DETAILED ACTION
This action is in response to papers filed on 11/12/2025. Claims 1-10, 21, and 23-41 of S. Henderson et al., 17/436,010 (09/02/2021) are pending examination on the merits: claims 1, 4, 7, 21, and 29 are amended, and claims 11-20, and 22 are canceled without prejudice. Claims 1-10, 21, and 23-41 are rejected.
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
This application is a 371 of PCT/US20/20976 filed on 03/04/2020, which claims benefit of 62/813,448 filed on 03/04/2019 and claims benefit of 62/837,136 filed on 04/22/2019.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/12/2025 has been entered.
Information Disclosure Statement
The Information Disclosure Statements (IDS) submitted on 11/12/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
Applicant’s Amendments
Independent claims 1, 4, 7, 21, and 29 have been amended to recite a method of treating a disease or disorder by administering a therapeutically effective amount of MCT administered in a pharmaceutical composition that is substantially protein- free and is administered in the substantial absence of proteins. Applicant’s Remarks at page 7. Applicant’s amendments acknowledged.
Withdrawn Rejections
The rejection of claims 1-10 and 25-28 are under 35 U.S.C. 102(a)(1) as being anticipated by Axona Description (11/2012) by Accera (“Accera”) (Written Opinion Reviewed) is withdrawn in view of Applicant’s amendment to independent claims 1, 4, 7, 21, and 29 as discussed above. Applicant’s arguments were persuasive and the rejection has been withdrawn. Applicant’s Remarks at page 7. The claims are now newly rejected under 35 USC § 103.
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 and 25-28 are rejected under 35 U.S.C. 103 as being unpatentable over Axona Description (11/2012) by Accera (“Accera”) (Written Opinion Reviewed).
Regarding claim 1, Accera teaches a method of treating mild to moderate Alzheimer’s Disease (AD) using a formulation containing medium-chain triglycerides (MCTs) for the clinical dietary management of the metabolic processes associated with mild to moderate AD. The formulation specifically contains caprylic triglyceride (1. Indications and Usage).
A therapeutically effective amount of MCT is administered in a pharmaceutical composition as disclosed by Accera (2. Administration): “Patients should start with a graduated dosing regimen for 7 days, or as directed by the supervising healthcare provider, before taking one full packet (40 grams) per day…” and that “Axona should
be added to 4 to 8 ounces (118 to 236 milliliters) of water or other liquids…”.
Moreover, Accera also discloses that Axona is taken orally once a day shortly after a full meal.
The claim’s recitation of:
wherein the MCT composition provides a maximum serum concentration (Cmax)
of total ketones within at least 3 hours after administration when administered 30
minutes after a standard meal and in the substantial absence of proteins.
is not given weight because it simply expresses the intended result of a process step positively recited. Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). See, MPEP 2111.04.
Regarding Applicant’s amendment, Accera does not expressly teach the administration of a therapeutically effective amount of MCT administered in a pharmaceutical composition that is substantially protein- free and is administered in the substantial absence of proteins per Applicant’s amendment.
However, a person of ordinary skill in the art would have strong technical and clinical reasons to deliberately design and administer the formulation, that is substantially protein- free and is administered in the substantial absence of proteins. One of ordinary skill would expect to solve the issue of patients allergic to these component ingredients, or their sources, per Accera’s teachings discussed below; thus, arriving at a formulation that is substantially protein- free and is administered in the substantial absence of proteins.
Accera teaches that patients allergic to milk or soy should not use the formulation as it contains caseinate (a milk-derived protein), whey, and lecithin (soy):
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The rationale to support a conclusion that the claim would have been obvious is that "a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103."KSR, 550 U.S. at 421, 82 USPQ2d at 1397.
An obvious to try rationale requires the following (MPEP § 2143):
(1) a finding that at the relevant time, there had been a recognized problem or need in the art, which may include a design need or market pressure to solve a problem;
As discussed above, Accera at the time disclosed (4) Contraindications; and (5) Warnings and Precautions about the MCT formulation. Accera teaches that patients allergic to milk or soy should not use the formulation as it contains caseinate (a milk-derived protein), whey, and lecithin (soy). This establishes a design need or market pressure to solve this problem.
(2) a finding that there had been a finite number of identified, predictable potential solutions to the recognized need or problem;
The formulation taught by Accera comprises medium-chain triglycerides (MCTs), specifically caprylic triglyceride (1. Indications and Usage), for the clinical dietary management of the metabolic processes associated with mild to moderate AD. Accera teaches that the formulation contains caseinate (a milk-derived protein), whey, and lecithin (soy).
To one of ordinary skill in the art, the most obvious and predictable potential solution to the problem of patients who are allergic to milk or soy, not being able to access the therapeutic because it contains caseinate (a milk-derived protein), whey, and lecithin (soy), is to remove these allergens all together (i.e., a formulation that is substantially protein- free and is administered in the substantial absence of proteins), and/or replace with alternatives in the art, as part of a routine optimization. Applicant’s disclosure recites the former. Applicants claim the former.
(3) a finding that one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success; and
To one of ordinary skill in the art, this would eliminate the risk of any hypersensitivity reactions, that could interfere, for example, with the therapeutic efficacy, as an alternative protein-free Accera formulation.
(4) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness.
Thus, “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103."KSR, 550 U.S. at 421, 82 USPQ2d at 1397. Claim 1, is obvious over Accera.
Regarding claim 2, and as disclosed and applied to claim 1, Accera’s teachings are discussed.
The limitation recited in claim 2 is not given weight because it simply expresses the intended result of a process step positively recited. Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). See, MPEP 2111.04.
Regarding claim 3, and as disclosed and applied to claim 1, Accera’s teachings are discussed.
Accera also teaches each individual packet of Axona is 40 grams of powder containing 20 grams of caprylic triglyceride (3. Forms and Strength).
The recitation of: “… and wherein the Cmax of total ketones is at least 400 μmol/L ...”, is not given weight because it simply expresses the intended result of a process step positively recited. Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). See, MPEP 2111.04. The manipulative step of the claimed invention may be practiced without the limitation, and as such, the limitation is not considered to be further limiting. See, MPEP 2111.04. Claim 3, as is claim 1, is anticipated by Accera.
Regarding claim 4, Accera teaches a method of treating mild to moderate Alzheimer’s Disease (AD) using a formulation containing medium-chain triglycerides (MCTs) for the clinical dietary management of the metabolic processes associated with mild to moderate AD. The formulation specifically contains caprylic triglyceride (1. Indications and Usage).
A therapeutically effective amount of MCT is administered in a pharmaceutical composition as disclosed by Accera (2. Administration): “Patients should start with a graduated dosing regimen for 7 days, or as directed by the supervising healthcare provider, before taking one full packet (40 grams) per day…” and that “Axona should
be added to 4 to 8 ounces (118 to 236 milliliters) of water or other liquids…”.
Moreover, Accera also discloses that Axona is taken orally once a day shortly after a full meal.
The claim’s recitation of:
wherein the MCT composition provides a maximum serum concentration (Cmax)
of b-hydroxybutyrate (BHB) within at least 3 hours after administration, when administered 30
minutes after a standard meal and in the substantial absence of proteins.
is not given weight because it simply expresses the intended result of a process step positively recited. Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). See, MPEP 2111.04.
Regarding Applicant’s amendment, Accera does not expressly teach the administration a therapeutically effective amount of MCT administered in a pharmaceutical composition that is substantially protein- free and is administered in the substantial absence of proteins per Applicant’s amendment.
However, a person of ordinary skill in the art would have strong technical and clinical reasons to deliberately design and administer the formulation, that is substantially protein- free and is administered in the substantial absence of proteins. One of ordinary skill would expect to solve the issue of patients allergic to these component ingredients, or their sources, per Accera’s teachings discussed below; thus, arriving at a formulation that is substantially protein- free and is administered in the substantial absence of proteins.
Accera teaches that patients allergic to milk or soy should not use the formulation as it contains caseinate (a milk-derived protein), whey, and lecithin (soy):
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The rationale to support a conclusion that the claim would have been obvious is that "a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103."KSR, 550 U.S. at 421, 82 USPQ2d at 1397.
An obvious to try rationale requires the following (MPEP §2143):
(1) a finding that at the relevant time, there had been a recognized problem or need in the art, which may include a design need or market pressure to solve a problem;
As discussed above, Accera at the time disclosed (4) Contraindications; and (5) Warnings and Precautions about the MCT formulation. Accera teaches that patients allergic to milk or soy should not use the formulation as it contains caseinate (a milk-derived protein), whey, and lecithin (soy). This establishes a design need or market pressure to solve this problem.
(2) a finding that there had been a finite number of identified, predictable potential solutions to the recognized need or problem;
The formulation taught by Accera comprises medium-chain triglycerides (MCTs), specifically caprylic triglyceride (1. Indications and Usage), for the clinical dietary management of the metabolic processes associated with mild to moderate AD. Accera teaches that the formulation contains caseinate (a milk-derived protein), whey, and lecithin (soy). To one of ordinary skill in the art, the most obvious and predictable potential solution to the problem of patients who are allergic to milk or soy, not being able to access the therapeutic because it contains caseinate (a milk-derived protein), whey, and lecithin (soy), is to remove these allergens all together (i.e., a formulation that is substantially protein- free and is administered in the substantial absence of proteins), and/or replace with alternatives in the art, as part of a routine optimization. Applicants claim the former.
(3) a finding that one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success; and
To one of ordinary skill in the art, this would eliminate the risk of any hypersensitivity reactions, that could interfere, for example, with the therapeutic efficacy, as an alternative protein-free Accera formulation.
(4) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness.
Thus, “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103."KSR, 550 U.S. at 421, 82 USPQ2d at 1397. Claim 4, is obvious over Accera.
Regarding claim 5, and as disclosed and applied to claim 4, Accera’s teachings are discussed.
The limitation recited in claim 5 does not comprise a manipulative step, and is not given weight because it simply expresses the intended result of a process step positively recited. Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). The manipulative step of claimed invention recited in claim 4, may be practiced without the limitation. See, MPEP 2111.04.
Regarding claim 6, and as disclosed and applied to claim 4, Accera’s teachings are discussed.
Regarding the recitation of: “… wherein the therapeutically effective amount of MCT is 20 g …”, Accera teaches each individual packet of Axona is 40 grams of powder containing 20 grams of caprylic triglyceride (3. Forms and Strength).
The recitation of: “…wherein the Cmax of BHB is at least 400 µmol/L…”, simply expresses the intended result of a process step positively recited in the claimed method of treatment. " Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).”. The manipulative step of the claimed invention recited in claim 4, may be practiced without the limitation, and as such, the limitation is not considered to be further limiting. See, MPEP 2111.04. Claim 6, as is claim 4, is also anticipated by Accera.
Regarding claim 7, Accera teaches a method of treating mild to moderate Alzheimer’s Disease (AD) using a formulation containing medium-chain triglycerides (MCTs) for the clinical dietary management of the metabolic processes associated with mild to moderate AD. The formulation specifically contains caprylic triglyceride (1. Indications and Usage).
A therapeutically effective amount of MCT is administered in a pharmaceutical composition as disclosed by Accera (2. Administration): “Patients should start with a graduated dosing regimen for 7 days, or as directed by the supervising healthcare provider, before taking one full packet (40 grams) per day…” and that “Axona should
be added to 4 to 8 ounces (118 to 236 milliliters) of water or other liquids…”. Moreover, Accera also discloses that Axona is taken orally once a day shortly after a full meal.
The claim’s recitation of:
wherein the MCT composition provides a maximum serum concentration (Cmax)
of acetoacetate (AcAc) within at least 2.5 hours after administration, when administered 30
minutes after a standard meal and in the substantial absence of proteins.
is not given weight because it simply expresses the intended result of a process step positively recited. Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). The manipulative step of the claimed invention may be practiced without the limitation, and as such, the limitation is not considered to be further limiting. See, MPEP 2111.04.
Regarding Applicant’s amendment, Accera does not expressly teach the administration a therapeutically effective amount of MCT administered in a pharmaceutical composition that is substantially protein- free and is administered in the substantial absence of proteins per Applicant’s amendment.
However, a person of ordinary skill in the art would have strong technical and clinical reasons to deliberately design and administer the formulation, that is substantially protein- free and is administered in the substantial absence of proteins. One of ordinary skill would expect to solve the issue of patients allergic to these component ingredients, or their sources, per Accera’s teachings discussed below; thus, arriving at a formulation that is substantially protein- free and is administered in the substantial absence of proteins.
Accera teaches that patients allergic to milk or soy should not use the formulation as it contains caseinate (a milk-derived protein), whey, and lecithin (soy):
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The rationale to support a conclusion that the claim would have been obvious is that "a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103."KSR, 550 U.S. at 421, 82 USPQ2d at 1397.
An obvious to try rationale requires the following (MPEP §2143):
(1) a finding that at the relevant time, there had been a recognized problem or need in the art, which may include a design need or market pressure to solve a problem;
As discussed above, Accera at the time disclosed (4) Contraindications; and (5) Warnings and Precautions about the MCT formulation. Accera teaches that patients allergic to milk or soy should not use the formulation as it contains caseinate (a milk-derived protein), whey, and lecithin (soy). This establishes a design need or market pressure to solve this problem.
(2) a finding that there had been a finite number of identified, predictable potential solutions to the recognized need or problem;
The formulation taught by Accera comprises medium-chain triglycerides (MCTs), specifically caprylic triglyceride (1. Indications and Usage), for the clinical dietary management of the metabolic processes associated with mild to moderate AD. Accera teaches that the formulation contains caseinate (a milk-derived protein), whey, and lecithin (soy). To one of ordinary skill in the art, the most obvious and predictable potential solution to the problem of patients who are allergic to milk or soy, not being able to access the therapeutic because it contains caseinate (a milk-derived protein), whey, and lecithin (soy), is to remove these allergens all together (i.e., a formulation that is substantially protein- free and is administered in the substantial absence of proteins), and/or replace with alternatives in the art, as part of a routine optimization. Applicants claim the former.
(3) a finding that one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success; and
To one of ordinary skill in the art, this would eliminate the risk of any hypersensitivity reactions, that could interfere, for example, with the therapeutic efficacy, as an alternative protein-free Accera formulation.
(4) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness.
Thus, “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103."KSR, 550 U.S. at 421, 82 USPQ2d at 1397. Claim 7, is obvious over Accera.
Regarding claim 8, and as disclosed and applied to claim 7, Accera’s teachings are discussed.
The limitation is not given weight because it simply expresses the intended result of a process step positively recited. Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). The manipulative step of claimed invention recited in claim 7, may be practiced without the limitation. See, MPEP 2111.04.
Regarding claim 9, and as disclosed and applied to claim 7, Accera’s teachings are discussed.
Accera also teaches each individual packet of Axona is 40 grams of powder containing 20 grams of caprylic triglyceride (3. Forms and Strength).
The recitation of: “… and wherein the Cmax of AcAc is at least 50 mmol/L, at least 60 mmol/L, at least 70 mmol/L, at least 80 mmol/L, at least 90 mmol/L, or at least 100 mmol/L.”, appears to recite an inherent result of practicing the claimed method of treatment. The manipulative step of the claimed invention may be practiced without the limitation, and as such, the limitation is not considered to be further limiting. See, MPEP 2111.04. Claim 9, as is claim 7, is also anticipated by Accera.
Regarding claim 10, and as disclosed and applied to claim 1, Accera’s teachings are discussed.
Accera teaches the claimed invention of claim 1.
The claim recites: “The method of claim 1, wherein the MCT pharmaceutical composition is stable at a pH of about 1 to about 3.”.
Both Accera and the claimed invention discloses the formulation as an oral formulation comprising caprylic triglyceride. The prior art formulation is therefore also expected to be stable at a pH of about 1 to about 3, the standard pH range of the stomach.
Applicants are reminded that the office does not have the facilities and resources to determine the shelf-life of the dosage tablet or capsule. In the absence of evidence to the contrary, the burden is on applicants to show that this property is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Regarding claim 25, and as disclosed and applied to claim 1, Accera’s teachings are discussed.
Accera teaches a method of treating mild to severe Alzheimer’s disease using the claimed method as recited in claim 1 (1. Indications and Usage). Claim 25, as is claim 1, is also anticipated by Accera.
Regarding claim 26, and as disclosed and applied to claim 25, Accera’s teachings are discussed.
Accera teaches “… wherein the disease or disorder associated with reduced cognitive function is selected from Alzheimer's Disease and Age-Associated memory
Impairment (1. Indications and Usage; 6. Adverse Reactions: Single-Administration Study). Claim 26, as is claim 25, is also anticipated by Accera.
Regarding claim 27, and as disclosed and applied to claim 1, Accera’s teachings are discussed.
Accera also discloses that under normal conditions, glucose is the primary energy source for the brain, and that the brains of AD patients show a decreased utilization of glucose in the brain.
Accera further teaches that a decrease in glucose metabolism (hypometabolism) “… may not be solely an artifact of cell atrophy since it occurs in asymptomatic patients at risk for AD, such as patients homozygous for the epsilon 4 variant of the apolipoprotein E gene (APOE4, a genetic risk factor for AD), as well as in familial forms of AD…” (1. Indications and Usage).
MPEP §2131.02(III) states that:
A reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination."
Based on the aforementioned citations from Accera, one of skill in art reading the reference would ‘at once envisage’ the claimed population also includes patients who lack the APOE4 gene such as those suffering from “cell atrophy” associated with age for example. Claim 27, as is claim 1, is therefore also anticipated by Accera.
Regarding claim 28, and as disclosed and applied to claim 1, Accera’s teachings are discussed.
The limitations of claim 28 seeks to further limit a non-limiting aspect of claim 1 (i.e., the inherent result of practicing the claimed method of treatment) as described above.
Similar to that which is disclosed above, the manipulative step of administering a therapeutically effective amount of MCT in a pharmaceutical composition in treating a disease or disorder in a subject in need thereof, as recited in claim 1, may be practiced without the limitation of claim 28. As such, the limitation of claim 28 is also not considered to be further limiting. See, MPEP 2111.04.
Claims 21, 23-24, and 29-41 are rejected under 35 U.S.C. 103 as being unpatentable over Vandenberghe et al., Curr Dev Nutr. 2017 Mar 22;1(4):e000257 (“Vandenberghe”) (Written Opinion Reviewed), and Axona Description (11/2012) by Accera (“Accera”) (Written Opinion Reviewed).
Regarding claim 21,Vendenberghe discloses a method of treating a subject in need thereof, comprising administering a therapeutically effective amount of medium chain triglycerides (MCT) (20 mL dose of C8 oil; page 2, fourth paragraph), wherein the therapeutically effective amount of MCT is administered in two portions (two 20 mL doses; Abstract), wherein the first portion comprises a first therapeutically effective amount of medium chain triglycerides (MCTs) that is substantially released within 3 hours upon administration to the subject (C8 alone significantly elevated plasma ketones at 0.5-1.5 hours; page 3, third paragraph), and wherein the second portion comprises a second therapeutically effective amount of medium chain triglycerides (MCTs) and protein (20mL dose of C8 oil was mixed with lactose free skim milk; page2, fourth paragraph), wherein these second amount of MCTs are substantially released from these second portion over 3 or more hours after administration of these second portion to the subject (the second dose of C8 significantly elevated plasma ketones from 4.5 to 6.5 hours; page 3, third paragraph).
Moreover, the limitations of: “wherein the second amount of MCTs are substantially released from the second portion over 3 or more hours after administration of the second portion to the subject” and regarding the first portion, “…. that is substantially released within 3 hours upon administration to the subject…”, although disclosed by the prior art, said limitations are not considered to be further limiting of the method step. The limitations are not given weight because they simply express the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). The manipulative step of the claimed invention therefore, may be practiced without the limitation, and as such, the limitation is not considered to be further limiting. See, MPEP 2111.04.
Regarding the amended limitation disclosing a therapeutically effective amount of MCT administered in a pharmaceutical composition that is substantially protein- free and is administered in the substantial absence of proteins per Applicant’s amendment, Vandenberghe does not expressly teach this, it is suggested.
A person of ordinary skill in the art would have strong technical and clinical reasons to deliberately design and administer the formulation, that is substantially protein- free and is administered in the substantial absence of proteins. One of ordinary skill would expect to solve the issue of patients allergic to these component ingredients, or their sources.
Accera teaches a similar MCT formulation as discussed and applied above to claims 1-10, and 25-28, and teaches that (2. Administration): “Patients should start with a graduated dosing regimen for 7 days, or as directed by the supervising healthcare provider, before taking one full packet (40 grams) per day…” and that “Axona should be added to 4 to 8 ounces (118 to 236 milliliters) of water or other liquids…”. Per Accera’s teachings, typical ingredient components including milk, and soy proteins, patients allergic said ingredients should not use the formulation as it contains caseinate (a milk-derived protein), whey, and lecithin (soy):
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The rationale to support a conclusion that the claim would have been obvious is that "a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103."KSR, 550 U.S. at 421, 82 USPQ2d at 1397.
An obvious to try rationale requires the following (MPEP §2143):
(1) a finding that at the relevant time, there had been a recognized problem or need in the art, which may include a design need or market pressure to solve a problem;
As discussed above, Accera at the time disclosed (4) Contraindications; and (5) Warnings and Precautions about the MCT formulation. Accera teaches that patients allergic to milk or soy should not use the formulation as it contains caseinate (a milk-derived protein), whey, and lecithin (soy). This establishes a design need or market pressure to solve this problem.
(2) a finding that there had been a finite number of identified, predictable potential solutions to the recognized need or problem;
The formulation taught by Accera comprises medium-chain triglycerides (MCTs), specifically caprylic triglyceride (1. Indications and Usage), for the clinical dietary management of the metabolic processes associated with mild to moderate AD. Accera teaches that the formulation contains caseinate (a milk-derived protein), whey, and lecithin (soy). To one of ordinary skill in the art, the most obvious and predictable potential solution to the problem of patients who are allergic to milk or soy, not being able to access the therapeutic because it contains caseinate (a milk-derived protein), whey, and lecithin (soy), is to remove these allergens all together (i.e., a formulation that is substantially protein- free and is administered in the substantial absence of proteins), and/or replace with alternatives in the art, as part of a routine optimization. Applicant’s claim the former.
(3) a finding that one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success; and
To one of ordinary skill in the art, this would eliminate the risk of any hypersensitivity reactions, that could interfere, for example, with the therapeutic efficacy, as an alternative protein-free Accera formulation.
(4) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness.
Thus, it would be obvious to combine the teachings, and “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103."KSR, 550 U.S. at 421, 82 USPQ2d at 1397. Moreover, "[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). Furthermore, making the MCT formulation protein free, to one of skill in the art, is routine based on a desirability to formulate and administer a dairy or protein free composition for subjects that may be intolerant. Therefore, the claim is rejected as obvious over Vandenberghe and Accera.
Regarding claim 23, and as disclosed and applied to claim 21, Vandenberghe and Accera teachings are discussed.
The limitation recited in claim 23 does not comprise a manipulative step, and is not given weight because it simply expresses the intended result of a process step positively recited. Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). The manipulative step of the claimed invention may be practiced without the limitation, and as such, the limitation is not considered to be further limiting. The manipulative step of claimed invention recited in claim 21, may be practiced without the limitation. See, MPEP 2111.04.
Regarding claim 24, and as disclosed and applied to claim 21, Vandenberghe and Accera teachings are discussed.
The limitation recited in claim 24 does not comprise a manipulative step, and is not given weight because it simply expresses the intended result of a process step positively recited. Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). The manipulative step of the claimed invention may be practiced without the limitation, and as such, the limitation is not considered to be further limiting. The manipulative step of claimed invention recited in claim 21, may be practiced without the limitation. See, MPEP 2111.04.
Regarding claim 29, Vandenberghe and Accera teaches the use of a pharmaceutical composition comprising a first component and a second component as recited in claim 29.
The rational disclosed and applied above to claim 21, applies to claim 29 regarding Vandenberghe and Accera’s teachings of the claimed pharmaceutical composition.
Moreover, the incorporation of limitations of: “wherein the second portion of MCTs
are substantially released from the second component over 3 or more hours after administration of the pharmaceutical composition to the subject…” and regarding the first portion, “…. that is substantially released within 3 hours upon administration to the subject…”, although disclosed by the prior art, said limitations are not considered to be further limiting of pharmaceutical composition. The limitation does not further limit the claimed structure of the composition, and is not given weight because it simply expresses the intended result of a process of using the composition. See, MPEP 2111.04. The claim is rejected as obvious over Vandenberghe and Accera.
Regarding claim 30, and as disclosed and applied to claim 29, Vandenberghe and Accera teachings are discussed.
The claimed structure is present in the system regardless of whether the above condition is met. The limitation does not further limit the claimed structure, and is not given weight because it simply expresses the intended result of a process step of using the claimed composition. See, MPEP 2111.04.
Regarding claim 31, Vandenberghe and Accera discloses a pharmaceutical composition comprising MCTs and at least one pharmaceutically acceptable excipient, wherein the composition is substantially free of proteins as required by the claim for use in a method of treatment as per the Abstract.
Vandenberghe teaches administering a therapeutically effective amount of medium chain triglycerides (MCT) (20 mL dose of C8 oil; page 2, fourth paragraph), wherein the therapeutically effective amount of MCT is administered in two portions (two 20 mL doses; Abstract), wherein the first portion comprises a first therapeutically effective amount of medium chain triglycerides (MCTs) that is substantially released within 3 hours upon administration to the subject (C8 alone significantly elevated plasma ketones at 0.5-1.5 hours; page 3, third paragraph), and wherein the second portion comprises a second therapeutically effective amount of medium chain triglycerides (MCTs) and protein (20mL dose of C8 oil was mixed with lactose free skim milk; page2, fourth paragraph), wherein these second amount of MCTs are substantially released from these second portion over 3 or more hours after administration of these second portion to the subject (the second dose of C8 significantly elevated plasma ketones from 4.5 to 6.5 hours; page 3, third paragraph). Vandenberghe also teaches in the Abstract a study whereby participants received two doses of a pharmaceutical composition comprising test oils (MCTs) prepared as an emulsion in lactose free-skim milk
The limitations of: “wherein the composition provides a maximum serum concentration… when administered 30 minutes after a standard meal…” are not considered to be further limiting of claimed pharmaceutical composition. The limitations are therefore are not given weight because they simply express the intended result of a process of using the composition, but does not further limit the structure of the claimed composition itself. See, MPEP 2111.04.
Regarding “in the substantial absence of proteins,”, this is interpreted based on Applicant’s Specification. Applicant’s Specification discloses in para. [0045] that in some embodiments, this means the MCT formulations may be administered in the substantial absence of protein containing foods, such as protein-based drinks (e.g., Ensure and similar protein-based drink and nutrition supplements). Applicant’s Specification at para. [0045] also states that in other embodiments, the MCT formulation itself is substantially protein-free and that at the time of administration, substantially no other proteins are administered concurrently with the MCT formulation. Vandenberghe does not expressly teach this.
However, a person of ordinary skill in the art would have strong technical and clinical reasons to deliberately design and administer the formulation, that is substantially protein- free and is administered in the substantial absence of proteins. One of ordinary skill would expect to solve the issue of patients allergic to these component ingredients, or their sources.
Accera teaches a similar MCT formulation as discussed and applied above to claims 1-10, and 25-28, and teaches that (2. Administration): “Patients should start with a graduated dosing regimen for 7 days, or as directed by the supervising healthcare provider, before taking one full packet (40 grams) per day…” and that “Axona should be added to 4 to 8 ounces (118 to 236 milliliters) of water or other liquids…” (i.e., Accera teaches that it is administered in water). Furthermore, per Accera’s teachings, typical ingredient components including milk, and soy proteins, patients allergic said ingredients should not use the formulation as it contains caseinate (a milk-derived protein), whey, and lecithin (soy):
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The rationale to support a conclusion that the claim would have been obvious is that "a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103."KSR, 550 U.S. at 421, 82 USPQ2d at 1397.
An obvious to try rationale requires the following (MPEP §2143):
(1) a finding that at the relevant time, there had been a recognized problem or need in the art, which may include a design need or market pressure to solve a problem;
As discussed above, Accera at the time disclosed (4) Contraindications; and (5) Warnings and Precautions about the MCT formulation. Accera teaches that patients allergic to milk or soy should not use the formulation as it contains caseinate (a milk-derived protein), whey, and lecithin (soy). This establishes a design need or market pressure to solve this problem.
(2) a finding that there had been a finite number of identified, predictable potential solutions to the recognized need or problem;
The formulation taught by Accera comprises medium-chain triglycerides (MCTs), specifically caprylic triglyceride (1. Indications and Usage), for the clinical dietary management of the metabolic processes associated with mild to moderate AD. Accera teaches that the formulation contains caseinate (a milk-derived protein), whey, and lecithin (soy). To one of ordinary skill in the art, the most obvious and predictable potential solution to the problem of patients who are allergic to milk or soy, not being able to access the therapeutic because it contains caseinate (a milk-derived protein), whey, and lecithin (soy), is to remove these allergens all together (i.e., a formulation that is substantially protein- free and is administered in the substantial absence of proteins), and/or replace with alternatives in the art, as part of a routine optimization. Applicants claim the former.
(3) a finding that one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success; and
To one of ordinary skill in the art, this would eliminate the risk of any hypersensitivity reactions, that could interfere, for example, with the therapeutic efficacy, as an alternative protein-free Accera formulation.
(4) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness.
Thus, it would be obvious to combine the teachings, and “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103."KSR, 550 U.S. at 421, 82 USPQ2d at 1397. Moreover, "[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). Furthermore, making the MCT formulation protein free, to one of skill in the art, is routine based on a desirability to formulate and administer a dairy or protein free composition for subjects that may be intolerant. Therefore, the claim is rejected as obvious over Vandenberghe and Accera.
Regarding claim 32, and as disclosed and applied to claim 31, Vandenberghe and Accera teachings are discussed.
The claimed structure is present in the system regardless of whether the above condition is met. The limitation does not further limit the claimed structure, and is not given weight because it simply expresses the intended result of a process step of using the claimed composition. See, MPEP 2111.04.
Regarding claim 33, and as disclosed and applied to claim 31, Vandenberghe teachings are discussed.
The limitations of claim 33 seeks to further limit a non-limiting aspect of claim 31 (i.e., the inherent result of using the claimed composition) as described above.
Similar to that which is disclosed above, the limitation recited in claim 33 does not further limit the claimed structure of claim 31. The claimed structure is present in the system regardless of whether the above condition is met and the function is actually performed. Similar to claim 31, the limitation appears to recite a result of using the claimed composition. As such, the limitation is not considered to be further limiting of the claimed structure recited in claim 31. See, MPEP 2111.04.
Regarding claim 34, and as disclosed and applied to claim 31, Vandenberghe and Accera’s teachings are discussed.
Vandenberghe teaches the MCT pharmaceutical composition as an emulsion (Abstract). Claim 34, as is claim 31, is also obvious.
Regarding claim 35, and as disclosed and applied to claim 34, Vandenberghe and Accera’s teachings are discussed.
The claim’s limitation of:
wherein the emulsion does not phase separate for at least 10 minutes, at least 20 minutes, at least 30 minutes, at least 45 minutes, at least 1 hour, at least 2 hours, at least 4 hours, at least 5 hours, or at least 24 hours.
Does further limit the claimed structure as recited in claim 34. The claimed structure is present in the system regardless of whether the above condition is met. The limitation does not further limit the claimed structure, and is not given weight because it simply expresses the intended result of a process step of using the claimed composition. See, MPEP 2111.04.
Regarding claim 36, and as disclosed and applied to claim 34, Vandenberghe and Accera teachings are discussed.
While Vandenberghe’s teachings do not expressly disclose the mean droplet diameter of the emulsion, one of skill in the art would reasonably know that the colloidal emulsion formed by combining the MCT with the lactose-free skim milk, as disclosed by Vandenberghe, would have a mean droplet diameter that may span between 100 nm and 1000 nm as recited in the claim, which is standard. As evidenced by Iyer et al., Hum Vaccin Immunother. 2015;11(7):1853-64, “Emulsions were prepared at average particle sizes of 80 nm, 100 nm, 150 nm, 200 nm and 250 nm.”, which spans the claimed range. Claim 36 is obvious.
Regarding claims 37-40, and as disclosed and applied to claim 31, Vandenberghe and Accera teachings are discussed.
Claims 37-40 recite specific formulations wherein the MCT (caprylic triglyceride) pharmaceutical composition comprises: at least 95% tri:C8 MCT; at least 98% tri:C8 MCT; at least 95% caprylic triglyceride; and 98% caprylic triglyceride.
As disclosed and applied above, Vandenberghe teaches a pharmaceutical formulation wherein caprylic triglyceride is present at 100% (page 2, Table 1). According to MPEP § 2144.05(I), obviousness may be found where the claimed ranges do not overlap with the prior art but are merely close. Since the proportions are sufficiently similar, one skilled in the art would reasonably expect them to exhibit the same properties. See Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). Claims 37-40, as is claim 31, are also obvious.
Regarding claim 41, and as disclosed and applied to claim 31, Vandenberghe in view of Accera’s teachings are discussed.
Vandenberghe teaches the administration of the above disclosed pharmaceutical composition to humans in need thereof as described in the Abstract. Claim 41, as is claim 31 is also obvious.
Applicant’s Arguments
Applicant argues that independent claims 1, 4, 7, 21, and 29 have been amended to recite a method of treating a disease or disorder by administering a therapeutically effective amount of MCT administered in a pharmaceutical composition that is substantially protein- free and is administered in the substantial absence of proteins. Applicant’s Remarks at page 7. Applicant argues that none of the prior art teach the amended limitations as recited. Applicant’s Remarks at pages 8-10.
Examiner’s Response
Applicant’s arguments are acknowledged and the claims are now newly rejected under 35 USC 103. As discussed above, Accera and Vandenberghe teach overlapping MCT formulations. While neither Accera or Vandenberghe expressly teach the administration of a therapeutically effective amount of MCT administered in a pharmaceutical composition that is substantially protein- free and is administered in the substantial absence of proteins per Applicant’s amendment, this is suggested by the prior arts.
A person of ordinary skill in the art would have strong technical and clinical reasons to deliberately design and administer the formulation, that is substantially protein- free and is administered in the substantial absence of proteins. One of ordinary skill would expect to solve the issue of patients allergic to these component ingredients, or their sources, per Accera’s teachings; thus, arriving at a formulation that is substantially protein- free and is administered in the substantial absence of proteins.
Accera teaches that patients allergic to milk or soy should not use the formulation as it contains caseinate (a milk-derived protein), whey, and lecithin (soy):
The rationale to support a conclusion that the claim would have been obvious is that "a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103."KSR, 550 U.S. at 421, 82 USPQ2d at 1397.
An obvious to try rationale requires the following (MPEP §2143):
(1) a finding that at the relevant time, there had been a recognized problem or need in the art, which may include a design need or market pressure to solve a problem;
As discussed above, Accera at the time disclosed (4) Contraindications; and (5) Warnings and Precautions about the MCT formulation. Accera teaches that patients allergic to milk or soy should not use the formulation as it contains caseinate (a milk-derived protein), whey, and lecithin (soy). This establishes a design need or market pressure to solve this problem.
(2) a finding that there had been a finite number of identified, predictable potential solutions to the recognized need or problem;
The formulation taught by Accera comprises medium-chain triglycerides (MCTs), specifically caprylic triglyceride (1. Indications and Usage), for the clinical dietary management of the metabolic processes associated with mild to moderate AD. Accera teaches that the formulation contains caseinate (a milk-derived protein), whey, and lecithin (soy). To one of ordinary skill in the art, the most obvious and predictable potential solution to the problem of patients who are allergic to milk or soy, not being able to access the therapeutic because it contains caseinate (a milk-derived protein), whey, and lecithin (soy), is to remove these allergens all together (i.e., a formulation that is substantially protein- free and is administered in the substantial absence of proteins), and/or replace with alternatives in the art, as part of a routine optimization. Applicants claim the former.
(3) a finding that one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success; and
To one of ordinary skill in the art, this would eliminate the risk of any hypersensitivity reactions, that could interfere, for example, with the therapeutic efficacy, as an alternative protein-free Accera formulation.
(4) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness.
Thus, “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103."KSR, 550 U.S. at 421, 82 USPQ2d at 1397.
Furthermore, Accera teaches that (2. Administration): “Patients should start with a graduated dosing regimen for 7 days, or as directed by the supervising healthcare provider, before taking one full packet (40 grams) per day…” and that “Axona should be added to 4 to 8 ounces (118 to 236 milliliters) of water or other liquids…”.
Applicant’s Specification discloses in para. [0045] that in some embodiments, this means the MCT formulations may be administered in the substantial absence of protein containing foods, such as protein-based drinks (e.g., Ensure and similar protein-based drink and nutrition supplements), which is covered by Accera. Applicant’s Specification at para. [0045] also states that in other embodiments, the MCT formulation itself is substantially protein-free and that at the time of administration, substantially no other proteins are administered concurrently with the MCT formulation.
Moreover, "[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). Furthermore, making the MCT formulation protein free is considered routine to one of skill in the art, based on a desirability to formulate and administered a protein free composition for subjects that may be allergic. Therefore, the claims rejected over the cited prior arts.
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 1-10 and 23-41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 18248186 (reference application) (‘186), in view of Vandenberghe and Accera.
Vandenberghe and Accera’s teachings are discussed above.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims 1-14 of ‘186 and claims 1-21 and 23-41 of the instant application, are directed to a method of treating Alzheimer’s Disease and Age-Associated memory impairment in a human lacking the ApoE4 genotype, by administering an oral pharmaceutical formulation, formulated as an emulsion, comprising a medium chain triglyceride (MCT); wherein the MCT is caprylic triglyceride.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-10 and 23-41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18563204 (reference application) (‘204), in view of Vandenberghe and Accera.
Vandenberghe and Accera’s teachings are discussed above.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims 1-15 of ‘204 and claims 1-21 and 23-41 of the instant application, are directed to a method of treating Alzheimer’s Disease and Age-Associated memory impairment in a human lacking the ApoE4 genotype, by administering an oral pharmaceutical formulation, formulated as an emulsion, comprising a medium chain triglyceride (MCT); wherein the MCT is caprylic triglyceride.
Claims 1-11 of ‘204 is directed to formulation of the pharmaceutical composition comprising various excipients and flavoring; while claims 12-15 is directed to a method of using said formulation in treating Alzheimer’s Disease and Age-Associated memory impairment in a human lacking the ApoE4 genotype.
The difference between the prior art and the claimed invention is the expressly described excipients present in the formulation of ‘204 and the two-dose regimen present in the instant claim resulting in a therapeutic effective dose of about 40 g of MCT per day.
While instant claims 29 and 31, directed to the formulation, does not expressly describe said excipients as disclosed in the co-pending claims, the term “comprising” does not preclude the incorporation of the same standard excipients. Moreover, the therapeutically effective amount of MCT disclosed in the co-pending claims also overlap with the effective dose of the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-10 and 23-41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 23, and 28-31 of copending Application No. 18098981 (reference application) (‘981), in view of Vandenberghe and Accera.
Vandenberghe and Accera’s teachings are discussed above.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims 23, and 28-31 of ‘981 and claims 1-41 of the instant application, are directed to a method of treating Alzheimer’s Disease and Age-Associated memory impairment in a human lacking the ApoE4 genotype, by administering an oral pharmaceutical formulation, formulated as an emulsion, comprising a medium chain triglyceride (MCT); wherein the MCT is caprylic triglyceride.
While instant claims 29 and 31, directed to the formulation, does not expressly describe said excipients as disclosed in the co-pending claim 23, the term “comprising” does not preclude the incorporation of the same standard excipients. Moreover, the therapeutically effective amount of MCT disclosed in the co-pending claims also overlap with the effective dose of the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4, 7, 26, and 37-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 53-54 and 56 of U.S. Application No. 10152147 (US Patent N0. 6,835,750 B1), in view of Vandenberghe and Accera.
Vandenberghe and Accera’s teachings are discussed above.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to a method of treating Alzheimer’s Disease and Age-Associated memory impairment in a patient, by administering an oral pharmaceutical formulation, formulated as an emulsion, comprising medium chain triglycerides (MCT); wherein one of said MCT is caprylic triglyceride that is administered at the same therapeutic dose.
Claims 1, 4, 7, 21 26, 29, and 37-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6-7, 10-11, 12 and 14 of U.S. Application No. 13445679 (U.S. Patent No. 8,426,468), in view of Vandenberghe and Accera.
Vandenberghe and Accera’s teachings are discussed above.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to a method of treating Alzheimer’s Disease and Age-Associated memory impairment in a patient, by administering an oral pharmaceutical formulation, formulated as an emulsion, comprising medium chain triglycerides (MCT); wherein one of said MCT is caprylic triglyceride that is administered at the same therapeutic dose.
Moreover, regarding the dosage, claim 11 of ‘679 is disclosed as a single dose, whereas in claims 21 and 29 of the claimed invention, a two-dose regimen in expressly disclosed only in these two claims. However, it is within the skill of one of ordinary skill in the art, to optimize the dosage schedule based on the most effective outcome.
Applicant’s Arguments
Applicant essentially argues for the rejections to be held in abeyance until allowable subject matter is found. Applicant also argues the amendment discussed above regarding the administration a pharmaceutical composition that is substantially protein- free and is administered in the substantial absence of proteins, asserting that the limitation is not taught or suggested by the prior arts.
Examiner’s Response
The Examiner acknowledges Applicant’s arguments. Applicant’s arguments have been addressed, but are also not found to be persuasive in view of the rejections and Examiner’s Response above.
Conclusion
No claims are allowed.
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/C A/Examiner, Art Unit 1622 January 16, 2026
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622