DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/26/2026 has been entered.
Response to Amendment
Applicant’s response of 01/ has 26/2026 been received and entered into the application file. Claims 1, 3-5, 12-15, 18-20, 22-25, and 32-36 are at issue.
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 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.
Claims 1, 3-5, 12-15, 18-20, 22-25 and 32-36 are rejected under 35 U.S.C. 103 as being unpatentable over Lowry et al. (Emulsification Increases the Acute Ketogenic Effect and Bioavailability of Medium-Chain Triglycerides in Humans, Current Developments in Nutrition, 2017), Turini et al. (US 6995189 B1, 2006), and Larson et al. (WO 2007/070701 A2).
Lowry et al. disclose that ketones are the brain’s main alternative energy substrate to glucose. Medium-chain triglycerides (MCTs) are rapidly oxidized (Abstract). Lowry et al teach that the ketones b-hydroxybutyrate and acetoacetate are the main alternative fuel to glucose for brain energy metabolism and can meet two-thirds or more of the brain’s total energy requirements during a prolonged fast (page 1,
Introduction). The composition of the MCTs was 60% octanoate and 40% decanoate. MCT formulations were emulsified in to lactose-free skim milk (lactose-free; 0 g lipids, 9 g carbohydrates, and 12 g proteins/250 mL) (page 2, MCT emulsification). Lowry et al. disclose that emulsified MCTs (MCT-Es) showed higher changes in plasma ketones compared to non-emulsified MCTs (MCT-NEs) (See Figure 3). Furthermore, normalized Area Under Curve (AUC) for plasma ketones (acetoacetate + b-hydroxybutyrate) during the 4-h metabolic test was much higher for MCT-Es than MCT-NEs (See Figure 4). A stable emulsion of MCTs in lactose-free skim milk improved the ketogenic effect while reducing diarrhea (page 6, Discussion section). Lowry et al. disclose that when MCTs are given as a daily supplement, MCTs have been shown to improve cognition in mild to moderate Alzheimer’s disease, so it seems plausible that the beneficial cognitive effect of MCTs occurs through the stimulation of ketogenesis (page 7, left col). Lowry discloses that MCT formulations are emulsified into lactose-free skim milk 12 g proteins/250 mL. For the MCT-Es, the volume of pre-emulsified product was proportional to the MCT dose (10 g = 100 mL), with the final 300-mL volume of the 10-g dose being made up with lactose-free skim milk. The resulting ratio yields 0.96 g protein to 1 g MCT (pg 2, MCT Emulsification, Metabolic test protocol sections). Lowry’s 10-g MCT dose would deliver at least 5 g of the MCTs as claimed in claim 1.
Turini et al. teach a composition for use as a nutritional product comprising at least one lipid wherein the lipid provides greater than 35% total energy of the composition. A preferred embodiment comprises a n-6/n-3 fatty acid ratio of about 2/1 to 7/1; a method of treatment or prevention of sepsis or inflammatory shock comprising administration of an effective amount of the composition is described (Abstract). A preferred composition comprises about 25% to about 70% of MCT by weight of total lipid (col 2, lines 21-25). Furthermore, composition comprises less than about 15% by weight of saturated fatty acids excluding MCT (col 2, lines 30-34). The composition preferably includes a protein source, a carbohydrate source and a lipid source. The protein source provides about 10% to about 25% of the energy of the composition (col 3, lines 1-15). It may be a liquid or powder product (col 4, lines 10-25).
Lowry and Turini do not explicitly mention MCT concentration of at least 40 g/L.
Larson et al. teach compositions and methods for preventing, reducing, or delaying decline in one or more of cognitive function, motor function, cerebrovascular function, or behavior in animals; compositions mad methods utilize medium chain triglycerides (Abstract). Larson et al. disclose a graph of blood BHB concentrations; each treatment group was given either 0, 1, or 2 g MCT/kg body weight/day (See Figure 1). The group that was fed 2 mg MCT/kg body weight/day showed higher BHB levels (Figure 1). In some embodiment, the composition is a liquid. The MCTs can be diluted before administration (pg 22, 1st paragraph). Depending on the weight of the subject, one could receive greater than 40 g of MCT per day.
Lowry et al. teach that MCTs emulsified in protein such as lactose-free skim milk improved ketogenic effects while reducing side effects. Turini et al. teach that MCTs with protein, carbohydrates and other lipids can be used for prevention of inflammatory conditions such as sepsis. Larson et al. disclose compositions comprising MCT concentration of above 40 g/L. Therefore, it would have been obvious to one of ordinary person in the art before the effective filing date of the claimed invention to have combined teachings of above to create a composition comprising protein/MCTs with improved ketogenic effects for certain conditions. This is combining prior art elements according to known methods to yield predictable results such as an improved MCT composition.
Regarding claim 3, Lowry et al. teach that the composition of the MCTs was 60% octanoate and 40% decanoate. MCT formulations were emulsified in to lactose-free skim milk (lactose-free; 0 g lipids, 9 g carbohydrates, and 12 g proteins/250 mL) (page 2, MCT emulsification). Furthermore, Turini et al. teach a composition comprising MCT, protein, and carbohydrates as discussed above.
Regarding claims 4-5, liquid/powder formulations are discussed above.
Regarding claims 12-14, Turini et al. teach a composition comprising MCT, protein, and carbohydrates as discussed above. Furthermore, one of ordinary skill in the art would immediately envisage different ratio of components within such composition. And it would have been obvious to do so in this instant case as well.
Regarding claim 15, octanoic or decanoic acid is discussed above.
Regarding claim 18, Lowry et al. teach normalized AUCs for plasma ketones (acetoacetate + b-hydroxybutyrate) as discussed above (See figure 4).
Regarding claim 19, Lowry et al. teach that MCT-Es (emulsified in protein) provided more ketones than other formulations (See figure 4).
Regarding claim 20, the composition in the form of a dairy product, liquid/powder are discussed above.
Regarding claims 22-23, Lowry et al. disclose that MCTs with protein improved cognition in mild to moderate Alzheimer’s disease as discussed above. Furthermore, one of ordinary skill in the art would, through routine experimentation, experiment with varying concentrations of each component within a composition and it would have been obvious to do so in this case.
Regarding claim 24, conditions are discussed above.
Regarding claim 25, improving cognitive function is discussed above.
Regarding claims 32-34, concentration of MCT is discussed above in claim 1.
Regarding claims 35-36, Larson et al. disclose that the compositions comprising MCTs can prevent, reduce, or delay decline in one or more of cognitive function, motor performance, cerebrovascular function, or behavior in an aging mammal (pg 4, 2nd paragraph).
Response to Arguments
Applicant’s arguments filed 01/26/2026 have been fully considered but they are not persuasive.
On pages 6-7 of Applicant’s response, applicant argues that the references do not disclose a composition wherein the weight ratio of protein is at least 1.0 g protein/1.0 g of MCTs. As discussed above, Lowry discloses a ratio of 0.96 g protein/1.0g of MCT. Applicants point to Product A, B, and C with protein/MCT ratio of 1.7, 0, and 0.4, respectively. Applicants then point to Figure 3 and state that Product A achieves a much higher average plasma concentration of ketone compared to Product B. In Figure 4, the half-life of Products A and B are 2.0 and 1.0 for Products A and B, respectively; longer half-life means more sustained level of ketones in plasma. The examiner agrees with the Applicants that Product A is clearly better than Product B. However, the comparison made is between a protein/MCT ratio of 1.7 and 0. Claim 1 is not commensurate in scope with the results presented – what is unexpected when the ratio is 1 g protein/1 g MCT? How is this significant compared to the ratio of 0.96 g protein/1 g MCT as disclosed in Lowry? If Lowry teaches that MCTs in lactose-free skim milk improved the ketogenic effect while reducing diarrhea, is it not obvious that a formulation comprising protein is superior? Is the ketone level significantly, unexpectedly better when the ratio of protein/MCT is 1:1? How much better when measured in certain time intervals? Applicants are encouraged to further amend the claims to reflect the data presented.
Claims 1, 3-5, 12-15, 18-20, 22-25 and 32-36 remain rejected.
Conclusion
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/JOHN SEUNGJAI KWON/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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