Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Cyclopentanohydrophenanthrene ring system doai
Reexamination Certificate
2000-02-04
2003-04-08
Jones, Dwayne C. (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Cyclopentanohydrophenanthrene ring system doai
C514S177000, C552S625000, C604S019000, C604S023000, C604S024000, 30
Reexamination Certificate
active
06544971
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to a method of increasing alertness in an individual by administering an effective amount of an alertness-increasing Vomeropherin to the individual; and to an alarm device that, when activated, emits an alertness-increasing vomeropherin. The method and device are especially useful in increasing alertness in individuals who are not readily responsive to external stimuli.
2. Background Information
Fire and smoke alarms are designed to alert the occupants of a building of the development of a fire. In recent years, they have been considered an essential life-saving device and have become a standard feature in most homes and commercial buildings. Most of the home fire alarms currently on the market produce an audible signal to warn and/or awaken individuals who are in the vicinity of a developing fire. Some fire alarms also produce visible signals such as flashing lights.
Carbon monoxide alarms are designed to alert the occupants of a building of carbon monoxide gas in the atmosphere of the building. They are becoming more popular for home use, since carbon monoxide cannot be detected by an unaided individual (the gas is colorless and odorless), and is the product of incomplete combustion and may be the product, for example, of either fire or, more commonly, a malfunctioning gas appliance such as a furnace. These alarms also typically produce an audible signal, and may also produce a visible signal.
Alarms may also be used to indicate the presence of other alarm conditions, which include but are not limited to, presence of radon (a tasteless, odorless, and invisible gas), propane gas, methane, apnea (suspension of respiration), or unauthorized entry (for burglar alarms).
Alarms may also be used to indicate the presence of an alarm condition (generally, in a non-hazardous situation) in which there is a request for an individual to respond, such as a ringing phone (request for the individual to answer the phone), a buzzing or ringing alarm clock (request for the individual to awaken), a ringing doorbell (request for the individual to answer the door), and the like.
However, for individuals who have a tendency to sleep deeply, whether normally, because of a sleeping disorder, because of drug- or alcohol-induced sleepiness, or because of conditions such as anosmia (lack of sense of smell), healing impairment, or blindness, the usual stimuli (either direct hazard-related stimuli such as the presence of smoke, or stimuli from alarm systems) may be ineffective in warning them of the alarm condition and enabling them to take appropriate action.
It is therefore desirable to develop a method of increasing the alertness of an individual. It is also desirable to develop an alarm device that would increase the alertness of an individual in the presence of an alarm condition, to enable the individual to respond more effectively to the alarm condition.
SUMMARY OF THE INVENTION
In a first aspect, this invention provides a method of increasing alertness in an individual, comprising administering to the vomeronasal organ (VNO) of that individual an alertness-increasing effective amount of a compound of the formula:
where:
R
1
is hydrogen, C
1-5
alkanoyl, or —SO
1
H or a salt thereof,
R
2
is hydrogen or methylene;
R
3
is hydrogen or C
1-4
alkyl;
one or two non-adjacent members of “a”, “b”, “c”, and “d” are optional double bonds; and
when R
2
is hydrogen, “e” is either a double bond or a 16&agr;, 17&agr;-epoxide, and
when R
2
is methylene “e” is absent and “f” is a double bond.
In a second aspect, this invention provides an alarm device for alerting an individual to the presence of an alarm condition, comprising:
(a) a detector for the presence of the alarm condition, and
(b) a dispenser for administering to the vomeronasal organ of the individual an alertness-increasing effective amount of a compound of the formula:
where:
R
1
is hydrogen, C
1-5
alkanoyl, or —SO
3
H or a salt thereof;
R
2
is hydrogen or methylene;
R
3
is hydrogen or C
1-4
alkyl;
one or two non-adjacent members of “a”, “b”, “c”, and “d” are optional double bonds; and
when R
2
is hydrogen “e” is either a double bond or a 16&agr;, 17&agr;-epoxide, and
when R
2
is methylene, “e” is absent and “f” is a double bond; and, optionally,
(c) a warning means.
DETAILED DESCRIPTION OF THE INVENTION
Definitions
Unless otherwise stated; the following terms used in the specification and claims have the meaning given below.
“Alertness” includes wakefulness and responsiveness to external stimuli. Thus, “increasing alertness in an individual” includes either or both of awakening that individual and increasing that individual's responsiveness to an external stimulus, an effect that may take place with lightening of a state of sleep but without full awakening. Thus, increasing alertness in an individual would mean increasing the responsiveness of that individual to external stimuli, such as a bell ringing, phone ringing, fire, smoke, and the like.
An “alarm condition” with respect to an individual is one in which the safety or health of that individual or others may be adversely affected by the lack of a response by that individual, or one in which there is a request for an individual to respond. Exemplary alarm conditions in which the safety or health of that individual or others may be adversely affected by the lack of a response by that individual include fire, smoke, toxic gas (such as carbon monoxide), unauthorized entry (e.g. into the individual's residence), and the like. Exemplary alarm conditions in which the safety or health of others may be adversely affected by the lack of response include the conditions listed above and others such as, for example, apnea (such as of a sleeping infant—baby monitors are commercially available to warn parents of such an occurrence). It also includes conditions in which an ailing person (such as a person with pulmonary or cardiovascular disease) may require immediate assistance and may summon assistance with a “call buzzer” or the like, particularly in a home health setting where the responding individual may not remain awake all night. Exemplary alarm conditions in which there is request for an individual to respond (generally, in non-hazardous situations) include, a buzzing alarm clock (request for an individual to awaken), a ringing phone (request to answer the phone), a ringing door bell (request to answer the door), and the like. An “alarm” or “alarm device” for such alarm conditions therefore includes not only an alarm in which the alarm condition is detected by detection of the presence of a condition in which the safety or health of that individual or others may be adversely affected by the lack of a response by that individual, but also by the detection of a condition in which there is a request for the individual to respond.
“C
1-4
Alkyl” refers to a cyclic, branched or straight chain monovalent hydrocarbon radical of 1 to 4 carbon atoms, such as methyl, ethyl, propyl, 2-propyl, cyclopropyl, butyl, 2-butyl, 2-methylpropyl, 1,1-dimethylethyl, and cyclopropylmethyl.
“C
1-5
Alkanoyl” refers to the group —C(O)—R where R is hydrogen or C
1-4
alkyl.
An “effective amount” refers to an amount sufficient to increase the alertness of an individual.
A “vomeropherin” is a compound that functions as a chemosensory messenger, binds to a specific vomeronasal neuroepithelial receptor, and induces a physiological or behavioral effect. The effect of a “vomeropherin” is mediated through its interaction with the vomeronasal organ (VNO).
The transitional term “comprising” is an open-ended term synonymous with “including” and does not exclude additional unrecited elements.
The Vomeropherins
The alertness-increasing vomeropherins usable in this invention are compounds of the formula:
where:
R
1
is hydrogen, C
1-5
alkanoyl, or —SO
3
H or a salt thereof;
R
2
is hydrogen or methylene;
R
3
is hydrogen or C
1-4
alkyl;
one or two non-adjacent members of “a”, “b”, “c”, and “d” are optional double bonds; and
when R
Berliner David L.
Jennings-White Clive L.
Monti Louis
Heller Ehrman White & McAuliffe LLP
Jones Dwayne C.
Pherin Pharmaceuticals, Inc.
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