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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/2/2026 has been entered.
Priority
This application is a national stage entry of PCT/GB2021/050935, filed 4/19/2021. This application claims foreign priority to GB2005987.9, filed 4/23/2020 and GB2008288.9, filed 6/2/2020.
Claim Status
Receipt of Remarks/Amendments filed on 4/2/2026 is acknowledged. Claims 11-13 and 15-26 are currently pending. Claims 15-19 are withdrawn. Accordingly, claims 11-13 and 20-26 are currently under examination.
Rejection(s) not reiterated from the previous Office Action are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set of rejections presently being applied to the instant application.
New/Maintained Claim Objection(s) / Rejection(s)
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 11, 13, 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Tawashi (US 5,648,101; Jul. 15, 1997) in view of Sanotize (Sanotize Research and Development Corp., April 22, 2020), Rahimpour (Drug Discovery Today, Volume 19, Number 5, May 2014) and Surber (US2009/0196930A1).
Tawashi throughout the reference teaches method of delivering nitric oxide to a desired situs on or in the body of humans. Specifically, the invention comprises methods and means for delivering the compositions of the invention to a desired situs on or in the body of humans. The composition is adapted to release or liberate nitric oxide at or adjacent a desired situs on or in the body of humans. (see: Abstract; Summary of Invention). Tawashi discloses the nitric oxide releasing composition comprises sodium nitrite (nitrite salt), citric acid (proton source) and mannitol (organic polyol as recited in claim 11 and 14) (see: Examples 1 and 2). Mannitol taught by Tawashi reads on the specific sugar alcohol recited in claims 11, 20 and 21. Tawashi also teaches administering the composition in the form of dry powder inhalation or aerosol metered dose inhaler wherein the nitric oxide is release into the respiratory tract and lungs (Example 11 and 12). Example 11 and 12 of Tawashi disclose the nitric oxide releasing composition comprises sodium nitrite (nitrite salt) and citric acid (proton source).
The teachings of Tawashi have been set forth above.
While Tawashi teaches mannitol in the tablet composition disclosed in examples 1 and 2, Tawashi does not teach composition in the form of inhaler, which is delivered to the lungs, comprises mannitol. However, Rahimpour and Surber cure this deficiency.
Surber also teaches formulations comprising nitric oxide donating compound including sodium nitrite, administered by inhalation to the lungs. Surber teaches the nitrite compound, preferably sodium nitrite, is typically administered in combination with a carrier or excipient which can include mannitol and lactose. (see e.g. abstract; claims; para 0224; 0290; 0293; 0308; 0309; 0340; entire document).
Rahimpour teaches alternative carriers in dry powder inhaler formulations. Rahimpour teaches use of mannitol as pharmaceutical excipient/carrier in dry powder inhalers. Mannitol is less hygroscopic than lactose and gives a suitable sweet aftertaste, which has a benefit to patients confirming them that a dose has been properly administered. Rahimpour also teaches insufficient delivery of drug to the lower airway is a major challenge for DPI formulations and the main goal in the inhalation field is to obtain reproducible high pulmonary deposition that can be greatly affected by physicochemical characteristics of the carrier. Rahimpour teaches mannitol providing higher drug delivery compared to lactose and other polyols such as sorbitol. (see e.g., Mannitol section; pg. 620; Abstract; Sorbitol section; Table 1; Concluding remarks; left column of page 623; entire document).
Tawashi does not teach a method of treating an infection arising from SARS-COV-2 or COVID-19 with the nitric oxide generating composition. However, Sanotize cures this deficiency.
Sanotize discloses that new tests conducted by the institute for Antiviral Research at Utah State University confirm nitric oxide releasing solution inactivated more than 99.9% of SARS-COV-2, the virus that causes COVID-19 (see: entire document).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to combine the teachings of Tawashi, Surber and Rahimpour and incorporate mannitol in the dry powder inhaler taught by Tawashi. One would have been motivated to do so because Tawashi in its example 11 discloses use of lactose in the dry powder inhaler in combination with sodium nitrite and, as discussed supra, Surber teaches formulations comprising nitric oxide donating compound including sodium nitrite, administered by inhalation to the lungs. Surber teaches the nitrite compound, preferably sodium nitrite, is typically administered in combination with a carrier or excipient which can include mannitol and lactose. Thus, it would have been obvious to substitute lactose with mannitol as both are taught to be useful carriers/excipients in combination with sodium nitrite. Further, as discussed supra, Rahimpour teaches use of mannitol as pharmaceutical excipient/carrier in dry powder inhalers wherein mannitol is less hygroscopic than lactose and gives a suitable sweet aftertaste, which has a benefit to patients confirming them that a dose has been properly administered. Rahimpour also teaches insufficient delivery of drug to the lower airway is a major challenge for DPI formulations and the main goal in the inhalation field is to obtain reproducible high pulmonary deposition that can be greatly affected by physicochemical characteristics of the carrier. Rahimpour teaches mannitol providing higher drug delivery compared to lactose and other polyols such as sorbitol. Tawashi in its example 11 discloses use of lactose in the dry powder inhaler and Rahimpour provides the motivation to include mannitol which offers more benefits. Thus, inclusion of mannitol in the inhaler formulation which is delivered to the lungs would have been prima facie obvious to one skilled in the art.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to combine the teachings of Tawashi and Sanotize and utilize the nitric oxide releasing composition of Tawashi to treat SARS-COV-2 or COVID-19 as suggested by Sanotize. Tawashi teaches that nitric oxide can be applied and used clinically in the treatment of a variety of diseases (col. 2, line 23-26). Sanotize discloses that nitric oxide releasing solution inactivated more than 99.9% of SARS-COV-2, the virus that causes COVID-19. Therefore, one skilled in the art would have been highly motivated to utilize the nitric oxide releasing composition of Tawashi to treat SARS-COV-2 or COVID-19.
Further, Sanotize teaches nitric oxide having an antiviral effect and therefore, it would have been obvious to one skilled in the art to determine an antivirally effective amount to treat the viral infection during routine experimentation. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
From the combined teaching of the cited references, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Tawashi (US 5,648,101; Jul. 15, 1997) in view of Sanotize (Sanotize Research and Development Corp., April 22, 2020), Rahimpour (Drug Discovery Today, Volume 19, Number 5, May 2014) and Surber (US2009/0196930A1) as applied to claims 11, 13, 20-22 above, and further in view of Mirazimi (Journal of Virology, Feb. 2005, p. 1966-1969).
The teachings of Tawashi, Sanotize, Rahimpour and Surber have been set forth above.
Tawashi, Sanotize, Rahimpour and Surber do not teach a method of treating an infection arising from SARS-COV and SARS with the nitric oxide generating composition. However, Mirazimi cures this deficiency.
Mirazimi teaches that nitric oxide significantly inhibited the replication cycle of SARS-COV and severe acute respiratory syndrome (SARS) which arises from this type of coronavirus. The results demonstrated that nitric oxide inhibits the replication cycle of SARS COV, most probably during the early steps of infection, suggesting that the production of nitric oxide results in an antiviral effect. (see: abstract; p. 1966-left col., p. 1967-right col.; entire document).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to combine the teachings of Tawashi and Mirazimi and utilize the nitric oxide releasing composition of Tawashi to treat SARS-COV and SARS as suggested by Mirazimi. Tawashi teaches that nitric oxide can be applied and used clinically in the treatment of a variety of diseases (col. 2, line 23-26). As discussed supra, Mirazimi teaches that nitric oxide significantly inhibited the replication cycle of SARS-COV and severe acute respiratory syndrome (SARS) which arises from this coronavirus. The results demonstrated that nitric oxide inhibits the replication cycle of SARS COV, most probably during the early steps of infection, suggesting that the production of nitric oxide results in an antiviral effect. Therefore, one skilled in the art would have been highly motivated to utilize the nitric oxide releasing composition of Tawashi to treat SARS-COV and SARS.
From the combined teaching of the cited references, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claims 23-26 are rejected under 35 U.S.C. 103 as being unpatentable over Tawashi (US 5,648,101; Jul. 15, 1997) in view of Sanotize (Sanotize Research and Development Corp., April 22, 2020), Rahimpour (Drug Discovery Today, Volume 19, Number 5, May 2014) and Surber (US2009/0196930A1) as applied to claims 11, 13, 20-22 above and further in view of Godara (Lung India, vol 28, issue 4, Oct. 2011), ADM (Archer Daniels Midland Company, Safety Data Sheet, May 2019) and Rai (Respiratory Physiology and Neurobiology 257 (2018) 51-54).
The teachings of Tawashi, Sanotize, Rahimpour and Surber have been set forth above.
Tawashi, Sanotize, Rahimpour and Surber do not teach wherein the organic acid (e.g., citric acid) is buffered to a higher pH than exhibited by an aqueous solution of the acid at the same concentration as required in claims 23-26. However, Godara, ADM and Rai cure this deficiency.
ADM discloses that based on the low pH of citric acid, inhalation of citric acid would be expected to cause irritation to the respiratory tract, resulting in a higher cough response. (see Entire document).
Godara discloses impact of inhalation therapy on oral health. Low pH is a risk factor for demineralization of the tooth. It has been found that the low pH may be due to the use of the inhaler. There was a significant decrease in the salivary pH to below the critical value of 5.5 for enamel demineralization after 30 mins following their use. (see: Abstract; Pathophysiology; Entire document).
Rai teaches the effect of pH on citric acid cough response. Inhalation of citric acid solution were administered to subjects. The pH of the solution altered by the addition of sodium bicarbonate to 2, 5 and 6 and total number of cough elicited was recorded for each inhalation. Cough response from inhalation of citric acid solution with a pH of 6 was the lowest. (see: Abstract; Results; Entire document).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to combine the teachings of the above cited references and buffer the citric acid taught by Tawashi to a higher pH than exhibited by an aqueous solution of the acid at the same concentration as required in claims 23-26. One would have been motivated to do so because the combination of ADM, Godara and Rai teach the low pH of citric acid causes adverse effect such as irritation to the respiratory tract, resulting in a higher cough response, and demineralization of the tooth. As discussed supra, Rai teaches citric acid solution having pH of 6 had lowest cough response and Godara teaches salivary pH below 5.5 causes demineralization of enamel. Thus, it would have been obvious to one skilled in the art to buffer the pH of citric acid to a pH of around 6 as this pH value is suggested to have least adverse effects in the prior art.
From the combined teaching of the cited references, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Response to Arguments
Applicant argued there is no motivation to select mannitol to increase the therapeutic efficacy of an inhaler formulation for treatment against SARSCoV or SARS-CoV-2. It is argued that Tawashi explicitly prefers lactose in its inhalable formulation and Tawashi does not suggest that a sugar alcohol is suitable for an inhaler formulation. Applicant also argued that Rahimpour broadly describes alternative carriers in dry powder inhaler formulations and is silent regarding a NO-releasing composition. Applicant stated that Rahimpour teaches mannitol as an inactive carrier having certain physicochemical characteristics and one skilled in the art would not have expected any therapeutic benefit.
In response, firstly the examiner argues that the claims do not require that mannitol is specifically selected to increase the therapeutic efficacy of an inhaler formulation for treatment against SARSCoV or SARS-CoV-2. As discussed supra, Rahimpour and Surber render obvious the inclusion of mannitol into the formulation of Tawashi. Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979); In re Baxter Travenol Labs., 952 F.2d 388, 21 USPQ2d 1281 (Fed. Cir. 1991); see also In re Woodruff, 919 F.2d 1575, 1577-78 (Fed. Cir. 1990) (obviousness rejection affirmed where using claimed elements in the manner suggested by the prior art necessarily resulted in claim-recited effect). MPEP 2145. Furthermore, the examiner directs applicant' s attention to MPEP 2121: PRIOR ART IS PRESUMED TO OPERABLE/ENABLING. When the reference relied on expressly anticipates or makes obvious all of the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on applicant to provide facts rebutting the presumption of operability. In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA 1980). Also see MPEP 716.07. The cited prior art in the rejections above render obvious the inclusion of mannitol and therefore, would necessarily be capable of increasing the therapeutic efficacy of the inhaler formulation against SARSCoV or SARS-CoV-2.
Regarding the argument that Tawashi explicitly prefers lactose in its inhalable formulation and Tawashi does not suggest that a sugar alcohol is suitable for an inhaler formulation, the examiner argues that nowhere does Tawashi teach that mannitol is not suitable for inhaler formulation. While Tawashi in the examples of inhaler formulation uses lactose, this does not teach away from using mannitol in the inhaler formulation. “Disclosed examples and preferred embodiments do not constitute a teaching away from the broader disclosure or non-preferred embodiment.” In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). MPEP 2123. As discussed supra, Surber teaches inhaler formulation comprising sodium nitrite can include lactose or mannitol as the carrier/excipient. Thus, use of mannitol in inhaler formulation in combination with sodium nitrite for generating nitric oxide was known in the art and, as discussed supra, Rahimpour further provides the motivation to include mannitol in place of lactose in inhaler formulation.
Regarding the argument that Rahimpour broadly describes alternative carriers in dry powder inhaler formulations and is silent regarding a NO-releasing composition, the examiner argues that Surber teaches formulations comprising nitric oxide donating compound including sodium nitrite, administered by inhalation to the lungs. Surber teaches the nitrite compound, preferably sodium nitrite, is typically administered in combination with a carrier or excipient which can include mannitol and lactose. Thus, it would have been obvious to substitute lactose with mannitol as both are taught to be useful carriers/excipients in combination with sodium nitrite. Further, Rahimpour teaches use of mannitol as pharmaceutical excipient/carrier in dry powder inhalers wherein mannitol is less hygroscopic than lactose and gives a suitable sweet aftertaste, which has a benefit to patients confirming them that a dose has been properly administered. Rahimpour also teaches insufficient delivery of drug to the lower airway is a major challenge for DPI formulations and the main goal in the inhalation field is to obtain reproducible high pulmonary deposition that can be greatly affected by physicochemical characteristics of the carrier. Rahimpour teaches mannitol providing higher drug delivery compared to lactose and other polyols such as sorbitol. Tawashi in its example 11 discloses use of lactose in the dry powder inhaler and Rahimpour provides the motivation to include mannitol which offers more benefits. Thus, inclusion of mannitol in the inhaler formulation which is delivered to the lungs would have been prima facie obvious to one skilled in the art and as mentioned above, Rahimpour teaches mannitol provides enhanced therapeutic efficiency to the active drug components in inhaler formulations.
Applicant argued the use of organic polyol and especially mannitol provide unexpected results because the amount of nitric oxide available is significantly greater in the presence of mannitol or sorbitol when compared to a composition with no polyol. Applicant point to figure 1, 11 and 16 to argue unexpected results.
In response, firstly the examiner argues that the results in the specification do not appear to be commensurate in scope of the instant claims because independent claim 11 recites organic polyol selected from sugar alcohol having 4, 5, 6, 7, 8, 9, 10, 11 or 12 carbon atoms and the examples of figure 1, 11 and 16 show data for only sorbitol and mannitol. Thus, the claimed organic polyols are broader in scope than the result provided in the specification and it is unclear if the same effect would occur over all the claimed organic polyol. Further, the instant claims recite the composition is administered to the lung of a subject and the examples of figure 1, 11 and 16 do not show that the greater nitric oxide produced is when it is administered to the lung of the subject. As discussed supra, Tawashi explicitly teaches using mannitol in combination with sodium nitrite and citric acid in a tablet form. Tawashi does not explicitly teach administration of this combination (mannitol, sodium nitrite and citric acid) to the lungs and the examples referring to figure 1, 11 and 16 also do not show administration to the lungs. Applicant should bring forth data which shows that the same effect would occur when the composition is administered to the lung of the subject. Further, as discussed supra, Rahimpour teaches use of mannitol as pharmaceutical excipient/carrier in dry powder inhalers wherein mannitol is less hygroscopic than lactose and gives a suitable sweet aftertaste, which has a benefit to patients confirming them that a dose has been properly administered. Rahimpour also teaches insufficient delivery of drug to the lower airway is a major challenge for DPI formulations and the main goal in the inhalation field is to obtain reproducible high pulmonary deposition that can be greatly affected by physicochemical characteristics of the carrier. Rahimpour teaches mannitol providing higher drug delivery compared to lactose and even other polyols such as sorbitol. Thus, the prior art does suggest that inclusion of mannitol enhances therapeutic efficiency and one skilled in the art would have expected that use of mannitol would provide greater availability of nitric oxide versus a composition not having any mannitol or polyol at all.
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 11-13 and 20-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, 48-58 of copending Application No. 17616485 (US20220257642A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because ‘485 also teaches a nitric oxide generating composition comprising nitrite salt, a proton source such as citric acid and organic polyol such as mannitol. The composition can be administered to the lungs and is used to treat SARSCoV or SARS-CoV-2. The pH of the proton source is buffered to a pH of about 3 to about 9.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the members of the recited categories of components in the copending claims, because they recite to do SO. Necessary selections of amounts of each component and routine work by the artisan of ordinary skill in light of the concentration teachings render the claimed ratios and concentrations obvious. The pH range overlaps with that instantly claimed, thereby rendering it obvious as well (see MPE 2144.05).
This is a provisional nonstatutory double patenting rejection.
Claims 11-13 and 20-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 52-64 of copending Application No. 19/649420.
Although the claims at issue are not identical, they are not patentably distinct from each other because ‘420 also teaches a nitric oxide generating composition comprising nitrite salt, a proton source such as citric acid and organic polyol such as mannitol. The composition can be administered to the lungs and is used to treat SARSCoV or SARS-CoV-2. The pH of the proton source is buffered to a pH of about 3 to about 9.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the members of the recited categories of components in the copending claims, because they recite to do SO. Necessary selections of amounts of each component and routine work by the artisan of ordinary skill in light of the concentration teachings render the claimed ratios and concentrations obvious. The pH range overlaps with that instantly claimed, thereby rendering it obvious as well (see MPE 2144.05).
This is a provisional nonstatutory double patenting rejection.
Claims 11-13 and 20-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of copending Application No. 19/156193 in view of Sanotize (Sanotize Research and Development Corp., April 22, 2020), Surber (US2009/0196930A1) and Mirazimi (Journal of Virology, Feb. 2005, p. 1966-1969).
‘193 also teaches a nitric oxide generating composition comprising nitrite salt, a proton source such as citric acid and organic polyol such as mannitol. The pH of the proton source is buffered to a pH of about 3 to about 9. The composition is used for treating respiratory diseases or disorders.
‘193 does not expressly teach the composition can be administered to the lungs and is used to treat SARSCoV or SARS-CoV-2. Sanotize, Mirazimi and Surber cure these deficiencies.
The teachings of Sanotize, Mirazimi and Surber discussed above are incorporated herein.
As discussed supra, Surber also teaches nitric oxide generating composition comprising nitrite salt wherein the composition can be used for treating respiratory/pulmonary conditions and the administered to the lungs. (see e.g. para 0591; 0003; entire document).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to combine the teachings of ‘193 and Sanotize and utilize the nitric oxide releasing composition treat SARS-COV-2 or COVID-19 as suggested by Sanotize. Sanotize discloses that nitric oxide releasing solution inactivated more than 99.9% of SARS-COV-2, the virus that causes COVID-19. Therefore, one skilled in the art would have been highly motivated to utilize the nitric oxide releasing composition to treat SARS-COV-2 or COVID-19.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to combine the teachings of ‘193 and Mirazimi and utilize the nitric oxide releasing composition to treat SARS-COV and SARS as suggested by Mirazimi. As discussed supra, Mirazimi teaches that nitric oxide significantly inhibited the replication cycle of SARS-COV and severe acute respiratory syndrome (SARS) which arises from this coronavirus. The results demonstrated that nitric oxide inhibits the replication cycle of SARS COV, most probably during the early steps of infection, suggesting that the production of nitric oxide results in an antiviral effect. Therefore, one skilled in the art would have been highly motivated to utilize the nitric oxide releasing composition to treat SARS-COV and SARS.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to combine the teachings of ‘193 and Surber and administer the nitric oxide releasing composition to the lung of the patient because Surber also teaches nitric oxide generating composition comprising nitrite salt wherein the composition can be used for treating respiratory/pulmonary conditions and the administered to the lungs. Thus, one skilled in the art would have found it obvious to treat respiratory condition such as SARS-CoV by administering the composition directly to the lungs.
From the combined teaching of the cited references, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art.
This is a provisional nonstatutory double patenting rejection.
Claims 11-13 and 20-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of copending Application No. 19/156233 in view of Sanotize (Sanotize Research and Development Corp., April 22, 2020), Surber (US2009/0196930A1) and Mirazimi (Journal of Virology, Feb. 2005, p. 1966-1969).
‘233 also teaches a nitric oxide generating composition comprising nitrite salt, a proton source such as citric acid and organic polyol such as mannitol. The pH of the proton source is buffered to a pH of about 3.8 to about 6.
‘233 does not expressly teach the composition can be administered to the lungs and is used to treat SARSCoV or SARS-CoV-2. Sanotize, Mirazimi and Surber cure these deficiencies.
The teachings of Sanotize, Mirazimi and Surber discussed above are incorporated herein.
As discussed supra, Surber also teaches nitric oxide generating composition comprising nitrite salt wherein the composition can be used for treating respiratory/pulmonary conditions and the administered to the lungs. (see e.g. para 0591; 0003; entire document).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to combine the teachings of ‘233 and Sanotize and utilize the nitric oxide releasing composition treat SARS-COV-2 or COVID-19 as suggested by Sanotize. Sanotize discloses that nitric oxide releasing solution inactivated more than 99.9% of SARS-COV-2, the virus that causes COVID-19. Therefore, one skilled in the art would have been highly motivated to utilize the nitric oxide releasing composition to treat SARS-COV-2 or COVID-19.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to combine the teachings of ‘233 and Mirazimi and utilize the nitric oxide releasing composition to treat SARS-COV and SARS as suggested by Mirazimi. As discussed supra, Mirazimi teaches that nitric oxide significantly inhibited the replication cycle of SARS-COV and severe acute respiratory syndrome (SARS) which arises from this coronavirus. The results demonstrated that nitric oxide inhibits the replication cycle of SARS COV, most probably during the early steps of infection, suggesting that the production of nitric oxide results in an antiviral effect. Therefore, one skilled in the art would have been highly motivated to utilize the nitric oxide releasing composition to treat SARS-COV and SARS.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to combine the teachings of ‘233 and Surber and administer the nitric oxide releasing composition to the lung of the patient because Surber also teaches nitric oxide generating composition comprising nitrite salt wherein the composition can be used for treating respiratory/pulmonary conditions and the administered to the lungs. Thus, one skilled in the art would have found it obvious to treat respiratory condition such as SARS-CoV by administering the composition directly to the lungs.
From the combined teaching of the cited references, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art.
This is a provisional nonstatutory double patenting rejection.
Conclusion
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/ALI S SAEED/Examiner, Art Unit 1616
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