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.
Election/Restrictions
Claims 19, 20, 24-28, 33, 37-41, 43, 45, 48, 50, and 51 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 01 December 2025.
Applicant's election with traverse of Group I (claims 1, 2, 6, 9, 17, and 52) and polysorbate 80, griffithsin, and PVA in the reply filed on 01 December 2025 is acknowledged. The traversal is on the ground(s) that the art does not teach the special technical feature. The Applicant argues that a skilled artisan would not have been motivated to use a surfactant with a HLB value of over 10. This is not found persuasive because Benita teaches non-limiting examples of suitable surfactants, such as those with a HLB value between 3 and 10. However, a skilled artisan would have been reasonably motivated to use a surfactant with a HLB over 10 for a hydrophobic drug, such as lopinavir, to solubilize and make insoluble drugs more water-soluble.
The Applicant argues that Benita teaches a microparticulated nanocapsule composition for oral use instead of a microemulsion delivery system for use in the lung. The limitation of use in the lung is considered intended use and is given minimal patentable weight. Additionally, Benita teaches oil-in-water emulsions and a microparticulated nanocapsule composition that comprises stearic acid dissolved in ethanol, an active agent, and a surfactant, which is interpreted similarly to a microemulsion system.
The requirement is still deemed proper and is therefore made FINAL.
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 1, 2, 6, 9, 17, and 52 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.
Claim 1 recites “a polar aprotic solvent comprising ethanol.” Ethanol is considered a polar protic solvent. Therefore, the claim is considered indefinite and the metes and bounds of the limitation cannot be determined. Claims 2, 6, 9, 17, and 52 are dependent from indefinite claim 1.
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, 6, 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, 2, and 6. 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, 6, 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 created 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, 6, 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.
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, 6, and 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 20220233455. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the reference patent recites a polymer-lipid nanocomplex comprising an inner microemulsion matrix comprising a hydrophobic active compound, a fatty acid dissolved in a polar aprotic solvent, and a solvent, with an outer shell comprising a hydrophilic polymer, which corresponds to instant claim 1. Claim 2 of the reference patent recites an outer shell comprising PVA and PEG, which corresponds to instant claim 6. Claim 3 of the reference patent recites a matrix with an organic carboxylic acid, which corresponds to instant claim 6. Claim 4 of the reference patent recites PLGA in the inner matrix, which corresponds to instant claim 9. Claim 5 of the reference patent recites a fatty acid, such as stearic acid, palmitic acid, and lauric acid, which corresponds to instant claim 1. Claim 6 of the reference patent recites a polar aprotic solvent, such as ethanol or acetone, which corresponds to instant claim 1. Claim 7 of the reference patent recites a surfactant with a HLB value over 10, which corresponds to instant claim 1.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danielle Kim whose telephone number is (571)272-2035. The examiner can normally be reached M-F: 9-5 p.m. PST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached at (571)272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613