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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/16/2026 has been entered.
Priority
The instant application is a 371 of PCT/US2021/030447 filed 05/03/2021 and claims domestic
benefit to US provisional application no. 63/018,920 filed on 05/01/2020.
Status of the Claims
The claim amendments and remarks filed on 04/16/2026 is acknowledged. Claims 1, 6, 10, 15, 18, and 24-25 are amended. Claims 2-5, 7, 14, and 22-23 are cancelled.
Accordingly, claims 1, 6, 8-13, 15-21, and 24-26 are pending and being examined on the merits herein.
Withdrawn Objections/Rejections
The objection to claim 1 is withdrawn because the comma before the semicolon was removed.
The 35 USC 112(b) rejections for claim 6, 10, and 18 are withdrawn because claim 6 now depends from claim 1, making it clear what the metes and bounds of the claim are. Furthermore, claims 10 and 18 have been amended to remove all of the previously cavities except for the nasal cavity, making it clear that the nasal spray formulation only coats the nasal cavity.
The 35 USC 112(d) rejection for claim 15 is withdrawn because claim 15 is amended such that the claimed formulation is formulated to be delivered as an aerosol, inhalant, intranasal spray, or aqueous spray, which properly further limits the claimed formulation.
All of the 103 rejections are withdrawn because the previous 103 rejections were applied based on the formulation requiring a pharmaceutically acceptable carrier. However, the claims have been amended such that the formulation now requires water, which has changed the scope of the claims and requires further search and consideration.
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) 1, 6, 8-13, 15-20, and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Vitins et al. (US20100111883A1 in IDS filed 02/24/2023) in view of Namburi et al. (US20060120967A1 in IDS filed 08/11/2023).
Vitins discloses various formulations comprising one or more cyclodextrins, said formulations being particularly useful for treating or preventing viral infections.
In specific embodiments, the formulations comprise throat and nose sprays, nose gels, lip balms, and emulsions (see Abstract).
Vitins discloses that their compositions can be used to treat viral infections such as hepatitis virus (HBV or HCV) (paragraph 0007). Vitins discloses that cyclodextrins, while not falling into the traditional antiviral categories, have been found effective at treating and preventing diseases caused by infectious viral agents (paragraph 0005). Therefore, Vitins discloses that it would be useful to have antiviral compositions provided in specific formulations that specifically target the areas associated with “breakouts” of various viral conditions and that are also convenient and discrete (paragraph 0005). Vitins discloses that their compositions can reduce duration of an active break associated with a viral infection or prevent recurrent viral breakouts. Vitins discloses that the term “preventing” refers to attenuating or reducing the ability of a virus to cause infection or disease, which meets the limitation of a method of reducing a risk of a microbial infection as recited in instant claim 16.
Vitins discloses various spray formulations including nose and throat sprays (paragraph 0073). Vitins discloses that the spray formulation is effective for treating viral infection and comprises one or more cyclodextrins that is preferably hydroxypropyl-beta-cyclodextrin (paragraph 0074) and in amounts such as 2.5% to 7.5% by weight of the formulation (claim 10). Vitins discloses that the spray formulation does not include any additional active agents (claim 16).
Vitins discloses their spray formulations are preferably water-based formulations and intended to mean that the formulation includes at least one aqueous solvent, preferably water as the major solvent (paragraph 0077). Vitins discloses in other embodiments that the spray formulation may include other solvents such polyols (paragraphs 0076-0077).
Here, even though Vitins does not explicitly teach or demonstrate a nasal spray formulation “consisting of” the recited cyclodextrin derivative and water, it would have been prima facie obvious before the effective filing date of the claimed invention to have prepared a nasal spray formulation consisting of 2.5% to 7.5% by weight hydroxypropyl-beta-cyclodextrin and water as suggested in Vitins to arrive at the claimed invention.
An ordinary skilled artisan would have prepared this formulation with a reasonable expectation of success because Vitins provides guidance of nasal spray formulations that are water-based and water as the major solvent. It is noted that even though Vitins provides embodiments that further include polyols such as in claim 9 in their spray formulation, Vitins also discloses embodiments that include 5% hydroxypropyl-beta-cyclodextrin (paragraph 0074), and further discloses embodiments in which water comprises up to 95% by weight of the formulation (paragraph 0078), which together suggests a spray formulation consisting of only the recited cyclodextrin derivative and water. Lastly, Vitins discloses that the formulation does not include any additional active agents.
Vitins, however, does not disclose a nasal spray formulation that further includes a recited thickening agent such as hydroxyethyl cellulose in the recited ratios of cyclodextrin to thickening agent.
Namburi discloses a method for treating diseases or conditions of the oral cavity, throat, or nose comprising administering a spray composition that includes cyclodextrin in an amount of from about 0.1% w/v to about 20% w/v; at least one essential oil in an amount of from about 0.001% w/v to about 5.0% w/v; an effective amount of an antimicrobial preservative composition; and water (see Abstract).
Namburi discloses that the composition is suitable for either oral or intranasal spray administration and can further comprise a mucoadhesive polymer thickening agent in an amount from 0.1% to 5.0% w/v (claim 1 and paragraph 0017). Namburi discloses the mucoadhesive polymer thickening agent can be cellulose derivatives such as hydroxylethyl cellulose and others (paragraph 0017). Namburi teaches that the mucoadhesive polymer thickening agent is added to achieve a longer residence time in the nose and to avoid dripping of spray liquid in the nose (paragraph 0017).
Namburi discloses that a useful pH range for a nasal formulation is from about 4.5 to about 7.0 (paragraph 0031). Namburi discloses their finished formulation can be filtered through an appropriate filter and the compositions are filled into commercially available bottles and fit with metered dose pumps for oral or nasal delivery of the drug products, which meets the limitation of a specialized device recited in instant claim 17.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the nasal spray composition of Vitins as described above by further including 0.1% to 5.0% by weight mucoadhesive polymer thickening agents such as hydroxylethyl cellulose as disclosed in Namburi to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to include mucoadhesive polymer thickening agents such as hydroxylethyl cellulose because Namburi provides guidance that the mucoadhesive polymer thickening agent is added to achieve a longer residence time in the nose and to avoid dripping of spray liquid in the nose.
One of ordinary skill in the art would have a reasonable expectation of success because both Vitins and Namburi disclose nasal spray compositions comprising cyclodextrins that are useful for treating diseases and conditions of the nasal cavity.
Furthermore, the nasal spray formulation as disclosed by the combined teachings of Vitins and Namburi described above would have an overlapping ratio range of the cyclodextrin to the thickening agent, rendering the recited ratio of cyclodextrin to thickening agent obvious. See MPEP 2144.05 I.
In regards to instant claims 9-13, the claimed functional feature of “forms a coating over a mucocutaneous lining, thereby preventing entry of a microbe or of a gaseous agent into the cell” would be necessarily present in the combined teachings of Vitins and Namburi because the combined teachings provide guidance of administering the claimed nasal spray formulation as described above to the same nasal cavity of a subject suffering from a viral infection.
MPEP 2112 section I states that "[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 claims 16-20, it would have also been prima facie obvious before the effective filing date of the claimed invention to have administered the nasal spray composition product as disclosed by the combined teachings of Vitins and Namburi described above to reduce risk of microbial infection as suggested in Vitins 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 and would have a reasonable expectation of success in doing so because Vitins provides guidance of using nasal spray compositions comprising cyclodextrin as the active agent for preventing viral infection, and Vitins discloses that the term “prevention” refers to in their disclosure attenuating or reducing the ability of a virus to cause infection or disease, which meets the limitation of a method of reducing a risk of a microbial infection as recited in instant claim 16.
Furthermore, the limitations “forms a coating over a mucocutaneous lining, thereby preventing entry of a microbe or of a gaseous agent into the cell” and “contact the cells susceptible to infection” would flow naturally from the combined teachings of Vitins and Namburi because the combined teachings provide guidance of administering the claimed nasal spray formulation as described above to the same nasal cavity of a subject suffering from a viral infection such as HCV or HBV.
MPEP 2145 II recites “The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter.m 1985) (The prior art taught combustion fluid analyzers which used labyrinth heaters to maintain the samples at a uniform temperature. Although appellant showed that an unexpectedly shorter response time was obtained when a labyrinth heater was employed, the Board held this advantage would flow naturally from following the suggestion of the prior art.). See also Lantech Inc. v. Kaufman Co. of Ohio Inc., 878 F.2d 1446, 12 USPQ2d 1076, 1077 (Fed. Cir. 1989), cert. denied, 493 U.S. 1058 (1990) (unpublished — not citable as precedent) ("The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.").”
In regards to instant claim 25, the nasal spray formulation as disclosed by the combined teachings of Vitins and Namburi described above contains an overlapping 0.1% to 5.0% by weight mucoadhesive polymer thickening agents such as hydroxylethyl cellulose, which renders the recited percent by weight for the recited cellulose derivatives obvious. See MPEP 2144.05 I.
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Vitins et al. (US20100111883A1 in IDS filed 02/24/2023) in view of Namburi et al. (US20060120967A1 in IDS filed 08/11/2023), as applied to claims 1, 9, and 11-12 above, and further in view of Carrouel et al. (Journal of Clinical Medicine, published 04/15/2020 in PTO-892 dated 07/14/2025).
The combined teachings of Vitins and Namburi are as described above. Even though these combined teachings teach the nasal spray formulation recited in instant claim 13 as discussed above, this alternative rejection over claim 13 is also being applied for purposes of compact prosecution.
The combined references, however, do not disclose wherein the virus is SARS-CoV-2 virus and variants thereof.
Carrouel discloses the use of mouthrinses and/or nasal applications containing beta-cyclodextrin and Citrox for preventing infection and progression of COVID-19 (see Abstract). Carrouel discloses that mouth rinses containing oxidative agents such as amphiphilic cyclodextrins, appear indicative for the purpose of reducing the salivary load of oral microbes (see page 5 second paragraph). Carrouel discloses that cyclodextrins attract viruses before irreversibly inactivating them and that by disrupting the outer shell of a virus, they can destroy infectious particles by simple contact, rather than just blocking viral growth (see page 5 second paragraph). Carrouel discloses that this property of beta-cyclodextrins can potentially be exploited for the reduction of viral load in the oral cavity with the use of disinfectant solutions (see page 5 second paragraph). Carrouel discloses that in addition, the use of therapeutic oral biofilm rinses and/or nasal applications might be considered in preventing viral transmission via the oropharyngeal route (see page 5 second paragraph).
It would have been prima facie obvious before the effective filing date of the claimed invention to have applied the nasal spray composition as disclosed by the combined teachings of Vitins and Namburi described above for preventing infection and/or progression of COVID-19 as suggested in Carrouel 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 and would have a reasonable expectation of success in doing so because Vitins provides guidance that even though cyclodextrin are not known as traditional antiviral agents, they have been found effective at treating and preventing diseases caused by infectious viral agents, and Carrouel provides further guidance that cyclodextrins can be exploited for the reduction of viral load in the oral cavity and suggest its use for nasal applications to treat COVID-19 patients.
Furthermore, the claimed functional feature of “forms a coating over a mucocutaneous lining, thereby preventing entry of a microbe or of a gaseous agent into the cell” would be necessarily present in the combined teachings of Vitins, Namburi, and Carrouel because the combined teachings provide guidance of administering the claimed nasal spray formulation in the same amounts as described above to the same nasal cavity of a subject suffering from SARS-CoV-2 virus.
MPEP 2112 section I states that "[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.”
Claim(s) 21 is rejected under 35 U.S.C. 103 as being unpatentable over Vitins et al. (US20100111883A1 in IDS filed 02/24/2023) in view of Namburi et al. (US20060120967A1 in IDS filed 08/11/2023), as applied to claims 1 and 16-17 above, and further in view of Kundoor et al. (Pharm Res, 2011 in PTO-892 dated 07/14/2025) and Inthavong et al. (Aerosol Science and Technology, 2006 in PTO-892 dated 07/14/2025).
The combined teachings of Vitins and Namburi are as described above and teach the nasal spray formulation recited in instant claims 1 and 16-17 as discussed above.
The combined references, however, do not disclose wherein the formulation is an aerosolized particulate delivered to the cells with the recited parameters in claim 21.
Kundoor et al. discloses the effect of formulation and administration-related variables on nasal spray deposition using a nasal cast (see Abstract). Kundoor et al. discloses that there is a need to systemically evaluate parameters of nasal administration for efficient drug delivery into the nasal cavity (see page 1895 right column to page 1896 left column). Kundoor et al. demonstrates the effect of nasal spray insertion depths ranging from 0 mm – 15 mm (see paragraph 1902 right column and Fig. 11 on page 1901). Kundoor et al. shows that an insertion depth of 10 mm had the highest deposition area. Kundoor et al. discloses that nasal spray pumps delivering larger volumes (100 microliters) had significantly greater nasal deposition area compared to nasal spray pumps delivering 50 microliters (page 1902 right column and Fig 13 on page 1902).
Inthavong et al. discloses a numerical study of spray particle deposition in a human nasal cavity (see Abstract). Inthavong et al. discloses that particle depositional studies from nasal sprays are important for efficient drug delivery (see Abstract). Inthavong et al. demonstrates in Fig. 10 on page 1043 the deposition patterns for 15 micrometer and 20 micrometer particles released at 10 m/s with spray cone angles of 20 degrees and 80 degrees (note: the claimed spray cone angle recited in claim 21 of π/4 to π/2 corresponds to of 45 degrees to 90 degrees). Inthavong et al. discloses that when the spray cone angle was at 80 degrees for 20 micrometer particles, a wider area of deposition was observed in the frontal zones, whilst those particles projected favorably towards the nasal valve and was able to travel beyond the 90-degree bend (see page 1043, right column).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the nasal spray composition product as disclosed by the combined teachings of Vitins and Namburi described above to have a 10mm insertion depth, 100 microliter spray volume, 10 m/s spray velocity, and 80 degree spray cone angle as disclosed in Kundoor and Inthavong to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated make these modifications because both Kundoor and Inthavong express a need to optimize intranasal administration for more efficient drug delivery uptake.
One of ordinary skill in the art would have a reasonable expectation of success because both Kundoor and Inthavong demonstrate that the described spray parameters result in increased deposition area in the nasal cavity for a nasal spray product.
Claim(s) 24 is rejected under 35 U.S.C. 103 as being unpatentable over Vitins et al. (US20100111883A1 in IDS filed 02/24/2023).
The teachings of Vitins are as described above.
Here, even though Vitins does not explicitly teach or demonstrate a nasal spray formulation “consisting of” the recited cyclodextrin derivative and water, it would have been prima facie obvious before the effective filing date of the claimed invention to have prepared a nasal spray formulation consisting of 2.5% to 7.5% by weight hydroxypropyl-beta-cyclodextrin and water as suggested in Vitins to arrive at the claimed invention.
An ordinary skilled artisan would have prepared this formulation with a reasonable expectation of success because Vitins provides guidance of nasal spray formulations that are water-based and water as the major solvent. It is noted that even though Vitins provides embodiments that further include polyols such as in claim 9 in their spray formulation, Vitins also discloses embodiments that include 5% hydroxypropyl-beta-cyclodextrin (paragraph 0074), and further discloses embodiments in which water comprises up to 95% by weight of the formulation (paragraph 0078), which together suggests a spray formulation consisting of only the recited cyclodextrin derivative and water. Lastly, Vitins discloses that the formulation does not include any additional active agents.
Response to Arguments
Applicant’s arguments filed on 04/16/2026 have been fully considered in so far as they apply to the rejections of the instant office action, but were not persuasive.
Applicant presents arguments over the previous prior art rejections on the basis that the amendments have limited the pharmaceutically acceptable carrier to water in claims 1 and 24-25, and that claim 1 was also amended to recite the transitional phrase “consisting of” for the recited composition, which excludes unrecited components.
However, the new rejections over Vitins as well as Vitins in view of Namburi addresses these new limitations as described above, rendering Applicant’s arguments over the previously applied prior art rejections moot.
Applicant further states in regards to rejection of claim 13 over Vitins in view of Namburi and
Carrouel that Carrouel does not teach or suggest removing a polyol or essential oil from the combined teachings of Vitins in view of Namburi, as required to arrive at Applicant’s claimed subject matter.
Applicant’s argument described above was not found persuasive because Carrouel is only relied
upon to apply the modified composition as disclosed by the combined teachings of Vitins and Namburi described above for preventing infection and/or progression of COVID-19 and not for removing a polyol or essential oil.
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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