U.S. patent application number 09/799852 was filed with the patent office on 2002-02-07 for research data collection and analysis.
Invention is credited to Brown, Stephen J..
Application Number | 20020016530 09/799852 |
Document ID | / |
Family ID | 23048168 |
Filed Date | 2002-02-07 |
United States Patent
Application |
20020016530 |
Kind Code |
A1 |
Brown, Stephen J. |
February 7, 2002 |
Research data collection and analysis
Abstract
The invention provides a method and system by which research
data can be collected and analyzed during the course of the
research testing, and the research testing itself possibly modified
to account for conclusions drawn from the research data. In a first
aspect of the invention, a research subject can respond to a
protocol stored on a server by manipulating input keys on a
remotely located client device onto which a research protocol has
been installed. The protocol can include questions concerning the
subject's physical or mental well being such as whether their
symptoms are relieved or not, or even exacerbated. The protocol can
also include calling for data obtained by coupling the client
device with another medical device such as a glucose monitor. In a
preferred embodiment, the subject is presented with narrowly
structured questions and suggested answers provided by the
protocol. The set of possible answers is restricted. In the event
that a suggested answer is ambiguous, inapplicable or raises new
questions, a protocol can present a new question to the subject.
This elimination of fuzzy answers imposes a logical structure upon
the subjects' assessments. In a second aspect of the invention,
data entered by the subject is relayed using a communication link
to a server device. This incoming data can be aggregated with other
incoming data from subjects and their associated client devices. In
a preferred embodiment, the data is statistically analyzed
according to parameters set by the protocol. In a third aspect of
the invention, a remote expert research clinician can review
incoming data from either the aggregated population or from
individuals as it is being analyzed. Such rapid collection and
analysis allows a researcher to change the protocol in response to
the trend of the data, correlate different parameters of the data
so as to better identify subjects that are responding to treatment
and schedule appropriate interventions as needed. The researcher
can also identify specific subgroups among the population of
subjects, initiate new lines of inquiry and test new sub-hypotheses
that may be raised by the incoming data. This includes correlating
different drug responses experienced by phenotypically similar
subjects with gene expression, and other variables.
Inventors: |
Brown, Stephen J.;
(Woodside, CA) |
Correspondence
Address: |
Michael S. Smith
BLACK LOWE & GRAHAM PLLC
816 Second Avenue
Seattle
WA
98104
US
|
Family ID: |
23048168 |
Appl. No.: |
09/799852 |
Filed: |
March 5, 2001 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
09799852 |
Mar 5, 2001 |
|
|
|
09274431 |
Mar 22, 1999 |
|
|
|
6196970 |
|
|
|
|
Current U.S.
Class: |
600/300 ;
128/920; 705/2 |
Current CPC
Class: |
A61B 5/1455 20130101;
A61B 5/7264 20130101; G16B 50/00 20190201; A61B 5/14532 20130101;
A61B 5/0871 20130101; G16H 10/20 20180101; Y10S 128/92 20130101;
A61B 5/0002 20130101; A61B 5/0205 20130101 |
Class at
Publication: |
600/300 ;
128/920; 705/2 |
International
Class: |
G06F 017/00; A61B
010/00; A61B 005/00; G06F 017/60 |
Claims
1. A method including steps for collecting data for a plurality of
subjects, using at least a portion of a protocol for collecting
data, wherein said protocol includes steps for receiving data from
an input device; sending data collected from said input device to a
server device relatively remote from said input device; performing
a data manipulation technique on data associated with more than one
of said subjects; presenting a result of said data manipulation
technique at a presentation device relatively remote from said
input device; wherein said steps for presenting occur in
conjunction with repeated performance of said steps for
collecting.
2. A method as in claim 1, including steps for modifying at least a
portion of said protocol in response to said result, wherein said
steps for collecting are altered for at least some performances
thereof.
3. A method as in claim 1, wherein each said subject is associated
with an individual input device.
4. A method as in claim 1, wherein said data manipulation technique
includes aggregating said data, combining said data, or performing
a statistical operation with regard to said data.
5. A method as in claim 1, wherein said data manipulation technique
includes storing said data at a device relatively remote from said
input device; receiving a data manipulation inquiry from said
presentation device; performing said data manipulation inquiry; and
presenting a result of said data manipulation inquiry at said
presentation device.
6. A method as in claim 1, wherein said data manipulation technique
is specified by at least a portion of said protocol.
7. A method as in claim 1, wherein said steps for sending data are
performed in response to a time period, an event associated with
said presentation device, or an event associated with said
subject.
8. A method as in claim 1, wherein at least a portion of said
protocol includes presenting instructions to one said subject and
receiving data from said input device in response thereto.
9. A method as in claim 8, wherein said input device includes a
keyboard, a microphone, a motion sensor, a pointing device, a set
of buttons, or a switch.
10. A method as in claim 8, wherein said input device includes a
medical device.
11. A method as in claim 1, wherein at least a portion of said
protocol includes presenting questions to one said subject and
receiving answers from said subject in response thereto.
12. A method as in claim 11, wherein said operation of presenting
questions includes presenting structured answers and said operation
of receiving answers includes receiving a selection from a set of
restricted possible answers.
13. A method as in claim 1, wherein at least a portion of said
protocol is performed at a client device located relatively
proximate to said input device.
14. A method as in claim, 13, wherein said portion is altered at
said client device in response to said presentation device.
15. A method as in claim 13, wherein said portion is received by
said client device in response to said server device.
16. A method as in claim 1, including steps for providing a second
protocol; selecting a portion of said plurality of subjects in
response to said data manipulation technique; and altering said
steps for collecting data to perform said one protocol for
unselected ones of said subjects, and to perform said second
protocol for selected ones of said subjects; wherein said steps for
collecting are altered for at least some performances thereof.
17. A method as in claim 16, wherein said steps for selecting are
performed in response to a genotype, a gene expression, or a
phenotype of one or more of said subjects.
18. Apparatus including an input device disposed for coupling to a
subject, said input device including a processor for performing at
least a portion of a protocol for receiving data from said subject;
a server device relatively remote from said input device; a
communication link between said input device and said server
device; a processor including software for performing a data
manipulation technique on data associated with more than one of
said subjects; a presentation device relatively remote from said
input device, coupled to said processor, said presentation device
disposed for presenting a result of said data manipulation
technique; wherein said steps for presenting occur in conjunction
with repeated performance of said steps for collecting.
19. Apparatus as in claim 18, including a message modifying at
least a portion of said protocol in response to said result,
wherein said steps for collecting are altered for at least some
performances thereof.
20. Apparatus as in claim 18, wherein said input device includes a
keyboard, a microphone, a motion sensor, a pointing device, a set
of buttons, or a switch.
21. Apparatus as in claim 18, wherein said input device includes a
medical device.
Description
RELATED APPLICATIONS
[0001] Inventions described herein can be used in combination or
conjunction with inventions described in the following patent
application(s):
[0002] Application Ser. No. ______, Express Mail Mailing No.
EE143637591US, filed Nov. 30, 1998, in the name of Stephen J.
Brown, titled "Leveraging Interaction with A Community of
Individuals," assigned to the same assignee, attorney docket number
HHN-007, and all pending cases claiming priority thereof.
[0003] Application Ser. No. ______, Express Mail Mailing No.
EJ384008769US, filed ______, in the name of Steven J. Brown, titled
"Patient Initiated Contact," assigned to the same assignee,
attorney docket number HHN-021, and all pending cases claiming
priority thereof.
[0004] These applications are each hereby incorporated by reference
as if fully set forth herein. These applications are collectively
referred to herein as "incorporated disclosures."
BACKGROUND OF THE INVENTION
[0005] 1. Field of the Invention
[0006] This invention relates to research data collection and
analysis.
[0007] 2. Related Art
[0008] Human beings are sometimes used as subjects in different
types of medical, psychological, and other research. Generally,
such research fits into one of several broad categories: academic
or industrial research, FDA clinical trials, and marketing and
sales research. Human beings are also used as research subjects in
experiments designed to correlate genotype and phenotype with drug
reactions. For example, a researcher may seek to learn whether
patients with the genotype for sickle cell disorder experience
greater light sensitivity when taking a specific antibiotic.
[0009] Academic and industrial investigators often employ human
subjects to learn how humans respond to some pre-determined stimuli
such as a drug or a psychological event. For a first example, an
academic researcher may use post-menopausal women as subjects in
experiments designed to widen our understanding of the
neuroendocrine response to ethanol. Many different types of data
can be obtained in such experiments. In this first example, a
researcher could correlate the data on different hormone levels
with blood alcohol levels, the frequency of selected patient
behaviors, number of cigarettes smoked and many other possible
factors. These data can be aggregated with similar data from other
researchers and conclusions can be drawn based upon their
observations.
[0010] A second area in which human subjects are sometimes used as
a research tool involves government approval of new drugs for human
patients. The Food and Drug Administration (FDA) approves new drugs
that are to be marketed for human consumption. Presently, FDA
approval is contingent upon the drug successfully passing three
phases of testing during which the drug is blindly administered to
human subjects. Taken together, these three phases of testing are
called clinical trials. Only those drugs that successfully complete
all three phases of clinical trials can be marketed.
[0011] In the general course of events, the sponsor of a drug will
submit an application and protocol to the FDA for clinical testing.
After the application is reviewed and approved, Phase I of clinical
testing begins. Experienced clinical investigators administer the
drug to a small number of healthy volunteers. Although drug dosage
and metabolism may be studied, the main focus of this initial
testing phase is drug safety. Since safety concerns are paramount,
testing is performed on a relatively small population (between 20
to 100 subjects) for a short period of time. Drugs that induce
toxic reactions or other adverse effects do not advance to Phase
II. This initial screening eliminates approximately 30% of all
applicants.
[0012] The main focus of Phase II testing is to determine whether
the drug is an effective treatment. Since the focus is on the
effectiveness of the drug and the threat of adverse reactions has
been largely ruled out, Phase II clinical trials involve a larger
number of subjects (up to several hundred) who suffer from a
problem the drug is designed to treat. Phase II trials may involve
the blind testing of up to several hundred subjects. Only 33% of
all drugs advance to phase III testing.
[0013] Phase III testing may involve up to several thousand
subjects. This phase lasts longer (between one to four years) than
either Phase I or Phase II. Here, the safety, dosage and
effectiveness of the new drug are all rigorously screened. Between
25-30% of all drugs pass phase III trials and receive the required
approval necessary for marketing.
[0014] An additional level of testing is also employed. After a new
drug has passed all three phases of clinical trials, researchers
may also want to learn if any adverse effects occur after the drug
is marketed. Thus, additional investigation may involve
post-marketing surveillance of patients who have been administered
the drug after it is approved by the FDA. Such post marketing
surveillance is a useful tool that helps researchers learn more
about how patients respond to a specific drug.
[0015] Known marketing and sales research includes attempting to
elicit responses from human participants regarding whether those
participants would be more or less likely to purchase selected
goods or services. It is known to attempt to correlate responses
with demographic data about the participants (such as age, gender,
household income, or residence locale), as well as psychological
and other information about participants (such as whether
participants are considered "early adopters").
[0016] Known methods for collecting and analyzing data from human
subjects in research suffer from several drawbacks. While these
methods generally achieve their respective goals of learning more
about the human response to various stimuli, screening out
ineffective and unnecessarily toxic drugs, and providing useful
information for marketing or sales, known methods suffer from
several drawbacks and limitations that can make them time-consuming
or inefficient.
[0017] A first problem in the known art is that collection of data
from subjects or participants in research or clinical trials often
involves obtaining and analyzing fizzy assessments from subjects
who are not necessarily under the continual observation of a
clinician or other personnel. Indeed, many subjects (such as the
controls in clinical trials) are not under the care of a physician
at all, but merely report to an expert researcher periodically for
testing and analysis. Such testing and analysis frequently involves
self-reporting a number of parameters. A subject's answer to an
inquiry often involves the making of a fuzzy assessment of physical
state, mood or quality of life. Accordingly, there is a need for a
method to evaluate and standardize such fuzzy self-assessments.
[0018] A second problem in the known art is that researchers are
unable to respond to incoming data in real time. In known methods,
data from research or clinical trials is collected and stored for
analysis at a later time. Frequently, researchers or lab
technicians enter their observations in a paper copy of a log book
or lab notebook. Often these results are entered near the end of an
experiment. This practice makes it impossible for an investigator
to evaluate the data or change the experimental design. While
researchers may have an approximate idea as to the general trend of
incoming data, they are frequently unable to respond to that trend
until the data is analyzed, well after any opportunity for altering
the method of collection or the nature of the data collected.
Accordingly, researchers are unable to modify a clinical protocol
while in process. This inability to evaluate and respond to
incoming data during data collection can create conditions that are
dangerous for the subjects of the research. It is believed that
morbidity and mortality associated with evaluation of new drugs
would be substantially reduced if researchers could respond during
the research, such as to halt the clinical trial or adjust the drug
dosage. Accordingly, there is a need to evaluate and respond to
subjects in real time.
[0019] A third problem in the known art is that collection of data
from research and clinical trials often calls for the aggregation
of data from many different geographical testing sites. It is
believed that drug testing and other research would be quicker if
there were a way to aggregate data and respond to it in real time,
during the time of the trials or research. Accordingly, there is a
need to aggregate and analyze data from many remote sites.
[0020] A fourth problem in the known art is that identification of
subjects in clinical trials who respond to a drug is not always
readily apparent because it frequently requires evaluation of many
different parameters. Part of this problem involves the nature of
disease. In some cases, an acute condition will spontaneously heal,
regardless of treatment. Chronic diseases often follow an
unpredictable course as symptoms abate for a time and then worsen.
Under these conditions, it is often difficult to determine whether
the change in the subject's condition may be attributed to the drug
or some other factor. Identifying subjects who respond to a drug is
particularly problematic in Phase II trials where the issue is the
efficacy of the drug. Accordingly, there is a need to be able to
distinguish responders from non-responders on the basis of many
different factors.
[0021] A fifth problem in the known art involves the nature of
research with human subjects. Most experiments involving
administration of drugs are either blinded or double blinded. In
blinded studies, the subject does not know whether they are
receiving the active drug or a placebo. In essence, although the
investigator knows what the subject is receiving, the subject does
not know whether or not they are being used as a control. In
double-blinded subjects, neither the researcher nor the research
subject is aware of the subject's status. Blinded studies are
problematic because researcher may impose his own bias on the
incoming data. Double-blinded studies are problematic because the
researcher may not be sensitive to phenomena that the subject is
experiencing. Another problem raised in double-blinded studies is
that the investigator very often becomes unblinded when observing
the effect of a drug on a research subject. According, there is a
need for an impartial, unbiased observer that remains responsive to
the research subjects.
[0022] Accordingly, it would be advantageous to provide a technique
by which research data can be collected and analyzed during the
course of the research testing, and the research testing itself
possibly modified to account for conclusions drawn from the
research data. For example, it would be advantageous to provide a
device that can be carried by a research subject or participant
that can be coupled and uncoupled to a communication system that is
also accessible to researchers and other remote experts. Such a
device would allow researchers to (1) collect, analyze and respond
to input from the research subjects or participants in real time,
(2) evaluate fuzzy assessments made by a subject or participant by
making progressively narrower inquiries designed to obtain specific
data, (3) aggregate and analyze data from a large number of remote
sites quickly, (4) change the research protocol in response to
input from subjects in real time and (5) rapidly identify
responders and non-responders by correlating the data with a number
of disparate parameters that are not necessarily apparent when the
study begins. These advantages are achieved in embodiments of the
invention in which a research subject enters data using a client
device that is coupled to a server via a communication link.
SUMMARY OF THE INVENTION
[0023] The invention provides a method and system by which research
data can be collected and analyzed during the course of the
research testing, and the research testing itself possibly modified
to account for conclusions drawn from the research data. In a first
aspect of the invention, a research subject can respond to a
protocol stored on a server by manipulating input keys on a
remotely located client device onto which a research protocol has
been installed. The protocol can include questions concerning the
subject's physical or mental well being such as whether their
symptoms are relieved or not, or even exacerbated. The protocol can
also include calling for data obtained by coupling the client
device with another medical device such as a glucose monitor. In a
preferred embodiment, the subject is presented with narrowly
structured questions and suggested answers provided by the
protocol. The set of possible answers is restricted. In the event
that a suggested answer is ambiguous, inapplicable or raises new
questions, a protocol can present a new question to the subject.
This elimination of fuzzy answers imposes a logical structure upon
the subjects' assessments.
[0024] In a second aspect of the invention, data entered by the
subject is relayed using a communication link to a server device.
This incoming data can be aggregated with other incoming data from
subjects and their associated client devices. In a preferred
embodiment, the data is statistically analyzed according to
parameters set by the protocol.
[0025] In a third aspect of the invention, a remote expert research
clinician can review incoming data from either the aggregated
population or from individuals as it is being analyzed. Such rapid
collection and analysis allows a researcher to change the protocol
in response to the trend of the data, correlate different
parameters of the data so as to better identify subjects that are
responding to treatment and schedule appropriate interventions as
needed. The researcher can also identify specific subgroups among
the population of subjects, initiate new lines of inquiry and test
new sub-hypotheses that may be raised by the incoming data. This
includes correlating different drug responses experienced by
phenotypically similar subjects with gene expression, and other
variables.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0026] In the following descriptions, a preferred embodiment of the
invention is described with regard to preferred process steps and
data structures. Embodiments of the invention can be implemented
using general-purpose processors or special purpose processors
operating under program control, or other circuits, adapted to
particular process steps and data structures described herein.
Implementation of the process steps and data structures described
herein would not require undue experimentation or further
invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0027] FIG. 1 shows a block diagram of a system 100 to collect and
analyze data from human research subjects.
[0028] FIG. 2 shows a process flow diagram of a method for
operating a system for interaction with a community of individuals,
including research subjects and investigators.
[0029] System Elements
[0030] FIG. 1 shows a block diagram of a system 100 to collect and
analyze data from human subjects engaged in medical research using
a protocol or other intelligent message, which acts in place of a
researcher, investigator, clinician or other medical expert.
[0031] A system 100 includes a set of subject devices 110, a set of
medical research expert devices 120 and a server device 130. The
subject device 110, the medical research expert device 120 and the
service device 130 are coupled using a communication network
140.
[0032] The set of research subject devices 110 is used by a set of
research subjects 111. Each research subject device includes an
output element 112, an input element 113 and a port 114. The
subject 111 manipulates the subject device 110 to send feedback
from the subject 111 to the server 130 and to receive information
from the protocol 131. Port 114 can be coupled to a variety of
medical appliances to send additional data to the server 130.
[0033] The set of medical research expert devices 120 is used by a
set of medical research experts 121. Each medical expert device
includes an output element 122 and an input element 123.
[0034] The server device 130 includes a protocol 131 and a database
132.
[0035] For further information regarding a data structure and
simplified research subject interface, and preferred embodiments of
the subject device 110, medical research expert device 120 and the
server device 130 including data base 132, see related application
Ser. No. ______, Express Mailing No. EE143637591US, filed Nov. 30,
1998 in the name of Stephen J. Brown, titled "Leveraging
Interaction with a Community of Individuals," assigned to the same
assignee, attorney docket number HHN-007, and other related
applications incorporated by reference therein.
[0036] For further information regarding the protocol or other
intelligent message used by the system, see related application
Ser. No. ______, Express Mailing No. EE143637565US, filed Dec. 1,
1998, in the name of Stephen, J. Brown, titled "Remote User Data
Collection Protocols Including Data Structures and User Interface,"
assigned to the same assignee, attorney docket number HHN-002 and
other related applications incorporated by references therein.
[0037] For information regarding a medicine dispenser which can be
used by the system, see related application Ser. No. 09/203,880,
Express Mail Mailing No. EE143637557US, filed Dec. 1, 1998, in the
name of Stephen J. Brown, et al., titled "Using a Computer
Communication System with Feedback to Dispense Medicine," assigned
to the same assignee, attorney docket number HHN-005, and other
related applications incorporated by reference therein.
[0038] For information regarding genotype and phenotype
correlation, see related application Ser. No. 08/850,840, Express
Mail Mailing No. EI113824573US, filed May 3, 1998 in the name of
Stephen J. Brown, et al. titled "System and Method for Preventing,
Diagnosing and Treating Genetic and Pathogen-Caused Disease",
assigned to the same assignee, attorney docket number RYA-128
application Ser. No 09/041,809, Express Mail Mailing No.
EE262620680US, filed Mar. 13, 1998 in the name of Stephen J Brown,
et al. titled Phenoscope and Phenobase" assigned to the same
assignee, attorney docket number RYA 136.
[0039] Method of Operation
[0040] FIG. 2 shows a process flow diagram of a method for
collecting data from human research subjects to be performed by the
system and for analyzing and reporting that data to research
experts.
[0041] A method 200 is performed by a system 100, as follows:
[0042] At a flow point 201, the system 100 is ready to proceed.
[0043] At a step 202, a medical research expert 121 enters
information concerning the type of data to be collected from a set
of subjects 111 and a protocol 131 on a medical research expert
device 120.
[0044] At a step 203, the research information and protocol 131
entered onto the medical research expert device 120 is sent to a
server device 130 using the communication network 140.
[0045] At a step 204, the server device 130 records the research
information and protocol 131 submitted by the medical research
expert 121 in the database 132.
[0046] At a step 205 in a preferred embodiment, the server device
130 sends the research information and protocol 131 to a set of
research subject devices 110 using the communication network 140.
In alternative embodiments, the server device 130 may send the
research and protocol 131 information to other medical research
experts 121 for review.
[0047] At a step 206 the set of research subjects 111 view some
portion of the protocol 131 that was sent to the set of research
subject devices 110 by looking at a presentation screen or other
output element 112 contained in the research subject device
110.
[0048] At a step 207, the set of subjects 111 respond to the
protocol 131 sent to the set of research subject devices 110 by
manipulating a keypad or other input 113 included in the research
subject device 110. Alternatively, the set of subjects 111 respond
to the protocol 131 sent to them by coupling the subject device
110, using a port 114 included in the research subject device 110,
to a medical appliance such as one or more of, or some combination
of, the following: a blood glucose meter, an oxymeter, a peak flow
meter, a blood pressure gauge, a weight scale, a pulse sensor, a
home infusion system, a CPAP sleep apnea device, a location sensing
device, a digital video camera or a drug dispensing apparatus.
[0049] At a step 208, the research subject 111 has completed
responding to the protocol 131.
[0050] At a step 209, the subject device 110 is coupled to a
communication network 140 which sends the information entered by
the subject 111 in response to the protocol 131 to the server
device 130.
[0051] At a step 210 the information received by the server device
130 is recorded in the database 132.
[0052] At a step 211, the information received from the research
subject devices 110 is aggregated and statistically analyzed.
[0053] At a step 212, in a preferred embodiment, the server device
130 sends the information received from the research subject
devices 110 to the various medical research experts 121. In an
alternative embodiment, the server device 130 does not send the
information. The information remains available on the server device
130 where it can be looked up by interested parties.
[0054] At a step 213, the information received by the server device
130 from the research subject device 110 is evaluated by the
protocol 131.
[0055] At a step 214, the protocol 131 updates the research
information and either leaves it unchanged or modifies it in
accordance with the protocol logic.
[0056] At a step 215, in a preferred embodiment, the server device
130 sends the updated research information and protocol 131 to the
set of research expert devices 121 using the communication network
140. In an alternative embodiment, the server device 130 does not
send the updated research information to the medical research
expert device 120.
[0057] At a step 216, the medical research expert 121 review the
updated information and protocol 131 and the other information
input by the set of research subjects 111 and either leave the
updated research information and protocol unchanged or modify it as
necessary. In an alternative embodiment, step 216 does not take
place.
[0058] At a step 217, in a preferred embodiment, the research
information and protocol 131 as unchanged or modified by the
medical research expert(s) 121 is sent to the server device 130
using the communications network 140. In an alternative embodiment,
step 217 does not take place.
[0059] At a step 218, the server device 130 records the modified
research and protocol 131 information sent by the medical research
expert 121 in the database 132. In an alternative embodiment, step
218 does not take place.
[0060] At a step 219 in a preferred embodiment, the server device
130 sends the research and protocol 131 information as unchanged or
as modified by the medical research expert 121 to the research
subject device 110 using the communication network 130. In an
alternative embodiment, step 219 does not take place.
[0061] At a step 220, the research subject 111 views the unchanged
or modified protocol, as they did in step 206.
[0062] At a step 221, the method repeats steps 207 through 216
until all desired information is obtained from the subject and the
protocol 131 has been completed. After sending the information to
the medical research expert(s) for final review (step 216), the
information resides in the database and the method is complete.
[0063] At a step 222, the method has completely performed a system
100.
[0064] Alternative Embodiments
[0065] Although preferred embodiments are disclosed herein, many
variations are possible which remain within the concept, scope and
spirit of the invention, and these variations would become clear to
those skilled in the art after perusal of this application.
* * * * *