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 .
Status of the Claims
Claims 1 – 9, 11, 14 and newly added claims 15 – 23 are pending and rejected.
Response to Applicant’s Remarks
Applicant’s amendments/remarks filed on March 9, 2026 have been fully considered.
The rejection under 35 U.S.C. §112(a) of claims 1 – 9, 11 and 14 (claims 12 – 13 are cancelled) is withdrawn in view of amendment to recite the limitation “… treatment of a disease or disorder associated with reduced cognitive function or selected from Alzheimer’s Disease and Age-Associated memory impairment in a subject in need thereof…” in claim 1.
The rejection under 35 U.S.C. §112(b) of claims 3 – 4 and 7 – 8 is withdrawn in view of amendments to delete the narrower limitations in each of the claims.
Regarding the rejection under 35 U.S.C. §102(a)(1) of claims 1 – 9, 11 and 14 (claims 10 and 12 – 13 are cancelled) as being anticipated by Walker et al., July 2020, AAIC 26-30 July 2020, Poster # 38787, Applicant’s remarks and Declaration of Samuel Henderson under 37 C.F.R. §1.130 has been considered. Applicant states that the subject matter of Walker et al. originated from an inventor, or co-inventors of the instant application. Walker et al. is published within one year of the priority date of the instant application and is disqualified as prior art under 35 U.S.C. §102(b)(1)(A) exception. The rejection is withdrawn.
Regarding the rejection under 35 U.S.C. §102(a)(1) of claims 1 – 9 and 11 (claims 10 and 12 – 13 are cancelled) as being anticipated by Croteau et al., Journal of Alzheimer’s Disease 64 (2018), pp. 551-561, Applicant’s amendment to recite the limitations “wherein the therapeutically effective amount of tricaprilin is achieved by titrating up to the final therapeutically effective amount, and wherein the titration is performed over 2 to 4 weeks, with adjustments in dosage of 5 g to 10 g of tricaprilin per week” has been considered. Applicant note that Croteau fails to recite a dose titration step performed over the specified time period, and with the specified dose increment.
However, in response to the amendments, it is noted that said limitation classifies the claim as a product-by-process claim. MPEP §2113(I) recites (emphasis added):
“[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).Furthermore, "[b]ecause validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes." Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340, 1370 n 14, 92 USPQ2d 1289, 1312, n 14 (Fed. Cir. 2009)”.
Since Croteau et al. teach the same method of administering tricaprilin in mild-moderate Alzheimer’s Disease (AD) patients, as claimed in instant claims, the teachings of Croteau et al. anticipate the instant claims. The rejection is maintained. The rejection has been updated to address the new limitations and claims pending in the instant application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on March 9, 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objection
Claim 14 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 – 9, 11 and 15 – 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Croteau et al., Journal of Alzheimer’s Disease 64 (2018), pp. 551-561, cited in the information disclosure statement filed on May 29, 2025.
Croteau et al. teach a method of administering 30 g/day of medium chain triglycerides (MCT) supplement, specifically tricaprylin (C8 triglyceride), in mild-moderate Alzheimer’s Disease (AD) patients. See, e.g., Abstract. Croteau et al. also teach administering said supplement to find “direct relationship between plasma ketones and brain uptake of ketones during a short-term ketogenic intervention of MCT”, and “assess the impact of the MCT supplement on 1) blood metabolite profile, 2) brain glucose uptake ([18F]- FDG tracer), 3) regional brain volume, 4) cortical thickness, 5) CBF, and 6) default mode network connectivity”. See, pp. 552, 2nd paragraph. The MCT supplement is prepared by emulsifying tricaprylin into skim milk under aseptic conditions and obtain a daily dose of 30g. See, e.g., pp. 551, 4th paragraph.
The prior art anticipates the instant claims as presented below:
Claims 1, 9 and 11, a method of administering tricaprylin for the treatment of Alzheimer’s Disease in a subject in need thereof, the method comprising administering a pharmaceutical composition comprising a therapeutically effective amount of tricaprylin to the subject in need thereof, and wherein the therapeutically effective amount of tricaprilin is 30 g.
The limitation “wherein the therapeutically effective amount of tricaprilin provides a maximum serum concentration (Cmax) of total ketones of at least 300 μmol/L” is an intended use limitation as governed by MPEP §2111.02(II). Intended use limitations are interpreted based on the structural limitations they impart to the invention. In this case, the intended use only requires that the therapeutically effective amount of tricaprilin is capable of providing a maximum serum concentration (Cmax) of total ketones of at least 300 μmol/L, but does not impart any specific limitations to the structure. Based on the teachings of Croteau et al., the pharmaceutical composition comprising a therapeutically effective amount of tricaprylin is capable of providing a maximum serum concentration (Cmax) of total ketones of at least 300 μmol/L. The limitation “wherein the therapeutically effective amount of tricaprilin is achieved by titrating up to the final therapeutically effective amount, and wherein the titration is performed over 2 to 4 weeks, with adjustments in dosage of 5 g to 10 g of tricaprilin per week” classified the claim as a product-by-process claim. MPEP §2113(I) recites (emphasis added):
“[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).Furthermore, "[b]ecause validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes." Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340, 1370 n 14, 92 USPQ2d 1289, 1312, n 14 (Fed. Cir. 2009)”.
Since Croteau et al. teach the same method of administering tricaprilin in mild-moderate Alzheimer’s Disease (AD) patients, as claimed in instant claims, the teachings of Croteau et al. anticipate the instant claims.
With respect to Claim 2, the limitation “wherein the therapeutically effective amount of tricaprilin provides a Cmax of tricaprilin of at least 500 ng/mL” is an intended use limitation as governed by MPEP §2111.02(II). Intended use limitations are interpreted based on the structural limitations they impart to the invention. In this case, the intended use only requires that the therapeutically effective amount of tricaprilin is capable of providing a Cmax of tricaprilin of at least 500 ng/mL, but does not impart any specific limitations to the structure. Based on the teachings of Croteau et al., the pharmaceutical composition comprising a therapeutically effective amount of tricaprylin is capable of providing a Cmax of tricaprilin of at least 500 ng/mL.
With respect to Claims 3 and 15 – 17, the limitations “the therapeutically effective amount of tricaprilin provides a maximum serum concentration (Cmax) of total ketones within at least 1 hour after administration”, “the therapeutically effective amount of tricaprilin provides a maximum serum concentration (Cmax) of total ketones within at least 2 hours after administration”, “the therapeutically effective amount of tricaprilin provides a maximum serum concentration (Cmax) of total ketones within at least 2.5 hours after administration”, and “the therapeutically effective amount of tricaprilin provides a maximum serum concentration (Cmax) of total ketones within at least 3 hours after administration” are intended use limitations as governed by MPEP §2111.02(II). Intended use limitations are interpreted based on the structural limitations they impart to the invention. In this case, the intended uses in claims 3 and 15 – 17 only require that the therapeutically effective amount of tricaprilin is capable of providing a maximum serum concentration (Cmax) of total ketones within at least 1 hour after administration, at least 2 hours after administration, at least 2.5 hours after administration, and at least 3 hours after administration respectively. It does not impart any specific limitations to the structure. Based on the teachings of Croteau et al., the pharmaceutical composition comprising a therapeutically effective amount of tricaprylin is capable of providing a maximum serum concentration (Cmax) of total ketones within at least 1 hour after administration, at least 2 hours after administration, at least 2.5 hours after administration, or at least 3 hours after administration.
With respect to Claims 4 and 18 – 19, the limitation “the Cmax of total ketones of at least 500 μmol/L”, “the Cmax of total ketones of at least 750 μmol/L”, and “the Cmax of total ketones of at least 1000 μmol/L” are intended use limitations as governed by MPEP §2111.02(II). Intended use limitations are interpreted based on the structural limitations they impart to the invention. In this case, the intended uses in claims 4 and 18 – 19 only require that the therapeutically effective amount of tricaprilin is capable of providing the Cmax of total ketones of at least 500 μmol/L, at least 750 μmol/L, and at least 1000 μmol/L respectively. It does not impart any specific limitations to the structure. Based on the teachings of Croteau et al., the pharmaceutical composition comprising a therapeutically effective amount of tricaprilin is capable of providing provide the Cmax of total ketones of at least 500 μmol/L, at least 750 μmol/L, or at least 1000 μmol/L.
Claims 5 – 6, Walker teaches that the subject in need thereof is an elderly subject lacking the ApoE4 genotype. See, e.g., 1st column, Abstract and Background; 2nd column, Background (Study KET-004-01); and 4th column, Methods and Results.
With respect to Claims 7 – 8 and 20 – 23, the limitations “the therapeutically effective amount of tricaprilin provides a Cmax of b-hydroxybutyrate (BHB) of at least 400 μmol/L, “the therapeutically effective amount of tricaprilin provides a Cmax of b-hydroxybutyrate (BHB) of at least 500 μmol/L” and “the therapeutically effective amount of tricaprilin provides a Cmax of acetoacetate (AcAc) of at least 50 μmol/L”, “the therapeutically effective amount of tricaprilin provides a Cmax of acetoacetate (AcAc) of at least 70 μmol/L”, “the therapeutically effective amount of tricaprilin provides a Cmax of acetoacetate (AcAc) of at least 90 μmol/L”, and “the therapeutically effective amount of tricaprilin provides a Cmax of acetoacetate (AcAc) of at least 100 μmol/L” are intended use limitations as governed by MPEP §2111.02(II). Intended use limitations are interpreted based on the structural limitations they impart to the invention. In this case, the intended uses in claims 7 and 20 only require that the therapeutically effective amount of tricaprilin is capable of providing a Cmax of b-hydroxybutyrate (BHB) of at least 400 μmol/L, or at least 500 μmol/L respectively. The intended uses in claims 8 and 21 – 23 only require that the therapeutically effective amount of tricaprilin provides a Cmax of acetoacetate (AcAc) of at least 50 μmol/L, at least 70 μmol/L, at least 90 μmol/L, and at least 100 μmol/L respectively. They do not impart any specific limitations to the structure. Based on the teachings of Croteau et al., the pharmaceutical composition comprising a therapeutically effective amount of tricaprylin is capable of providing the Cmax of b-hydroxybutyrate (BHB) and acetoacetate (AcAc) as recited in the instant claims.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sagar Patel whose telephone number is (571)272-1317. The examiner can normally be reached Monday - Friday: 9am to 5pm EST.
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/Sagar Patel/Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626
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