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 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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/17/2026 has been entered.
Claims 1 and 15-17 are amended; claim 6 is canceled; and claims 20-21 are new.
Claims 1-5 and 7-21 are currently pending and are examined on the merits herein.
Priority
The instant application, filed 02/15/2022, claims domestic benefit to US provisional application 02/16/2021.
Withdrawn Objections and Rejections
In the office action of 10/17/2025,
Claim 17 was rejected under 35 USC 102(a)(1) over Adili. Upon further consideration, the rejection is withdrawn in favor of the modified rejection below.
Claims 15 and 16 were rejected under 35 USC 102(a)(1) over Holman. Upon further consideration, the rejections are withdrawn in favor of the modified rejection below.
Claims 1 and 4 were rejected under 35 USC 102(a)(1) over Bombardelli. Upon further consideration, the rejections are withdrawn in favor of the modified rejection below.
Claims 2-3 and 8-11 were rejected under 35 USC 103 over Bombardelli and Jin; claims 4, 5, and 7 were rejected under 35 USC 103 over Bombardelli, Adili, and Khanna; claims 12 and 13 were rejected under 35 USC 103 over Bombardelli and Holman; claim 14 was rejected under 35 USC 103 over Bombardelli in view of Stebbing; and claim 18 was rejected under 35 USC 103 over Adili, and Virchow. Upon further consideration, the rejections are withdrawn in favor of the modified rejection below.
The following objections and rejections are new.
Drawings
The drawings are objected to because of the following informalities: the drawings comprise figures that are illegible. For instance, see Fig. 2. Additionally, Figs 3-5 are too dark and the information provided therein is difficult to see.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 7 is objected to for the following informality: the claim recites the limitation “wherein the 12-LO inhibitory is an inhibitory nucleic acid”. The recitation of “the 12-LO inhibitory” should be corrected to “the IL-12 LO inhibitor”.
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, 8, 17, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Song, J., et al (2021) The comprehensive study on the therapeutic effects of baicalein for the treatment of COVID-19 in vivo and in vitro Biochemical Pharmacology 183(114302); 1-9; published online 27 Oct 2020 as evidenced by US 2017/0001955 A1 (Maloney, D.J., et al) 5 Jan 2017.
Song provides a preclinical study of baicalein on the treatment of COVID-19 and teaches that baicalein inhibited cell damage induced by SARS-Cov-2 and improved the morphology of Vero E6 cells at a concentration of 0.1μM and above. Furthermore, baicalein significantly inhibited the body weight loss, the replication of the virus, and relieved the lesions of lung tissue in hACE2 transgenic mice infected with SARS-CoV-2. In LPS-induced acute lung injury of mice, baicalein improved the respiratory function, inhibited inflammatory cell infiltration in the lung, and decreased the levels of IL-1β and TNF-α in serum. Song concludes that baicalein could inhibit SARS-CoV-2 induced injury both in vitro and in vivo. Therefore, baicalein might be a promising therapeutic drug for the treatment of COVID-19 (abstract).
Baicalein meets the instant claim limitation of a 12-LO inhibitor based on the instant specification, pages 6-7, [0030], which states that 12-LO inhibitors include, for example,… baicalein. Additionally, the prior art recognizes baicalein as a 12-LO inhibitor as evidenced by US’955 page 14, [0200], which also identifies baicalein as a 12-LOX inhibitor.
Song teaches that the coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has led to a global public health crisis. Some patients infected with SARS-CoV-2 showed respiratory distress or even respiratory failure. A massive number of non-invasive ventilators are needed for patients to achieve mechanical ventilation. Critical illness patients with respiratory failure or multiorgan failure require ICU monitoring treatment urgently. The pandemic brings a huge challenge to the public health-care system and drug discovery for the treatment of COVID-19 is urgent (page 1, paragraph bridging columns).
Baicalein is an active compound isolated from Scutellaria baicalensis Georgi (Huangquin), a traditional medicine with the pharmacological effects of anti-inflammation and anti-virus. Baicalein or the extract of Huangquin exhibited broad-spectrum anti-viral effects, including influenza A virus, Zika virus, and dengue virus. In the study provided, Song studied the therapeutic effects of baicalein against SARS-CoV-2 both in vivo and in vitro. An LPS-induced acute lung injury model was also carried out in mice to reveal the effects of baicalein on the related symptoms of COVID-19 (page 2, left column, paragraph 2). Song provides the structure of baicalein in Fig. 1B, demonstrating that it is a small molecule (page 4).
Song teaches that a crystal form of baicalein (crystal form β) shows a higher bioavailability than other crystal forms of baicalein and teaches that baicalein has been developed as a pharmaceutical form of baicalein chewable tablets used in clinical trials (page 2, left column, paragraph 3). Song also teaches oral and intravenous injection of baicalein (page 2, right column, paragraph 2). As Song teaches in vivo administration of the pharmaceutical formulations of baicalein and their use in clinical trials, the formulations would necessarily comprise a physiologically compatible carrier.
Thus, Song anticipates instant claims 1-4, 8, 17, and 21.
Claims 15-18 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US 2017/0001955 A1 (Maloney, D.J., et al) 5 Jan 2017.
US’955 teaches compounds that display nM potency against 12-LOX and excellent selectivity over related lipoxygenases and cyclooxygenases. The compounds can be used in methods for treating or preventing 12-lipoxygenase mediated disease or disorders (abstract).
US’955 further teaches pharmaceutical compositions comprising the 12-LOX inhibitors and a pharmaceutically acceptable carrier (page 8, [0131]). The pharmaceutical formulation can also contain suitable pharmaceutically acceptable carriers comprising excipients and auxiliaries that facilitate processing of the active compounds into preparations that can be administered (page 10, [0150]). The compositions can also contain preservatives (page 9, [0143]).
US’955 teaches that the composition may be presented in unit-dose or multi-dose containers, sealed ampules and vials, and may be stored in freeze-dried condition requiring only the addition of a sterile liquid carrier immediately prior to use (page 10, [0157]).
US’955 teaches that the pharmaceutical compositions can be administered in an amount effective to treat a condition, disorder, or disease and may be administered via various routes which include intrapulmonary or intranasally (page 11, [0162]-[0163]) indicating that the formulation can be for pulmonary delivery.
US’955 teaches dosages for the compositions over a wide range from about 0.001 mg/kg to 10 mg/kg of body weight per day or about 0.0001 to about 1000 mg per patient per day (page 13, [0182] and [0184]). US’955 teaches that the dosage may vary depending on the dosage form employed and the route of administration utilized (page 13, [0179]).
While US’955 does not explicitly disclose that the 12-LOX compositions are used for the treatment of COVID-19, as recited in instant claims 15 and 16, such limitations are intended use limitations. The composition of US’955 are in dosage amounts that would be capable of performing the intended use as recited and, therefore, the composition of US’955 meets the instant claim limitations.
See MPEP 2111.02 II which states “[d]uring examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim. See, e.g., In re Otto, 312 F.2d 937, 938, 136 USPQ 458, 459 (CCPA 1963)... To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997).”
Additionally, although US’955 does not explicitly use the term “kit” or teach the inclusion of a dosing schedule or instructions for using the 12-LO inhibitor containing composition as recited in instant claims 15 and 16, US’955 teaches the physical component of the claimed product including containers comprising a 12-LOX inhibitor and teaches dosage forms and amounts that are sufficient for treating 12-LOX mediated disease or disorders. US’955 also teaches that the compounds display nM potency against 12-LOX. The dosing schedule and instructions recited in instant claims 15 and 16 do not add structural limitation to the claimed product and; therefore, the product disclosed by US’955 meets the instant claim limitations.
See MPEP 2111.05, which discusses functional and nonfunctional descriptive material. For instance, MPEP 2111.05 section I.B. states “Where a product merely serves as a support for printed matter, no functional relationship exists. These situations may arise where the claim as a whole is directed towards conveying a message or meaning to a human reader independent of the supporting product… Additionally, where the printed matter and product do not depend upon each other, no functional relationship exists. For example, in a kit containing a set of chemicals and a printed set of instructions for using the chemicals, the instructions are not related to that particular set of chemicals”.
Regarding claims 17-18, the recitation of “for treatment of a coronavirus infection” in claim 17 and “for pulmonary delivery” in claim 18 are intended use limitations. See MPEP 2111.02 II. As the pharmaceutical composition disclosed by US’955 would be capable of performing the intended use recited, the composition of US’955 anticipates the instant claims.
Thus, US’955 anticipates instant claims 15-18.
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.
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 1-5, 8-10, and 12-21 are rejected under 35 U.S.C. 103 as being unpatentable over Song, J., et al (2021) The comprehensive study on the therapeutic effects of baicalein for the treatment of COVID-19 in vivo and in vitro Biochemical Pharmacology 183(114302); 1-9; published online 27 Oct 2020 in view of US 2017/0001955 A1 (Maloney, D.J., et al) 5 Jan 2017.
The teachings of Song are as discussed above and, as discussed in detail above, Song teaches the method of claim 1, the pharmaceutical composition of claim 17, and the method of claim 21.
Song further teaches that several drugs have been tested for efficacy and safety against COVID-19, such as remdesivir, chloroquine, hydroxychloroquine, and favipiravir, some of which have displayed antiviral effects against SARS-CoV-2 in vitro. It was reported that remdesivir, chloroquine, and favipiravir could effectively protect Vero E6 cells by inhibiting the infection of SARS-CoV-2 with the half-maximal effective concentrations. Song also teaches the use of lopinavir-ritonavir treatment and convalescent plasma (page 2, left column, paragraph 1).
Song, however, does not teach that the 12-LO inhibitor is ML335 as recited in claim 5; that the 12-LO inhibitor is administered intranasally or for pulmonary delivery as recited in claims 9 and 10, respectively; that the 12-LO inhibitor is administered intermittently or continuously as recited in claims 12 and 13, respectively; that the method further includes a second COVID-19 therapeutic as recited in claim 14; the kit of claims 15 and 16; that the composition is for pulmonary delivery as recited in claim 18; or that the composition/kit further includes an additional therapeutic agent(s) as recited in claims 19 and 20.
The teachings of US’955 are as discussed above.
As discussed above, US’955 teaches compositions comprising 12-LOX inhibitors and teaches that the inhibitors can be administered intrapulmonary or intranasally (page 11, [0163]); and that the compositions may be presented in unit-dose or multi-dose containers, sealed ampules or vials (page 10, [0157]).
US’955 further teaches that a 12-LOX inhibitor can be an organic compound, an inorganic compound, a biological compound, e.g. proteins or fragments thereof, antibodies or fragments thereof, nucleic acids, nucleic acid analogs, saccharides, or peptides, or any combination thereof. A 12-LOX inhibitor can also be synthetic or naturally occurring. US’955 further teaches examples of 12-LOX inhibitors including baicalein and ML355 (page 14, [0200]). US’955 teaches that ML355 has been found to show low toxicity and good clearance from the body demonstrating its therapeutic value (page 15, [0203]).
US’955 also teaches that the compounds can be delivered over prolonged periods of time, for periods of one week to one year or as a single administration. Certain medical devices may be employed to provide a continues, intermittent, or on demand dosing of a patient. The devices may be a pump or diffusion apparatus, or other device containing a reservoir of drug and, optionally, diagnostic or monitoring components to regulate the delivery of the drug. Various slow-release, depot, or implant dosage forms can be utilized (page 11, [0164]). Other examples include provision of the compounds by sustained release delivery systems containing biodegradable compositions (page 11, [0165]).
US’955 teaches pharmaceutical compositions comprising a pharmaceutically acceptable carrier and at least one 12-LO inhibitor. US’955 further teaches that the 12-LO inhibitors disclosed can be administered in combination with other pharmaceutical agents in a variety of protocols for effective treatment of diseases (page 8, [0131]-[0132]). The composition can also include additional therapeutic agents. The additional therapeutic agent(s) can also be co-administered as part of an independent dosage form. Such additional therapeutic agent(s) can be any agent(s) having therapeutic or other value when administered (pages 10-11, [0159]-[0160]).
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the methods and compositions taught by Song with the teachings of US’955 to arrive at the instantly claimed invention. Specifically, it would have been obvious to substitute the baicalein disclosed by Song with ML355; to administer the baicalein intermittently or continuously and intrapulmonary or intranasally; to further administer/include a second therapeutic, for instance remdesivir, chloroquine, favipiravir, or lopinavir-ritonavir; and to present the baicalein in unit-dose or multi-dose containers, sealed ampules or vials as disclosed by US’955.
It would have been obvious to substitute the baicalein of Song with the ML355 of US’955 as US’955 teaches baicalein and ML355 as alternative 12-LO inhibitors suggesting analogous properties. Additionally, US’955 teaches that ML355 has low toxicity and good clearance from the body demonstrating its therapeutic value. Thus, an ordinarily skilled artisan would have had a reasonable expectation of success.
It would have been obvious to administer the 12-LO inhibitor intermittently or continuously and intrapulmonary or intranasally as taught by US’955 as US’955 teaches such administration for the delivery of 12-LO inhibitors, including baicalein, demonstrating that such administration routes had been considered in the art and providing a reasonable expectation of success.
It would have further been obvious to additionally administer/include a second therapeutic in the method/compositions of Song as disclosed by US’955 as US’955 teaches the further inclusion of additional agent(s) in combination with 12-LO inhibitors. It would have also been obvious to have the additional agent(s) be remdesivir, chloroquine, favipiravir, and/or lopinavir-ritonavir as Song teaches that these therapeutics have been studied regarding their treatment of COVID-19. An ordinarily skilled artisan would have had a reasonable expectation of success because US’955 teaches the combination of additional agent(s) that are effective for a given disease.
It would have been obvious to present the baicalein in unit-dose or multi-dose containers, sealed ampules or vials as disclosed by US’955 as US’955 teaches such containers for the presentation of 12-LO inhibitor compositions, providing a reasonable expectation of success. Although Song and US’955 do not explicitly use the term “kit” or the inclusion of a dosing schedule/instructions for using the 12-LO inhibitor containing composition as recited in instant claims 15 and 16, the combination of Song and US’955 teaches the physical component of the claimed product including containers comprising a 12-LOX inhibitor and teaches dosage forms and amounts that are sufficient for treating 12-LOX mediated disease or disorders. The schedule/instructions recited in instant claims 15 and 16 do not add structural limitation to the claimed active product and; therefore, the product disclosed by the combination of Song and US’955 meets the instant claim limitations. See MPEP 2111.05.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Song, J., et al (2021) The comprehensive study on the therapeutic effects of baicalein for the treatment of COVID-19 in vivo and in vitro Biochemical Pharmacology 183(114302); 1-9; published online 27 Oct 2020 in view of US 2017/0001955 A1 (Maloney, D.J., et al) 5 Jan 2017 as applied to claim 1 above and in further view of CN107362366A (Li, H. and X. Zhang) 21 Nov 2017; English translation acquired from https://worldwide.espacenet.com on 04/30/2026.
The combination of Song and US’955 teach the method of claim 1 as discussed above.
As discussed above, the combination of Song and US’955 teaches baicalein, which is a small molecule 12-LOX inhibitor. US’955 teaches baicalein as a 12-LOX inhibitor and further teaches that the 12-LOX inhibitor can, alternatively, be a nucleic acid or nucleic acid analog (page 14, [0200]).
The combination of Song and US’955, however, does not explicitly disclose that the nucleic acid is an inhibitory nucleic acid that targets the ALOX-12 gene product.
CN’366 teaches that lipoxygenase (ALOX) is a class of enzymes that can catalyze the production of biologically active metabolites from arachidonic acid, linoleic acid, fatty acids, and other polyunsaturated fatty acids, which participate in inflammation and immune responses. Based on the different specific positions of oxygen molecule insertion into arachidonic acid, mammalian ALOX is divided into four subtypes: ALOX5, ALOX8, ALOX12, and ALOX15 (page 3, [0004]). ALOX12 can catalyze the formation of 12-HPETE and 12-HETE from arachidonic acid, which in turn can catalyze the metabolism of linoleic acid to produce hydroxyoctadecadienols (HODEs). Current research suggests that ALOX12 is involved in the pathogenesis of diseases such as skin disease, platelet aggregation, diabetes, diabetic nephropathy, and diabetic neuropathy (page 4, [0007]). Ischemia reperfusion injury refers to a phenomenon where blood reperfusion after ischemia in tissues and organs fails to restore their function and exacerbates functional impairment and structural damage. Ischemia-reperfusion injury can occur in many vital organs, including the lungs (page 4, [0008]).
CN’366 teaches ALOX12 inhibitors and methods of using the inhibitors in treating inflammatory diseases (page 6, [0019]). The ALOX12 inhibitor may be an inhibitor of the activity or level of the ALOX12 protein or an inhibitor that inhibits the mRNA level of ALOX12 (page 7, [0027]). Inhibitors that inhibit the activity or level of the ALOX12 protein include antibodies, proteins, peptides, enzymes, and small molecule compounds (page 7, [0028]). Inhibitors that suppress the mRNA level of ALOX12 can be its antisense nucleic acid sequence, siRNA, miRNA, shRNA, dsRNA, or other proteins, peptides, enzymes, or compounds that can suppress the mRNA level of ALOX12 (page 7, [0029]).
CN’366 also teaches that small molecule compounds that inhibit the activity or level of ALOX12 protein can be a variety of compounds with ALOX inhibitory activity, including baicalein or ML355 (pages 6-7, [0031]).
CN’366 teaches that the medicaments disclosed can be administered by various routes in the art including orally, intravenously, or intranasally (page 9, [040]).
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to substitute the 12-LO inhibitor in the method taught by the combination of Song and US’955 with an inhibitor that inhibits the mRNA level of ALOX12, such as its antisense nucleic acid sequence, siRNA, miRNA, shRNA, or dsRNA, as disclosed by CN’366. One of ordinary skill in the art could have made this substitution with a reasonable expectation of success because CN’366 teaches the inhibitors of the mRNA level of ALOX12 as an alternative to baicalein and ML355, which are 12-LOX inhibitors taught by the combination of Song and US’955. Therefore, one of ordinarily skill in the art would have expected analogous properties and have a reasonable expectation of success.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Song, J., et al (2021) The comprehensive study on the therapeutic effects of baicalein for the treatment of COVID-19 in vivo and in vitro Biochemical Pharmacology 183(114302); 1-9; published online 27 Oct 2020 in view of US 2017/0001955 A1 (Maloney, D.J., et al) 5 Jan 2017 as applied to claim 1 above, and in further view of Rangaraj, N., et al (2019) Insight into pulmonary drug delivery: Mechanism of drug deposition to device characterization and regulatory requirements Pulmonary Pharmacology & Therapeutics 54; 1-21.
The combination of Song and US’955 teach the method of claim 1 as discussed in detail above.
As discussed above, US’955 teaches that 12-LOX inhibitors can be administered intrapulmonary.
The combination of applied references, however, does not disclose that the 12-LO inhibitor is formulated into an aerosol of dispersion particles.
Rangaraj teaches that the practice of pulmonary drug delivery dates back to thousands of years and was believed to be used for locally acting drugs in the treatment of ailments such as asthma, infections, cystic fibrosis, and chronic obstructive pulmonary disease. Rangaraj further teaches that pulmonary drug delivery can be achieved through oral or nasal inhalation. Rangaraj teaches advantages of pulmonary drug delivery including: provides local or systemic delivery; rapid onset of action; no effect of pH, food, and first pass metabolism compared to oral delivery; large surface area for absorption; decreased effective dose and thus associated side effects are reduced; painless drug delivery and hence comfortable as compared to injectables; and the devices are tamper proof (page 1, left column, Introduction).
Rangaraj teaches aerosol devices and teaches that they are generally suspensions of liquid or solids in carrier gas that deliver the drugs to the lower airway. These aerosol systems are divided into three main types which differ in the delivery and chemistry. Rangaraj also provides a comparison in terms of advantages and disadvantages with various devices in Table 1 (page 3, right column, 3) which comprise dispersion particles. For instance, Rangaraj teaches pressurized metered dose inhalers (pMDIs) and teaches that the pMDIs contain product concentrate that may be solubilized or dispersed in liquefied propellant under high vapor pressure (page 5, 3.2; 3.2.3). This approach is suitable for insoluble drug particles which are dispersed in liquid propellant to produce a heterogenous system. The size of the aerosolized particle depends on the initial particle size and hence the probably of oropharyngeal deposition is higher (page 5, 3.2.3.1).
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method taught by the combination of Song and US’955 by formulating the 12-LOX inhibitor into an aerosol of dispersion particles for intrapulmonary delivery as disclosed by Rangaraj. An ordinarily skilled artisan would have been motivated to formulate the inhibitor into an aerosol for intrapulmonary delivery in order to obtain the benefits of pulmonary drug delivery taught by Rangaraj such as local or systemic delivery, rapid onset of action, no effect of pH, food, and first pass metabolism, large surface area for absorption, decreased effective dose requirements and reduced side effects, painless drug delivery, and tamper proof devices. An ordinarily skilled artisan would have had a reasonable expectation of success as Song teaches that baicalein improved respiratory function and inhibited inflammatory cell infiltration in the lung, demonstrating the relevance of the lungs and airways in COVID-19 and US’955 teaches that 12-LOX inhibitors can be administered intrapulmonary.
Response to Arguments
Applicant’s arguments filed in the response of 04/17/2026 have been fully considered in so far as they apply to the rejections of the instant office action, but were not persuasive.
Applicant’s arguments with respect to the previously applied rejections and prior art have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
It is noted; however, that in the response regarding claims 15-17, applicant has argued that the reference that was applied did not teach that the inhibitors were formulated in a dosage amount for the treatment of COVID-19. Applicant argues that the present invention is based on the discovery that infection with SARS-COV-2 virus leads to stimulation of 12-LO expression coincident with lung injury.
In so far as this rejection could apply to the rejections of the instant office action, for instance to the rejection of claims 15-18 under 35 USC 102 over US’955, they are not persuasive.
Instant claims 15-18 are drawn to products, specifically a kit and a pharmaceutical composition. The recitations concerning the products being used “for treatment of a coronavirus” or “for treatment of COVID-19” are intended use limitations. MPEP 2111.02 II. states “To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997).”
In this case, because the reference teaches the structure of the claimed products at dosages that would be effective in inhibiting 12-LOX and treating coronavirus/COVID-19, the references meet the instant claim limitations as they would be capable of performing the intended use recited.
Conclusion
No claims are allowed.
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/AUDREY L BUTTICE/Examiner, Art Unit 1647
/SCARLETT Y GOON/Supervisory Patent Examiner
Art Unit 1693
Prosecution Insights