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 .
Priority
The instant application was filed 30 January 2023 and is the national stage entry of PCT/IB2021/057057 filed 02 August 2021. The Applicant claims priority to foreign applications ZA2020/04918, ZA2020/04917, and ZA2020/04916 all filed 07 August 2020. English-translated copies of the foreign documents have been provided. Therefore, the effective filing date of the instant application is 07 August 2020.
Examiner’s Note
The Applicant's amendments and arguments filed 22 June 2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections
not reiterated from previous office actions are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 22 June 2026, it is noted that claim 1 has been amended, claim 6 has been canceled, and no new claims have been added. Support for the amendment can be found from the canceled claim. No new matter has been added.
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.
Claim(s) 1, 2, 9, 17, and 52 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rao et al. (WO 2007113665 A2), Sahu (Advancements in Microemulsion Based Drug Delivery Systems for Better Therapeutic Effects, J Pharm Sci Dev Res, 2015), Salmaso (Stealth Properties to Improve Therapeutic Efficacy of Drug Nanocarriers, Journal of Drug Delivery, 2013), Morgan (US 10,933,045 B2), Mishra (Structure-function and application of plant lectins in disease biology and immunity, Food and Chemical Toxicology, 2019), as evidenced by Millet (Middle East respiratory syndrome coronavirus infection is inhibited by griffithsin, Antiviral Research, 2016).
Rao teaches a solid lipid nanoparticle drug delivery system (title; abs; entire teaching) that may be a liquid solution or suspension [0049] and may be in the form of emulsions [0005]. Carriers for the drug include stearic acid [0009], drugs include antiviral agents [0045], solvents include dichloromethane (polar aprotic solvent), surfactants such as lecithin (Example 1), a lectin as a further component on the outer shell [0016], and PVA as the outer shell (Example 3), partially addressing claims 1 and 2. The limitation of nebulized for administration by inhalation in claim 52 is interpreted as intended use and is given minimal patentable weight (see MPEP 2111.02(II)). The composition in the form of a liquid solution [0049] is also interpreted as addressing claim 52.
Rao does not specifically teach polysorbate 80 as the surfactant with a HLB value of greater than 10, griffithsin as the antiviral agent, treating influenza or SARS-CoV, or PEG as the hydrophilic polymers from the Applicant’s election and claims 1, 2, 9, and 17.
Sahu teaches that microemulsions are able to incorporate a wide range of drug molecules and are thermodynamically stable mixtures stabilized by surfactants (abs). Microemulsions are easy to make (abs). Tween-80 (Table 2) is a common surfactant used in microemulsions and creates optimized and stable microemulsions used for nasal delivery (pg. 12). Ethanol (Table 2) may be used as a common co-surfactant.
Salmaso teaches that PEG is the polymer of choice to make stealth nanocarriers that are able to deliver drugs more effectively and prepared in aqueous media (pg. 3, 2.2 and 2.2.1).
Morgan teaches intranasal microemulsion compositions (col. 22, lns. 31-35) that may include citric acid as a pH modifying agent in order to create a more stable pharmaceutical product (col. 10, lns. 27-67).
Mishra teaches that lectins are used with micro and nanoparticles to reduce transit time of pharmaceutical formulations and are used for nasal mucosa delivery to enhance the contact time between the drug and site of absorption (pg. 12, 8.13). Griffithsin (GRFT) is known in the art to have antiviral effects (pg. 7, 6.6), such as with SARS-CoV respiratory virus (evidenced by Millet, pg. 5, 3.3), addressing claim 17.
In regards to selecting the combination of stearic acid, antiviral agents, PVA, surfactants, and solvents, “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G.Pro, 425 U.S. 273, 282 (1976)). “When the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various combinations of various disclosed ingredients from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Rao teaches compositions comprising a solid lipid nanoparticle drug delivery system, whereas the claimed invention is directed towards a polymer-lipid microemulsion composition comprising at least one fatty acid, a polar aprotic solvent, a surfactant with a HLB value over 10, a hydrophilic polymer outer shell, and a drug. Since Rao teaches the individual components of the claimed composition, it is obvious for one of ordinary skill in the art to select the different combinations of ingredients to arrive at the claimed invention with a reasonable expectation of success.
Since Rao does not specifically teach polysorbate 80 as the surfactant with a HLB value of greater than 10, griffithsin as the antiviral agent, treating influenza or SARS-CoV, or PEG as the hydrophilic polymers from the Applicant’s election and claims 1, 2, 9, and 17, one of ordinary skill in the art would have been motivated to use the teachings from Sahu, Salmaso, Morgan, and Mitra with a reasonable expectation of success. Sahu teaches that Tween-80 (polysorbate-80) is a common surfactant used in microemulsions and helps to create stable microemulsions for intranasal delivery and that microemulsions are easy to make. Salmaso teaches that PEG on the outside of nanocarrier systems help to deliver drugs more efficiently. Morgan teaches that citric acid may be used as a pH modifying agent in intranasal microemulsion compositions to create a more stable product. Mishra teaches that lectins, which include GRFT, are useful in nanocarrier systems for nasal delivery and for antiviral effects, such as for HIV or SARS-CoV (evidenced by Millet). Therefore, a skilled artisan would have recognized the benefit of utilizing the components taught by the art and would have been motivated to combine the teachings to improve the composition taught by Rao.
Response to Arguments
Applicant's arguments filed 22 June 2026 have been fully considered but they are not persuasive.
The Applicant argues that Rao does not disclose or suggest the claimed microemulsion architecture, specifically an inner microemulsion matrix containing an organic carboxylic acid, or an outer shell comprising a combination of PVA and PEG (Remarks, pgs. 15-16). The Applicant further argues that Sahu is a general review article (Remarks, pg. 16), Salmaso generally discusses various polymers used to modify nanocarrier surfaces (Remarks, pg. 17), Morgan discloses citric acid as a pH-modifying agent in an external aqueous phase of an intranasal formulation (Remarks, pgs. 17-18), and Mishra and Millet are cited for the general utility and antiviral properties of lecithins (Remarks, pg. 18). The Applicant argues that each of the references, either individually or in combination, do not teach the claimed invention (Remarks, pgs. 18-19).
Applicant’s argument is not found persuasive. Rao teaches a solid lipid nanoparticle drug delivery system (title; abs; entire teaching) that may be a liquid solution or suspension ([0049]) and may be in the form of emulsions ([0005]). Carriers for the drug include i) stearic acid ([0009]), drugs include iii) antiviral agents ([0045]), solvents include dichloromethane (polar aprotic solvent), surfactants such as lecithin (Example 1), a lectin as a further component on the outer shell ([0016]), and ii) PVA as the outer shell (Example 3). Therefore, the composition is interpreted as having an inner emulsion matrix and outer shell portion, as recited in instant claim 1.
Since Rao does not specifically teach polysorbate 80 as the surfactant with a HLB value of greater than 10, griffithsin as the antiviral agent, treating influenza or SARS-CoV, or PEG as the hydrophilic polymers from the Applicant’s election and claims 1, 2, 9, and 17, one of ordinary skill in the art would have been motivated to use the teachings from Sahu, Salmaso, Morgan, and Mitra with a reasonable expectation of success. Sahu teaches that Tween-80 (polysorbate-80) is a common surfactant used in microemulsions and helps to create stable microemulsions for intranasal delivery and that microemulsions are easy to make. Salmaso teaches that PEG on the outside of nanocarrier systems help to delivery drugs more efficiently. Morgan teaches that citric acid may be used as a pH modifying agent in intranasal microemulsion compositions to create a more stable product. Mishra teaches that lectins, which include GRFT, are useful in nanocarrier systems for nasal delivery and for antiviral effects, such as for HIV or SARS-CoV (evidenced by Millet). Therefore, a skilled artisan would have recognized the benefit of utilizing the components taught by the art and would have been motivated to combine the teachings to improve the composition taught by Rao.
In regards to Applicant’s argument that the references are general teachings and do not address all of the limitations within a single reference, art is art, not only for what it expressly teaches, but also for what it would reasonably suggest to the skilled artisan, including alternative or non-preferred embodiments (see MPEP § 2123).
The Applicant argues that the cited references do not provide a reasonable expectation of success in arriving at the claimed composition (Remarks, pg. 19).
Applicant’s argument is not found persuasive. As previously discussed, Sahu teaches that Tween-80 (polysorbate-80) is a common surfactant used in microemulsions and helps to create stable microemulsions for intranasal delivery and that microemulsions are easy to make. Salmaso teaches that PEG on the outside of nanocarrier systems help to delivery drugs more efficiently. Morgan teaches that citric acid may be used as a pH modifying agent in intranasal microemulsion compositions to create a more stable product. Mishra teaches that lectins, which include GRFT, are useful in nanocarrier systems for nasal delivery and for antiviral effects, such as for HIV or SARS-CoV (evidenced by Millet). A skilled artisan would have recognized the benefit of utilizing the components taught by the art and would have been motivated to combine the teachings to improve the composition taught by Rao. “Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).”
The Applicant argues that combining the references would not yield the associated properties as described in the present application, such as the thermodynamic stability, small droplet size, and long-term stability (Remarks, pg. 19).
Applicant’s argument is not found persuasive. The arguments of counsel cannot take the place of evidence in the record (see MPEP 2145(I)). The Applicant is encouraged to show unexpected results regarding the thermodynamic stability, small droplet size, and long-term stability.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
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