IP Library › Granted Patent US 12,329,774
Granted Patent B2
US 12,329,774 · App. 17/222,953 · Granted Jun 17, 2025

Method and composition for enhancing the quality and benefits of sleep

Inventors: Deanna J. Nelson (Raleigh, NC); James R. Komorowski (Trumbull, CT)
Assignee: BioLink Life Sciences, Inc.
A61K33/06A23L33/10A23L33/16A61K9/0019A61K9/0053A61K31/191A61P25/20
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Quick Facts
Patent No.
US 12,329,774
App. No.
17/222,953
Granted
Jun 17, 2025
Kind
B2
Abstract

Compounds, compositions and methods of making and using for enhancing the quality and benefit of sleep and/or wakefulness in a subject in need thereof.

Claims (12)

1. A composition comprising magnesium di-L-theanate:

wherein the magnesium di-L-theanate exhibits an optical rotation of 3-4°.

2. A method of improving sleep in a subject in need thereof, the method comprising the step of administering an effective amount of magnesium di-L-theanate, wherein the effective amount is about 20 mg/kg body weight, wherein the effective amount is sufficient to decrease sleep latency and/or increase length of sleep, wherein said magnesium di-L-theanate is a solid having a molecular structure of

an optical rotation of 3-4°, and contains 5.5-6.0% by weight magnesium and 94.0-94.5% by weight L-theanate.

3. The method of claim 2 , wherein the magnesium di-L-theanate is formulated for administration to a mammal.

4. The method of claim 3 , wherein the step for administration is administration by mouth.

5. A method of preparation for a magnesium di-L-theanate compound, comprising the steps of:

(a) Dissolving 2 mole equivalents of L-theanine and 1 mole equivalent of magnesium ethoxide in an aqueous alcohol solution, wherein the alcohol in said aqueous alcohol solution is ethanol or methanol;

(b) Allowing said solution to stir at ambient or elevated temperature until a clear solution is obtained;

(c) Removing volatile solvents from said clear solution by evaporation to provide a solid;

(d) Dispersing the solid in an immiscible solvent and removing said solvent by filtration to provide a solid filtrand of purified magnesium di-L-theanate;

(e) Drying said solid filtrand to remove residual solvents and provide purified magnesium di-L-theanate.

Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 5, 2023
From: NUTRITION 21, LLC
To: BIOLINK LIFE SCIENCES, INC.
Reel/Frame 064796/0258 →
SECURITY INTEREST Recorded Nov 9, 2021
From: NUTRITION 21, LLC
To: CAPITAL ONE, NATIONAL ASSOCIATION, AS AGENT
Reel/Frame 058060/0535 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 21, 2021
From: JDS THERAPEUTICS, LLC
To: NUTRITION 21, LLC
Reel/Frame 056933/0653 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 5, 2021
From: NELSON, DEANNA J.; KOMOROWSKI, JAMES R.
To: JDS THERAPEUTICS, LLC
Reel/Frame 055829/0497 →
Continuity (2)
Provisional Application 63005080 · Apr 3, 2020
Related Publication 20210308081A1 · Oct 7, 2021
References Cited (43)
US 4013699A · Passedouet · 1977 [cited by examiner]
US 5501866A · Kakuda et al. · 1996 [cited by applicant]
US 10335384B2 · Henderson et al. · 2019 [cited by applicant]
US 10449148B2 · Gutierrez et al. · 2019 [cited by applicant]
US 10517322B1 · Lee · 2019 [cited by applicant]
US 20010001307A1 · Ueda · 2001 [cited by examiner]
US 20020122835A1 · Bucci et al. · 2002 [cited by applicant]
US 20060246129A1 · Linardakis et al. · 2006 [cited by applicant]
US 20080009505A1 · Hodges · 2008 [cited by examiner]
US 20080039526A1 · Ozeki · 2008 [cited by examiner]
US 20150320814A1 · Patel et al. · 2015 [cited by applicant]
US 20200121624A1 · Liu · 2020 [cited by examiner]
CN 102827896 · 2012 [cited by applicant]
JP 2005289948 · 2005 [cited by applicant]
WO WO2003090738 · 2003 [cited by applicant]
WO WO2006090640 · 2006 [cited by applicant]
Grodowska et al. “Organic Solvents in the Pharmaceutical Industry”. 2010. Acta Poloniae Pharmaceutical. 67(1): 3-12. (Year: 2010). [cited by examiner]
Gupta et al. Salts of Therapeutic Agents: Chemical, Physicochemical, and Biological Considerations. Molecules. 23(1719): 1-15. (Year: 2018). [cited by examiner]
Kakuda et al. “Inhibiting Effects of Theanine on Caffeine Stimulation Evaluated by EEG in the Rat”. IBiosci. Biotechnol. Biochem., 64(2):287-293 (Year: 2000). [cited by examiner]
STN Compound Entry Date (Year: 2021). [cited by examiner]
Abbasi et al., “The effect of magnesium supplementation on primary insomnia in elderly: A double-blind placebo-controlled clinical trial,” J Res Med Sci., 2012; 17(12): pp. 1161-1169. PubMed PMID: 23853635; PubMed Centr… [cited by applicant]
Ates et al., “Dose-dependent absorption profile of different magnesium compounds,” Biol Trace Elem Res., 2019; 192(2): pp. 244-251. [cited by applicant]
Coskuner et al., “Adenosine triphosphate (ATP) reduces amyloid-β protein misfolding in vitro,” J Alzheimers Dis., 2014; 41(2): pp. 561-574. PubMed PMID: 24625803. [cited by applicant]
Deckert et al., “Adenosinergic psychopharmaceuticals?” Trends Pharmacol Sci., 1989; 10: pp. 99-100. [cited by applicant]
Ding et al., “Changes in the composition of brain interstitial ions control the sleep-wake cycle,” Science, 2016; 352(6285): pp. 550-555. [cited by applicant]
Dominguez et al., “Nutritional prevention of cognitive decline and dementia,” Acta Biomed., 2018; 89(2): pp. 276-290. [cited by applicant]
Hafner et al., “Why sleep matters—the economic costs of insufficient sleep. A cross-country comparative analysis,” Rand Corp., Santa Monica, CA; 2016. [cited by applicant]
Haskell et al., “The effects of L-theanine, caffeine and their combination on cognition and mood,” Biol Psychol., 2008; 77(2): pp. 113-122. PubMed PMID: 18006208. [cited by applicant]
International Search Report and Written Opinion issued in PCT/US2021/025836, mailed Jun. 30, 2021. [cited by applicant]
Jackson et al, “The requirement for bivalent cations in formation of nicotinamide-adenine dinucleotide by nicotinamide mononucleotide adenylyltransferase of pig-liver nuclei,” Biochem J., 1966;101(1): pp. 208-213. [cited by applicant]
Jang et al., “L-theanine partially counteracts caffeine-induced sleep disturbances in rats,” Pharmacol Biochem Behav., 2012; 101(2): pp. 217-221. [cited by applicant]
Jo et al., “Polygonatum sibiricum rhizome promotes sleep by regulating nonrapid eye movement and GABAergic/serotonergic receptors in rodent models,” Biomed Pharmacother., Sep. 2018; 105: pp. 167-175. [cited by applicant]
Kakuda, “Neuroprotective effects of theanine and its preventive effects on cognitive dysfunction,” Pharmacol Res., Aug. 2011; 64(2): pp. 162-168. PubMed PMID: 21477654. [cited by applicant]
Kim et al., “GABA and I-theanine mixture decreases sleep latency and improves NREM sleep,” Pharm Biol. 2019; 57(1): 64-72. [cited by applicant]
Kimura et al., “L-Theanine reduces psychological and physiological stress responses,” Biol Psychol., Jan. 2007; 74(1): pp. pp. 39-45. PubMed PMID: 16930802. [cited by applicant]
Lawless et al., “The taste of calcium and magnesium salts and anionic modifications,” Food Qual Prefer, 2003; 14: pp. 319-325. [cited by applicant]
Nathan et al. “The neuropharmacology of L-theanine (N-ethyl-L-glutamine): a possible neuroprotective and cognitive enhancing agent,” J Herb Pharmacother., 2006; 6(2): pp. 21-30. PubMed PMID: 17182482. [cited by applicant]
NIH State-of-the-Science Conference Statement on manifestations and management of chronic insomnia in adults. NIH Consens State Sci Statements., Jun. 13-15, 2005; 22(2): pp. 1-30. [cited by applicant]
Paterson et al., “A translational, caffeine induced model of onset insomnia in rats and healthy volunteers,” Psychopharmacology (Berlin) 2007; 191: pp. 943-950. [cited by applicant]
Sharma et al., “L-Theanine: An astounding sui generis integrant in tea,” Food Chem., 2018; 242: pp. 601-610. PubMed PMID: 29037735. [cited by applicant]
Shinomiya et al., “Effects of chlorogenic acid and its metabolites on the sleep-wakefulness cycle in rats,” Eur J Pharmacol, 2004; 504: pp. 185-189. [cited by applicant]
Wiedmann et al., “Pharmaceutical salts: Theory, use in solid dosage forms and in situ preparation in an aerosol,” Asian J Pharm. Sci., 2016; 11: pp. 722-734. [cited by applicant]
Xiong et al., “Erythrocyte intracellular Mg(2+) concentration as an index of recognition and memory,” Sci Rep., 2016; 6: pp. 1-12. doi: 10.1038/srep26975. [cited by applicant]