DETAILED ACTION Notice of Pre-AIA or AIA Status The present application, filed on or after June 0 7 , 2023, is being examined under the first inventor to file provisions of the AIA. Status of the Application Receipt is acknowledged of Applicants’ claimed invention filed on 06 /0 7 /2023 in the matter of Application N° 18/ 256 , 231 . Said documents are entered on the record. The Examiner further acknowledges the following: Thus, claims 1-1 0 represent all claims currently under consideration. 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- 10 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. ( WO2009022798A2 ), in view of Jing Lin ( US20 060275358A1 ) . Regarding claim s 1 , 2, and 3, Lee et al. disclose s wherein an aqueous medium and a self- microemulsifying drug delivery system (SMEDDS) composition with coenzyme Q10 emulsified inside are the components of the aqueous composition. Coenzyme Q10, a surfactant polyglycerol fatty acid ester, a co-surfactant polyoxyethylene -sorbitan fatty acid ester, and possibly a stabilizer makes up the aforementioned SMEDDS formulation. A preparation technique that involves co-melting coenzyme Q10, a surfactant, and a co-surfactant, mixing them to create a SMEDDS composition, and then combining the SMEDDS composition with an aqueous medium is provided as well. The mixture is formed without the employment of a particular tool or the use of a significant amount of physical force, and it has good stability (See Description, page 1, line 6 to page 21, line 2, and page 26, table 12, and claims 1-8 ) . Regarding claim 4, Lee et al. disclose the coenzyme Q10 , wherein Caprylic/capric acid mono-, or di-glycerides. Triglyceride produced by transesterification or natural vegetable oil (See page 11, line 4, and page 12, line 6). Regarding claim 5, Lee et al. disclose the coenzyme Q10 microemulsion made of polyoxyethylene sorbitan monooleate (See page 20, example 1). Regarding claim 6, Lee et al. disclose wherein a SMEDDS composition was created by dissolving coenzyme Q10 with decaglycerin myristic acid ester ( Decaglycerol Monomylistate ), as indicated in table 1 (See Example 1, and Table 1). A combination of mono, di, and tri esters of sorbitol , sorbitan, and sorbide ; free sorbitol, sorbitan, and sorbide ; and fatty acid salt is referred to as sorbitan fatty acid ester (See page 12, lines 7 and 8). Lee et al. also discloses the mobile phase: 60% methanol + 40% ethanol (See page 29, Test example 3). Regarding claim 7, Lee et al. discloses compositions comprising coenzyme Q10 (CoQ10) and describes that CoQ10 possesses poor solubility, high crystal lattice energy, and significant cry stallization instability. Lee et al. teaches that due to these properties, COQ10 tends to precipitate, recrystallize, and lose potency during storage, especially at low temperatures or in formulations containing other ingredients in large amounts. Lee et al. therefore recognizes the need for solubilization and stabilization strategies to address these crystallization-related defects in CoQ10 formulations (See page 3, lines 4-11). Tocopherol or tocopherol acetate would have been reasonably expected to function as a crystallization inhibitor (i.e. a solubility stabilizer) for coenzyme Q10 in a SMEDDS or microemulsion system, as such compounds are well known to suppress precipitation and crystal growth of lipophilic actives in emulsified systems. Tocopherol can function as an anti-crystallization agent, and it is commonly characterized that way in SMEDDS microemulsions, and lipid-based systems, especially for lipophilic actives like coenzyme Q10. Lee et al. disclose wherein surfactants that are appropriate for usage as food additives should be taught. A typical example of a surfactant is polyglycerin fatty acid ester (See page 9, lines 5-6). Lee et al. also discloses the following food additives may be further comprised by the self- microemulsifying drug delivery system composition including coenzyme Q10 and the aqueous composition containing coenzyme Q10 of the present invention in order to enhance the composition’s stability, flavor, and taste. Tocopherol and tocopherol acetate are examples of stabilizers (See page 13, lines 14-17, and page 15, line 2). However, Lee et al. does not explicitly teach the use of tocopherol or tocopherol acetate as an anti-crystallization agent, nor does it explicitly teach a microemulsion containing such agents. However, Lee et al. teaches that tocopherol and tocopherol acetate are suitable stabilizers that may be incorporated into a self microemulsifying drug delivery system (SMEDDS) or into aqueous compositions containing CoQ10 to enhance stability. Lee et al. explicitly identifies tocopherol and tocopherol acetate as additives useful in stabilizing CoQ10-containing compositions and improving their handling, storage, and performance (See page 13, lines 14-17, and page 15, line 2). Given that Lee et al. recognizes CoQ10’s inherent crystallization, precipitation, and low-temperature instability, and expressly teaches the need for solubilization and stabilization, one of ordinary skill in the art would have been motivated to incorporate known stabilizing additives, such as tocopherol or tocopherol acetate into a CoQ10 formulation to reduce crystallization and enhance stability. Since Lee et al. identifies tocopherol and tocopherol acetate as stabilizers compatible with CoQ10 microemuisifying system, it would have been obvious to include such materials in Lee et al.’s CoQ10 formulation to achieve improved storage stability and reduced crystallization. See MPEP 2141 and 2144 (routine optimization and selection of known additives for their known stabilizing effects). The use of tocopherol or tocopherol acetate in this context would reasonably be expected to function as an anti-crystallization agent because such agents are well-known lipophilic stabilizers that interfere with crystallization and precipitation of lipophilic actives within emulsified or microemulsified systems. Incorporating one of these stabilizers into Lee et al. represents the predictable use of a known stabilizer for the known purpose of improving CoQ10 stability. Regarding claims 9, and 10, Lee et al. disclose the use of coenzyme Q10 for drugs, cosmetics, health-care beverages, functional foods, etc. A person skilled in the art would have been motivated to apply the microemulsion of coenzyme Q10 to the preparation of drugs, cosmetics, food, and beverages; additionally, the preparation of an oral liquid would have been easily conceivable (See page 2, lines 7-12). However, regarding claim 1, Lee et al. do not disclose a total amount of the coenzyme Q10 microemulsion. Lin discloses that the self-emulsifying mixture’s content of at least one hydrophilic surfactant ranges from 20 to 70% by weight (See claim 3). Additionally, Lin discloses that the concentration of at least one lipophilic co-surfactant in the self-emulsi fying combination ranges between 1.5 and 50% by weight (See claim 4). Lin discloses wherein the concentration of at least one hydrophobic solvent in said self-emulsifying mixture is in the range of from 2 to 50 % by weight (See claim 5). Lin discloses a dosage form of a low water-solubility active ingredient that contains at least one low water - solubility active ingredient in a self- microemulsifying mixture that includes at least one hydrophilic surfactant and at least one lipophilic co-surfactant, where the hydrophile-lipophile balance of the hydrophilic surfactant is greater than 12 and the hydrophile- lipophile balance of the lipophilic co-surfactant is less than 8, and at least one hydrophobic solvent (See claim 11). It would have been obvious to a person of ordinary skill in the art, at the time of the invention, to formulate Lee’s SMEDDS/microemulsion using ingredient amounts within Lin’s disclosed ranges (and/or to adjust the relative proportions of the surfactant/co-surfactant/solvent system consistent with Lin) in order to obtain a stable self- microemulsifying system and thereby arrive at a microemulsion having predictable formation behavior, stability, and emulsification performance. Determining the specific “total amount” and the relative percentages of these known formulation components represents routine optimization of result-effective variables (e.g. droplet size, clarity, robustness to dilution physical stability, precipitation resistance), using known guidance in the art as exemplified by Lin. The last sentence is the key: you’re not “inventing” a new ingredient system, just optimizing result-effective variables with known ranges. One of ordinary skill in the art would have recognized that the amounts of hydrophilic surfactant/emulsifier and lipophilic co-surfactant disclosed in Lin represent routine, predictable concentration ranges for SMEDDS systems and would have found it obvious to adjust the relative proportions of coenzyme Q10, carrier oil, lipophilic emulsifier, and hydrophilic emulsifier in Lee et al. composition to fall within the claimed ranges in order to achieve desirable micro emulsion formation, solubilization efficiency, and stability, as taught in Lin. Optimization of component ratios in self-emulsifying systems amounts to routine experimentation to achieve workable or improved formulations. See e.g. MPEP 2144.05 (“optimizing a result-effective variable is ordinarily obvious”), and In re Aller, 220 F.2d 454 (CCPA1955). Regarding claim 8, Lin teaches a self- microemulsifying mixture that includes coenzyme Q10, at least one hydrophilic surfactant, at least one lipophilic co-surfactant, where the hydrophile-lipophile balance (HLB) of the hydrophilic surfactant is greater than 12 and the HLB of the lipophilic co-surfactant is less than 8, and at least one hydrophobic solvent (See abstract, and claims 1-15). However, Lin does not teach the use of a carrier oil in combination with CoQ10, nor does Lin disclose including an anti-crystallization agent such as tocopherol or tocopherol acetate. Lee et al. on the other hand, recognizes that CoQ10 exhibits poor solubility, high crystal lattice energy, and significant crystallization instability, including precipitation, recrystallization, and loss of potency during storage (See page 3, lines 4-11). Thus, Lee et al. identifies crystallization as a major formulation problem and teaches that stabilizing agents are needed to prevent such defects. Lee et al. further discloses that tocopherol and tocopherol acetate can be incorporated into CoQ10-containing emulsifying or microemulsifying systems as stabilizers to improve stability (See page 13, lines 14-17, and page 15, line 2), and these agents are well-known lipophilic additives capable of suppressing crystal formation and precipitation of lipophilic actives. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Ling’s CoQ10 microemulsion by including a carrier oil and further including an anti-crystallization agent such as tocopherol or tocopherol acetate as taught by Lee et al. Lee et al. expressly identifies crystallization and instability as problems in CoQ10 systems and teaches tocopherol and tocopherol acetate as suitable stabilizers for improving stability. A POSITA would have reasonably expected that incorporating such well-known lipophilic stabilizers into Ling’s microemulsion would inhibit CoQ10 crystallization, enhance solubilization, and improve storage stability. Such a modification constitutes the predictable use of known stabilizing materials for their known purpose, consistent with MPEP 2143 and 2144 (use of known agents to achieve expected improvements). Therefore, the claimed method, which requires preparing a CoQ10 microemulsion comprising a carrier oil and an anti-crystallization agent selected from tocopherol or tocopherol acetate, would have been obvious over Ling in view of Lee et al. Conclusion No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kimberly Barber whose telephone number is FILLIN "Insert your individual area code and phone number." \* MERGEFORMAT (703) 756-5302. 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