Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Reexamination Certificate
1997-04-29
2003-10-28
O'Sullivan, Peter (Department: 1621)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
C514S416000, C514S418000, C514S419000, C548S491000, C548S494000, C548S495000, C548S496000
Reexamination Certificate
active
06638963
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This application relates to circadian rhythms in humans, and particularly to the synchronization of such human circadian rhythms with the external environment. Specifically, this invention describes methods for achieving a chronobiologic (circadian phase-shifting) effect in humans. The invention provides methods to specifically advance or delay the phase of certain circadian rhythms in humans. Specific embodiments of the invention comprise methods for alleviating the effects of transmeridional travel (i.e., jet lag); methods for alleviating certain circadian phase disturbance-based psychopathological disorders such as winter depression (or seasonal affective disorder); methods for achieving synchrony between a human's wake/sleep cycle or other circadian rhythms and the human's occupational and other human activity schedules; and methods for achieving synchrony between a human's wake/sleep cycle and other circadian rhythms.
2. Background of the Related Art
The phenomenon of circadian rhythms in biology is well known, and circadian rhythms are exhibited by all eukaryotic plants and animals, including man. Biological rhythms are periodic fluctuations in biological properties over time; these include circadian as well as seasonal variations. Circadian, or approximately 24-hour, rhythms include the production of biological molecules such as hormones, the regulation of body temperature, and behaviors such as wakefulness, sleep and periods of activity.
In nature, circadian rhythms are closely tied to environmental cues that impose a 24-hour pattern on many of these fluctuations. When these cues are absent, most circadian rhythms have a periodicity different (in humans, usually slightly greater) than 24 hours. Circadian rhythms that are no longer regulated by environmental cues are said to be free running. The regulation of circadian rhythms by signals from the environment is said to involve entrainment of circadian rhythms. The environmental signals that affect entrainment have been termed zeitgebers, an example of which is the light/dark cycle.
It is thought in this art that the control of circadian rhythms in mammals is mediated by a portion of the brain called the superchiasmatic nuclei (SCN). Circadian rhythms are primarily entrained by the light and dark cycle; light signals are conveyed by the retina to the SCN, and the pineal gland, which is regulated by the SCN, produces melatonin (N-acetyl-5-methoxytryptamine).
Disruption of circadian rhythms can result in a number of pathophysiological states in humans; one of the most common of these is jet lag. The use of melatonin to ameliorate the effects of jet lag has been described in the prior art.
U.S. Pat. Nos. 4,665,086 and 4,600,723 teach the use of melatonin to alleviate the symptoms of jet lag. These patents teach the use of >1 to 10 mg of melatonin, taken at destination bedtime, and again upon premature awakening in the middle of the night.
Gwinner and Benzinger, 1978
, J. Comp. Physiol.
126: 123-129 teach that daily injections of melatonin can entrain the activity/rest cycle in birds.
Arendt et al., 1984
, Neurosci. Lett.
45: 317-325 and Arendt et al., 1985
, CIBA Found. Symp.
117: 266-283 disclose that melatoriin in high doses increases tiredness and the tendency to sleep in humans.
Underwood, 1986
, J. Pineal Res.
3: 187-196 discloses a phase response curve for melatonin in the lizard
Sceloporus occidentalis.
Arendt et al., 1987
, Ergonomics
30: 1379-1393 disclose the administration of melatonin to alleviate jet lag by oral administration of exogenous melatonin 4 to 6 hours prior to the human's normal bedtime.
Mallo et al. 1988
, Acta Endocrinol.
119: 474-480 teach that the administration of 8 mg of melatonin to humans, one hour before bedtime over a course of four days, results in a slight phase advance in the melatonin rhythm three days after cessation of the melatonin treatment but not in other circadian rhythms.
Armstrong et al., 1989
, Experientia
45: 932-938 disclose the effects of exogenous melatonin administration on the circadian rhythm of the sleep/wake cycle in rats, and that the effect was greatest when exogenous melatonin was administered a few hours before the effective start of the nocturnal activity cycle.
Petrie et al., 1989
, Brit. Med. J.
298: 705-707 teach the administration of 5 mg of melatonin to humans on a schedule of three days before flight, during flight, and once a day for three days after arrival to alleviate jet lag caused by flights from Auckland, New Zealand to London and back.
Skene et al., 1989
, Sleep '
88 (J. Horne, ed.), pp. 39-41 teach the use of melatonin to treat jet lag.
Sack & Lewy, 1989
, Amer. Coll. Neuropsychopharm
. Abstract suggest the possibility of achieving a phase advance in a human using melatonin administered in the evening.
Samel et al., 1991
, J. Biol. Rhythms
6: 235-248 teach the use of melatonin for the treatment of jet lag using an administration schedule of melatonin administration at 1800 local time for 3 days before the time shift, and at 1400 local time for 4 days afterwards.
Nichelsen et al., 1991
, Adv. Pineal Res.
5: 303-306 teach the administration of 5 mg melatonin at destination bedtime for the treatment of jet lag resulting from 6, 9 and 11 hour time-shifts.
Dahlitz et al., 1991
, The Lancet
337: 1121-1124 disclosethe use of melatonin to treat delayed sleep phase disorder.
Claustrat et al., 1992
, Biol. Psychiatry
32: 705-711 teach the use of melatonin to affect circadian rhythms.
Sack et al., 1994
, Sleep Research
23: 509 disclose melatonin administration to promote adaptation to shift work.
Zaidan et al., 1994
, Neuroendocrinol.
60: 105-112 describe a melatonin phase response curve.
Deacon & Arendt, 1995
, Brain Res.
688: 77-85 disclose dose-dependent phase-shifting effects with melatonin administration.
U.S. Pat. No. 5,449,683 issued Sep. 12, 1995 to Wurtman teaches the use of low dose melatonin formulations to induce sleep.
U.S. Pat. No. 5,498,423, issued Mar. 12, 1996 to Zisapel, teaches melatonin administration in formulations provided to mimic a human's endogenous nighttime melatonin profile.
Similarly, inhibition of endogenous melatonin production (using, for example, beta-blockers) for affecting human circadian rhythms have been reported in the prior art.
Schlager et al., 1993
, Soc. Light Treat. Biol. Rhythms
Abstracts 5: 23 teach early morning administration of short-acting beta-blockers for treatment of winter depression.
Schlager, 1994
, Amer. J. Psych.
151: 1383-1385 teach early morning administration of short-acting beta-blockers for treatment of winter depression.
Schlager et al., 1996
, Soc. Light Treat. Biol. Rhythms
Abstracts #15 teach early morning administration of short-acting beta-blockers for treatment of winter depression.
The use of light to entrain circadian rhythms is known in the prior art.
Lewy et al, 1983
, Psychopharmacol. Bull.
19: 523-525 disclose a phase response curve to light in humans and bright light treatment of delayed sleep phase syndrome.
Waver et al., 1983
, Eur. J. Physiol.
396: 85-87 disclose light for resetting human temperature and activity rhythms.
Daan & Lewy, 1984
, Psychopharmacol. Bull.
20: 566-568 disclose a phase response curve to light in humans and treatment of jet lag by scheduled exposure to light.
Lewy et al, 1985, in
Photoperiodism, Melatonin and the Pineal Gland
(Evered et al., eds.), pp. 231-252 disclose bright light treatment of advanced sleep phase syndrome.
Czeisler et al., 1986
, Science
233: 667-671 disclose light for resetting the circadian rhythm pacemaker.
Lewy et al, 1987
, Science
235:352-354 disclose circadian phase-shifting and antidepressant effects of light treatment
Eastman, 1987
, Temporal Disorder in Human Oscillatory Systems
, (Rensing et al., eds.) discloses light to promote adaptation to shift work.
Honma & Honma, 1988
, Jap. J. Psychiatry Neurol.
42: 167-168 disclose a light phase response curve in humans.
Wever, 1989
, J. Biol. Rhythms
4: 161-186 disclo
Lewy Alfred J.
Sack Robert L.
McDonnell & Boehnen Hulbert & Berghoff
O'Sullivan Peter
Oregon Health and Science University
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