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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-3, 5-8, 10-21, 23, 26-28, 31 and 68) in the reply filed on 3/20/2026 is acknowledged.
The following species were elected by Applicant:
Lecithin: soy (vegetable) lecithin
Hydrophilic linker: polyglycerol-10 caprylate/caprate
Carrier oil: ethyl oleate
Polar oil active: ibuprofen
Lipophilic linker: monoglyceride
Low molecular weight organogelator: sterol-based gelling agents
Encapsulating agent: shellac
Claim 36 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/20/2026.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The use of terms such as Cremophor EL, Tween 20, and Pluronic L-81, which are trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore, the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 5-6 and 13 are objected to because of the following informalities:
Claim 5 recites “wherein the hydrophilic linker is about 10% to about 86 wt%”. Examiner suggests amending to, for example, “wherein the hydrophilic linker concentration is about 10% to about 86 wt%” for consistency.
Claim 6 recites “Cc”. Examiner suggests amending to “characteristic curvature” for consistency.
Claim 13 recites “the self-emulsifying system” whereas the other claims recite “the system” in the body of the claim (following the preamble). Examiner suggests amending to “the system” for consistency and to avoid potential confusion.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 1-3, 5-8, 10-21, 23, 26-28, 31, and 68 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 “the HL or each of the HLs within the combination having one hydrocarbon group with at least 50% or more alkyl chain distribution between 6 to 10 carbon atoms”. This renders the claim indefinite as it is unclear how a single hydrocarbon group can have an alkyl chain distribution expressed as a percentage. For purposes of compact prosecution, the limitation will be interpreted to read “each HL having one hydrocarbon group with an alkyl chain, wherein at least 50% of the alkyl chains present in the HL component have C6-C10 carbon atoms”. Furthermore, the elected species polyglyerol-10 caprylate/caprate and any of the hydrophilic linkers recited in claims 7 and 8 will be considered to meet the instant claim limitation.
Claim 1 also recites “the combination of two or more HLs having a characteristic curvature of about -5 or more negative than about -5”. It is unclear from the claims whether this indicates that each hydrophilic linker in the combination must individually meet the instant limitation or if the entire mixture must have a characteristic curvature of the claimed values. Furthermore, it is unclear on the face of the claim how the characteristic curvature is calculated. Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience. Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993). For purposes of compact prosecution, if the prior art teaches the claimed values, it will be considered to read on the limitation.
Claims 2-3, 5-8, 10-21, 23, 26-28, 31, and 68 depend from claim 1 and do not cure the deficiencies of claim 1. Therefore, claims 2-3, 5-8, 10-21, 23, 26-28, 31, and 68 inherit the deficiencies of parent claim 1.
Claims 2 and 68 recite the limitation “the fully dilutable in aqueous phase self-microemulsifying composition of claim 1”. There is insufficient antecedent basis for this limitation in these claims.
Claim 5 recites the limitation “wherein the hydrophilic linker is about 10% to about 86”.
There is insufficient antecedent basis for this limitation in this claim. Claim 5 depends from claim 1, thus, it is unclear if this recitation refers to a single hydrophilic linker, the combination of two hydrophilic linkers, or the totality the hydrophilic linkers present in the system. For purposes of compact prosecution, if the prior art teaches the recited amounts, it will be considered to read on the limitation.
Claim 6 recites the limitation “wherein the combination of two or more HLs includes at least one amphiphilic compound with a Cc less negative than about -5 and the Cc of the combination is about -5 or more negative than about -5.” This renders the instant claim indefinite. As discussed in the 112(b) rejection of claim 1 above, it is unclear on the face of the claim how the characteristic curvature is calculated.
The metes and bounds of the instant claim are also unclear when read in light of the specification. The specification refers to hydrophilic linkers having a Cc less negative than -5 as “conventional hydrophilic linkers” and states that the difference between a conventional hydrophilic linker and an extreme hydrophilic linker (i.e. HL with a Cc of -5 or more negative) is primary observed through their Cc values [Specification pg. 24]. Furthermore, the formula that is supplied for calculating the Cc of a test surfactant on page 33 recites b, k, and CT , which are defined only as “constants that depend on the surfactant used and the electrolyte dissolved in the aqueous phase” [Specification pg. 8]. The specification provides exemplary values, such as “b = 0.12 (%NaCl^-1) for C9E5, according to Zarate et al.”, but does not further explain what these values represent. The cited reference, Zarate, does not provide additional clarity. Taken together, it is difficult to ascertain whether a given compound would read on the instant claim and whether a combination of compounds would have the instantly claimed Cc value. The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. Applicant’s species election in the response dated 3/20/2026 asserts polyglycerol-10 caprylate/caprate as reading on claim 6. Thus, for purposes of compact prosecution, if the prior art teaches poylyglycerol-10 caprylate/caprate, it will be considered to meet the limitations of claim 6.
Claim 7 recites “polyglucosides (n>2)”. The parenthetical recitation of “(n>2)” renders the claim indefinite because it is unclear whether the recitation in parentheses is part of the claimed invention. Description of examples and preferences is properly set forth in the specification rather than in a single claim. See MPEP 2173.05(d). For purposes of compact examination, the instant limitation is being interpreted as “polyglucosides with a degree of polymerization n>2.”
Claim 7 is also indefinite as it is unclear whether “C6-C10” in the recitation of “C6-C10 alkyl polyphosphates, polyphosphonates, polycarboxylates, sulfosuccinates, glutamates” is meant to modify the entire list of claimed elements (i.e. C6-C10 alkyl polyphosphates, C6-C10 polyphosphonates, C6-C10 polycarboxylates, C6-C10 sulfosuccinates, C6-C10 glutamates), or if “C6-C10” applies only to alkyl polyphosphates. The “C6-C10” preceding “esters of polyhydric alcohols, polyvinyl alcohol, polyglycerols” also creates the same confusion. The instant specification at page 25 suggests the former interpretation. Additionally, it is unclear if the recitation of “and their co-polymers” following “polyhydric alcohols, polyvinyl alcohol, polyglycerols” applies only to polyglycerols, or if the claim is intended to embrace copolymers of polyhydric alcohols, copolymers of polyvinyl alcohol, and copolymers of polyglycerols.
Claim 7 is also rendered unclear due to the use of a semicolon following “C6-C10 alkyl polyphosphates, polyphosphonates, polycarboxylates, sulfosuccinates, glutamates”, whereas the elements in the remainder of the claim are separated using commas. This suggests two distinct groupings. Since “C6-C10” appears three times in the list of elements separated by commas, it suggests that C6-C10 applies only to the elements immediately subsequent to its recitation (i.e. C6-C10 esters of polyhydric alcohols, C6-C10 amines, and C6-C10 alkyl aminopropionic acids) and the remaining elements are meant to be interpreted as written (e.g. sorbitol without any modifications). The use of the semicolon following “C6-C10 alkyl polyphosphates, polyphosphonates, polycarboxylates, sulfosuccinates, glutamates” also creates confusion as to whether “mixtures thereof” applies to “C6-C10 alkyl polyphosphates, polyphosphonates, polycarboxylates, sulfosuccinates, glutamates”, or if “mixtures thereof” only applies to the listed elements following the semicolon (i.e. C6-C10 esters of polyhydric alcohols and onward). For purposes of compact prosecution, if the prior art teaches any of the recited elements, it will be considered to read on the claim.
Claim 16 recites “C5+ alcohols”. This renders the scope of the claim indefinite as it is unclear if “C5+” is intended to be inclusive or exclusive of alcohols with 5 carbon atoms. In other words, it is unclear if the “+” indicates “at least” or “more than”. For purposes of compact prosecution, the limitation is being interpreted as inclusive of alcohols with 5 carbon atoms.
Claim 17 recites “wherein the one or more polar active compounds include ibuprofen, nonylphenol, cannabidiol, and eugenol”. This renders the claim indefinite. The term “include” is synonymous with the transitional term “comprise”, which is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim. MPEP 2111.03. The use of “and” also suggests that all the listed elements are required. In contrast, the use of “one or more” seems to imply that only one of the names elements must be present. Thus, the use of this contradicting language renders the scope of the claim indefinite. For purposes of compact prosecution, the instant limitation is being interpreted to read “wherein the one or more polar active compounds include ibuprofen, nonylphenol, cannabidiol, or eugenol”.
Claim 21 recites “C12+ alcohols, fatty acids, monoglyceride, sorbitan ester, sucrose ester, glucose ester, cholesterol, and esters of lauric acid, palmitic acid, oleic acid, omega 6-fatty acids, omega 3-fatty acids with sorbitol, maltitol, xylitol, isomalt, lactitol, erythritol, pentaerythritol, and glycerol”. It is unclear whether the recitation of “C12+” is intended to modify the entire list of claimed elements (i.e. C12+ alcohols, C12+ fatty acids, C12+ monoglyceride, etc.) or if “C12+” applies only to alcohols. It is also unclear if the recitation of “omega 3-fatty acids with” is intended to modify the entire list of elements following this term (i.e. omega 3-fatty acids with sorbitol, omega 3-fatty acids with maltitol, omega 3-fatty acids with xylitol, etc.), or “omega 3-fatty acids with” applies only to sorbitol. The instant specification at page 25, and the fact that, glycerol, for example, is not lipophilic, suggests the former interpretation. For purposes of compact prosecution, if the prior art teaches any of the recited elements, it will be considered to read on the claim.
The recitation of “C12+ alcohols” also renders the scope of the claim indefinite as it is unclear if “C12+” is intended to be inclusive or exclusive of alcohols with 12 carbon atoms. In other words, it is unclear if the “+” indicates “at least” or “more than”. For purposes of compact prosecution, the limitation is being interpreted as inclusive of alcohols with 12 carbon atoms.
Examiner Comments
The Examiner has cited particular columns and line numbers, paragraphs, or figures in the references as applied to the claims for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested from the applicant, in preparing the responses, to fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
The Examiner would like to note that in light of Applicant’s species elections, the elected species will be considered to read on any claim limitations that recite properties of the claimed compounds. A composition and its properties are inseparable, therefore, the claimed properties are presumed to be inherent. For example, if the prior art teaches the elected encapsulation agent, shellac, this will be considered to read on the limitations of claim 28. Accordingly, this also applies to claims 1, 6, 10, 13, 15, 23, and 26.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 2, 3, 5-8, 10-21, 23, 31, and 68 are rejected under 35 U.S.C. 103 as being unpatentable over Nouraei (2018) in view of Chu et al. (2014).
Regarding claims 1, 3, 5-8, 10-17, 19-21, 31, and 68, Nouraei teaches a fully dilutable self-microemulsifying delivery system comprising 38% carrier oil (reads on claims 1, 11), 8.5% lecithin (reads on claims 1, 3), 8.5% lipophilic linker (reads on claims 19-20), 40% hydrophilic linker (reads on claims 1, 5), 5% ibuprofen (reads on claims 13-17) [Table 3-4]. The lipophilic linker comprises of glycerol monooleate (reads on monoglyceride, elected species of claims 19, 21). The system is free of water, polyethylene glycol, propylene glycol, and short and medium-chain alcohols [Table 3-4], and the particle size is below 100 nm [pg. 87] (reads on claims 31, 68). The carrier oil taught in Table 3-4 is ethyl caprate, however, Nouraei teaches that replacing ethyl caprate with ethyl oleate (elected species, reads on claims 1 and 10-12) would be desirable, as its tasteless/odorless properties are conducive food-related applications, and increases drug solubility and lymphatic transportation [pg. 157-158]. Nouraei teaches that in linker-based microemulsion systems, soy lecithin (elected species, reads on claims 1, 3) may be used as the main surfactant and C8/C10 polyglycerols as a hydrophilic linker (HL) [pg. 10]. Nouraei teaches the use of C8/C10 polyglycerols, but does not explicitly disclose the use of polyglycerol-10 caprylate/caprate. Chu et al. teaches lecithin-linker microemulsions comprising soybean lecithin, lipophilic linker, and hydrophilic linker [Abstract]. Chu teaches that decaglyceryl caprylate/caprate (i.e. polyglycerol-10 caprylate/caprate, elected species) is a suitable hydrophilic linker for use in formation of SMEDS [Abstract]. The selection of a known material based on its suitability for its intended use is prima facie obvious. MPEP 2144.07. Thus, it would be obvious to one of ordinary skill, before the effective filing date of the claimed invention, to modify the teachings of Nouraei with that of Chu, and select polyglycerol-10 caprylate/caprate as the hydrophilic linker in the SMEDS of Nouraei (reads on claims 1 and 5-8). With respect to the Cc, as discussed above, the prior art makes obvious the elected species and as a compounds and its properties are inseparable, the elected species would be reasonably expected to have the claimed Cc property. The Examiner would also like to note that even though the SMEDS of Chu also comprise of PEG-6 caprylic/capric glycerides, the instant claims exclude polyethylene glycol, and “polyethylene glycol” is not defined as embracing PEG-based surfactants in the instant claims or instant specification.
Regarding claims 2 and 18, Nouraei teaches the administration of SMEDS to rats via oral gavage [pg. 74], thus the solubilization of the SMEDS in the gastric juices [pg. 89] reads on an aqueous phase of biological fluids. Examiner would like to note that claim 2 does not recite any additional structural distinctions to the composition of claim 1 and is thus being interpreted as intended use, and does not constitute a functional limitation. Nouraei teaches a composition that is capable of oral delivery [Figure 3-10; pg. 74], thus the prior art formula is capable of performing the intended use as recited and meets the claim.
Regarding claim 6, Applicant’s species election in the response dated 3/20/2026 asserts polyglycerol-10 caprylate/caprate as reading on claim 6. Since polyglycerol-10 caprylate/caprate is a blend of two compounds, it will be considered to meet the instant limitation of two hydrophilic linkers, consistent with Applicant’s species election. As the composition of claim 1 comprising poylyglycerol-10 caprylate/caprate has been made obvious in the rejection above over Nouraei and Chu, it is it considered to read on the instant claim limitations.
Regarding claim 23, Nouraei teaches the use of phytosterols as low molecular weight gelators (reads on sterol-based gelling agent, elected species) [pg. 105]. The addition of the phytosterols to the SMEDS in the range of 1-30% by weight of the gel [pg. 116] solidified the SMEDS to a gel over the course of 48 hours [pg. 117]. Nouraei further teaches that the gelled SMEDs demonstrated an extended-release profile [pg. 136].
Claims 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Nouraei (2018) in view of Chu et al. (2014), as applied to claim 1 above, and further in view of Patel (US2020/0061191 A1, published 2/27/2020).
Regarding claims 26 and 28, Nouraei teaches that techniques such as microencapsulation and coatings are known in the art as mechanisms to achieve extended-release profiles [pg. 107]. These techniques may be used to produce a free-flowing powder that can form dilutable microemulsions [pg. 108; pg. 160; see also pg. 145]. Nouraei teaches that the composition may be protected with enteric coatings to protect them from gastric juices and allow for drug release in the intesting [pg. 146], but does not explicitly teach encapsulating agent to be shellac. Patel teaches solid carrier particles for delivery of active pharmaceutical ingredients comprising a substrate and an encapsulation coat on the substrate [Abstract]. The substrate may be a liquid or semi-liquid substrate material [0117] and may comprise of surfactants and solubilizers [0016], such as soy lecithin [Table 18], polyglycerol fatty acid esters [0097], monoglycerides [Table 9], sterol derivatives [0072], ethyl oleate [Table 17]. The encapsulated drug may be ibuprofen [0036]. Patel further teaches that the encapsulation coat may be an enteric coating [0172] for protection from gastric juices and to effect drug release in the lower gastrointestinal tract [0180-0181]. Patel teaches shellac to be a preferred polymer for the enteric coating [0182; 0192]. The selection of a known material based on its suitability for its intended use is prima facie obvious. MPEP 2144.07. Thus, it would be obvious to one of ordinary skill, before the effective filing date of the claimed invention, to modify the teachings of Nouraei and Chu with that of Patel, and select shellac as the coating of the SMEDS made obvious by Nouraei and Chu.
Regarding claim 27, this claim recites the limitation wherein the encapsulating agent is present in the amount of from about 10% to about 90% by weight. Neither Nouraei nor Patel explicitly discloses this claimed concentration. However, differences in concentration will generally not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. MPEP 2144.05. Furthermore, Patel teaches the coating thickness must be sufficient to ensure that the oral dosage form remains intact until the desired site of delivery in the intestinal tract [0188]. The thickness of the coating (which is fundamentally an expression of amount) may be readily adjusted by one of skill in the art to achieve delivery to a specific site, for example, only the small intestine, only the large intestine, or both the small and large intestines [0171]. "[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). As the thickness, or amount, or shellac comprising the enteric coating is known to be a result effective variable, the normal desire to discover of an optimum value of a variable in a known process is obvious. MPEP 2144.05. Thus, it would be obvious to one of ordinary skill to optimize the concentration of shellac in order to arrive at the instantly claimed formulation.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA LYNN CHI whose telephone number is (571)272-0026. The examiner can normally be reached Monday - Friday 9 am-5pm ET.
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.
/AMANDA LYNN CHI/Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
Prosecution Insights