for this limitation in the claim. Claim 5 does not provide support for this limitation because it does not recite a “unit dose”.
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 5, 7 and 51-52 are rejected under 35 U.S.C. 102(a)(1) (a)(2) as being anticipated by CN 111297838. (Recitations from attached English translation by Google patents).
CN ‘838 teaches an antiviral drug inhalation spray comprising components in percentage by mass: 0-30% of antiviral active agent, 0-30% of adjuvant, 0-30% of taste masking agent and the balance of solvent, inhaled into the respiratory tract of a patient treating the severe respiratory tract and lung infection caused by the virus. In particular embodiment, the mass percentage of the antiviral active agent is 0.1-10%, preferably 1-5%; the mass percentage of the auxiliary agent is 0.1-10%, preferably 1-5%; the mass percentage of the taste masking agent is 0.1-10%, preferably 1-5% (See Abstract, page 4 and claims 1-2).
Regarding claim 5, CN ‘838 teaches the method of administering by inhalation (aerosol) to a subject to treat viral lung infections, comprising 1-10% by mass of an antiviral active and 0.1-10% by mass of a taste masking active and a solvent.
Additionally, CN ‘838 teaches that the said antiviral active agent is an active agent against the novel coronavirus COVID-19, and is selected from one or more of hydroxychloroquine sulfate, chloroquine phosphate, favipiravir, remdesivir, oseltamivir phosphate, ribavirin, rimantadine hydrochloride, etc, (See page 4, 1st, 5th and 11th full para and claim 3).
Regarding claims 5, 7 and 51-52, it is disclosed that the said antiviral medicinal inhalation spray is filled in an atomizer, preferably an air compression atomizer, a heating atomizer, a vibrating screen micropore atomizer or an ultrasonic atomizer and wherein the said taste masking agent is a sugar alcohol compound selected from one or more of xylitol, sorbitol or mannitol, and the solvent is water, ethanol, etc. The antiviral active is completely dissolved in the solvent (See claims 6-7 and page 5, 4th-7th and 11th para).
Further regarding claim 5, CN ‘838 teaches that the medicine spray (liquid spray) is a preparation which is filled with medicine-containing solution, in a special device, and when in use, the content is released in the form of mist by means of pressure of a manual pump heating and ultrasonic vibration, and the medicine spray (liquid spray) is used for lung inhalation (See page 5, last para).
Example 1 discloses the preparation method comprising the following steps:
(1) taking water, mannitol, propylene glycol, hydroxychloroquine sulfate and essence according to the prescription amount; (2) after complete dissolution, filtering; (3) quantitative filling; (4) and (6) packaging. The medicine spray is put into a proper atomization device, the atomized particle size formed by atomization is 1-5 µm, and the medicine is mainly deposited in the pulmonary tail end alveolus (in the final 5-6 level bronchi) (See Example 1 on pages 7-8).
Example 6 discloses a preparation for treating COVID-19, SARS-CoV and influenza comprising remdesivir, xylitol, propylene glycol and flavor.
Example 12 discloses a preparation for treating coronavirus and influenza comprising favipiravir, xylitol, propylene glycol and flavor.
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 5, 7-15, 43-46 and 50-52 are rejected under 35 U.S.C. 103 as being unpatentable over CN 111297838 (Recitations from attached English translation by Google patents), in view of Dalby et al (A review of the development of Respimat® Soft Mist TM Inhaler) and Coomes et al (Favipiravir, an antiviral for COVID-19?).
CN ‘838 teachings regarding claims 5, 7 and 51-52 are delineated above and incorporated herein.
Regarding claims 8-15, CN ‘838 teaches that the said antiviral drug inhalation spray has a concentration specification of said antiviral active agent and adjuvant of 1 mg-300 mg/ml, preferably 1 mg/ml, 5 mg/ml, 10 mg/ml. The dosage of the drug administered is significantly reduced compared to oral and injection administration, and the actual dose to be taken depends on the concentration of the nebulizer and the frequency of administration, and if the required dose is higher, the concentration of the nebulizer and the frequency of use can be appropriately increased, and vice versa (See page 5, 9th and 10th paras and claim 9).
Regarding claims 44-45 and 50, CN ‘838 teaches that the new coronavirus infection is mainly in nasal cavity and upper respiratory tract in early stage, and develops pneumonia in later stage to burst the whole respiratory system. When the atomized particle size is larger than 15 microns and larger than 10 microns, the medicine stays in the oral cavity and the nasal cavity; when the particle size of the atomized particles is larger than 10 µm and larger than 5 µm, the medicine can reach the inner part of the first 6-grade branch trachea of the lower respiratory tract; when the atomized particle size is larger than 5 microns and larger than 1 micron, the medicine can reach the pulmonary alveolus at the tail end (in the final 5-6 grade bronchi) (See page 5, 8th para), and that a medicinal inhalation spray for resisting new coronavirus is provided, which is applied to treat novel coronavirus (COVID-19), other coronaviruses, syncytial virus, atypical pneumonia (SARS-CoV), middle east respiratory syndrome (MERS-CoV), and influenza (See page 12, Example 6).
The medicinal inhalation spray of the present application enters the lung in the form of aerosol, which refers to small particles of solid or liquid, a colloidal system dispersed and suspended in a gaseous medium. In medical treatment, the medicine is atomized into aerosol for a patient to inhale to a respiratory system, so that the aim of treating diseases locally and systemically is fulfilled.
CN ‘838 lacks a specific disclosure on the device being soft mist inhaler the concentration in mg or the FPF of the particles. These are either obvious from CN ‘838 or in view of Dalby et al and Coomes et al.
Specifically, CN ‘838 teaches that the inhalation can be via mist, but does not expressly disclose a soft mist inhaler is used. Dalby et al renders this feature obvious.
Regarding claims 5 and 46, Dalby et al teach that the Respimat® Soft Mist™ Inhaler (SMI) Respimat® Soft Mist™ Inhaler (SMI) is a new generation inhaler from Boehringer Ingelheim developed for use with respiratory drugs. The device functions by forcing a metered dose of drug solution through a unique and precisely engineered nozzle (the uniblock), producing two fine jets of liquid that converge at a pre-set angle. The collision of these two jets generates the soft mist. The soft mist contains a high fine particle fraction (FPF) of approximately 65 to 80%. The features of the soft mist, result in larger amounts of the drug reaching the lungs and less being deposited in the oropharynx compared with either pMDIs or DPIs. Generation of the soft mist from Respimat® SMI is purely mechanical, so propellants are not necessary. The innovative design of Respimat® SMI, using water-based drug formulations, ensures patients receive consistent and reliable doses of the drug with each actuation. Clinical studies have confirmed that Respimat® SMI is effective and safe in delivering bronchodilators to patients with asthma or chronic obstructive pulmonary disease (See abstract).
Regarding claim 43, it is disclosed that Respimat® SMI is a new generation, propellant-free, multi-dose inhaler developed by Boehringer Ingelheim. The term ‘soft mist’ is used to describe both the mechanism of aerosol generation and the qualities of the aerosol cloud, and represents an innovative approach to patient-oriented inhalation therapy (See page 2, 2nd col, 2.).
Regarding claims 44-45, CN ‘838 teach the different size ranges for deposition in each part of the respiratory system and that particles from 5 to 10 microns deposit in the lower and upper part of the respiratory system. Dalby et al also teach that the efficacy of an inhaled drug is largely dependent on the amount of the drug deposited in the lungs and its topographical anatomical distribution. It may be possible to deliver drugs more precisely by using aerosols with a defined particle size distribution; for example, particles with a diameter of 2–5 μm are generally deposited in the smaller bronchioles and peripheral airways. Larger particles tend to be deposited in the upper airways, whereas those smaller than 2 μm are, to a large extent, breathed in and out of the alveoli with minimal actual deposition (See page 2, 1st col). Dalby et al also disclose in Fig. 5, typical aerodynamic particle size distribution for the aerosol generated by Respimat® Soft Mist™ Inhaler, using an aqueous drug solution and an Andersen cascade impactor (See page 6, 2nd col).
Dalby et al conclude that “Respimat® SMI has been shown to allow a reduction in the dose of a combination bronchodilator compared with delivery via CFC-MDI, while offering the same level of therapeutic efficacy and safety. Therefore, the development of Respimat® SMI represents a significant step forward in pulmonary drug delivery (See Conclusion on page 8).
Regarding claims 8-15, CN ‘838 teaches that the concentration specification of said antiviral active agent and adjuvant is from 1mg-300 mg/ml, preferably 1mg/ml, 5mg/ml, 10mg/ml. The dosage of the drug administered is significantly reduced compared to oral and injection administration, and the actual dose to be taken depends on the concentration of the nebulizer and the frequency of administration, and if the required dose is higher, the concentration of the nebulizer and the frequency of use can be appropriately increased, and vice versa (See page 5, 9th and 10th paras and claim 9).
Additionally, Coomes et al teach that patients with COVID-19, SARS-CoV-2, respiratory infections have been treated with favipiravir at doses of 600-800 mg orally (See article).
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 Coomes et al and Dalby et al with CN ‘838 to arrive at the instant invention with a reasonable expectation of success. It would have been obvious to do so because CN ‘838 teaches a method of treating viral lung disease by administering to a subject via inhalation (aerosol) a composition comprising an antiviral active including favipiravir or hydroxychloroquine, a taste masking agent including mannitol and a solvent including water or water and ethanol. The said compositions are delivered via an ultrasonic vibration or mist. Additionally, Dalby et al teach that a soft mist inhaler can advantageously by used for delivering medicinal compositions to the respiratory system wherein the higher amount of the medicine reaches the lung and thus smaller doses can be used. This is in addition to fact that soft mist inhalers are better for environment and have other advantages. Thus, one of ordinary skill in the art is more than motivated to deliver CN ‘838’s compositions to the subject via Dalby et al’s soft mist inhaler and be able to not only reduce the dosage but achieve better results and be less harmful to the environment. In other words, the claims would have been obvious because the technique for improving a particular formulation (delivery method) was part of the ordinary capabilities of a person of ordinary skill in the art, in view of the teaching of the technique for improvement in other situations.
It also would have been obvious to one of ordinary skill in the art to select from or adjust the dosage amount or concentration of the said antiviral active agents of CN ‘838 because CN ‘838 discloses suitable ranges and teach that the amount of the medicament administered via inhalation is much less than its oral dosage. Dalby et al teach that using soft mist inhalers are more effective in delivering the medicinal formulation to the respiratory system and as such less of the said active agents is needed. Furthermore, Coomes et al teach that suitable oral doses of favipiravir include 600 or 800 mg. Thus, the combination of references would have led one of ordinary skill in the art to optimize and adjust the dosage and the concentration of the antiviral active agent for the desired treatment.
In this regard the courts have held that “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969); Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed.Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997). (See MPEP 2144.05).
From the combined teaching of the cited references, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claims 5, 43-47 and 51-52 are rejected under 35 U.S.C. 103 as being unpatentable over CN 111297838 (Recitations from attached English translation by Google patents), in view of Surber (US 20150044288).
Teachings of CN ‘838 are delineated above and incorporated herein.
CN ‘838 does not teach an FPF range or value for the delivered liquid formulation. This would have been known to one of ordinary skill in the art as taught by Surber.
Surber teach formulations of imatinib or a phenylaminopyrimidine derivative compound for aerosolization and use of such formulations for inhaled aerosol administration for the prevention or treatment of various fibrotic, viral infectious diseases, including diseases associated with the lung (See abstract).
Regarding claim 5, Surber teach administration of such formulation via a nebulizer including a liquid nebulizer. The said nebulizer may be an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber.
Regarding claim 43, Surber teach that the said nebulizers contain two or more doses of the active compound. There is no limit to the total number of containers provided in a multi-dose kit (See [0434]).
Regarding claims 44-47, Surber teach a formulation having a mass median aerodynamic diameter (MMAD) of droplet size of the aqueous solution emitted with the vibration generator of about 1 μm to about 5 μm; and a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer of at least about 30%, at least about 40%, at least about 45%, at least about 50%, at least about 55%, at least about 60%, at least about 65% (See [0020]-[0021]).
Regarding claims 51-52, Surber et al teach that the said formulations may also comprise a pharmaceutical carrier or excipient, including mannitol, lactose, etc, (See [0393] and [0504]). (Mannitol solutions are hypertonic solutions, at least per Specification).
Regarding claim 52, Surber et al teach that hypertonic formulations (e.g., osmolalities greater than about 350 mOsmol/kg), other compounds/formulations can be combined with imatinib, a phenylaminopyrimidine derivative or salt thereof, and other mucolytic agents for aerosol administration to improve antifibrotic and/or antiinflammatory activity through better distribution from reduced sputum viscosity, and improved clinical outcome through improved pulmonary function (from improved sputum mobility and mucociliary clearance) and decreased lung tissue damage from the immune inflammatory response (See [0575]).
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 Surber with CN ‘838 to arrive at the instant invention with a reasonable expectation of success. It would have been obvious to do so because CN ‘838 teaches a method of treating viral lung disease by administering to a subject via inhalation (aerosol) a composition comprising an antiviral active including favipiravir or hydroxychloroquine, a taste masking agent including mannitol and a solvent including water or water and ethanol. The said compositions are delivered via an ultrasonic or vibrating mesh. However, CN ‘838 is silent with regard to the fine particle fraction of the formulation or delivered dose. One of ordinary skill in the art would have been motivated to have incorporated this feature from Surber because it is disclosed that formulations delivered via a vibrating mesh nebulizer can deliver a dose with FPF of from 30% to over 60%.
It also would have been obvious to have added mannitol and hypertonic solutions to aerosol formulations because Surber et al disclose the benefit of doing so in improved treating of lung diseases and reducing lung damage.
That is, the combination of references would have led one of ordinary skill in the art to the claimed invention.
Response to Arguments
Applicant's arguments filed 04/16/26 have been fully considered but they are not persuasive.
Regarding the rejection of claims as being anticipated by CN ‘838, Applicant argues that “For a reference to anticipate under §102, it must enable a person of ordinary skill in the art to make and use the disclosed invention. CN '838 is not an enabling reference for a formulation in which the active agent component consists of only one or more antibiotics or one or more antiviral drugs” (See Remarks, page 8).
The argument is not persuasive. CN ‘838 teaches embodiments wherein the composition for aerosolization into the pulmonary system for treating lung infections caused by COVID or influenza comprise one antiviral active agent and suitable excipients. CN ‘838 teach that the formulation may comprise an antiviral and/or an auxiliary (an antibiotic). It is clearly stated that both the antiviral and the auxiliary cannot be present at 0% at the same time. That means one can be present at 0%. I.e., the formulation may comprise one active agent, meeting the claimed language of “consisting of”. In addition to the disclosure, CN ‘838 provides multiple examples of the disclosed formulations. The rejection previously pointed to Example, 1. In addition, the examiner points to other Exemplified formulations, such as Examples 6 and 12. For Applicant’s continence, the Examiner has attached an English translation of the CN ‘838 by EPO (Espacenet), wherein an easier to read version of the said examples are provided. (The previously provided translation is by Google patent). Thus, contrary to Applicant’s argument, CN ‘838 fully and properly anticipates the claims, not only by disclosure but by specific examples.
Applicant’s next argument is that “The full context of the CN '838 disclosure is nonsensical because it teaches that some antiviral drug inhalation sprays may have 0% antiviral agent. For example, CN '838 describes: "[0016] An antiviral drug inhalation spray, comprising the following components in mass percentage: 0% to 30% of antiviral active agent, 0% to 30% of auxiliary agent, 0% to 30% of taste masking agent, and the balance is solvent; the content of the antiviral active agent and auxiliary agent is not 0% at the same time." ….. CN '838 does not leave any room for compositions that do not contain antiviral active agent and the antibiotic adjuvant/auxiliary agent. In this regard, CN '838 requires that there be a combination of an antiviral and an antibiotic” (See Remarks, page 8).
The above argument is also not found persuasive. As stated above, CN ‘838 teach multiple embodiments, when the amount of the antiviral and/or antibiotic can be selected based on the formulation desired. The examples show that CN ‘838 provides teachings on formulations that comprise one antiviral agent, one antibiotic or both. Thus, the formulation wherein the antibiotic is present alone, the antiviral is at 0%. CN ‘838’s teaching of multiple variations of the formulation cannot be held against it. The claimed formulations have clearly been disclosed and anticipated.
Regarding Example 1, stated in the rejection, Applicant argues that “Example 1 of CN '838 describes a purely hypothetical method for taking water, mannitol, propylene glycol, hydroxychloroquine sulfate and essence according to the prescription amount; (2) after complete dissolution, filtering; (3) quantitative filling; (4) and (6) packaging, characterized as having a viscosity of 1-2 cP. However, CN '838 claims to deliver via nebulizer a solution that has a viscosity up to 100 cP (preferably 1-50 cP, more preferably 1-25 cP. Even taking the lower range of 1-25 cP, dairy cream has viscosity of 16.5 cps; ….. It is without merit that a formulation with those viscosity ranges could be delivered via nebulizer” (See Remarks, pages 8-9).
The argument is not convincing. It is impermissible to pick and choose from a reference only the recitations that help Applicant’s arguments. As shown above, CN ‘838 teach that the formulations can have a viscosity of from 1 to 25. While the upper limit may not be suitable for all applications, including nebulization, one of ordinary skill in the art is more than capable of determining the proper viscosity for each formulation. However, CN ‘838 also recite that - Aerosol formation and particle size are related to the chosen spray device and the viscosity of the spray- and that - By adjusting the parameters of the atomizing device and the viscosity of the spray, the present invention helps to ensure that the drug reaches the lesion site with high virus content, improves the deposition rate, and thus improves the therapeutic effect-.
Regarding the rejection of claims under obviousness over CN ‘838, Dalby et al and Coomes et al, Applicant’s arguments regarding CN ‘838 are similar to those responded to above. As for Dalby et al’s teachings, Applicant argues that “Dalby et al. describes the Respimat* soft mist inhaler and discusses its advantages in delivering bronchodilators …. Dalby is a device-focused reference, rather than focusing on any formulation for treating a viral lung disease. It does not disclose antiviral agents, antiviral formulations, or antiviral treatment of infectious diseases such as COVID-19 or influenza. …. A reference directed to inhaler mechanics cannot supply missing limitations relating to the composition itself. Accordingly, Dalby does not cure the failure of CN '838 to teach or suggest the claimed antiviral-only composition” (See Remarks, page 10).
The above argument is also not found persuasive. The claims are directed to a method of treating a viral lung disease…. comprising administering a composition administered to the patient with a soft mist inhaler, a nebulizer….. The formulation is clearly and properly taught by CN ‘838. Dalby reference was relied upon for its teachings of the delivery device. Dalby et al’s teachings are not formulation or drug focused because they are not made or disclosed for any specific medication.
Regarding the teachings of Coomes, the argument is that “Coomes discusses the antiviral activity of favipiravir and reports oral systemic dosing regimens, including oral doses on the order of hundreds of milligrams per day. Coomes does not disclose inhalation delivery, aerosolized antiviral formulations, or administration via soft mist inhalers or vibrating mesh nebulizers. ….. At most, Coomes establishes that favipiravir is an antiviral agent when administered orally. That disclosure does not supply the missing composition and delivery limitations absent from CN '838…… Additionally, the claimed methods further distinguish over the cited art by virtue of the dramatically reduced unit doses of favipiravir recited in Applicant's specification and claims. Specifically, Applicant's disclosure teaches and claims inhaled per-unit doses of favipiravir in the range of approximately 1-10 mg, with narrower embodiments down to 1-5 mg per unit dose. These doses are orders of magnitude lower than the dose regimens disclosed in the Coomes reference” (See Remarks, pages 10-11).
The argument is not sufficing to overcome the rejection. Again, CN ‘838 teaches the formulation and teaches that the dose is 1 mg/ ml or 5 mg/ml or 10 mg/ml. Thus, they disclose a range that meets the claimed range of from 0.01 to 20 mg or 1-5 mg. Coomes is also relied upon for teaching a suitable oral dosage amount for favipiravir in a method of effectively treating COVID-19. As known in the art and stated by CN ‘838, the dose for inhalation is much smaller than that for oral administration and one of ordinary skill in the art having possession of both references can easily determine the proper dosage of favipiravir for inhalation / nebulization.
Further argument is regarding the rejection of claims over CN ‘838 in view of Surber. Applicant argues that “Surber discloses formulation and delivery considerations for those compounds, including use of vibrating mesh nebulizers and certain aerosol particle size parameters. However, Surber does not disclose or suggest: antiviral agents; antiviral treatment of viral lung diseases such as COVID-19 or influenza; antiviral solubility or stability considerations; or inhalation of antiviral agents without auxiliary antibiotics. Thus, Surber does not supply the missing teaching in CN '838 of an antiviral-only active composition. At most, Surber provides general aerosolization parameters for entirely different classes of compounds, formulated for entirely different therapeutic purposes” (See Remarks, pages 12-13).
This argument is similarly unconvincing. Contrary to Applicant’s interpretation of the references, CN ‘838 teaches the formulations as stated above. Surber also teach compositions comprising active agents for treating viral infections, especially lung infections. In fact, Surber teach a method of treating infectious diseases including influenza (See at least abstract and [0063]-[0064]). However, one of ordinary skill in the art is more than motivated to look at references for their teachings regarding, for example, inhalation specifics such as devices, FPF, particle size, etc, from a reference that has a different active agent. There is no evidence that the said teachings are specific to any active agent or formulation.
Claims 5, 7-15, 43-47 and 50-52 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mina Haghighatian whose telephone number is (571)272-0615. The examiner can normally be reached M-F, 7-5 EST.
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/Mina Haghighatian/
Mina Haghighatian
Primary Examiner
Art Unit 1616
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