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 .
DETAILED ACTION
2. Claims 1 – 3, 6 – 7, 9 – 11, 13 – 15, 17 – 18, 20, and 22 – 27 are pending in this application. Applicant’s amendment, filed April 21, 2023, is entered, wherein claims 6 – 7, 9 – 11, 13 – 15, 17 – 18, 20, and 22 – 24 are amended and claim 27 is new.
Priority
3. This application is a national stage application of PCT/EP2021/079402, filed October 22, 2021, which claims benefit of foreign priority document GB2016771.4, filed October 22, 2020.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/05/2023 and 11/25/2024 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Interpretation
5. The transitional phrase “consisting essentially of” in claim 17 is not defined in the specification. For the purposes of searching and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, the phrase will be construed as equivalent to “comprising”.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7, 9, 11, 15, 18, 20, 23, and 27 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
a. Regarding claims 7, 11, 15, 18, 20, and 27, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claim 9 is also indefinite because it depends from claim 7. The phrase “such as” will be interpreted as exemplary language, and therefore non-limiting under the broadest reasonable interpretation.
b. Claim 23 recites “substantially free” in line 2. This is a relative term which renders the claim indefinite. The phrase “substantially free” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of the skill in the art would not be reasonably apprised of the scope of the invention. Although the specification discloses “in some embodiments, the formulation comprises less than 0.01% w/v oxidizing agent”, it is not directly pointed to the definition of “substantially free”. Therefore, the scope of “substantially free” cannot be determined. For the purpose of examination, “substantially free” will be interpreted as the composition comprising less than 0.01% w/v oxidizing agent.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 27 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for in-vitro suppression or reduction of SARS-CoV-2 in a cell-culture assay, does not reasonably provide enablement for a method of preventing infection or transmission of coronavirus. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The Applicant’s attention is drawn to re Wands, 8 USPQ2d 1400 (CAFC1988) at 1404 where the court set forth eight factors to consider where assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
(1) The nature of the invention;
(2) the state of the prior art;
(3) the relative skill of those in the art;
(4) the predictability or unpredictability of the art;
(5) the breadth of the claims;
(6) the amount of direction or guidance presented;
(7) the presence or absence of working examples; and
(8) the quantity of experimentation necessary.
The nature of the invention & The breadth of claims:
The claimed invention is directed to a method of preventing infection or transmission of coronavirus comprising administering the formulation of claim 1 to a subject in need thereof. As mentioned above, “such as” will be interpreted as exemplary language, and therefore non-limiting. Therefore, the recitation “coronavirus such as SARS-CoV-2” is interpreted as exemplary, such that claim 27 encompasses coronaviruses generally and is not limited to SARS-CoV-2. In order to be enabled for the full scope of the method, one skilled in the art must reasonably be able to ascertain which compositions are effective and which coronaviruses infection or transmission the compositions are able to prevent. Moreover, “preventing” infection or transmission of coronavirus is interpreted as including administering the claimed formulation to a subject not suffering from coronavirus infection in such a manner that the subject does not experience coronavirus infection in the future.
The state of prior art:
While several human coronaviruses are known in the prior art, the state of art is not particularly advanced with respect to antiviral agents against these pathogens. For example, Yao et al. (Journal of Medical Virology, February 2020, Vol. 92, Issue 6, Reference included with PTO-892) teach that there are different coronaviruses, such as COVID-19, SARS-CoV, and MERS-CoV (page 536, Right Col., para. 2). Some in-vitro studies of SARS-CoV demonstrate that the combination of lopinavir and ritonavir may inhibit the SARS-CoV 3CLpro enzyme. Another study shows that neither lopinavir nor ritonavir has an effect on the replication of SARS-CoV. However, studies have revealed that lopinavir has antiviral activity against SARS-CoV (page 557, Left Col., para. 2 – 3). Some in-vitro studies of MERS-CoV shows LPV inhibition. Other study shows that LPV is not effective (page 557, Left Col., para. 5). For COVID-19, there are no reported in-vitro studies. A treatment of LPV/r was given to four patients and three patients showed significant improvement in pneumonia-associated symptoms (page 562, Left Col., para. 4). Yao et al. demonstrate variability in the antiviral efficacy of LPV/r across different coronavirus species, indicating that a single treatment cannot be presumed effective against all coronaviruses. Yao et al. also assert that there is no specific antiviral therapies for COVID-19 (Abstract), thus, there was no established therapies for treating COVID-19 at the time of filing, let alone for prevention of infection or transmission.
The relative skill of those in the art:
The relative skill of those in the art is high.
The predictability or unpredictability of the art:
As disclosed by Yao et al., the antiviral efficacy of LPV, alone or in combination with ritonavir, varies across different coronaviruses species, including SARS-CoV, MERS-CoV, and COVID-19. This variability in antiviral activity across closely related coronavirus species indicates that therapeutic efficacy could not be reliably extrapolated from one coronavirus to another. Given the unpredictability of the therapeutic agents, the use of antiviral agents for prevention of infection would also have been uncertain.
The amount of direction or guidance presented & The presence or absence of working examples:
The specification provides direction for in-vitro evaluation of SARS-CoV-2 infection in cultured cells using two regimens: (1) treating virus prior to infection and (2) treating cells prior to viral introduction. However, the disclosure does not provide guidance for enabling prevention of infection or transmission as claimed and enabling prevention of infection or transmission across coronaviruses generally. The working examples disclosed demonstrate that the exemplified sulphated polysaccharide reduces the percentage of infected cells in vitro in both regimens. The examples further show that the effect varies depending on the type of carrageenan, dilution, treatment regimen, and composite ratios (page 20, lines 20 – 35; page 21, lines 1 – 35; page 22, lines 1 – 15). These working examples are only limited to SARS-CoV-2 and do not provide working examples demonstrating prevention of infection or transmission. The data only shows the reduction in infection or transmission.
The quantity of experimentation necessary:
In order to carry out the claimed preventative treatment, one of ordinary skill in the art would need to develop specifically preventative treatment from scratch with no assistance from Applicant’s declaration beyond the general idea that carrageenan is an antiviral agent effective against coronaviruses. Because coronaviruses respond differently toward the same treatment, determining which coronaviruses would respond to the therapy would be difficult and unpredictable based on the state of the art.
Genentech, 108 F.3d at 1366, states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion.” And “patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable.”
Therefore, in view of the Wands factors, as discussed above, particularly the state of art and the lack of guidance or working examples, Applicant fails to provide information sufficient to practice the claimed invention.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claims 1, 3, 6 – 7, 9, 14, 20, 23, and 27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Song et al. (CN111686125A, published September 2020).
a. Independent claim 1 is directed to a sprayable antiviral formulation comprising an antiviral agent and a carrier polymer, wherein the antiviral agent comprises a sulphate polysaccharide and the carrier polymer comprises a non-sulphated polysaccharide. Dependent claim 3 is directed to the formulation, wherein the formulation is use as a multi-surface spray. Dependent claim 6 is directed to the formulation, wherein the antiviral agent comprises a mucoadhesive sulphated polysaccharide. Dependent claims 7 and 9 are directed to the formulation, wherein the antiviral agent is carrageenan, wherein the carrageenan is iota-carrageenan. Dependent claim 14 is directed to the formulation, wherein the carrier polymer comprises a mucoadhesive non-sulphated polysaccharide. Dependent claim 17 is directed to the formulation, wherein the formulation has a total polymer concentration consisting of the concentration of antiviral agent and the concentration of carrier polymer in the formulation. Dependent claim 20 is directed to the formulation, wherein the ratio of antiviral agent to carrier polymer is from 90:10 to 10:90. Dependent claim 23 is directed to the formulation, wherein the formulation is free or substantially free of oxidizing agents. Independent claim 27 is directed to a method of preventing infection or transmission of coronavirus comprising administering the formulation of claim 1 to a subject in need.
Song et al. teach an application of carrageenan in resisting novel coronavirus. The carrageenan can be used for preparing medicines for preventing or treating coronavirus infection, including spray, aerosol, powder spray, lotion, ointment, liniment, nasal spray, etc. The carrageenan can also be used for preparing protective articles for preventing coronavirus infection, and comprises liquid soap, a mask filter element and the like (Abstract). In one embodiment, hydroxyethyl cellulose is dissolved in an aqueous solution of carrageenan for preparing carrageenan disposable hand sanitizer, wherein hydroxyethyl cellulose is in 4% and carrageenan is 0.005/100 mL in water (page 3, lines 20 – 22). The carrageenan used is iota-carrageenan (page 2, line 23).
Song et al. provide example for preparing hand sanitizer comprising dissolving hydroxyethyl cellulose in carrageenan aqueous solution, wherein hydroxyethyl cellulose is the mucoadhesive non-sulphated polysaccharide and carrageenan, in particular iota-carrageenan, is the mucoadhesive sulphated polysaccharide. The formulation is in the form of a spray, wherein hand sanitizer spray may be sprayed on different surfaces, which addresses the limitation “multi-surface spray” of claim 3. This example contains no other polymer and no oxidizing agent, which addresses the limitations of claims 17 and 23. For the ratio of antiviral agent to carrier polymer, Song et al. disclose 4% of hydroxyethyl cellulose and 0.005/100 mL of carrageenan in water. The ratio after calculation is 10:80, which addresses the limitation of claim 20.
For these reasons above, Song et al. anticipates the claimed invention.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
i. Determining the scope and contents of the prior art.
ii. Ascertaining the differences between the prior art and the claims at issue.
iii. Resolving the level of ordinary skill in the pertinent art.
iv. 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 – 3, 6 – 7, 9 – 11, 13 – 15, 17 – 18, 20, and 22 – 27 are rejected under 35 U.S.C. 103 as being unpatentable over Song et al. (CN111686125A) in view of Mahdi et al. (International Journal of Pharmaceutics, 2015, Vol. 488, Issue 1 – 2, Reference included with PTO-892). Claims 1, 3, 6 – 7, 9, 14, 20, 23, and 27 are rejected here because they have been rejected by the primary reference under 102 above.
b. Regarding claims 1 – 3, 6 – 7, 9 – 11, 13 – 15, 17 – 18, 20, and 22 – 27, Song et al. teach an application of carrageenan in resisting novel coronavirus. The carrageenan can be used for preparing medicines for preventing or treating coronavirus infection, including spray, aerosol, powder spray, lotion, ointment, liniment, nasal spray, etc. The carrageenan can also be used for preparing protective articles for preventing coronavirus infection, and comprises liquid soap, a mask filter element and the like (Abstract). The medicine also includes pharmaceutically acceptable excipients, including diluents (page 2, lines 26 – 29). In one embodiment for nasal spray preparation, 40 g of sodium chloride, 100 g of citric acid, 100 g of sodium citrate, and 1 g of benzalkonium chloride are stirred and dissolved with 10 times the amount of purified water and the solution is mixed with another solution containing 10 g of carrageenan and 500 mL of purified water. After combining the solution, dilute to 10 liters with purified water (page 3, lines 9 – 11). In another embodiment, hydroxyethyl cellulose is dissolved in an aqueous solution of carrageenan for preparing carrageenan disposable hand sanitizer, wherein hydroxyethyl cellulose is in 4% and carrageenan is 0.005/100 mL in water (page 3, lines 20 – 22). The carrageenan used is iota-carrageenan (page 2, line 23).
However, Song et al. do not teach the formulation has a dynamic viscosity of 0.05 to 100 Pa∙s at 25 ⁰C. Song et al. do not teach the carrier polymer is gellan. Song et al. do not teach a spray device comprising the formulation, a body for containing the formulation, and a nozzle for spraying the formulation, wherein the spray device is a nasal spray device.
Mahdi et al. teach mucoadhesive sprayable gellan gum fluid gels (Title). Liquid nasal sprays are useful dosage forms for local and systemic delivery, but often suffer from poor retention, dripping out of the nose or down the back of the throat, which leads to reduced bioavailability. One way to address this problem is by formulating nasal sprays that contain polymers, which are mucoadhesive. These polymers possess suitable rheological properties that enable them to flow during administration and then to adhere to mucosal tissue, consequently increasing the residence time and improved bioavailability. Gellan gum is a promising polymer for use in nasal formulations because of its ability to form a gel in situ on exposure to physiological concentrations of cations (page 4, lines 20 – 26; lines 37 – 39). The application of mucoadhesive polymers in nasal drug delivery systems enhances the retention of the dosage form in the nasal cavity. The gel is sufficient to spray through a standard nasal spray device (Abstract):
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The gellan solutions are prepared by adding precise amounts of high and low acryl gellan gum to produce a 0.25% w/w final polymer concentration to deionized water (page 6, lines 82 – 83). Viscosity measurements of all samples made are taken at 20 ⁰C (page 7, line 95). The viscosities of low acyl gellan and high acyl gellan at 0.5% w/w NaCl are ~0.020 Pa∙s and ~0.045 Pa∙s (page 10, lines 160 – 163).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the carrageenan nasal spray formulation comprising iota-carrageenan, sodium chloride solution, and benzalkonium chloride as taught by Song et al. with gellan gum in view of Mahdi et al. because Song et al. teach the preparation of conventional nasal spray with carrageenan and Mahdi et al. teach that gellan gum is a promising polymer for use in nasal formulations. One would have been motivated to combine the carrageenan nasal spray formulation comprising iota-carrageenan, sodium chloride solution, and benzalkonium chloride as taught by Song et al. with gellan gum in view of Mahdi et al. because Mahdi et al. teach that the addition of gellan gum will enhance the residence time of the formulation and improve bioavailability. Mahdi et al. teach the viscosity of the gellan formulation in the form of nasal spray. One would have performed routine experimentation to discover the best viscosity of the formulation for optimal nasal delivery. The concentration of carrageenan in the nasal spray formulation is 0.1% w/v after calculation. Therefore, the total concentration of polymer and the ratio of carrageenan to gellan are 0.35% w/v and 10:25, respectively. For the dispersing agent, Song et al. teach the composition comprising benzalkonium chloride, which is a common dispersing agent. The combination of Song et al. and Mahdi et al. does not teach that the formulation would comprise other polymers and oxidizing agents. One of the ordinary skill in the art would have had a reasonable expectation of success to combine the carrageenan nasal spray formulation comprising iota-carrageenan, sodium chloride solution, and benzalkonium chloride as taught by Song et al. with gellan gum in view of Mahdi et al. because Song et al. teach a conventional nasal spray formulation comprising carrageenan and Mahdi et al. teach that the inclusion of gellan in a nasal spray would be beneficial in achieving longer residence time and better bioavailability, thereby yielding an improved nasal spray formulation.
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 1 – 2, 6 – 7, 9 – 11, 14 – 15, 18, 20, and 22 – 27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, 23, 28 – 30, 37, and 40 – 41 of copending Application No. 18/009,566 in view of Song et al. (CN111686125A) and Mahdi et al. (International Journal of Pharmaceutics, 2015, Vol. 488, Issue 1 – 2, Reference included with PTO-892).
a. Regarding claims 1 – 2, 6 – 7, 9 – 11, 14 – 15, 18, 20, and 22 – 27, ‘566 teaches a pharmaceutical composition comprising a sulphated polysaccharide and a shear-thinning fluid gel (claim 1), wherein the sulphated polysaccharide is a carrageenan (claims 9, 23, and 28). The carrageenan is iota carrageenan (claims 29 – 30). The shear-thinning fluid gel has a viscosity of 5 Pa∙s or greater when exposed to zero shear (claim 37). The shear-thinning fluid gel comprises gellan (claims 40 – 41).
However, ‘566 does not teach that the pharmaceutical composition is formulated as a nasal spray and it is for preventing infection or transmission of coronavirus. ‘566 does not teach the formulation further comprises a diluent. ‘566 does not teach the concentration of carrageenan is from 0.1 – 1.0%, the total concentration of polymer is from 0.1 to 2.0% w/v, and the ratio of carrageenan to carrier polymer is from 90:10 to 10:90. ‘566 does not teach that the formulation further comprising a dispersing agent and is free of oxidizing agents. ‘566 does not teach that the formulation is in a nasal spray device with a body for containing the formulation and a nozzle.
Song et al. teach an application of carrageenan in resisting novel coronavirus. The carrageenan can be used for preparing medicines for preventing or treating coronavirus infection, including spray, aerosol, powder spray, lotion, ointment, liniment, nasal spray, etc. The carrageenan can also be used for preparing protective articles for preventing coronavirus infection, and comprises liquid soap, a mask filter element and the like (Abstract). The medicine also includes pharmaceutically acceptable excipients, including diluents (page 2, lines 26 – 29). In one embodiment for nasal spray preparation, 40 g of sodium chloride, 100 g of citric acid, 100 g of sodium citrate, and 1 g of benzalkonium chloride are stirred and dissolved with 10 times the amount of purified water and the solution is mixed with another solution containing 10 g of carrageenan and 500 mL of purified water. After combining the solution, dilute to 10 liters with purified water (page 3, lines 9 – 11). The carrageenan used is iota-carrageenan (page 2, line 23).
Mahdi et al. teach mucoadhesive sprayable gellan gum fluid gels (Title). Liquid nasal sprays are useful dosage forms for local and systemic delivery, but often suffer from poor retention, dripping out of the nose or down the back of the throat, which leads to reduced bioavailability. One way to address this problem is by formulating nasal sprays that contain polymers, which are mucoadhesive. These polymers possess suitable rheological properties that enable them to flow during administration and then to adhere to mucosal tissue, consequently increasing the residence time and improved bioavailability. Gellan gum is a promising polymer for use in nasal formulations because of its ability to form a gel in situ on exposure to physiological concentrations of cations (page 4, lines 20 – 26; lines 37 – 39). The application of mucoadhesive polymers in nasal drug delivery systems enhances the retention of the dosage form in the nasal cavity. The gel is sufficient to spray through a standard nasal spray device (Abstract):
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The gellan solutions are prepared by adding precise amounts of high and low acryl gellan gum to produce a 0.25% w/w final polymer concentration to deionized water (page 6, lines 82 – 83).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to formulate the carrageenan and gellan composition as taught by ‘566 to a nasal spray formulation stored in a standard nasal spray device for preventing coronavirus infection in view of Song et al. and Mahdi et al. because Song et al. confirm that carrageenan is an effective antiviral agent against coronavirus and both Song et al. and Mahdi et al. teach that carrageenan and gellan maybe be formulated as a nasal spray. One would have been motivated to formulate the carrageenan and gellan composition as taught by ‘566 to a nasal spray formulation stored in a standard nasal spray device for preventing coronavirus infection in view of Song et al. and Mahdi et al. because Song et al. teach that carrageenan is an effective antiviral agent for coronavirus and Mahdi et al. teach that gellan gum used in a nasal spray formulation will enhance the residence time of the formulation and improve bioavailability. The concentration of carrageenan in the nasal spray formulation is 0.1% w/v after calculation. Therefore, the total concentration of polymer and the ratio of carrageenan to gellan are 0.35% w/v and 10:25, respectively. For the dispersing agent, Song et al. teach the composition comprising benzalkonium chloride, which is a common dispersing agent. The combination of ‘566, Song et al. and Mahdi et al. does not teach that the formulation would comprise other polymers and oxidizing agents. One of the ordinary skill in the art would have had a reasonable expectation of success to formulate the carrageenan and gellan composition as taught by ‘566 to a nasal spray formulation stored in a standard nasal spray device for preventing coronavirus infection in view of Song et al. and Mahdi et al. because ‘566 teaches the composition of carrageenan and gellan, Song et al. teach that carrageenan is effective against coronavirus, and Mahdi et al. teach that the inclusion of gellan in a nasal spray would be beneficial in achieving longer residence time and better bioavailability, thereby yielding an improved nasal spray formulation.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is found to be allowable.
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/H.Y.L./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693