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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-6, in the reply filed on 7/27/2026 is acknowledged.
Claim 7-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/27/2026.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code in paragraph [0009]. 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.
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 and 6 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.
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, claim 5 recites the broad recitation 0.5% to 5%, and the claim also recites preferably about 3.5% 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 6 recites “every 5-10 minutes,” it is unclear if the limitation is defining a concentration per time, wherein the total dosage time is undefined or if the administration is only for the recited time period. For purposes of examination, administration of the composition once for 5-10min will be deemed to read on the claim.
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.
Claim(s) 1-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Badhe (2021).
Badhe teaches the use of negative oxygen ion clusters and bicarbonate ions as a supportive treatment of COVID-19 infections (abs). Badhe teaches that it is reported that the pH of the bronchoalveolar fluids of a COVID-19 patient is acidic (resulting in respiratory acidosis with a pH < 7.3). Badhe teaches that HCO3- ions supplied intermittently through ventilator or oxygen concentrator along with O2- (H2O)n clusters as nebulized sodium bicarbonate will change the acidic bronchial environment to neutral/alkaline conditions leading to enhanced CO2 exhale (pg. 2). It is proposed that intermittently (5–10 ml every 6 h) nebulized sodium bicarbonate (NSB) therapy with 3.5–5% concentration (4.2% reported for some COVID-19 patients) can be delivered through the same inspiratory limb of the ventilator tubing or by connecting to the nebulizer mask of oxygen concentrator tubing. The NSB will change the pH of the bronchoalveolar fluids.
While Badhe teaches a hypothesized treatment and doesn’t actually teach an active step of inhalation, it would have been prima facie obvious to a skilled artisan to administer 3.5-5% NSB, reading on effective amounts, to a COVID-19 patient having respiratory acidosis to treat the acidosis, as Badhe teaches that administration of the NSB is expected to change the pH of the bronchoalveolar fluids to a neutral/alkaline pH.
Regarding claims 2-3: Badhe teaches using a nebulizing mask.
Regarding claim 4: Badhe teaches sodium bicarbonate.
Claim(s) 1-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over RU2735502, Mendez (2019) and Khalil (US 2020/0113958).
RU’502 teaches a medicinal composition in the form of a solution, intended for obtaining an aerosol suitable for inhalation [0015]. The medicinal composition comprises 1.2% sodium bicarbonate [0064] in distilled water [0067]. RU’502 teaches the formulation to be an aqueous solution which suggests that the sodium bicarbonate is dissolved in the water [0062]. RU’502 teaches the formulation to suitable for use with jet inhalers, nebulizers and ultrasonic compression [0063].
RU’502 teaches that the composition can be used to treat obstructive bronchitis [0083]. RU’502 teaches administration of the composition to a subject using a nebulizer for inhalation. Inhalation was performed 3 times a day each lasting up to 5min each. Use of the composition resulted in immediate dissolution of thick pus, thick mucus with streaks of blood, improving their expectoration, facilitating breathing, widening the lumen of the bronchi, increasing the oxygen content in the bronchi without local irritant action, without increasing the symptoms of obstructive bronchitis, without the development of pneumonia, acidosis, alcohol intoxication and bronchospasm [0087].
Regarding claims 2-3: As discussed above, RU’502 teaches the composition to be nebulized with the use of a nebulizer (i.e. delivery system).
Regarding claim 4: As discussed above, RU’502 teaches the composition to comprise sodium bicarbonate.
Regarding claims 1 and 5: As discussed above, RU’502 teaches the composition to comprise 1.2% sodium bicarbonate with overlaps with the claimed effective amounts.
However, RU’502 does not teach administering the composition to treat acidosis.
Mendez teaches that chronic obstructive pulmonary disorder (COPD) is a common, preventable and treatable disease characterized by persistent respiratory symptoms and airflow limitation due to airway and/or alveolar abnormalities. It is characterized by a spectrum of clinical scenarios such as
emphysema originated by lung parenchyma destruction, and chronic bronchitis due to increased mucus production and bronchial tissue inflammation (pg. 79). Exacerbations of COPD are taught to include chronic bronchitis (pg. 81). Mendez teaches that a pathophysiological consequence related to chronic obstruction of the airway is that patients are prone to carbon dioxide retention which can progress to respiratory acidosis (pg. 79).
Khalil teaches that treatments with sodium bicarbonate can be used for any type of acidosis. This can be done either by mouth or in an intravenous (IV) drip to raise the pH of the blood. The treatment for other types of acidosis can involve treating their cause. Treatments for respiratory acidosis are usually designed to help lungs functioning. Like giving drugs to dilate airway, or giving oxygen or a continuous positive airway pressure (CPAP) device. The CPAP device can help in breathing if patient has an obstructed airway or muscle weakness. Patients with hyperchloremic acidosis may be given oral sodium bicarbonate. Acidosis from kidney failure may be treated with sodium citrate. Diabetics with ketoacidosis receive IV fluids and insulin to balance out their pH. Lactic acidosis treatment might include bicarbonate supplements, IV fluids, oxygen, or antibiotics, depending on the cause [0012].
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of RU’502 with those of Mendez and Khalil. In view of the teachings of Mendez and Khalil, a skilled artisan would recognize that the inhalable formulation of RU’502 could be used to effectively treat patients with chronic bronchitis and those also suffering from acidosis as a results of the chronic obstruction. One of skill in the art would have a reasonable expectation of success as Mendez teaches that respiratory acidosis is a pathophysiological consequence related to chronic obstruction of the airway and Khalil teaches that sodium bicarbonate can be used to treat any type of acidosis. One of skill in the art would have a reasonable expectation of success as RU’502 teaches the formulation to treat chronic bronchitis and teaches that the formulation does not increase the symptoms of obstructive bronchitis and does not increase acidosis and Khalil teaches that treating respiratory acidosis involves helping the lungs function, such as giving drugs to dilate airway, which the composition of RU’502 does.
Claim(s) 1-5 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over RU2735502, Mendez (2019) and Khalil (US 2020/0113958), as applied to claims 1-5 above, and further in view of Dhuppad (US 2018/0133151) and Pipkin (US 2007/0202054).
The above reference make obvious the limitations of claims 1-5, and RU’502 teaches performing an inhalation for 5min, however, they do not teach the composition to be inhaled at a rate of 4-6mL.
Dhuppad teaches methods of treating inflammatory or obstructive airway diseases (abs) such as COPD [0003] with nebulized compositions [0015] delivered via a jet nebulizer, ultrasonic nebulizer, etc. [0023]. Dhuppad teaches that the volume of the composition may be from 0.1-5mL [0063 and 0069].
Pipkin teaches inhalable formulations comprising corticosteroids adapted for administration to a subject by nebulization with any known nebulizer (abs) which can be used to treat a disease or disorder of the air passageways e.g. respiratory or pulmonary disorders such as bronchoconstrictive disorders [0283] including chronic bronchitis [0294]. Pipkin teaches that the time required to administer or deliver a dose of corticosteroid is less than 30 min and teaches that the time will vary according to the dose of corticosteroid in, the concentration of corticosteroid in, and the volume of the inhalable composition in the reservoir of a nebulizer, and it will also depend upon the nebulizer format, nebulization efficiency, and reservoir volume. In a given nebulizer, the lower the volume of the inhalable composition, the more quickly a corresponding dose of corticosteroid is nebulized. The higher the concentration of corticosteroid in an inhalable composition, the faster a dose of the corticosteroid can be administered or delivered [0096]. The output rate (the rate at which the dose corticosteroid is administered or delivered) will vary according to the performance parameters of the nebulizer used to administer it. The higher the output rate of a given nebulizer, the lower the amount of time required to deliver or administer an inhalable composition, as defined herein, or dose of corticosteroid [0097].
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of the above references with those of Dhuppad and Pipkin. In view of the teachings of Dhuppad and Pipkin, a skilled artisan would recognize that the inhalable formulation of RU’502 could be formulated to have a volume of 0.1-5mL as this is taught by the art to be a common volume size for inhalation treatment for obstructive airway diseases. As discussed above, RU’502 teaches administering the nebulizing treatment for 5min, based on the teaching of Pipkin a skilled artisan would have been motivated to optimize the time frame of the treatment along with the volume size as this directly affects how quickly the dose is nebulized and how fast a dose can be administered to the patient.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jennifer A Berrios whose telephone number is (571)270-7679. The examiner can normally be reached Monday-Thursday from 9am-4pm and Friday 9am-3:30pm.
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/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
