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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 03/13/2025 is/are acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) has/have been considered by the examiner. See attached copy(ies) of PTO-1449.
Response to Restriction
Applicants' election without traverse of Group I (claims 1-4, 23, 25 and 58-64) in the reply filed on 06/26/2026 is acknowledged. In accordance with 37 CPR 1.499, the claims must be restricted.
I. Claims 1-4, 23, 25 and 58-64, drawn to a liquid pharmaceutical formulation.
II. Claim 33, 36, 38-40, 46-47 and 53-53, drawn to a method of treating or preventing viral infection.
The requirement is proper and is made FINAL. For examining purpose, Claims 1-4, 23, 25 and 58-64 of Group I are examined in this office action.
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.
Claim(s) 1-4, 23, 58-62 and 64 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dor et al. (US 20090074786 A1)
Claims 1-4, 58-61 and 64,
Dor et al. teach the liquid formulations which may be administered by topical administration. (0365). Routes of administration that may be used to administer a liquid formulation include but are not limited to intrapulmonary, intrathoracic, intratracheal, nasal. (0030). Therapeutic agents that may be antiviral agents. (0303). Surfactants that may include but are not limited to polyoxyethylene-sorbitan-fatty acid esters, or Polysorbate 20 (Tween 20) or Polysorbate 80 (Tween 80). (0325). One of solvents may be included oleic acid, (0303, 0305, 0307, 0313), which has surfactant capability, and may be listed as stabilizer as well, (0338-0339), which is a free form.
With regard to claims 23 and 62,
In some variations, any of the liquid formulation may be diluted. In some variations, the liquid formulation may be diluted any of about 5-1.1 fold. In some variations, the liquid formulation is diluted with an aqueous liquid (including, but not limited to, water or saline). (0249).
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 non-obviousness.
Claim(s) 1, 58 and 25, 63 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dor et al. (US 20090074786 A1) in view of JP 2013513664 A.
The teachings of Dor et al. are described in Claim 1 and 58.
Even though Dor et al. do not teach directly the liquid pharmaceutical formulation wherein the liquid pharmaceutical formulation is a pressured liquid formulation, but Dor et al. teach intratracheal, nasal, or aerosolized using aerosol propellants (0030), which means the formulations use chemical propellants, (such as pressurized metered-dose inhalers, or pMDIs) are highly pressurized.
JP 2013513664 A teaches a liquid /liquid suspension in the form of a nasal spray in a liquid formulation, or a respirable particulate spray nasal spray inhaled by a patient. of active compounds for making spray nasal drops or nasal include the active compound and suitable excipients. (pg. 43, 4th par.). The active compound is delivered by topical administration, including inhalation, or targeted drug delivery. Inhalation methods include liquid instillation, instillation as a pressurized liquid formulation via a metered dose inhaler or equivalent, or aerosolized solution nebulization via a nebulizer, dry powder inhalation, and mechanical ventilation. (pg. 44, par. 4-5th).
It would have been obvious to one of ordinary skill in the art before the effective filing date invention to have the liquid formulations which may be administered by topical administration to intrapulmonary, intrathoracic, intratracheal, nasal, therapeutic agents that may be antiviral agents; Surfactants that may include but are not limited to polyoxyethylene-sorbitan-fatty acid esters, Polysorbate 20, or Polysorbate 80; One of solvents may be included oleic acid, which has surfactant capability, and may be listed as stabilizer as well, and is a free form, and the formulations can be aerosolized using aerosol propellants such as pressurized metered-dose inhalers, or pMDIs) are highly pressurized, taught by Dor et al., in addition, inhalation methods include liquid instillation, instillation as a pressurized liquid formulation via a metered dose inhaler or equivalent, or aerosolized solution nebulization via a nebulizer, dry powder inhalation, and mechanical ventilation, taught by JP 2013513664 A, since they have pointed out formulation for pulmonary delivery can be aerosolized by pressurizing liquid formulations.
Conclusion
No claim is allowed.
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/NGOC-ANH THI NGUYEN/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
