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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/02/2026 has been entered.
Priority
The instant application is a 371 of PCT/US2021/042868 filed on 07/23/2021, which claims domestic benefit to US provisional application no. 63/181,612 filed on 04/29/2021 and US provisional application no. 63/055,415 filed on 07/23/2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/02/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Status of the Claims
The claim amendments and remarks filed on 03/02/2026 is acknowledged. Claim 9 is amended. Claims 1-8, 10-12, 15-20, 23-27, and 30-41 are cancelled. Claim 42 is newly added.
Accordingly, claims 9, 13-14, 21-22, 28-29, and 42 are pending and being examined on the merits herein.
Withdrawn Objections/Rejections
The objection to claims 9-10 and 25 is withdrawn in view of claim 9 now having the suggested amendment and claims 10 and 25 being cancelled.
The 35 USC 103 rejection over Barbosa in view of Yao for claims 9-10, 13-15, 21-22, and 28-29 are withdrawn because this rejection previously relied on the treatment of SARS-CoV-2, and the claims have been amended to treat an influenza A infection as well as a new limitation of administering by inhalation, which has changed the scope of the claims and requires new search and consideration. Furthermore, claims 10 and 15 are cancelled.
The 35 USC 103 rejection over Imperi in view of Yao for claims 25 and 36-37 are withdrawn in view of these claims being cancelled.
The non-statutory double patenting rejection over U.S. Patent No. 10,653,784 (‘784) in view of Yao and Barbosa for claims 9-10, 13-15, 21-22, and 28-29 as well as in view of Yao and Imperi for claims 25 and 36-37 are withdrawn because this rejection previously relied on the treatment of SARS-CoV-2, and the claims have been amended to treat an influenza A infection as well as a new limitation of administering by inhalation, which has changed the scope of the claims and requires new search and consideration. Furthermore, claims 10, 15, 25, and 36-37 are now cancelled.
The non-statutory double patenting rejection over U.S. Patent No. 11,052,153 (‘153) in view of Yao and Barbosa for claims 9-10, 13-15, 21-22, and 28-29 as well as in view of Yao and Imperi for claims 25 and 36-37 are withdrawn because this rejection previously relied on the treatment of SARS-CoV-2, and the claims have been amended to treat an influenza A infection as well as a new limitation of administering by inhalation, which has changed the scope of the claims and requires new search and consideration. Furthermore, claims 10, 15, 25, and 36-37 are now cancelled.
The following grounds of rejection are new as necessitated by Applicant’s amendments.
Claim Interpretation
Claim 42 is being interpreted such that the recited composition is inhaled as a powder form.
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.
Claim(s) 9, 13-14, 21-22, and 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Jurgeit et al. (PloS Pathog., 2012 in PTO-892) in view of Yao et al. (WO2017059433A1 in PTO-892 dated 07/24/2025).
Jurgeit discloses that niclosamide is a weak lipophilic acid that inhibited infection with pH-dependent human rhinoviruses (HRV) and influenza virus (Abstract). Jurgeit discloses that structure-activity studies showed that antiviral efficacy and endolysosomal pH neutralization co-tracked, and acidification of the extracellular medium bypassed the virus entry block, and further discloses that niclosamide did not affect the vacuolar H+-ATPase, but neutralized coated vesicles or synthetic liposomes, indicating a proton carrier mode-of-action independent of any protein target (Abstract).
Jurgeit demonstrates in Figure 1 on page 3 that niclosamide effectively inhibited influenza virus (strain A/Puerto Rico/8/34/H1N1 depicted PR8) with an IC50 of 0.83 mM in human lung adenocarcinoma epithelial A549 cells, a cell line fully permissive for influenza virus replication (also see right column page 2).
Jurgeit concludes that their data demonstrates that niclosamide has broad antiviral effects (Abstract). Furthermore, Jurgeit discloses that niclosamide has been safely used in humans and can be tested in animal models for viral infection inhibition, ideally by application via the inhaled route in order to obtain high local concentrations for maximal efficacy (last paragraph right column page 9).
Jurgeit suggests a method of treating influenza A virus infection by administering via inhalation niclosamide to the patient in need thereof. However, Jurgeit does not further disclose or suggest administering OHPP with the niclosamide.
Yao discloses the use of materials comprising a highly branched carbohydrate polymer or polysaccharides such as octenyl succinate hydroxypropyl phytoglycogen (OHPP) and others (see paragraph 0039) as solubilizing agents for increasing the solubility and stability of solute compounds therein (paragraph 0003). Yao discloses that poor water solubility of some active pharmaceutical ingredients (APIs) is one of the major problems in drug formulation and drug absorption, and that systems to improve the water solubility of these drugs are essential for their bioavailability (paragraph 0009).
Yao et al. discloses their soluble composition is a combination of at least one solubilizing agent with at least one solute compound (paragraph 0089). Yao et al. discloses that the hydrophobic solute compound can be a compound or a mixture of compounds selected from nutrients, vitamins, drugs, coloring agents, etc. (see paragraph 0076). Yao et al. discloses that the hydrophobic solute compound can be niclosamide as well as antiviral agents such as acyclovir, antibacterial agents such as penicillin, antifungal agents, and anti-inflammatory agents (see paragraphs 0080-0081).
Yao et al. discloses that their compositions are for increasing the solubility and stability of solute compounds as well as solubilizing agents that may be used to improve solubility, stability, and/or bioavailability of solute compounds for the food, nutraceutical, personal care, skin care, cosmetics, pharmaceuticals, medical, paint and coating, and agricultural industries (see paragraph 0003). Yao et al. discloses that their compositions can be incorporated into various formulations and may contain pharmaceutically acceptable solvents, surfactants, adjuvants, …, excipients, ..., preservatives or mixtures thereof (see paragraph 0090). Yao et al. discloses that their soluble compositions contain bioactive hydrophobic compounds that may be administered to a warm-blooded animal, particularly a human, in need of the therapy (see paragraph 0092). Yao discloses that their aqueous solutions can be in the phase of an emulsion, colloid, suspension, or aerosol (paragraph 0031), as well as in the form of powder, granulated, and others that is desirable for appropriate formulations or dosage forms (paragraph 0052).
Yao et al. exemplifies a composition containing OHPP and niclosamide (see Example 6-2, paragraph 00128). Yao et al. demonstrates in Figure 2 that the solubility of niclosamide was significantly increased when incorporated with OHPP in comparison to niclosamide alone (see Fig.2 and paragraph 0021). Yao et al. discloses that the solubility of niclosamide was around 2,178 ug/mL with niclosamide-OHPP, which was much greater than that of niclosamide alone (around 13.2 ug/mL) and niclosamide-HPMCAS (around 35.4 ug/mL), and Nic-Soluplus (around 353.8 ug/mL) (see paragraph 00133). Yao discloses that Soluplus is another developed polymer agent to improve the solubility and bioavailability of poorly soluble drug substances (paragraph 00130).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the niclosamide composition disclosed in Jurgeit by including OHPP as disclosed in Yao to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to include the OHPP because Yao discloses that poor water solubility of some active pharmaceutical ingredients (APIs) is one of the major problems in drug formulation and drug absorption, and that systems to improve the water solubility of these drugs are essential for their bioavailability. One of ordinary skill in the art would have a reasonable expectation of success because Yao discloses and demonstrates that their OHPP material can be formulated with niclosamide to improve its solubility and stability and further discloses that their compositions can be in the form of powders, suspensions, and aerosols as well as any appropriate formulations or dosage forms, and include various excipients, surfactants, solvents, and others.
In regards to instant claims 21-22, it would have also been prima facie obvious before the effective filing date of the claimed invention by further including an additional agent such as an additional antiviral agent as disclosed in Yao et al. to the modified nano-formulation as described in the combination of Jurgeit and Yao above to arrive at the claimed invention. One of ordinary skill in the art would have combined prior art elements according to known methods to yield predictable results because Yao et al. provides guidance of improving the solubility and formulating a mixture of solute compounds which include niclosamide as well as other antiviral agents.
In regards to instant claim 28, the recited “increasing oral bioavailability of niclosamide to at least 2 times higher than that of niclosamide alone” would be necessarily present in the OHPP-niclosamide nano-formulation as described in the combination of Jurgeit and Yao above because as evidenced in the instant specification, a formulation of niclosamide and OHPP mixed in a 1:3 ratio (see paragraph 0135 in instant specification) resulted in 5-10 times increase in bioavailability over niclosamide alone (see FIG. 8 and paragraphs 0098-0099 in instant specification), and the combined references described above provides guidance of incorporating the same OHPP with the same niclosamide at the same ratio of 1:3 (see paragraph 00128 of Yao).
MPEP 2112 section I recites "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable”. Furthermore, MPEP 2112.01 section II recites “Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.”
In regards to instant claim 29, it would have been prima facie obvious before the effective filing date of the claimed invention to further include the Soluplus disclosed in Yao into the modified OHPP-niclosamide nano-formulation as disclosed by the combination of Jurgeit and Yao described above. One of ordinary skill in the art would have combined prior art elements according to known methods to yield predictable results because Yao provides guidance of soluble compositions comprising at least one solubilizing agent, and provides further guidance that Soluplus is another developed polymer agent to improve the solubility and bioavailability of poorly soluble drug substances such as niclosamide.
Additionally, the recited “further improved oral bioavailability of niclosamide” would also be necessarily present in the described combination because Yao et al. discloses that soluplus also improves the bioavailability of niclosamide as described above.
Claim(s) 42 is rejected under 35 U.S.C. 103 as being unpatentable over Jurgeit et al. (PloS Pathog., 2012 in PTO-892) in view of Yao et al. (WO2017059433A1 in PTO-892 dated 07/24/2025), as applied to claim 9 above, and further in view of US11045434B1 (in PTO-892 and effective filing date of 04/01/2020).
The combined teachings of Jurgeit and Yao are as described above and teach the method of claim 9 as discussed above. Furthermore, Yao teaches that their modified highly branched carbohydrate polymers can be used for purposes other than increasing solubility, such as the physical, chemical, or physicochemical stability of the solute compound. Physical stability includes the stability of a solute compound in terms of its amorphous form, crystal size, crystalline structure or form (e.g. polymorphs), or a combination thereof. Chemical stability includes the stability of a solute compound in terms of its resistance to oxidation, reduction, chemical reaction, structure change or degradation, or a combination thereof. Physicochemical stability includes physical stability, chemical stability, or a combination thereof (paragraph 0073).
The combined references, however, do not teach that the administered composition is a powder.
US’434 discloses a method of treating a viral infection caused by or associated with SARS-CoV-2 in a subject comprising administering the subject by inhalation, intraorally, and/or intranasally a therapeutically effective amount of a formulation comprising niclosamide, or a pharmaceutically acceptable salt thereof, and a cyclodextrin (Abstract). US’434 discloses the viral infection may also be caused by or associated with influenza virus and others (column 9 lines 38-45).
US’434 discloses that their inhalable composition comprising niclosamide can be in the form of a powder and discloses the powder comprises particles that are of a respirable size (column 29 lines 50-61). US’434 discloses that other components in their inhalable composition can include polymer, stabilizers, and others (column 30 lines 44-57)
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the niclosamide formulation as disclosed by the combined teachings of Jurgeit and Yao described above by forming and administering as a powder inhalation as disclosed in US’434 to arrive at the claimed invention.
One of ordinary skill in the art would have combined prior art elements according to known methods to yield predictable results of forming and administering a powder inhalation of the modified composition because Jurgeit suggests administering the niclosamide via inhalation, Yao provides guidance that their OHPP material can be additionally used to stabilize the compound and provide resistance to oxidation, reduction, chemical reaction, structure change or degradation as well as the OHPP-niclosamide composition being in the form of powders and any suitable formulations or dosage forms, and US’434 provides guidance that niclosamide can be formulated into a powder inhalation to treat viral infections including influenza and further discloses that the inhalable composition can include various other ingredients including polymers and stabilizers.
Response to Arguments
Applicant' s arguments filed on 03/02/2026 have been fully considered in so far as they apply to the rejections of the instant office action, but were not persuasive.
Applicant states that the previous rejection over Barbosa in view of Yao does not disclose treating an influenza A virus infection and administering the recited composition by inhalation.
Applicant’s argument described above was not found persuasive because the new rejections described above address treating an influenza A virus infection by administering the recited composition by inhalation.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 9, 13-14, 21-22, and 28-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 10,653,784 (‘784) in view of Yao et al. (WO2017059433A1 in PTO-892 dated 07/24/2025) and Jurgeit et al. (PloS Pathog., 2012 in PTO-892).
Claim 1 of ‘784 recites a method of making an aqueous composition of an active pharmaceutical ingredient (API) and a solubilizing agent, comprising the steps of: a) providing a highly branched carbohydrate polymer; b) activating the highly branched carbohydrate polymer using a basic solution; c) reacting the activated highly branched carbohydrate polymer with a polyalkylene glycol or alkylene oxide to form a modified highly branched carbohydrate polymer; d) adding to the modified highly branched carbohydrate polymer with a hydrophobic or amphiphilic group to yield said solubilizing agent; and e) combining said solubilizing agent with API, wherein the hydrophobic or amphiphilic group of step d) comprises octenyl succinate group. Claim 7 of ‘784 recites that a hydrophobic solute compound is mixed with the solubilizing agent using a method selected from the group consisting of extrusion, mixing, spray drying, vacuum drying, kneading, rolling, ultra-sonication, vibration, and milling.
The difference between the claims of ‘784 and the claimed invention is the claims of ‘784 do not recite a method of treating influenza A infection comprising administering to a patient in need thereof an effective amount of a composition comprising OHPP and niclosamide by inhalation.
The independent teachings of Yao and Jurgeit are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to substitute the active pharmaceutical ingredient (API) and the solubilizing agent recited in the claims of ‘748 with the OHPP-niclosamide disclosed in Yao et al. and further administer by inhalation to treat a patient with influenza A as suggested in Jurgeit to arrive at the claimed invention.
One of ordinary skill in the art would have simply substituted known elements (API and solubilizing agent) for others (OHPP and niclosamide) to obtain predictable results because Yao et al. demonstrates an OHPP-niclosamide product that was prepared by the method recited in the claims of ‘784.
One of ordinary skill in the art could have combined prior art elements according to known methods to yield predictable results of administering by inhalation the OHPP-niclosamide for treating influenza A because Jurgeit provides guidance of administering niclosamide by inhalation to treat influenza A, and Yao discloses that their OHPP compositions can be in the form of powders, suspensions, and aerosols as well as any appropriate formulations or dosage forms, and include various excipients, surfactants, solvents, and others.
In regards to instant claims 21-22, it would have also been prima facie obvious before the effective filing date of the claimed invention by further including an additional agent such as an additional antiviral agent as disclosed in Yao et al. to the modified nano-formulation as described in the combination of the claims of ‘748 and the teachings of Yao and Jurgeit above to arrive at the claimed invention. One of ordinary skill in the art would have combined prior art elements according to known methods to yield predictable results because Yao et al. provides guidance of improving the solubility and formulating a mixture of solute compounds which include niclosamide as well as other antiviral agents.
In regards to instant claim 28, the recited “increasing oral bioavailability of niclosamide to at least 2 times higher than that of niclosamide alone” would be necessarily present in the OHPP-niclosamide nano-formulation as described in the combination of the claims of ‘748 and the teachings of Yao and Jurgeit above because as evidenced in the instant specification, a formulation of niclosamide and OHPP mixed in a 1:3 ratio (see paragraph 0135 in instant specification) resulted in 5-10 times increase in bioavailability over niclosamide alone (see FIG. 8 and paragraphs 0098-0099 in instant specification), and the combined references described above provides guidance of incorporating the same OHPP with the same niclosamide at the same ratio of 1:3 (see paragraph 00128 of Yao).
MPEP 2112 section I recites "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable”. Furthermore, MPEP 2112.01 section II recites “Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.”
In regards to instant claim 29, it would have been prima facie obvious before the effective filing date of the claimed invention to further include the Soluplus disclosed in Yao into the modified OHPP-niclosamide nano-formulation as disclosed by the combination of the claims of ‘748 and the teachings of Yao and Jurgeit described above. One of ordinary skill in the art would have combined prior art elements according to known methods to yield predictable results because Yao provides guidance of soluble compositions comprising at least one solubilizing agent, and provides further guidance that Soluplus is another developed polymer agent to improve the solubility and bioavailability of poorly soluble drug substances such as niclosamide.
Additionally, the recited “further improved oral bioavailability of niclosamide” would also be necessarily present in the described combination because Yao et al. discloses that soluplus also improves the bioavailability of niclosamide as described above.
Claims 9 and 42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 10,653,784 (‘784) in view of Yao et al. (WO2017059433A1 in PTO-892 dated 07/24/2025), Jurgeit et al. (PloS Pathog., 2012 in PTO-892), and US11045434B1 (in PTO-892 and effective filing date of 04/01/2020).
The combination of the claims of ‘784 and the combined teachings of Yao and Jurgeit are as described above and recite the method of instant claim 9 as discussed above.
The combined references, however, do not recite the administered composition is a powder.
The teachings of US’434 is as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to modify the formulation as disclosed by the combination of the claims of ‘784 and the combined teachings of Yao and Jurgeit described above by forming and administering as a powder inhalation as disclosed in US’434 to arrive at the claimed invention.
One of ordinary skill in the art would have combined prior art elements according to known methods to yield predictable results of formulating and administering the OHPP-niclosamide composition as a powder inhalation because Jurgeit suggests administering the niclosamide via inhalation, Yao provides guidance that their OHPP material can be additionally used to stabilize the compound and provide resistance to oxidation, reduction, chemical reaction, structure change or degradation as well as their OHPP composition being in the form of powders and any suitable formulations or dosage forms, and US’434 provides guidance that niclosamide can be formulated into a powder inhalation to treat viral infections including influenza and further discloses that the inhalable composition can include various other ingredients including polymers and stabilizers.
Claims 9, 13-14, 21-22, and 28-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,052,153 (‘153) in view of Yao et al. (WO2017059433A1 in PTO-892 dated 07/24/2025) and Jurgeit et al. (PloS Pathog., 2012 in PTO-892).
Claim 1 of ‘153 recites a modified highly branched alpha-D-glucan having greater than 4% branch density, the modified highly branched alpha-D-glucan comprising octenyl succinate, the modified highly branched alpha-D-glucan further comprising hydroxypropyl, hydroxyethyl, polyethylene glycol, polypropylene glycol, or combinations thereof. Claim 4 of ‘153 recites the modified highly branched alpha-D- improves a property of a solute compound, wherein the property is selected from the group consisting of the aqueous solubility, dissolution rate, and stability against crystallization, oxidation, degradation, deterioration, reduction, or structure change, and combinations thereof. Claim 9 of ‘153 recites the solute compound is selected from the group consisting of niclosamide, ivermectin, sirolimus, indomethacin, paclitaxel, griseofulvin, ibuprofen, quercetin, curcumin and thymol.
The difference between the claims of ‘153 and the claimed invention is the claims of ‘153 do not recite a method of treating influenza A infection comprising administering to a patient in need thereof an effective amount of a composition comprising OHPP and niclosamide by inhalation.
The independent teachings of Yao and Jurgeit are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to select niclosamide as the solute compound as recited in the claims of ‘153, substitute the modified highly branched alpha-D-glucan recited in the claims of ‘153 with the OHPP disclosed in Yao, and further administer by inhalation to treat a patient with influenza A as suggested in Jurgeit to arrive at the claimed invention.
One of ordinary skill in the art could have combined prior art elements according to known methods to yield predictable results for selecting niclosamide and substituting with the OHPP because the claims of ‘153 and Yao recite that their respective polysaccharide agents are useful for the same purpose of improving the solubility of niclosamide.
One of ordinary skill in the art could have combined prior art elements according to known methods to yield predictable results of administering by inhalation the OHPP-niclosamide nano-formulation for treating influenza A because Jurgeit provides guidance of administering niclosamide by inhalation to treat influenza A, and Yao discloses that their OHPP compositions can be in the form of powders, suspensions, and aerosols as well as any appropriate formulations or dosage forms, and include various excipients, surfactants, solvents, and others.
In regards to instant claims 21-22, it would have also been prima facie obvious before the effective filing date of the claimed invention by further including an additional agent such as an additional antiviral agent as disclosed in Yao et al. to the modified nano-formulation as described in the combination of the claims of ‘153 and the teachings of Yao and Jurgeit above to arrive at the claimed invention. One of ordinary skill in the art would have combined prior art elements according to known methods to yield predictable results because Yao et al. provides guidance of improving the solubility and formulating a mixture of solute compounds which include niclosamide as well as other antiviral agents.
In regards to instant claim 28, the recited “increasing oral bioavailability of niclosamide to at least 2 times higher than that of niclosamide alone” would be necessarily present in the OHPP-niclosamide nano-formulation as described in the combination of the claims of ‘153 and the teachings of Yao and Jurgeit above because as evidenced in the instant specification, a formulation of niclosamide and OHPP mixed in a 1:3 ratio (see paragraph 0135 in instant specification) resulted in 5-10 times increase in bioavailability over niclosamide alone (see FIG. 8 and paragraphs 0098-0099 in instant specification), and the combined references described above provides guidance of incorporating the same OHPP with the same niclosamide at the same ratio of 1:3 (see paragraph 00128 of Yao).
MPEP 2112 section I recites "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable”. Furthermore, MPEP 2112.01 section II recites “Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.”
In regards to instant claim 29, it would have been prima facie obvious before the effective filing date of the claimed invention to further include the Soluplus disclosed in Yao into the modified OHPP-niclosamide nano-formulation as disclosed by the combination of the claims of ‘153 and the teachings of Yao and Jurgeit described above. One of ordinary skill in the art would have combined prior art elements according to known methods to yield predictable results because Yao provides guidance of soluble compositions comprising at least one solubilizing agent, and provides further guidance that Soluplus is another developed polymer agent to improve the solubility and bioavailability of poorly soluble drug substances such as niclosamide.
Additionally, the recited “further improved oral bioavailability of niclosamide” would also be necessarily present in the described combination because Yao et al. discloses that soluplus also improves the bioavailability of niclosamide as described above.
Claims 9 and 42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11,052,153 (‘153) in view of Yao et al. (WO2017059433A1 in PTO-892 dated 07/24/2025), Jurgeit et al. (PloS Pathog., 2012 in PTO-892), and US11045434B1 (in PTO-892 and effective filing date of 04/01/2020).
The combination of the claims of ‘153 and the combined teachings of Yao and Jurgeit are as described above and recite the method of instant claim 9 as discussed above.
The combined references, however, do not recite the administered composition is a powder.
The teachings of US’434 is as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to modify the formulation as disclosed by the combination of the claims of ‘153 and the combined teachings of Yao and Jurgeit described above by forming and administering as a powder inhalation as disclosed in US’434 to arrive at the claimed invention.
One of ordinary skill in the art would have combined prior art elements according to known methods to yield predictable results of formulating and administering the OHPP-niclosamide composition as a powder inhalation because Jurgeit suggests administering the niclosamide via inhalation, Yao provides guidance that their OHPP material can be additionally used to stabilize the compound and provide resistance to oxidation, reduction, chemical reaction, structure change or degradation as well as their OHPP composition being in the form of powders and any suitable formulations or dosage forms, and US’434 provides guidance that niclosamide can be formulated into a powder inhalation to treat viral infections including influenza and further discloses that the inhalable composition can include various other ingredients including polymers and stabilizers.
Claims 9, 13-14, 21-22, and 28-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 10,117,937 (‘937) in view of Yao et al. (WO2017059433A1 in PTO-892 dated 07/24/2025) and Jurgeit et al. (PloS Pathog., 2012 in PTO-892).
Claim 1 of ‘937 recites a composition for increasing solubility of a solute compound, comprising: a highly branched alpha-D-glucan in an aqueous solution. Claim 2 of ‘937 recites wherein the highly branched alpha-D-glucan is glycogen, phytoglycogen, or a modified form thereof. Claims 3-4 of ‘937 recite wherein the rate of dissolution of the solute compound in aqueous solvent is greater than the rate of dissolution of the solute compound in the absence of the highly branched alpha-D-glucan, and wherein the solubility is increased by at least about a factor of two relative to the solubility of the solute compound in the absence of the highly branched alpha-D-glucan. Claim 8 of ‘937 recites wherein the solute compound is selected from the group consisting of drugs, vitamins, pesticides, herbicides, anti-oxidants, herb extracts, Chinese medicine, coloring agents, hormones, essential oils, or a combination thereof.
The difference between the claims of ‘937 and the claimed invention is the claims of ‘937 do not recite a method of treating influenza A infection comprising administering to a patient in need thereof an effective amount of a composition comprising OHPP and niclosamide by inhalation.
The independent teachings of Yao and Jurgeit are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to substitute the solute compound and the solubilizing agent recited in the claims of ‘937 with the OHPP-niclosamide disclosed in Yao et al. and further administer by inhalation to treat a patient with influenza A as suggested in Jurgeit to arrive at the claimed invention.
One of ordinary skill in the art would have simply substituted known elements (solute compound and solubilizing agent) for others (OHPP and niclosamide) to obtain predictable results because the claims of ‘937 and Yao recite that their respective polysaccharide agents are useful for the same purpose of improving the solubility of solute compounds such as drugs.
One of ordinary skill in the art could have combined prior art elements according to known methods to yield predictable results of administering by inhalation the OHPP-niclosamide nano-formulation for treating influenza A because Jurgeit provides guidance of administering niclosamide by inhalation to treat influenza A, and Yao discloses that their OHPP compositions can be in the form of powders, suspensions, and aerosols as well as any appropriate formulations or dosage forms, and include various excipients, surfactants, solvents, and others.
In regards to instant claims 21-22, it would have also been prima facie obvious before the effective filing date of the claimed invention by further including an additional agent such as an additional antiviral agent as disclosed in Yao et al. to the modified nano-formulation as described in the combination of the claims of ‘937 and the teachings of Yao and Jurgeit above to arrive at the claimed invention. One of ordinary skill in the art would have combined prior art elements according to known methods to yield predictable results because Yao et al. provides guidance of improving the solubility and formulating a mixture of solute compounds which include niclosamide as well as other antiviral agents.
In regards to instant claim 28, the recited “increasing oral bioavailability of niclosamide to at least 2 times higher than that of niclosamide alone” would be necessarily present in the OHPP-niclosamide nano-formulation as described in the combination of the claims of ‘937 and the teachings of Yao and Jurgeit above because as evidenced in the instant specification, a formulation of niclosamide and OHPP mixed in a 1:3 ratio (see paragraph 0135 in instant specification) resulted in 5-10 times increase in bioavailability over niclosamide alone (see FIG. 8 and paragraphs 0098-0099 in instant specification), and the combined references described above provides guidance of incorporating the same OHPP with the same niclosamide at the same ratio of 1:3 (see paragraph 00128 of Yao).
MPEP 2112 section I recites "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable”. Furthermore, MPEP 2112.01 section II recites “Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.”
In regards to instant claim 29, it would have been prima facie obvious before the effective filing date of the claimed invention to further include the Soluplus disclosed in Yao into the modified OHPP-niclosamide nano-formulation as disclosed by the combination of the claims of ‘937 and the teachings of Jurgeit and Yao described above. One of ordinary skill in the art would have combined prior art elements according to known methods to yield predictable results because Yao provides guidance of soluble compositions comprising at least one solubilizing agent, and provides further guidance that Soluplus is another developed polymer agent to improve the solubility and bioavailability of poorly soluble drug substances such as niclosamide.
Additionally, the recited “further improved oral bioavailability of niclosamide” would also be necessarily present in the described combination because Yao et al. discloses that soluplus also improves the bioavailability of niclosamide as described above.
Claims 9 and 42 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 10,117,937 (‘937) in view of Yao et al. (WO2017059433A1 in PTO-892 dated 07/24/2025), Jurgeit et al. (PloS Pathog., 2012 in PTO-892), and US11045434B1 (in PTO-892 and effective filing date of 04/01/2020).
The combination of the claims of ‘937 and the combined teachings of Yao and Jurgeit are as described above and recite the method of instant claim 9 as discussed above.
The combined references, however, do not recite the administered composition is a powder.
The teachings of US’434 is as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to modify the formulation as disclosed by the combination of the claims of ‘937 and the combined teachings of Yao and Jurgeit described above by forming and administering as a powder inhalation as disclosed in US’434 to arrive at the claimed invention.
One of ordinary skill in the art would have combined prior art elements according to known methods to yield predictable results of formulating and administering the OHPP-niclosamide composition as a powder inhalation because Jurgeit suggests administering the niclosamide via inhalation, Yao provides guidance that their OHPP material can be additionally used to stabilize the compound and provide resistance to oxidation, reduction, chemical reaction, structure change or degradation as well as their OHPP composition being in the form of powders and any suitable formulations or dosage forms, and US’434 provides guidance that niclosamide can be formulated into a powder inhalation to treat viral infections including influenza and further discloses that the inhalable composition can include various other ingredients including polymers and stabilizers.
Response to Arguments
Applicant’s arguments filed on 03/02/2026 have been fully considered in so far as they apply to
the rejections of the instant office action, but were not persuasive.
Applicant states that the previous double patenting rejections do not disclose treating an influenza A virus infection and administering the recited composition by inhalation.
Applicant’s argument described above was not found persuasive because the new double patenting rejections described above address treating an influenza A virus infection by administering the recited composition by inhalation.
Conclusion
No claim is found allowable.
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/D.H.C./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693
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