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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. The instant application, filed on 09/01/2023 claims domestic benefit to U.S. provisional application no. 63/402,991, filed on 09/01/2022.
Status of Claims/Application
Claims 1 – 6, filed on 09/01/2023, are currently pending and are examined on the merits herein. No preliminary amendment was submitted.
Information Disclosure Statement
Information disclosure statement (IDS) submitted by the applicant on 09/15/2023 is in compliance with the provisions of 37 CFR 1.97. It has been considered by the examiner.
Specification Objection
The use of the term TWEEN, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The term TWEEN appears in Tables 1 ,2, 3, and 4 in pages 3 and 4, and in (line 12, pg. 3), (line 9, pg. 4), (line 10, pg. 5) of the instant specification. Appropriate correction is required.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The instant specification includes two hyperlinks on pg. 5, line 18 and line 32. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 is 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.
Claim 1 contains the trademark/trade name TWEEN. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe polysorbate 80 which is used as a stabilizer and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 103
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 - 6 are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0241307 (PTO-892).
US’307 teaches the use of inhaled ivermectin in various viruses and parasitic infections (treatment and/or prophylaxis) that are present or manifest in the lungs or respiratory tract (Abstract).
US’307 teaches that treatment of SARS-Cov-2, as well as other viruses that gain entry into the human body via the nasal or respiratory tract (e.g., SARS-Cov-1, Middle Eastern Respiratory Syndrome (MERS), and other human Coronaviruses such as HCoV-229E, HCoV-0C43, HCoV-NL63, and HCoV-HKU1) causing mild to severe respiratory symptoms can benefit from a dosage form that delivers Ivermectin directly to the lungs ([0008], pg. 1, col. 2). One preferred embodiment of US’307 is an aqueous suspension with pharmaceutically acceptable excipients for use with commercially available nebulizers for use at home or a hospital setting ([0012], pg. 2, col. 1). US’307 provides a method for treating a virus, wherein the method comprises administering to a human in need thereof via inhalation a formulation of ivermectin, in order to treat the virus ([0015], pg. 2, col. 2). In certain embodiments of US’307, the formulation is for delivery to the human using a nebulizer ([0016], pg. 2, col. 2). US’307 teaches the preparation of inhalable micro or nano particles of Ivermectin using traditional milling techniques such as air jet-milling, wet or dry media milling, high pressure homogenization (Gaulin APV, Microfluidizer, BEEI), spray-drying, spray-freeze drying, controlled precipitation from organic solutions, and extraction from supercritical fluids (SCF). For drug particles to reach the deep lung and be effective, aerosol particles are required to have aerodynamic diameters between 0.5 μm-5 μm ([0019], pg. 2, col. 2). US’307 teaches a dose of up to 40 mg per delivered dose, also 10-20 mg per delivered dose, but doses as low as 0.1 mg and up to 40 mg are expressly contemplated ([0027], pg. 3, col. 1). US’307 teaches that a preferred dosing regimen for the prophylaxis and treatment of COVID-19 is up to 40 mg administered daily over a period of up to seven days ([0027], pg. 3, col. 1).
Exemplary embodiments of US’307 include nebulized formulations. Pharmaceutically acceptable excipients may be added to the formulation to aid in delivery and aerosolization. For example, in nebulized formulations, aqueous buffered saline may be used to suspend Ivermectin to match the osmolality of the lung fluid (~300 mosmol/l). Other excipients that aid in stabilizing the suspension may be used. Examples of such excipients include: (1) surfactants such as Polysorbate 80 (Tween 80), Polysorbate 20 (Tween 20), sorbitan laurate, and Poloxamer 188; (2) stabilizers such as citric acid, ascorbic acid, tartaric acid, malic acid, fumaric acid, adipic acid, methyl paraben, propyl paraben, glycerol, EDTA, N-acetyl cysteine, cysteine, ascorbyl palmitate, sodium metabisulfite, butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), propyl gallate, thioglycerol, tocopherols, D-α-tocopherol polyethylene glycol 1000 succinate (TPGS), and calcium chloride; (3) buffering agents such as sodium citrate, monobasic and dibasic sodium phosphate, and trometamol; and (4) pH modifiers such as sodium hydroxide (NaOH) and hydrochloric acid (HCl); and (5) osmolality modifiers such as sodium chloride (NaCl) for adjusting osmolality ([0028], pg. 3, col. 1). US’307 teaches that the formulation is used to treat the virus selected from the group consisting of SARS-Cov-1, SARS-Cov-2, MERS, HCoV-229E, HCoV-0C43, HCoV-NL63, and HCoV-HKU1. In certain embodiments, the virus is SARS-CoV-2. In certain embodiments, the virus is a variant of SARS-CoV-2. In certain embodiments, the virus is a SARS-CoV-2 or a variant thereof selected from B.1.617.2, B.1.351, Cluster 5, Lineage B.1.1.207, Lineage B.1.1.7, Variant of Concern 202102/02, Lineage B.1.1.317, Lineage B.1.1.318, Lineage B.1.351, Lineage B.1.429, Lineage B.1.525, Lineage P.1, D614G, E484K, N501Y, S477G/N, and P681H ([0038], pg. 4, col. 2).
US’307 teaches that the inhaled formulation of ivermectin comprises: ivermectin, and a surfactant. In certain embodiments, the surfactant is a polysorbate. In certain embodiments, the surfactant is polysorbate 80. In certain embodiments, the surfactant is present in the inhaled formulation in an amount of from about 0.01% w/v to about 0.1% w/v. In certain embodiments, the surfactant is present in the inhaled formulation in an amount of from about 0.5% w/w to about 5.0% w/w ([0044], pg. 4, col. 2). US’307 teaches that the inhaled formulation further comprises a tonicity modifier. In certain embodiments, the tonicity modifier is sodium chloride or calcium chloride ([0048], pg. 5, col. 1). US’307 teaches that the inhaled formulation further comprises a buffer. In certain embodiments, the buffer comprises citric acid, or a pharmaceutically acceptable salt thereof ([0049], pg. 5, col. 1). US’307 teaches that the inhaled formulation further comprises water ([0050], pg. 5, col. 1). US’307 exemplifies 11 different inhaled ivermectin formulations including the following formulations - a formulation comprising ivermectin, polysorbate 80, sodium chloride, and water, and a formulation comprising ivermectin, polysorbate 80, sodium chloride, sodium citrate, citric acid, EDTA, and water ([0057], pg. 5, col. 2).
US’307 exemplifies a formulation of a nebulized suspension formulation of Ivermectin in Example 2 as shown below ([0086], pg. 7, col. 2).
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Regarding claim 1, US’307 does not teach a formulation containing at least 0.1 mg/mL tween 80 stabilizer. However, as it teaches that the surfactant, polysorbate 80 is present in the inhaled formulation in an amount of from about 0.01% w/v to about 0.1% w/v. In certain embodiments, the surfactant is present in the inhaled formulation in an amount of from about 0.5% w/w to about 5.0% w/w ([0044], pg. 4, col. 2), it would have been obvious to adjust the amount of tween 80 before the effective filing date of the claimed invention to arrive at the pharmaceutical composition of ivermectin nano-suspension of the instantly claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to modify the teachings of US’307 to effectively change the amount of tween 80 to achieve the nano-suspension suitable for use in a nebulizer.
Regarding claim 2, US’307 teaches the preparation of inhalable micro or nano particles of Ivermectin, aerodynamic diameters between 0.5 μm-5 μm and further teaches the relationship between geometric and aerodynamic particle size ([0019], pg. 2, col. 2). Therefore, it would have been obvious to prepare particles of suitable size before the effective filing date of the claimed invention to arrive at the pharmaceutical composition of ivermectin nano-suspension, wherein a particle size is below 600 nm. It would have been prima facie obvious for one of ordinary skill in the art to modify the teachings of US’307 to arrive at the desired sized nano-particles suitable for use in a nebulizer. One of ordinary skill in the art would have a reasonable expectation of success because US’307 teaches that particles with smaller aerodynamic size can be prepared by either decreasing geometric size, decreasing particle density, and/or increasing the shape factor (making them more spherical) ([0026], pg. 3, col. 1).
Regarding claim 3, US’307 does not teach the amount of ivermectin is 1.2 mg/mL. However, as it teaches the ivermectin doses as low as 0.1 mg and up to 40 mg are expressly contemplated ([0027], pg. 3, col. 1), and a dose of 1 mg/mL in Example 2 shown above, it would have been obvious to adjust the dose of ivermectin in the composition to 1.2 mg/mL before the effective filing date of the claimed invention to arrive at the pharmaceutical composition of ivermectin nano-suspension of the instantly claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to modify the teachings of US’307 by optimizing the dose of ivermectin to obtain an effective therapeutic composition that could be efficiently employed to address the treatment of lung diseases, including Covid-19 in patients in need of such a treatment.
Regarding claim 4, US’307 teaches that the inhaled formulation further comprises a tonicity modifier, sodium chloride or calcium chloride ([0048], pg. 5, col. 1), and US’307 teaches that the inhaled formulation further comprises a buffer, the buffer comprises citric acid, or a pharmaceutically acceptable salt thereof ([0049], pg. 5, col. 1).
Regarding claims 5 and 6, US’307 teaches that the formulation is used to treat the virus selected from the group consisting of SARS-Cov-1, SARS-Cov-2, MERS, HCoV-229E, HCoV-0C43, HCoV-NL63, and HCoV-HKU1 ([0038], pg. 4, col. 2).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANAKI ANANTH MAHADEVAN whose telephone number is (571)272-0230. The examiner can normally be reached Monday-Friday 8-5PM.
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/JANAKI ANANTH MAHADEVAN/Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693