US 4278676A
· Krogsgaard-Larsenpovl
· 1981
[cited by applicant]
US 4353910A
· Perregaard
· 1982
[cited by applicant]
US 4362731A
· Hill
· 1982
[cited by applicant]
US 5929065A
· Lancel
· 1999
[cited by applicant]
US 8236958B2
· Cooper
· 2012
[cited by applicant]
US 9339495B2
· During
· 2016
[cited by examiner]
US 9351968B1
· During
· 2016
[cited by applicant]
US 9399034B1
· During et al.
· 2016
[cited by applicant]
US 9446028B2
· During
· 2016
[cited by examiner]
US 9682069B2
· During
· 2017
[cited by applicant]
US 9717716B2
· During et al.
· 2017
[cited by applicant]
US 9744159B2
· During
· 2017
[cited by examiner]
US 9801864B2
· During
· 2017
[cited by examiner]
US 9913833B2
· During
· 2018
[cited by applicant]
US 20020165217A1
· Howard
· 2002
[cited by applicant]
US 20040024038A1
· Ebert et al.
· 2004
[cited by applicant]
US 20040157876A1
· Elema et al.
· 2004
[cited by applicant]
US 20050137222A1
· Ebert et al.
· 2005
[cited by applicant]
US 20050215521A1
· Lalji et al.
· 2005
[cited by applicant]
US 20050234093A1
· Sanchez
· 2005
[cited by examiner]
US 20070032553A1
· McKernan et al.
· 2007
[cited by applicant]
US 20070112017A1
· Barlow et al.
· 2007
[cited by applicant]
US 20080269278A1
· Lundahl et al.
· 2008
[cited by applicant]
US 20090048288A1
· Ebert et al.
· 2009
[cited by applicant]
US 20090143335A1
· Larsen
· 2009
[cited by examiner]
US 20090203731A1
· Sanchez et al.
· 2009
[cited by applicant]
US 20090269795A1
· Smith
· 2009
[cited by applicant]
US 20100093787A1
· Lundahl et al.
· 2010
[cited by applicant]
US 20100286762A1
· Gourdie et al.
· 2010
[cited by applicant]
US 20110046090A1
· Barlow et al.
· 2011
[cited by applicant]
US 20120035207A1
· McKernan et al.
· 2012
[cited by applicant]
US 20150313913A1
· Catterall et al.
· 2015
[cited by applicant]
US 20150352085A1
· During
· 2015
[cited by applicant]
US 20170014393A1
· During
· 2017
[cited by applicant]
US 20170065572A1
· During
· 2017
[cited by applicant]
US 20170340619A1
· During
· 2017
[cited by applicant]
US 20170348232A1
· During
· 2017
[cited by applicant]
US 20180042903A1
· During
· 2018
[cited by applicant]
US 20180098974A1
· During
· 2018
[cited by applicant]
US 20180140586A1
· During
· 2018
[cited by applicant]
US 20180235942A1
· During et al.
· 2018
[cited by applicant]
US 20180338960A1
· During
· 2018
[cited by applicant]
US 20180344708A1
· During
· 2018
[cited by applicant]
CN 102137667A
· 2011
[cited by applicant]
DE 102005020882A1
· 2006
[cited by applicant]
EP 0000338A2
· 1979
[cited by examiner]
EP 0000338A3
· 1979
[cited by applicant]
EP 0840601B1
· 2001
[cited by applicant]
EP 1337247B1
· 2006
[cited by applicant]
EP 1641456B1
· 2010
[cited by applicant]
GB 2410434A
· 2005
[cited by applicant]
JP 2012501301A
· 2012
[cited by applicant]
WO 9702813A1
· 1997
[cited by applicant]
WO 2005023256A1
· 2005
[cited by applicant]
WO 2005058313A1
· 2005
[cited by applicant]
WO 2005094820A1
· 2005
[cited by applicant]
WO 2006013397A1
· 2006
[cited by applicant]
WO 2009021521A2
· 2009
[cited by applicant]
WO 2009056146A1
· 2009
[cited by applicant]
WO 2014085668A1
· 2014
[cited by applicant]
WO 2014123909A1
· 2014
[cited by applicant]
WO 2015189744A1
· 2015
[cited by applicant]
WO 2017015049A1
· 2017
[cited by applicant]
WO 2017070680A1
· 2017
[cited by applicant]
Olmos-Serrano (Developmental Neuroscience vol. 33 pp. 395-403. Published 2011) (Year: 2011).
[cited by examiner]
Reagan-Shaw (FASEBJ vol. 22 pp. 659-661 published 2007 (Year: 2007).
[cited by examiner]
Lancel, Marike, et al., “g-Aminobutyric acidA (GABAA) agonist 4, 5, 6, 7-tetrahydroisoxazolo [4, 5-c] pyridin-3-ol persistently increases sleep maintenance and intensity during chronic administration to rats,” Journal o…
[cited by applicant]
Shin, Jang-Woo, et al., “Interpretation of animal dose and human equivalent dose for drug development,” The Journal of Korean Medicine, May 2010, pp. 1-7, 31.3.
[cited by applicant]
English translation of Japanese Office Action issued Oct. 4, 2022, corresponding to counterpart Japanese Application No. 2018-502084; 9 pages.
[cited by applicant]
Brazilian Office Action (with cited references in English) dated Jun. 28, 2022, corresponding to counterpart Brazilian Application No. BR1120180009334; 5 total pages.
[cited by applicant]
English Translation of Taiwanese Office Action dated Oct. 28, 2021, corresponding to Taiwanese Application No. 105122538; 5 pages.
[cited by applicant]
Banerjee, Anwesha, et al., “Impairment of cortical GABAergic synaptic transmission in an environmental rat model of autism,” International Journal of Neuropsychopharmacology, Jul. 2013, pp. 1309-1318, 16.6.
[cited by applicant]
Machine Translation of Mexican Office Action for related application No. MX/a/2022/004734, May 12, 2023, 9 pages.
[cited by applicant]
International Search Report and Written Opinion of the International Searching Authority, dated Jul. 18, 2017, corresponding to International Application No. PCT/US17/34443; 5 total pages.
[cited by applicant]
International Search Report and Written Opinion of the International Searching Authority, dated Sep. 27, 2016, corresponding to International Application No. PCT/US16/42238; 8 total pages.
[cited by applicant]
International Search Report and Written Opinion, dated Jan. 26, 2018, corresponding to International Application No. PCT/US17/62685; 17 total pages.
[cited by applicant]
International Search Report and Written Opinion, dated Oct. 31, 2017, corresponding to International Applicaiton No. PCT/US17/46256; 10 total pages.
[cited by applicant]
International Search Report and Written Opinion, dated Oct. 4, 2016, corresponding to International Application No. PCT/US16/50702; 9 total pages.
[cited by applicant]
Jacquemont et al., “Fragile-X syndrome and fragile X-associated tremor/ataxia syndrome: two faces of FMR1,” Neurology, The Lancet, vol. 6, Jan. 2007, pp. 45-55.
[cited by applicant]
James K. Walsh, Ph.D., “Enhancement of Slow Wave Sleep: Implications for Insomnia,” Journal of Clinical Sleep Medicine, Supplement to vol. 5, No. 2, (2009); pp. 827-832.
[cited by applicant]
Japanese Office Action (with English Summary) dated May 12, 2020, corresponding to counterpart Japanese Application No. 2018-502084; 4 total pages.
[cited by applicant]
Journal of Labelled Compounds and Radiopharmaceuticals, 1982, vol. 19, No. 5; pp. 689-702.
[cited by applicant]
Kazdoba et al., “Modeling fragile X syndrome in the Fmr1 knockout mouse,” Intractable & Rare Diseases Research (2014), vol. 3, No. 4; pp. 118-133.
[cited by applicant]
Kesisoglou et al., “Utility of PBPK Absorption Modeling to Guide Modified Release Formulation Development of Gaboxadol, a Highly Soluble Compound with Region-Dependent Absorption,” Research Article—Pharmaceutics, Drug D…
[cited by applicant]
Lancel et al., “Effect of the GABAA Agonist Gaboxadol on Nocturnal Sleep and Hormone Secretion in Healthy Elderly Subjects,” Am J. Physiol Endoctrinol Metab, vol. 281; (2001), pp. E130-E137.
[cited by applicant]
Lancel et al., “The GABAA Agonist THIP (Gaboxadol) Increases Non-REM Sleep and Enhances Delta Activity in the Rat,” Sleep and Rhythms, NeuroReport, Rapid Science Publishers, vol. 7, No. 13; Sep. 1996; pp. 2241-2245.
[cited by applicant]
Larsen et al.,—Research Paper—“Intestinal Gaboxadol Absorption via PAT1 (SLC36A1): Modified Absorption in vivo Following Co-administration of L-tryptophan,” British Journal of Pharmacology (BJP), vol. 157, (2009); pp. 1…
[cited by applicant]
Loescher, W., “Development of Tolerance to the Anticonvulsant Effect of GABA-mimetic Drugs in Animal Models of Seizure States in Tolerance to Beneficial and Adverse Effects of Antiepileptic Drugs,” Koella et al. (eds.),…
[cited by applicant]
Lozano et al., “Modulation of the GABAergic pathway for the treatment of fragile X syndrome”, Neuropsychiatric Disease and Treatment (2014), vol. 10 (Dovepress); pp. 1769-1779.
[cited by applicant]
Lundahl et al., “Short-term Treatment with Gaboxadol Improves Sleep Maintenance and Enhances Slow Wave Sleep in Adult Patients with Primary Insomnia,” Psychopharmacology, vol. 195, (2007); pp. 139-146.
[cited by applicant]
Marike Lancel, “Role of GABAA Receptors in the Regulation of Sleep: Initial Sleep Responses to Peripherally Administered Modulators and Agonists,” Sleep, vol. 22, No. 1, (1999); pp. 33-42.
[cited by applicant]
Marike Lancel, “The GABAA Agonist THIP Increases Non-REM Sleep and Enhances Non-REM Sleep-Specific Delta Activity in the Rat During the Dark Period,” Sleep, vol. 20, No. 12, American Sleep Disorders Association and Slee…
[cited by applicant]
Martin et al., “Deficient Tonic GABAergic conductance and synaptic balance in the fragile X syndrome amygdala,”, J. Neurophysiol (May 21, 2014), vol. 112, pp. 890-902.
[cited by applicant]
Mathias et al., “Effect of Repeated Gaboxadol Administration on Night Sleep and Next-Day Performance in Healthy Elderly Subjects,” Neuropsychopharmacology, vol. 30, (2005) pp. 833-841.
[cited by applicant]
Mathias et al., “The GABAA Agonist Gaboxadol Improves the Quality of Post-Nap Sleep,” Psychopharmacology, vol. 157 (2001); pp. 299-304.
[cited by applicant]
Miyashiro et al., “RNA Cargoes Associating with FMRP Reveal Deficits in Cellular Functioning in Fmr1 Null Mice” Neuron, Feb. 6, 2003, vol. 37; pp. 417-431.
[cited by applicant]
Nagar et al., “Orally disintegrating tablest: formulation, preparation techniques and evaluation”, Journal of Applied Phramaceutical Science, vol. 01, No. 04, 2011; pp. 35-45.
[cited by applicant]
Natural Patterns of Sleep-Healthy Sleep—http://healthysleep.med.harvard.edu/healthy/science/what/sleep-pat-terns-rem-nrem (2007); 3 pages.
[cited by applicant]
Notification Concerning Transmittal of International Preliminary Report on Patentability, dated Jun. 6, 2019, International Preliminary Report on Patentability dated May 28, 2019, corresponding to counterpart Internatio…
[cited by applicant]
Oakley et al., “Synergistic GABA-Enhancing Therapy against Seizures in a Mouse Model of Dravet Syndrome,” The Journal of Pharmacology and Experimental Therapeutics, vol. 345, May 2013; pp. 215-224.
[cited by applicant]
Olmos-Serrano et al., “Defective GABAergic Neurotransmission and Pharmacological Rescue of Neuronal Hyperexcitability in the Amygdala in a Mouse Model of Fragile X Syndrome,” The Journal of Neuroscience, Jul. 21, 2010, …
[cited by applicant]
Olmos-Serrano et al., “The Gabaa Receptor Agonist THIP Ameliorates Specific Behavioral Deficits in the Mouse Model of Fragile X Syndorme,” Developmental Neuroscience, vol. 33, Fragile X Syndrome/Review, (2011), pp. 395-…
[cited by applicant]
Paluszkiewicz et al., “Fragile X Syndrome: The GABAergic System and Circuit Dysfunction,” Developmental Neuroscience (2011); vol. 33; pp. 349-364.
[cited by applicant]
PCT Notice concerning Transmittal of International Preliminary Report on Patentability (Chapter I of the Patent Cooperation Treaty), International Preliminary Report on Patentability and Written Opinion of the Internati…
[cited by applicant]
Peixoto et al., “Effects of gabaergic drugs on reserpine-induced oral dyskinesia,” Behavioural Brain Research, vol. 160, (2005); pp. 51-59.
[cited by applicant]
Petersen et al., “THIP: A Single Blind Controlled Trial in Patients with Epilepsy,” Acta Neurol. Scand. 67; pp. 114-117 (1983).
[cited by applicant]
Ransdell Pierson, Update 2-Merck, Lundbeck scrap insomnia drug after trials, Rueters, (Dow Jones); Mar. 26, 2007; 2 pages.
[cited by applicant]
Reagan-Shaw et al., “Dose translation from animal to human studies revisited”, FASEB J, vol. 22, No. 3, Oct. 17, 2007; pp. 659-661.
[cited by applicant]
Reddy et al., “Review on: Pulsatile Drug Delivery Systems”, Journal of Pharmacetucial Sciences and Research, (ISSN: 0975-1459), vol. 1, No. 4, 2009; pp. 109-115.
[cited by applicant]
Rio et al., The contribution of inhibitory interneurons to cirecuit dysfunction in Fragile X Syndrome, Froneiers in Cellular Neuroscience (Aug. 25, 2014), vol. 8, Article 245; pp. 1-7.
[cited by applicant]
Sarah DeWeerdt, “Fragile X Mice Show Brain-Wave Abnormalities During Sleep,” SFARI, Simons Foundation, Autism Research Initiative, Jan. 25, 2013; 2 pages.
[cited by applicant]
Stephanie Saul, “Merck Cancels Work on a New Insomnia Medication,” The New York Times, Mar. 29, 2007; 2 pages.
[cited by applicant]
Tassone et al., “Elevated Levels of FMR1 mRNA in Carrier Males: A New Mechanism of Involvement in the Fragile X Syndrome,” Am. J. Hum. Genet., 2000, vol. 66; pp. 6-15.
[cited by applicant]
Thaker et al., “Brain γ-Aminobutyric Acid Abnormality in Tardive Dyskinesia,” Archives of General Psychiatry, (1987), vol. 44, No. 6; pp. 522-529.
[cited by applicant]
The United States Pharmacopeia (USP) disintegration test method set forth at section 701 Disintegration, Revision Bulletin Official Aug. 1, 2008; pp. 1-3.
[cited by applicant]
Tropea et al., “Partial Reversal of Rett Syndrome-like Symptoms in MeCP2 Mutant Mice,” PNAS, vol. 106, No. 6, Feb. 10, 2009; pp. 2029-2034.
[cited by applicant]
Turner et al., “Prevalence of fragile X syndrome,” Am. J. Med. Genet. (1996), vol. 64; pp. 196-197.
[cited by applicant]
Turner et al., “Preventive Screening for the Fragile X Syndrome,” The New England Journal of Medicine (1986), vol. 315, No. 10; pp. 607-609.
[cited by applicant]
Vardya et al., “Positive Modulation of delta.-Subunit Containing GABAA Receptors in Mouse neurons,” Neuropharmacology, (2012), vol. 63; pp. 469-479.
[cited by applicant]
Walsh et al.,, “The Selective Extrasynaptic GABAA Agonist, Gaboxadol, Improves Traditional Hypnotic Efficacy Measures and Enhances Slow Wave Activity in a Model of Transient Insomnia,” Sleep, vol. 30, No. 5, 2007; pp. 5…
[cited by applicant]
Walter Alexander, “Sleep: Gaboxadol Enhances Slow Wave Sleep,” Perelman, School of Medicine, Jun. 22, 2006; 3 pages.
[cited by applicant]
Webb, et al., “The frequency of the fragile X chromosome among schoolchildren in Coventry”, Journal of Medical Genetics, 1986, vol. 23; pp. 396-399.
[cited by applicant]
Williams et al., “Conference Report—Angelman Syndrome 2005: Updated Consensus for Diagnostic Criteria,” American Journal of Medical Genetics, vol. 140A,, 2006; pp. 413-418.
[cited by applicant]
Yang et al., “Memantine Effects on Verbal Memory in Fragile X-associated Tremor/Ataxia Syndrome (FXTAS): A Double-Blind Brain Potential Study,” Neuropsychopharmacology, 2014, vol. 39; pp. 2760-2768.
[cited by applicant]
Yang et al., “Memantine improves Attentional Processes in Fragile X-Associated Tremor/Ataxia Syndrome: Electrophysiological Evidence from a Randomized Controlled Trial,”, Scientific Reports, Sep. 25. 2015, www. nature.c…
[cited by applicant]
Yapar et al., “Orally Disintegrating Tablets: An Overview,” Journal of Applied Pharmaceutical Science, Feb. 2014, vol. 4, No. 02, pp. 118-125.
[cited by applicant]
Youings, et al., FRAXA and FRAXE: the results of a five year survey. J. Med. Genet. 2000, vol. 37: pp. 415-421.
[cited by applicant]
European Search Report dated Feb. 13, 2019, corresponding to European Application No. 16828266.3; 103 pages.
[cited by applicant]
Peters, S. U., et al., “Autism in Angelman syndrome: implications for autism research,” Clinical genetics, Dec. 2004, pp. 530-536, 66.6.
[cited by applicant]
Yang, Jin-Chen, et al., “Neural substrates of executive dysfunction in fragile X-associated tremor/ataxia syndrome (FXTAS): a brain potential study,” Cerebral Cortex, Nov. 2013, pp. 2657-2666, 23.11.
[cited by applicant]
Yang, Jin-Chen, et al., “Phenotypes of hypofrontality in older female fragile X premutation carriers,” Annals of heurology, Aug. 2013, pp. 273-283, 74.2.
[cited by applicant]
“Fragile X-Associated Tremor/Ataxia Syndrome,” Genetics Home Reference, Oct. 30, 2018; 6 pages.
[cited by applicant]
“Lennox-Gastaut Syndrome”, Wikipedia articile, dated Jul. 10, 2016.
[cited by applicant]
Bacalman et al., “Psychiatric Phenotype of the Fragile X-Associated Tremor/Ataxia Syndrome (FXTAS) in Males: Newly Described Fronto-Subcortical Dementia,” J. Clinicial Psychiatry, 2006, vol. 67; pp. 87-94.
[cited by applicant]
Berman et al., “Mouse Models of Fragile X-Associated Tremor Ataxia,” J. Investig Med., Dec. 2009, vol. 57, No. 3, pp. 837-841.(10 pages).
[cited by applicant]
Bharawaj et al., “Orally Disintegrating Tablets: A Review”, Drug Invention Today, vol. 2, No. 1, (ISSN: 0975-7619), 2010; pp. 81-88.
[cited by applicant]
Boateng et al., “Characterisation of freeze-dried wafers and solvent evaporated films as potential drug delivery systems to mucosal surfaces,” International Journal of Pharmaceutics, vol. 389, Issues 1-2, Apr. 15, 2010,…
[cited by applicant]
Boyle et al., “Next-day residual effects of gaboxadol and flurazepam administered at bedtime: a randomized double-blind study in healthy elderly subjects,” Human Psychopharmacology, 2009, vol. 24, pp. 61-71.
[cited by applicant]
Boyle et al., “Tolerability, pharmacokinetics and night-time effects on postural sway and critical flicker fusion of gaboxadol and zolpidem in elderly subjects,” British Journal of Clinical Pharmacology, 2008, vol. 67, …
[cited by applicant]
Braat et al., “Fragile X Syndrome Neurobiology Translates Into Rational Therapy,” Drug Discovery Today, vol. 00, No. 00, Feb. 2014; pp. 1-10.
[cited by applicant]
Braat et al., “Insights into GABAAergic system deficits in fragile X syndrome lead to clinical trials,” Neuropharmacology (Jan. 2015), vol. 88; pp. 48-54.
[cited by applicant]
Braat et al., “The GABAA receptor is an FMRP target with therapeutic potential in fragile X syndrome,” Cell Cycle (Sep. 15, 2015) vol. 14, No. 18; pp. 2985-2995.
[cited by applicant]
Bradford et al., “Incidence of Fragile X Syndrome by Newborn Screening for Methylated FMR1 DNA,” The American Journal of Human Genetics (Oct. 9, 2009), vol. 85; pp. 503-514.
[cited by applicant]
Brown et al., “Microarray Identification of FMRP-Associated Brain mRNAs and Altered mRNA Translational Profiles in Fragile X Syndrome,” Cell, vol. 107, Nov. 16, 2001; pp. 477-487.
[cited by applicant]
Brown et al., “Pharmacological Characterization of a Novel Cell Line Expressing Human.alpha.4.beta.3.delta. GABAA Receptors,” British Journal of Pharmacology, vol. 136, No. 7, 2002; pp. 965-974.
[cited by applicant]
Chaturvedi et al., “Fast Dissolving Films: A Review,” Current Drug Delivery, 2011, vol. 8; pp. 373-380.
[cited by applicant]
Cheng et al., “Inducing Anesthesia with a GABA Analog, THIP,”, Anesthesiology, vol. 63, No. 2, Aug. 1985; pp. 147-151.
[cited by applicant]
Chilean Office Action dated Feb. 13, 2019, corresponding to Chilean Application No. 201800142; 7 pages.
[cited by applicant]
Chinese Office Action (with cited references in English) dated Mar. 20, 2020, corresponding to counterpart Chinese Application No. 201680054308.1; 11 total pages.
[cited by applicant]
Ciper and Bodmeier, “Preparation and characterization of novel fast disintegrating capsules (Fastcaps) for administration in the oral cavity,” Science Direct, International Journal of Pharmaceutics, 2005, vol. 303; pp. …
[cited by applicant]
Crawford, et al., “FMR1 and the Fragile X Syndrome: Human Genome Epidemiology Review,” Genet. Med. 2001, vol. 3, No. 5 (Author Manuscript); pp. 359-371.
[cited by applicant]
Crawford, et al., “Prevalence of the Fragile X Syndrome in African-Americans,” American Journal of Medical Genetic (Jul. 1, 2002), vol. 110, Issue 3: pp. 226-233.
[cited by applicant]
Curia et al., “Downregulation of Tonic GABAergic Inhibition in a Mouse Model of Fragile X Syndrome,” Cerebral Cortex (Jul. 2009), vol. 19; pp. 1515-1520.
[cited by applicant]
Deacon et al., “Effect of Short-Term Treatment with Gaboxadol on Sleep Maintenance and Initiation in Patients with Primary Insomnia,” Sleep, vol. 30, No. 3, 2007; pp. 281-287.
[cited by applicant]
Dictenberg et al., “A Direct Role for FMRP in Activity-Dependent Dendritic mRNA Transport Links Filopodial-Spine Morphogenesis to Fragile X Syndrome,” Dev Cell (Jun. 2008), vol. 14, No. 6 (Author Manuscript); pp. 926-93…
[cited by applicant]
Ebert et al., “Treating Insomnia: Current and Investigational Pharmacological Approaches,” Pharmacology & Therapeutics, (2006), vol. 112; pp. 612-629.
[cited by applicant]
Egawa et al., “Decreased Tonic Inhibition in Cerebellar Granule Cells Causes Motor Dysfunction in a Mouse Model of Angelman Syndrome,” Neurodegenerative Disease, Science Translational Medicine, vol. 4, Issue 165 (163ra1…
[cited by applicant]
Egawa et al., “Pathophysiological power of improper tonic GABA(A) conductances in mature and immature models.” Frontiers in Neural Circuits, Oct. 24, 2013, vol. 7, Article 170; pp. 1-15.
[cited by applicant]
El Idrissi et al., “Decreased GABA(A) receptor expression in the seizure-prone fragile X mouse,” Neurosci Lett (2005) vol. 377, No. 3; pp. 141-146.
[cited by applicant]
English translation of Israeli Office Action issued May 14, 2020, corresponding to counterpart Israeli Application No. 256912; 5 pages.
[cited by applicant]
English translation of Taiwanese Search Report dated Mar. 30, 2020, corresponding to counterpart Taiwanese Application No. 105122538; 1 pages.
[cited by applicant]
Entezam et al.. , “Regional FMRP deficits and large repeat expansions into the full mutation range in a new Fragile X premutation mouse model,” Gene, 2007, vol. 395, No. 1-2, pp. 125-134 (18 pages).
[cited by applicant]
European Communication dated May 7, 2020, corresponding to counterpart European Application No. 16 828 266.3; 6 pages.
[cited by applicant]
European Search Report dated Nov. 18, 2019, corresponding to European Application No. 19190461.4; 11 pages.
[cited by applicant]
Faulhaber et al., “The GABAA Agonist THIP Produces Slow Wave Sleep and Reduces Spindling Activity in NREM Sleep in Humans,” Psychopharmacology, vol. 130, 1997; pp. 285-291.
[cited by applicant]
Fu et al., “Drug Release Kinetics and Transport Mechanisms of Non-degradable and Degradable Polymeric Delivery Systems,” NIH Public Access, Author Manuscript, National Institute of Health, Expert Opin Drug Deliv., Apr. …
[cited by applicant]
Gaboxadol, Bluelight, http://www.bluelight.org/vb/threads/370965-Gaboxadol-(2014); 1 page.
[cited by applicant]
Gaboxadol, from Wikipedia, the free encylopedia,http://en.wikipedia.org/wiki/Gaboxadol, 2014; 2 pages.
[cited by applicant]
Gaboxadol, Investigational Agent—Drug Development Technology, http//www.drugdevelopment-technology.com/projects/gaboxadol—2014; 3 pages.
[cited by applicant]
Gantois et al., “Expression profiling suggests underexpression of the GABA(A) receptor subunit delta in the fragile X knockout mouse model,” Neurobiol Dis (2006), vol. 21, No. 2; pp. 346-357.
[cited by applicant]
Glykys et al., “The Main Source of Ambient GABA Responsible for Tonic Inhibition in the Mouse Hippocampus,” J Physiol, (2007), vol. 582, No. 3; pp. 1163-1178.
[cited by applicant]
Guidance for Industry, Orally Disintegrating Tablets, United States Department of Health and Human Services, Food and Drug Administraction, Center for Drug Evaluation and Research (CDER), Dec. 2008, Chemistry, pp. 1-8.
[cited by applicant]
Gupta Nitan Bharti et al., “Pulsatile Drug Delivery as Modified Release Dosage Form: A Review”, Journal of Drug Delivery & Therapeutics, vol. 2, No. 6, 2012; pp. 102-110.
[cited by applicant]
Hagerman et al., “Fragile X-associated tremor/ataxia syndrome”, Annals of the New York Academy of Sciences, Issue: The Year in Nurology and Psychiatry, (ISSN 0077-8923), 2015; pp. 1-13.
[cited by applicant]
Hagerman et al., “Treatment of fragile X-associated tremor ataxia syndrome (FXTAS) and related neurological problems”, Clinical Intervention in Aging, 2008, vol. 3, No. 2; pp. 251-262.
[cited by applicant]
Hajak et al., “A 2-week Efficacy and Safety Study of Gaboxadol and Zolpidem Using Electronic Diaries in Primary Insomnia Outpatients,” Sleep Medicine, vol. 10, 2009; pp. 705-712.
[cited by applicant]
Iber et al., “The AASM Manual for the Scoring of Sleep and Associated Events,” American Academy of Sleep Medicine (2007); pp. 3-59 (57 pages).
[cited by applicant]
International Search Report and Written Opinion of the International Searching Authority, dated Apr. 24, 2018, corresponding to International Application No. PCT/US18/16602; 15 total pages.
[cited by applicant]
International Search Report and Written Opinion of the International Searching Authority, dated Aug. 26, 2015, corresponding to International Application No. PCT/US15/34018; 12 total pages.
[cited by applicant]
International Search Report and Written Opinion of the International Searching Authority, dated Aug. 14, 2015, corresponding to International Application No. PCT/US2015/029155; 19 total pages.
[cited by applicant]
Nanba, Eiji, Diagnosis and Treatment of Fragile X Syndrome—update and review, Brain and Development, Mar. 2015, pp. 112-116, 47,2. Machine Translation submitted.
[cited by applicant]
Anonymous, “General Guidelines for Clinical Evaluation of New Drugs,” Jun. 29, 1992, Yakushinyaku No. 43, Notification of the Director of the New Drugs Division, Pharmaceutical Affairs Bureau, Ministry of Health and Wel…
[cited by applicant]
Terao et al., “Frontiers in the Development of Drugs for Insomnia,” Folia Pharmacol. Jpn., 2007, pp. 35-41, 129. Machine Translation submitted.
[cited by applicant]
Japanese Office Action for application No. 2021-87584, Oct. 22, 2024, 30 pages. Machine Translation submitted.
[cited by applicant]