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Us000008013127b220110906

(i2) United States Patent
(io) Patent No.:
US 8,977,517 B2
(45) Date of Patent:
Mar. 10, 2015
(54) SYSTEM AND METHODS FOR EVALUATING
EFFICACY OF APPETITE-AFFECTING
10/1998 Kissinger (75) Inventor: Roger D. Reidelberger, Omaha, NE
7/1999 Castel ano (73) Assignee: Creighton University, Omaha, NE (US)
( * ) Notice: Subject to any disclaimer, the term of this patent is extended or adjusted under 35 U.S.C. 154(b) by 1885 days.
(21) Appi. No.: 11/809,948 Jun. 4, 2007
6,542,850 B2 * 4/2003 Ulman et al. . . . 702/179 4/2003 Holschneider Prior Publication Data
US 2007/0280887 Al 5/2005 Deneintolis Related U.S. Application Data
7,459,432 B2 * 12/2008 Cowley et al. 514/1.1 (60) Provisional application No. 60/811,040, filed on Jun. 2005/0277912 A l* 12/2005 John . 604/890.1 (51) Int.Cl.
2007/0083090 A l* 4/2007 Sterling et al. . . 600/300 A0 IK 1/00 2009/0126640 A l* 5/2009 Ulman et al. . . . . . 119/54 A61K 49/00 GO IN 33/50 OTHER PUBLICATIONS (52) U.S. Cl.
Columbus Instruments; Feeding Computer: Feed Scale CPC . . A61K49/0008 (2013.01); G01N33/5088 Research Diets, Inc; BioDAQ Food Intake Monitor USPC . 702/179; 119/340; 119/417
(58) Field of Classification Search
* cited by examiner See application file for complete search history.
Primary Examiner — Anna Skibinsky (74) Attorney, Agent, or Firm — Advent, LLP
U.S. PATENT DOCUMENTS System and methods to evaluate and administer drugs. The present invention instantaneously identifies the effects that drugs, including appetite-affecting agents, have on animals. Data is collected automatically and analyzed and further organized to identify feeding patterns and the effect an appe­ tite-affecting agent has on those feeding patterns. The present 4/1991 Prat et al.
invention includes a system for data management, including a program with a data acquisition phase and a data analyzing phase to determine the feeding patterns of animals to aid in the evaluation of appetite-affecting drug efficacy.
1/1997 Castel ano 11 Claims, 5 Drawing Sheets
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SYSTEM AND METHODS FOR EVALUATING
rent methods is limited, it is difficult to maximize the efficacy EFFICACY OF APPETITE-AFFECTING
of agents to augment an animal's feeding patterns. Limited data hinders an accurate analysis of feeding patterns as wel as the ability to track changes in these patterns. Increasing the This application claims the benefit of U.S. Provisional 5 number of animals observed cannot al eviate these problems, Application No. 60/811,040 filed Jun. 5, 2006.
thus, these problems prevent sufficient data management, including collection and analysis, to optimize the efficacy of FIELD OF THE INVENTION The present invention relates to a system and methods for A demand therefore exists for a system and methods to evaluating the efficacy of drugs, or agents. More particularly, administer and evaluate drugs. Data is collected and analyzed the present invention relates to a system and methods by to determine the effects that a particular agent has on appetite which data can be managed, such as collected analyzed and including, for example, identifying feeding patterns and the organized, to determine the effect that a particular agent may effect the agent has on those feeding patterns. The present have on appetite, including, for example, feeding patterns and invention satisfies the demand.
changes thereto.
SUMMARY OF THE INVENTION BACKGROUND OF THE INVENTION Embodiments of the present invention administer and For purposes of this application, the present invention is 20 evaluate drugs. The present invention instantaneously identi­ discussed in reference to efficacy of appetite-affecting drugs, fies the effects that drugs, including appetite-affecting agents, or agents, but the present invention is applicable to any drug have on animals. Data is collected, analyzed and organized to for which the efficacy is sought.
identify feeding patterns and the effect the agent has on those Drug efficacy is a constant study conducted in numerous feeding patterns. Feeding patterns include, for example, research fields. Particularly, with respect to drug efficacy on 25 amount, duration and frequency of food intake as distinct appetite, it is desirable to determine whether chronic admin­ meals. A meal is defined as an interval of feeding during istration of such drugs, or agents, can produce a sustained which food intake is greater than a predetermined value, the decrease in daily food intake.
minimum meal size. This interval of feeding must also be It has long been known to administer appetite-affecting preceded and followed by a pause in food intake greater than agents, such as putative anorexigenic or anti-obesity agents, 30 to an animal and then observe the effects, if any, on the a predetermined value, the minimum between-meal interval animal's feeding pattern, or eating habits. Known methods of The present invention includes at least one cage and scale administering appetite-affecting agents typical y include assembly, or cage scale assembly, and a drug-delivery device. either daily injections or insertion of an osmotic mini-pump The cage scale assembly includes a cage and a scale. The cage beneath the skin or into the peritoneal cavity to deliver agents can be anything that houses the animal being administered continuously for a week or more. In addition, the food pro­ with the drug, for example, a box, corral, crate, enclosure, or vided to the animal is weighed on a regular basis so that daily pen, to name a few. The cage houses an animal, which is any food intake can be monitored. Typically, these methods are multicel ular organism, such as a human, monkey, or rat, such inconclusive due to an increase in food intake between as a Sprague-Dawley rat. The scale measures the weight or administrations of the agent as wel as a developed tolerance 40 mass of an object, and is preferably electronic, although it is to the agent.
contemplated the scale could be a beam scale, balance scale, After the administration is complete, the animals are evalu­ spring scale, or even a hydraulic or pneumatic scale.
ated to determine what effect, if any, the appetite-affecting The scale measures the weight or mass of a food source agent had on the animal's eating habits. Typically, such evalu­ available to the animal. The term "food source" for purposes ation has been limited to analyzing the animal's daily food 45 of this application means any substance, usual y composed intake by weight and dissecting the animal to determine adi­ primarily of carbohydrates, fats, water and/or proteins, that posity, which is the amount and type of fat stored in fatty can be eaten or drunk by an animal for nutrition and/or plea­ tissue. Conclusions regarding the agent's overall efficacy are sure, including solid block food, pel et food, liquid food, to based primarily on this evaluation.
Methods for evaluating drug efficacy have problems. For 50 The drug-delivery device includes a pump and a drug example, animals can experience decreased appetite follow­ source. The pump administers the drug from the drug source ing administration of appetite-affecting agents, and thus an to the animal. The pump can be any apparatus that delivers, or overall decrease in food intake for a duration of time. It is also moves, liquids, for example, a positive displacement pump, a known that animals may experience hyperphagia, or exces­ centrifugal pump, or a kinetic pump.
sive hunger leading to an increased food intake. This typical y 55 The drug source houses the drug, or appetite-affecting occurs following an anorexic episode that follows a dose of an agent, to be administered to the animal. The drug source can anti-obesity appetite-affecting agent. Similarly, an animal be a syringe, piston apparatus, vial, bag, bottle, beaker, or may develop a tolerance to the appetite-affecting agent if flask, to name a few. The appetite-affecting agent, for pur­ administered in a particular dose over too long a duration of poses of this application, is any drug or agent whose effect, if time. Thus, evaluating the efficacy of an administered drug 60 any, on appetite is being studied and may include a placebo requires an ability to measure the instantaneous effects of used in such study. Examples of such appetite-affecting different doses including frequency of administration of the agents include, for example, peptides, such as Peptide YY3_36 drug on feeding patterns.
(PYY), cholecystokinin, amylin, salmon calcitonin, gluca- A specific example related to the above-described problem gon-like peptide-1 (GLP-1), exendin-4, oxyntomodulin, pan­ includes difficulty in adjusting administration of the agent 65 creatic polypeptide, gastrin-releasing peptides GRP-27 and with respect to dosage and frequency to balance hyperphagia GRP-10, enterostatin, apolipoprotein A-IV, leptin, melano- against anorexic episodes. Because the data collected by cur­ cortin receptor 3 and 4 agonists including melanotan I , opioid receptor antagonists including naloxone and naltrex­ The data determines the efficacy of the drug. For example, one, and endocanabinoid receptor antagonists AM251 and the present invention determines the effect of a particular Rimonabant, to name a few.
dose, frequency and location of administration of an appetite- It is contemplated that one pump can control a plurality of affecting agent on feeding patterns and amount of food drug sources, although the drug sources need not be grouped 5 intake.
and each individual drug source may instead be associated The present invention includes a system for data manage­ with its own individual, dedicated pump.
ment, including data collection, analysis and further organi­ The pump administers, or delivers, the appetite-affecting zation into data records. According to the present invention, agent from the drug source to the animal via an infusion line. the data management system includes a program with a data A swivel-tether connector is positioned within the infusion 10 acquisition phase and a data analyzing phase. Data is col­ line to allow the animal to move freely. The animal is at ached lected during the data acquisition phase. As discussed above, to the infusion line by a catheter surgically implanted, for data includes animal identification number, date, time, and example, in its jugular vein, peritoneal cavity, or under the value of food weight, date and time of agent delivery, type of skin. The animal wears a jacket that includes a harness to keep appetite-affecting agent delivered to the animal, location of the catheter and infusion line intact during and subsequent to 15 agent delivery, dose and volume infusion rate.
administration of the appetite-affecting agent.
The data acquisition phase includes an initial setup seg­ A switchbox controls one or more cage scale assemblies. ment and a data collection segment. The initial setup segment The switchbox allows data to be received from each cage can be entered via a graphical user interface on a control unit, scale assembly either sequentially, or randomly, switching 20 or computer, implementing the program. The initial setup between the plurality of cage scale assemblies.
segment facilitates the input of the parameters for evaluating After the switchbox receives data from each cage scale the efficacy of drugs. The parameters include control param­ assembly, the data is sent to a control unit, such as a computer. eters and information parameters regarding overall variables, The control unit communicates with the cage scale assembly, such as study identification, date, animal environment lights drug-delivery device, or both. The control unit can commu­ 25 on/off times, and start/stop times. The initial setup segment nicate the operation of the pump to administer the appetite- may also allow input of control parameters and information affecting agent. The control unit can be pre-programmed with parameters pertaining to each animal, for example, an ani­ a particular sequence of operation or can determine the mal's identification number, corresponding scale identifica­ administration of the appetite-affecting agent based on the tion number, and treatment information, such as agent and data received from the cage scale assembly.
30 dose. The initial setup segment also includes pump setup for The control unit can communicate with the cage scale the input of control parameters and information parameters assembly, drug-delivery device, or both, via a network. The that may include pump identification number corresponding network can include, for example, Integrated Services Digital to a particular animal, the syringe diameter, infusion rate, and Network (ISDN), Digital Subscriber Line (DSL), Fiber Optic infusion periods. Additional inputs may include control Network, Satel ite Networks (SN), Wireless Wide Area Net­ 35 parameters and information parameters regarding the period­ works (WWAN), Recommended Standard 232 (RS232) icity of the retrieval of data from the scales associated with the Computer Serial Interface Networks, and Universal Serial food source of each animal, such as the interval at which data Bus (USB) Networks, to name a few.
will be collected from each scale, and the control parameters It is also contemplated that embodiments of the present defining the feeding of an animal. Such feedings typical y invention may include a plurality of control units. For 40 include a change of weight of the food source from one data example, a first computer may be configured to communicate interval to the next that exceeds a predetermined threshold with the drug-delivery device, and a second computer con­ figured to communicate with the scale. Each of these com­ At a predetermined time, the program starts and switches puters, in turn, may be configured to communicate with a "on" the pump of the pump assembly. The appetite-affecting third computer, for example to receive instructions regarding 45 agent is delivered to the animal according to the parameters operation of the system. Each of the computers may be further input during the initial setup segment. The first scale is polled configured to communicate with each other over a network, as to collect data associated with a first cage and a first animal. discussed above, or by being directly connected to one The program compares the current value of the food weight to another. Other embodiments may consolidate the functions of the previously pol ed food weight from the same scale, to the first and second computers into a single computer that is 50 determine whether the absolute change in food weight configured to communicate with the drug-delivery device and exceeds a predetermined threshold value indicative of feed­ the scale, and which may be further configured to communi­ ing behavior. If the change in value is greater than the prede­ cate with and be control ed by the third computer.
termined threshold value, the data is recorded for later analy­ The control unit is configured to manage data received sis. If the change in value is less than the predetermined from the switchbox of the cage scale assembly. The data is 55 threshold value, no data is recorded. The switchbox instructs collected into a database and analyzed. The data, or database, the system to switch to the next cage, or second cage, to poll can further be organized into records. The data includes ani­ the second scale weight.
mal identification number, date, time, and value of food The data analyzing phase analyzes the data col ected into a weight, amount of food intake during specified intervals of database. The data analyzing segment includes a program time, time of occurrence, duration, size and frequency of 60 setup, which may include, for example, data records to ana­ distinct meals, and average meal size, meal duration and lyze, the animal identification data to analyze, and the meal number of meals during specified intervals of time.
criteria. Defining meal criteria may include defining the mini­ The control unit can also be configured to manage data sent mum meal size in terms of change in food weight, and defin­ to and received from the drug-delivery device, such as animal ing the minimum between-meal interval. The minimum identification number, date of drug delivery, type of appetite- 65 between-meal interval is defined as a predetermined time affecting agent delivered, location of drug delivery, dose and period of no eating that must be met to define the end of one volume infusion rate.
meal and the start of another.
The data analyzing program imports the stored data. The Another object of the present invention is to determine data records preferably contain information necessary to feeding patterns associated with appetite-affecting agents for determine feeding patterns in the animals being studied, such the treatment of obesity and excessive leanness.
as animal identification numbers, the time and date the data Yet another object of the present invention is to manage, were collected, food weight from previous data acquisition, 5 collect and analyze data to identify feeding patterns.
and food weight from current data acquisition. The program The present invention and its attributes and advantages will then sorts the data into records. The data records may be be further understood and appreciated with reference to the sorted by date, animal identification number, and/or the time detailed description below of presently contemplated that the data was recorded. Other sorting may also be per­ embodiments, taken in conjunction with the accompanying formed according to predefined criteria, such as the user's 10 drawings.
Once the program has sorted the data into records, for BRIEF DESCRIPTION OF THE DRAWINGS example, by date, animal identification number, and time of recording, it may determine feeding patterns during specific The preferred embodiments of the invention will be intervals of time for each animal according to predetermined 15 described in conjunction with the appended drawings pro­ parameters. Examples of feeding patterns may include iden­ vided to illustrate and not to limit the invention, where like tifying the time of occurrence, duration, size and frequency of designations denote like elements, and in which: distinct meals. A meal is defined as an interval of successive FIG. 1 is a top view of an embodiment of a system to determine drug efficacy according to the present invention; food weight data for a specified animal showing a beginning 20 FIG. 2 is a side view of the embodiment of FIG. 1 according to end difference in food weight that is greater than a prede­ to the present invention; termined value, the minimum meal size. This interval of FIG. 3 is a flowchart of an embodiment of a data manage­ successive food weight data must also be preceded and fol­ ment system including a data acquisition phase and a data lowed by a pause in food weight recording greater than a analyzing phase according to the present invention; predetermined value, the minimum between-meal interval. 25 FIG. 4 is a flowchart of an embodiment of the data acqui­ Additional feeding pat ern data may include meal start time, sition phase of FIG. 3 according to the present invention; and meal duration (defined as the absolute value of meal start time FIG. 5 is a flowchart of an embodiment of the data analyz­ minus meal end time for a particular animal), and post-meal ing phase of FIG. 3 according to the present invention.
interval (preferably defined as the absolute value of meal start time plus meal duration minus next meal start time for a 30 DETAILED DESCRIPTION particular animal), and average meal size, meal durations and number of meals during specified intervals of time. After one The present invention relates to a system and methods for or more feeding patterns have been identified, the program evaluating the efficacy of drugs, or agents. For purposes of preferably saves the data.
this application, the present invention is discussed in refer­ Once one or more feeding patterns have been identified, the 35 ence to efficacy of appetite-affecting drugs, or agents, but the program may perform the step of displaying the feeding pat­ present invention is applicable to any drug for which the tern data on, for example, a graphical user interface using efficacy is sought. It is contemplated that the present inven­ graphics and/or text. Displaying the feeding pat ern data in tion is applicable to all types of settings, including research graphics and/or text allows instantaneous identification of settings, without regard to the animals used or the drugs data trends as wel as an instantaneous visualization of the 40 administered to the animals, and advantageously permits a effects of the agent on an animal's feeding patterns, or on wide scope of research to be conducted.
average feeding patterns from a group of identical y treated FIG. 1 shows a schematic for an embodiment of a system 100 for administering and evaluating the efficacy of appetite- An object of the present invention is to optimize the deter­ affecting agents in a plurality of animals. In particular, the mination of the efficacy of drugs.
45 system 100 is configured for the automatic administration of Another object of the present invention is to allow precise appetite-affecting agents to animals and managing the data administration of drugs, or agents, to animals.
from each respective animal. The system 100 includes a plu­ Another object of the present invention is to instanta­ rality of cage and scale assemblies 110, termed also cage neously identify the effects that drugs, including appetite- scale assemblies 110 for purposes of this application. As affecting agents, have on animals.
50 described below, one embodiment of such cage scale assem­ Another object of the present invention is to resolve the bly 110 includes a cage 120, an animal 125 within the cage intense debate regarding the inhibitory effects of appetite- 120, a food source 130, and a scale 140 associated with the affecting drugs on food intake and body weight.
food source 130 that may be configured to communicate over Another object of the present invention is to determine the a network 200.
efficacy of oral and/or intragastric administration of appetite- 55 The system 100 of FIG. 1 includes a plurality of drug- affecting agents.
delivery device 150, each of which includes a pump 160 and An object of the present invention is to identify substances one or more drug sources 170. A fluid from the drug source that can sustain a reduction in daily food intake and body fat 170 is delivered to an animal 125 as shown by infusion lines in obese animals, and sustain an increase in daily food intake 152A-P in FIG. 1. The cage scale assemblies 110 and drug- and body fat in excessively lean animals.
60 delivery device 150, which are described in greater detail Another object of the present invention is to minimize below with respect to FIG. 2, may further be configured to known obstacles to optimizing efficacy for appetite-affecting communicate with a control unit 180, such as computer 182, drugs, for example hyperphagia between intervals of infusion over a network 200, for example to receive operating instruc­ and the development of tolerance to such drugs.
tions or manage the col ected and analyzed data. As shown in Another object of the present invention is to allow an 65 the system 100 of FIG. 1, multiple drug sources 170 may be animal free access to food sources such that an animal's grouped together with the pump 160 of the drug-delivery consumption of the food source is not restricted.
device 150. Such groupings allow for common control of a plurality of drug sources 170 by one pump 160. The drug system 300 may include two phases, the data acquisition sources 170 need not be grouped, however, and each indi­ phase 302 and the data analyzing phase 304.
vidual drug source 170 may instead be associated with its own As shown in FIG. 3, the data acquisition phase 302 includes individual, dedicated pump 160.
one or more systems 306, 308, 310 that deliver appetite- The system 100 may include a control unit 180, such as 5 affecting agents to animals, and further collect data. The computer 182, which may be configured to communicate desired times and desired amounts of delivery of the appetite- with and operate the drug-delivery device 150. The computer affecting-agents can be dependent upon the data collected. 182 may be configured to receive and analyze data received Thus, the data received and analyzed dictates the administra­ from the plurality of cage scale assemblies 110. Preferably, tion of the appetite-affecting agent.
each cage scale assembly 110 of a group of cage assemblies 10 As explained in greater detail below, data acquisition sys­ 110A-P is operatively connected to a switchbox 145. One tems 306, 308,310 may include a program implemented on a embodiment of the switchbox 145 allows data to be received control unit 180, such as the computer 182 shown in FIG. 1. from each cage scale assembly 110 by sequentially, or ran­ The control unit 180 not only controls the drug-delivery domly, switching between the plurality of cage scale assem­ device 150, but also collects data, for example, animal iden­ blies 110A-P. The data received by the switchbox 145 is sent 15 tification number, date, time, and food weight. The overall to a control unit 180 having a storage medium for managing system 300 is scalable to accommodate any number of ani­ the data. It is contemplated that the switchbox 145 may com­ mals in one or more locations. As explained in greater detail municate with and be control ed by the control unit 180, here below, the data analyzing phase 304 may include use of a computer 182.
program 312 that may be implemented on a control unit 180 FIG. 2 is a side view of the embodiment of FIG. 1 according 20 to use data collected during the data acquisition phase 302 to to the present invention. The system 100 includes a cage scale determine effects of the drug on feeding patterns.
assembly 110 and a drug-delivery device 150. In general, the Although the system 100 shown and described with respect drug-delivery device 150 includes a drug source 170, here a to FIGS. 1 and 2 employ only a control unit 180, or computer syringe 172 that delivers a quantity of the drug, or fluid. Drug 182, embodiments of the system 100 may include a plurality source 170 may be operatively mounted to a pump 160. 25 of control units 180, or computers 182, to operate the system Pumps 160 are wel known in the art, and are control ed by a 100. For example, the system 100 may include a first com­ control unit 180. As shown in FIG. 2, pump 160 is connected puter configured to communicate with the drug-delivery to a control unit 180 by cable 181. Pump 160 may also be device, and a second computer configured to communicate remotely control ed or actuated for delivery of the fluid at with the scale. Each of these computers, in turn, may be desired times and desired amounts. The pump 160 provides 30 configured to communicate with a third computer, for the fluid to an animal 125 from the drug source 170.
example to receive instructions regarding operation of the Other embodiments may include wireless communication drug-delivery device and food source. Each of the computers between the pump 160 and control unit 180. The animal 125, may be further configured to communicate with each other such a Sprague-Dawley rat for example, may be connected to over a network, or by being directly connected to one another. the drug source 170 such as through an infusion line 152A 35 Other embodiments may consolidate the functions of the first that is preferably connected to a catheter implanted in the and second computers into a single computer that is config­ jugular vein, peritoneal cavity, or under the skin of the animal ured to communicate with the drug-delivery device and the 125, or any other methods that are wel known in the art. A scale, and which may be further configured to communicate swivel-tether connector 184 between the infusion line 152A with and be control ed by the third computer.
allows the animal 125 to move freely about its cage 120. In 40 Determining animal feeding patterns ideally requires the this embodiment, as shown in FIG. 2, the drug-delivery control and monitoring of a number of factors and conditions. device 150 may be placed in a supported position such as a FIG. 4 is a flowchart of an embodiment of the data acquisition shelf 50, with a horizontal member 51 and vertical member 53 phase 302 of the present invention. In one embodiment, a data near and/or above the cage 120. Of course, the drug source acquisition program 400 is stored in a processor of a com­ 170 need not be so placed, and can be placed in any conve­ 45 puter. The data acquisition program 400 includes an initial nient location.
setup segment 410 and a data collection segment 450.
The cage scale assembly 110 includes an animal 125 The initial setup segment 410 facilitates the input of the within a cage 120. A food source 130 is available to the animal parameters for evaluating the efficacy of drugs. In one pre­ 125, through a hole (not shown) in the base of a side-com­ fer ed embodiment, the initial setup segment 410 includes partment 132 at ached to the cage 120. The food source 130 50 four main components 412, 414, 416, 418. Each component may be placed on a stand 134 that sits in a dish 136, which 412, 414, 416, 418 may include control parameters and/or functions to catch falling food that may become dislodged identification parameters. The initial setup 412 allows for from the food source 130 as the animal 125 engages in eating. input of control parameters and information parameters The food source 130 is further associated with a scale 140 for regarding overall variables, such as study identification, date, measuring the weight of the food source 130. The scale 140 is 55 animal environment lights on/off times, and start/stop times. preferably electronic and may be in communication with the The initial setup 412 may also allow input of control param­ switchbox 145. The switchbox 160 can wirelessly communi­ eters and information parameters pertaining to each animal. cate with the cage scale assembly 110 and further with the The animal treatment setup 414 allows for the input of control control unit 180. A shown in FIG. 2, the switchbox 145 parameters and information parameters directed to individual communicates with the scale 140 by way of cable 187. The 60 animals, which facilitates tracking of information after scale 140 may be alternately configured to communicate with completion. Such information may include, for example, an and be control ed by the control unit 180, over a network 200 animal's identification number, corresponding scale identifi­ as described in reference to FIG. 1.
cation number, and treatment information, such as agent and The embodiment in FIGS. 1 and 2 includes a system for dose. The pump setup 416 allows for the input of control data management, including data collection and analysis. 65 parameters and information parameters that may include FIG. 3 is a flowchart of a data management system 300 pump identification number corresponding to a particular according to the present invention. The data management animal, the syringe diameter, infusion rate, and infusion peri­ ods. The scale setup 418 allows for the input of control and recorded by the data collection segment 450 as described with information parameters regarding the periodicity of the reference to FIG. 4. The data analyzing program 500 is pref­ retrieval of data from the scales associated with the food erably stored in a processor of a computer. The data analyzing source of each animal, such as the interval at which data will program 500 need not necessarily be on the same computer as be collected from each scale, and the control parameters 5 the software implementing the data acquisition program 400, defining the feeding of an animal. Such feeding parameters and may instead be on a separate computer (not shown). In a typical y include a change of weight of the food source from preferred embodiment, the data analyzing program 500 pro­ one data interval to the next that exceeds a predetermined cesses the data collected and recorded by the data manage­ threshold value. The initial setup segment 410 may be imple­ ment system 300.
mented via a graphical user interface on a computer imple­ 10 The initial step 501 of the data analyzing program 500 menting the program 400, such as computer 182 of FIG. 1. So includes performing the program setup, which may include, configured, the program 400 implementing the initial setup for example, data records to analyze, animal identification segment 410 may automatically begin, administer, and con­ data to analyze, and the meal criteria. Defining meal criteria clude the delivery of agents to the animals and the collection may include defining the minimum meal size in terms of 15 change in food weight, and defining the minimum between- Following the initial setup segment 410, the data acquisi­ meal interval. The minimum between-meal interval is defined tion phase 302 controls the delivery of agents and monitoring as a predetermined time period of no eating that must be met of the food consumption of the animals. At a predetermined to define the end of one meal and the start of another. So time, the program 400 starts at step 451. The next step 452 configured, the data analyzing program 500 may evaluate switches the pump 160 (FIG. 1) "on" and a dose of the agent 20 animal feeding patterns from the data collected throughout a is delivered to the animal according to the parameters input specified duration, which in one preferred embodiment during initial setup segment 410. The program 400 then per­ includes data collected at twenty second intervals.
forms the next step 453 and switches to the first cage scale Fol owing the initial setup step 501, the data analyzing assembly 110 (FIG. 1). The program 400 then performs the program 500 performs the start step 502. After starting, the step 454 and polls the first scale to collect data, such as the 25 program 500 performs the step 503 of importing data records weight of the food source 130 (FIG. 1) associated with a first stored by the data collection segment 450 of the data acqui­ cage and a first animal. The program compares the current sition program 400. The data records preferably contain value of the food weight to the previously pol ed food weight information necessary to identify feeding patterns in the ani­ from the same scale and animal, to determine whether the mals being studied, such as the time and date the data was absolute change in food weight exceeds a predetermined 30 collected, the animal identification data, food weight from threshold value indicative of feeding behavior. If this change previous data acquisition, and food weight from cur ent data in food weight is greater than the predetermined threshold acquisition. The latter two data points allow the program 500 value, the program 400 performs the step 456 of recording the to determine food intake, if any, across a series of successive data for later analysis.
food weight acquisitions for a particular animal.
The data recording step 456 preferably includes recording 35 The program 500 then performs the step 504 of sorting the information sufficient to identify an animal's feeding pat­ data records. The data records may be sorted by date, animal terns. Such information typical y includes the animal identi­ identification data, and the time that the data was recorded. fication number, the date and time the food weight measure­ Other sorting may also be performed according to predefined ment was taken, the previous food weight, and the current criteria, such as the user's preferences.
food weight, although it is contemplated that any other infor­ 40 Once the program 500 has sorted the data records, it may mation may be included as necessary. Fol owing the data determine feeding patterns according to predetermined recording step 456, the program 400 performs the step 457 of parameters, as shown with respect to step 505 in FIG. 5. determining whether the stop time has been reached. If so, Examples of feeding pat ern data may include identifying the then the process is stopped per step 459, and no further data is time of occurrence, duration, size and frequency of distinct collected and recorded. Furthermore, agents are no longer 45 meals. A meal is defined as an interval of successive food delivered to the animals. Similarly, if the change in value in weight data for a specified animal showing a beginning to end step 455 was less than the predetermined threshold value, the difference in food weight that is greater than a predetermined program 400 does not perform step 456 to record data, but value, the minimum meal size. This interval of successive instead step 457 is performed to determine whether the stop food weight data must also be preceded and followed by a time has been reached.
50 pause in food weight recording greater than a predetermined If, after performing step 457 and determining that the stop value, the minimum between-meal interval. Additional feed­ time has not been reached, the program 400 then performs ing pat ern data may include meal start time, meal duration step 458, which switches to the next cage, if any, whereupon (defined as the absolute value of meal start time minus meal the program 400 performs step 454 to poll the next scale end time for a particular animal), post-meal interval (prefer­ weight. The method continues forthe second cagejust as with 55 ably defined as the absolute value of meal start time plus meal the first cage, and the third cage, if any, and so forth. In a duration minus next meal start time for a particular animal), preferred embodiment, each cage is polled every twenty sec­ and average meal size, meal duration and number of meals onds, and the program 400 is configured to control the timing during specified intervals of time. After one or more feeding of steps 454 to 458 to accomplish regular polling of the cages. patterns have been identified, the program 500 preferably When the program 400 has pol ed each cage, it begins again 60 saves the feeding pat ern data to a file in the computer's data at step 454 by polling the first cage. This method runs con­ storage medium per step 506.
tinual y until the program 400 has determined that the stop Once one or more feeding patterns have been identified, the time has been reached in step 457, whereupon the program program 500 may perform the step of displaying the feeding will stop at step 459.
pat ern data on, for example, a graphical user interface using FIG. 5 is a flowchart of an embodiment of the data analyz­ 65 graphics and/or text, per step 507. Displaying the feeding ing phase 304 according to the present invention. The data pat ern data in graphics and/or text allows researchers to analyzing program 500 analyzes the data collected and quickly identify data trends. In addition, a graphical display of the feeding pat ern data allows an instantaneous visualiza­ 7. A system for determining the efficacy of drugs on an tion of the effects of the agent on an animal 's feeding patterns, animal, comprising: or on average feeding patterns from a group of identical y a plurality of drug-delivery devices, each of said drug- treated animals.
delivery devices including a drug source and a pump, The above description of il ustrated embodiments of the 5 wherein said pump initiates delivery of a predetermined invention is not intended to be exhaustive or to limit the amount of at least one appetite-affecting agent from said invention to the precise form disclosed. While specific drug source to the animal, and said each of said drug- embodiments of, and examples of, the invention are described delivery devices is configured to wirelessly send drug- in the foregoing for illustrative purposes, various equivalent delivery device data to and wirelessly receive the drug- modifications are possible within the scope of the invention, 10 delivery device data from a control unit; as those skilled in the relevant art will realize. Moreover, the a plurality of cage scale assemblies, each of said cage scale various embodiments described above can be combined to assemblies including a cage, a scale and a food source, provide further embodiments. Accordingly, the invention is wherein each of said scales are associated with each of not limited by the disclosure, but instead the scope of the said food source for the animal, wherein said each of invention is to be determined entirely by the following claims. 15 said cage scale assemblies is configured to wirelessly send cage scale assembly data to and wirelessly receive What is claimed is: cage scale assembly data from a switchbox, the cage 1. A system for determining the efficacy of drugs on an scale assembly data consisting of poll date, animal ID, animal, comprising: current time, previous scale weight and current scale a plurality of cage scale assemblies, each cage scale assem­ 20 bly including a cage, a food source, and a scale, wherein a control unit configured to: said cage scale assembly is configured to wirelessly send store study setup data consisting of study ID, date, lights- cage scale assembly data to and wirelessly receive the on time, lights-off time, experiment start time and cage scale assembly data from a switchbox; experiment stop time, said food source available to the animal; store animal treatment setup data consisting of animal ID, said scale associated with said food source and in wireless cage scale ID, treatments ID, agent(s) and dose(s), communication with the switchbox; store pump setup data consisting of pump ID, syringe said cage scale assembly data consisting of poll date, ani­ diameter, infusion rate and infusion periods, mal ID, current time, previous scale weight and current store scale setup data consisting of polling interval and threshold weight change, a drug-delivery device in wireless communication with a wirelessly receive the cage scale assemblies data from the control unit, the drug-delivery device including a drug switchbox and wirelessly receive the drug-delivery source for delivering a predetermined amount of at least device data from at least one of said each of said drug- one appetite-affecting agent to the animal, delivery devices at a predetermined interval, and a control unit configured to: determine, for each of said cage scale assemblies, if the store study setup data consisting of study ID, date, lights- previous scale weight exceeds the current scale weight on time, lights-off time, experiment start time and by greater than the threshold weight change and if so, experiment stop time, store the cage scale assembly data and the drug-delivery store animal treatment setup data consisting of animal ID, cage scale ID, treatments ID, agent(s) and dose(s), send instructions to the drug delivery device to stop deliv­ store pump setup data consisting of pump ID, syringe ering the predetermined amount of the at least one appe­ diameter, infusion rate and infusion periods, tite-affecting agent upon determining that the previous store scale setup data consisting of polling interval and scale weight exceeds the current scale weight by an threshold weight change, amount greater than the threshold.
collect the cage scale assembly data from said switchbox at 45 8. The system of claim 7, wherein said each of said scales a predetermined interval, is configured to determine food weight and transmit food determine if the previous scale weight exceeds the current weight data to a processor.
scale weight by an amount greater than the threshold 9. The system of claim 7, wherein a storage medium is weight change indicating feeding behavior, and if so operatively associated with said control unit.
record the cage scale assembly data, and 10. The system of claim 7, wherein said appetite-affecting analyze the cage scale assembly data to determine feeding agent is at least one from the following group of: Peptide patterns of the animal; y y 3_36 (PYY), cholecystokinin, amylin, salmon calcitonin, send instructions to the drug delivery device to stop deliv­ glucagon-like peptide-1 (GLP-1), exendin-4, oxyntomodu- ering the predetermined amount of the at least one appe­ lin, pancreatic polypeptide, gastrin-releasing peptides GRP- tite-affecting agent upon determining that the previous 55 27 and GRP-10, enterostatin, apolipoprotein A-IV, leptin, scale weight exceeds the cur ent scale weight by an melanocortin receptor 3 and 4 agonists including melanotan amount greater than the threshold.
II, opioid receptor antagonists including naloxone and naltr­ 2. The system of claim 1, wherein said appetite-affecting exone, and endocanabinoid receptor antagonists AM251 and agent is Peptide YY3_36.
3. The system of claim 1, wherein said scale is configured 60 11. A method of determining the efficacy of a drug, the to communicate over a network.
method comprising: 4. The system of claim 1, wherein said drug-delivery providing a plurality of drug-delivery devices, each of the device is configured to communicate over a network.
drug-delivery devices being capable of delivering a pre­ 5. The system of claim 1, wherein said control unit is determined amount of at least one appetite-affecting configured to communicate over a network.
agent to an animal of a plurality of animals, at least one 6. The system of claim 1, wherein said drug-delivery of the drug-delivery devices being connected to one of device comprises a plurality of said drug sources.
the plurality of animals; providing a control unit configured to: date, animal ID, current time, previous scale weight and store study setup data consisting of study ID, date, lights- current scale weight via the switchbox; on time, lights-off time, experiment start time and gathering drug-delivery device data wirelessly sent from at experiment stop time, least one of the plurality of drug-delivery devices to the store animal treatment setup data consisting of animal ID, 5 control unit, wherein the drug-delivery device data cage scale ID, treatments ID, agent(s) and dose(s), includes an identification number of the animal, a date of store pump setup data consisting of pump ID, syringe the at least one appetite-affecting agent delivered to the diameter, infusion rate and infusion periods, and animal, a type of the at least one appetite-affecting agent store scale setup data consisting of a polling interval and a delivered to the animal, a dose of the at least one appe­ threshold weight change indicating feeding behavior, 10 tite-affecting agent delivered to the animal, an infusion administering the at least one appetite-affecting agent to rate of the at least one appetite-affecting agent delivered the one of the plurality of animals; to the animal, and at least one time interval of delivery of supplying at least one food source available to one of the the at least one appetite-affecting agent delivered to the plurality of animals; arranging a plurality of scales, at least one of the plurality 15 evaluating the scale data and the drug-delivery device data of scales being in association with the at least one food to obtain feeding patterns of the animals of the plurality source, wherein the plurality of scales are in wireless of animals with respect to the at least one appetite- communication with a switchbox; monitoring food consumption of the animals of the plural­ stopping delivery of the at least one appetite-affecting agent upon determining that the previous scale weight determining if the previous scale weight exceeds the cur­ exceeds the current scale weight by greater than the rent scale weight by greater than the threshold weight threshold weight change.
change and if so, recording scale data consisting of poll

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