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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
This office action is a response to applicant’s communication submitted April 30, 2024, wherein claims 4, 7-9 were preliminarily amended.
Claims 1-12 are pending in this application.
Priority
This application was filed April 30, 2024 and claims foreign priority to TW112147700 filed December 7, 2023. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Interpretation
With respect to instant claim 8, which is directed to a pharmaceutical composition and recites the phrase “is administered by way of”. The Examiner notes that it is well settled that “intended use” of a composition or product, e.g., “is administered by way of”, will not further limit claims drawn to a composition, so long as the prior art discloses the same composition comprising the same ingredients in an effective amount, as the instantly claimed (See MPEP 2111.02 (II)).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4 and 8 are rejected under 35 U.S.C. 102(A)(1) as being anticipated by Painter (WO 2021/159044, cited on PTO-892).
Regarding claims 1-4 and 8: Painter teaches N4-hydroxycytidine derivatives, pharmaceutical compositions and methods related thereto (abstract). In certain embodiments, the disclosure relates to methods of treating or preventing a SARS-Co V-2 infection in the CNS, comprising administering an effective amount of EIDD-1931 to a subject in need thereof (pg. 54, lines 1-3). In certain embodiments, the pharmaceutical composition is in the form of a tablet, capsule, pill, or aqueous buffer, such as a saline or phosphate buffer (pg. 2, lines 20-22). In certain embodiments, the disclosed pharmaceutical compositions can comprise a compound disclosed herein and a propellant, the propellant is an aerosolizing propellant such as compressed air, ethanol, nitrogen, carbon dioxide, nitrous oxide, hydrofluoroalkanes (HFAs), 1,1,1,2, tetrafluoroethane, 1,1,1,2,3,3,3-heptafluoropropane, or combinations thereof (pg. 2, lines 23-27). The composition comprising the propellant can be contained in manual pump spray, inhaler, meter-dosed inhaler, dry powder inhaler, nebulizer, vibrating mesh nebulizer, jet nebulizer, or ultrasonic wave nebulizer (pgs. 2-3, bridging para.). Painter teaches EIDD-1931 was dissolved in sterile saline at 8 mg/mL for I.V. dosing (pg. 156, line 10).
Claims 1 and 3-9 are rejected under 35 U.S.C. 102(A)(1) as being anticipated by Pekoz (WO 2022/055449, cited on PTO-892).
Regarding claims 1, 3-4, and 7-9: Pekoz teaches favipiravir, mannitol, hydroxychloroquine, umifenovir, molnupiravir, pimodivir, and/or remdesivir, and/or their water-soluble salt forms, and/or their water-soluble cyclodextrin complexes, and/or their water-soluble forms, and/or pharmaceutically acceptable derivatives thereof are used with soft mist inhaler through inhalation route for the treatment of viral lung diseases, especially COVID-19 (pg. 19, lines 27-32). The size range of the aerosol droplets released from the device is in the range of 1-7 micrometers, and said aerosol droplets are targeted to the lungs (pg. 21, lines 25-27). Said active substances can be used individually or in combination, and may contain excipients (pg. 22, lines 5-6). Pharmaceutically acceptable reconstituting solvents such as sterile water for injection, water for inhalation, sterile normal saline solution (0. 9% NaCl), sterile half saline solution (0.45% NaCl), sterile phosphate buffer solution (pH 4.5-7.4) and/or sterile 5% dextrose solution are used for reconstitution of the dosage form to form a solution or a fine particle suspension of pharmaceutically active substance prior to oral or nasal inhalation via VMT nebulizer or soft mist inhaler (pg. 23, lines 13-17). In specific embodiments, Pekoz teaches formulations comprising 2 mg/mL of Favipiravir in phosphate buffer (pg. 36, lines 7-10, 11-15). Although Pekoz does not explicitly demonstrate molnupiravir in a specific embodiment, given its specific mention and a genus of 7 possible compounds, a reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination (See MPEP 2131.02 (III).
Regarding claims 5-6: Pekoz teaches the formulation can additionally include EDTA as an antioxidant which protects the formulation from free radicals (pg. 26, lines 1-3). Pekoz teaches EDTA is a chelating agent (pg. 27, lines 18).
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.
Claims 5-6 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Pekoz (WO 2023/055449, cited on PTO-892) as applied to claims 1 and 3-9 above.
Regarding claims 5-6: Even if assuming for the sake of argument that Pekoz does not specifically teach inclusion of EDTA, the claims would have been rendered obvious over Pekoz. As discussed above, Pekoz teaches the composition of claim 1 and device of claim 9. Pekoz teaches the formulation can additionally include EDTA as an antioxidant which protects the formulation from free radicals (pg. 26, lines 1-3). Pekoz teaches EDTA is a chelating agent (pg. 27, lines 18). Antioxidants, which are natural or synthetic substances which prevent or interrupt the oxidation of active agents and or oxidative injury in stressed tissues and cells, can be used in the subject-matter of pharmaceutical composition. Thus, it would have been prima facie obvious to include EDTA in the composition for the purpose of protecting the formulation from free radicals as taught by Pekoz.
Regarding claims 11-12: Pekoz teaches the formulation is atomized and forms uniform and stable aerosol particles (pg. 30, line 29). Pekoz teaches the size range of the aerosol droplets released from the device is in the range of 2-6 micrometers (pg. 7, lines 16-18). Pekoz teaches particle size ranges from 1-6 µm are preferred because diameter of 6-10 µm do not move beyond the larger lung airways (pg. 19, lines 20-22). The droplet size range of the soft mist inhaler is quite narrow due to drug/active substance accumulation and ease of use provided by the soft mist inhaler (pg. 20, lines 11-14). Although Pekoz does not teach wherein at least 50% of the particles are smaller than 5.8 um, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (See MPEP 2144.05 (I)). Additionally, wherein the art establishes it is advantageous to have such a size range in order to move beyond the larger lung airways, it would have been prima facie obvious to optimize wherein most of the particles are within the claimed size range in order to do so. Where 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 (See MPEP 2144.05 (II)).
Regarding claim 10: Pekoz teaches the carrier solution in the composition is used up to the required volume in order to obtain a solution containing 0.01-20 mg, preferably 0.01-10 mg of molnupiravir (pg. 23, lines 25-26). The solution of active substance is packaged and used as a one-time administration dose (pg. 24, line 1). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (See MPEP 2144.05 (I)). Additionally, Pekoz teaches In the soft mist inhaler, dose adjustment depending on weight and age may be performed easily by the physician in the hospital (pg. 20, lines 18-19).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Pekoz (WO 2023/055449, cited on PTO-892) as applied to claims 1 and 3-12 above in view of Pekoz (WO 2023/177366, cited on PTO-892), hereinafter referred to as Pekoz ‘366.
Regarding claim 10: Even assuming for the sake of argument that Pekoz teaches preferred doses of less than 13 mg, the present claim 10 would still have been rendered obvious in view of Pekoz ‘366.
As discussed above, Pekoz teaches the device of claim 9. Pekoz teaches the carrier solution in the composition is used up to the required volume in order to obtain a solution containing 0.01-20 mg, preferably 0.01-10 mg of molnupiravir (pg. 23, lines 25-26). The solution of active substance is packaged and used as a one-time administration dose (pg. 24, line 1).
Pekoz does not teach wherein the dose per spray is at least 13 mg.
However, Pekoz ‘366 teaches the present invention relates to a pharmaceutical composition that comprises aerosol formulation for direct delivery of at least one active substance used against viral diseases, for example favipiravir and/or umifenovir and/or molnupiravir and/or ritonavir and/or pimodivir and/or hydroxychloroquine and/or remdesivir and/or salt forms thereof and/or cyclodextrin complexes thereof and/or pharmaceutically acceptable derivatives thereof to the lungs with pressurized metered dose inhalers (pMDis) in the treatment of COVID-19 or other viral lung diseases; wherein active substances used against viral diseases can be in water-soluble form, water soluble salt form, solution form or suspension form (abstract). Molnupiravir, which is a prodrug that is metabolized into active antiviral ribonucleoside analogue 13-D-N4-hydroxycytidin (NHC) (pg. 7, lines 1-3). It has activity against a number of RNA viruses, including SARS-CoV-2, SARS-CoV,MERS-CoV, and seasonal and pandemic influenza viruses (pg. 7, lines 1-4). The present invention provides administration of at least one active substance used against viral diseases such as favipiravir alone or in combination with hypertonic saline solution and/or mannitol in the deep lung region through inhalation devices (pg. 8, lines 9-11). Inhalation devices used in the treatment of lung diseases are metered dose inhaler (MDI), dry powder inhaler (DPI), nebulizers (Jet, ultrasonic, new type nebulizer (e.g., VMT and electronic)), and soft mist inhalers (pg. 3, lines 2-4). Pekoz ‘366 teaches for favipiravir 5-200 mg dose; for umifenovir, molnupiravir, ritonavir, or pimodivir 10-200 mg, more specifically 10-100 mg can be used (pg. 10, lines 28-29).
Taken together it would have been prima facie obvious to modify the composition of Pekoz such that the dose of molnupiravir to be administered is between 10-100 mg as taught by Pekoz ‘366. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success as these dose amounts are known in the art to be effective for the treatment of viral diseases via inhalation devices. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (See MPEP 2144.05 (I)).
Conclusion
No claims are allowed in this action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL L GALSTER whose telephone number is (571)270-0933. The examiner can normally be reached Monday - Friday 8:00 AM - 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Y Goon can be reached at 571-270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAMUEL L GALSTER/Examiner, Art Unit 1693
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