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Att rn y' DocKet N 111™* PATENT ^-g* 

III T HE UNITED STATES PATENT AND TRADEMARK OFFICE S° §jj s 

In re application of: Goodman et al. Group No.: 

Serial No.: 0 / 

Filed: Examiner: 

For A Method of Incentivising Members of a Disease Management Programme 

to Comply with the Programme 
Assistant Commissioner for Patents 
Washington, D.C. 20231 

TRANSMITTAL OF CERTIFIED COPY 

Attached please find the certified copy of the foreign application from which priority is 
claimed for this case: 

Country: SOUTH AFRICA 
Application 

Number. 2000/4682 

Filing Date: 06 SEPTEMBER 2000 

WABNIHO: Wen a — that * quired ^j*^^ 

photocopy or facsimile transmission of tfie certficaUon)/ n/H aSp^ptaOpf 3/ u-w i.*FJ tempi**** 

added). 




SIGNATURE OF ATTORNEY 

Reg. No. 19,066 PHILLIP S. OBERLIN 



(type of print name of attorney) 

Tel No. f 419 ) 249-7149 MARSHALL & MELHORN, LLC 
Fax No (419)249-7151 ; 



P.O. Address 

FOUR SEAGATE - 8TH FLOOR 
TOLEDO, OHIO 43bu4 



NOTE Jne Cairn to priority need be in no special form and may be made by ti» *ttomey or agent, if the foreign 
application is referre d to in the oath or declaration, as required by § 1.63. 

CERTIFICATE UNDER 37 CFR 1.10 OF MAILING BY "EXPRESS MAIL" 

EL 469910497US 9**"fV 7/ / 

"Express Mail" Label Number ?/ te of Deposit 

I hereby certify this correspondence is being deposited with the 
United States Postal Service "Express Mail Post Office to Addressee 
service under 37 CFR 1.10 on the date indicated above and is 
addressed to the Commissioner for Patents, Washington, D.C. 



20231, 



)f'person mailing cdrr 



Signature ofperson mailing correspondence 

Kathlee n J. Moore 

Typed or printed name of person mailing correspondence 



P023 



£?>erttfikaat 



PATENTKANTOOR 



DEPARTEMENT VAN HANDEL 
EN NYWERHEID 



REPUBLIEK VAN SUID-AFRIKA °* 




REPUBLIC OF SOUTH AFRICA 



Certificate 



^00 



PATENT OFFICE 



DEPARTMENT OF TRADE 
AND INDUSTRY 



Hiermee word gesertifiseer dat 

This is to certify that documents at t a ched hereto are true copies of the Forms P2, P6, 

provisional specification and drawings of South African Patent Application No. 2000/4682 in 
the name of Discovery Health Limited 



Filed 
Entitled 



6 September 2000 

A Method of Incentivising Members of a 
Disease Management Programme to 
Comply with the Programme 



Getekente p D r TnD ,A indie Republiek van Suid-Afrika. hierdie // dag van ^^~^^t 
Signed at ™- 1 UM,A in the Republic of South Africa, this / day-of / ff 7~ 7 (7^^ f 




G.P.-S. 019-0096 



SPOOR AND FISHER 



APPLICATION FOR A P^TE^J. „ 

AND ACKNOWLEDGEMENT OF R ECEIPf ■ oA0 °. 
(Section 30 (1) - Regulation 22) 



The 



21 



s 0 :60.00 

HASH 505 

le granting of a patent is hereby requested by the undermentioned applicant orf^he basis of the pf$S£iit application filed in duplicate 

- Ll\=J REPUBLIEK VAN SUtD AFRIKA f=7^T 
^IAL APPLICA 



REPUBLIC OF SOUTH AFRI 
PATENTS ACT, 19J8 



SAPUBLIC OF SOUTH AFRICA Rvn , 
REVENUE TORktf>.1 



OFFICIAL APPLICATION NO 



01 



S & F REFERENCE 



PA129488/P 



FULL NAME(S) OF APPLICANT(S) 



71 


DISCOVERY HEALTH LIMITED 


?FGISTRAR OF PATENTS. DESIGNS, 
.JADE MARKS AKO C0PYR8GKT r 




ADDRESS(ES) OF APPLICANT(S) 








25 FREDMAN DRIVE, SANDTON, GAUTENG, SOUTH AFRICA 


2000 -09- 06 




TITLE OF INVENTION 






54 


A METHOD OF iHCENTIVISllvlG MEMB^kS OP A DlS£AS£ MANIAC 
WITH THE PROGRAMME 


HAMDELSMERKE EN OUTLURSREG 





THE APPLICANT CLAIMS PRIORITY AS SET OUT ON THE ACCOMPANYING FORM P.2. THE EARLIEST PRIORITY CLAIM IS: 



COUNTRY: NIL 



NUMBER: NIL 



DATE: NIL 



THIS APPLICAT I ON I S FOR A PATENT OF ADD I TION TO PATENT APPLICAT I ON NO. 



21 



01 



THIS APPL I CAT I ON IS A FRESH APPLICAT I ON IN TERMS OF SECT I ON 37 AND I S BASED ON APPL I CAT I ON NO. 









21 


01 





THIS APPLICATION IS ACCOMPANIED. BY: t 

v 

E<] . 1 . A single copy of a provisional specification of 14 pages. 

D 2. Drawings of sheets 

□ 3. Publication particulars and abstract (Form P.8 in duplicate). 

□ 4. A copy of Figure of the drawings (if any) for the abstract. 

□ 5. Assignment of invention. 

□ 6. Certified priority document. 

□ 7. Translation of the priority document. 

□ 8. Assignment of priority rights. 

□ 9. A copy of the Form P.2 and the specification of SJK. Patent Application No . 

□ 10. Declaration and power of attorney on Form P.3. 

□ 11. Request for ante-dating on Form P.4. 
Q 12. Request for classification on Form P.9. 
S 13. Form P.2 in duplicate. 

□ 14. Other. 



74 ADDRESS FOR SERVICE: SPOOR AND FISHER, SANDTON 



Dated: 6 September 2000 



SPOOR AND FISHER 
PATENT ATTORNEYS FOR THE APPLICANT(S) 





TsiSTKAirOf PATE UTS, DESIGNS, 

;AOE tfBjfi&WiB COPYRIGHT 






! 2000 -09- 06 ; 






R.-.'oTRATEiJr VAN PAIfcNIt, MUUfcLll. 
MANRFISMFBKE EN OUTEURSREG 




REGISTRAR OF PATENTS 




FORM P.2 



REPUBLIC OF SOUTH AFRICA REGISTER OF PATENTSFt~ PATENTS ACT, 1 978 



OFFICIAL APPLICATION 


LODGING DATE: PROVISIONAL 


ACCEPTANCE DATE 


21 


2UUU4bbY 


22 


6 SEP 2000 


47 




INTERNATIONAL CLASSIFICATION 


LODGING DATE: COMPLETE 


GRANTED DATE 


51 




23 








FULL NAME(S) OF APPLICANT(S)/PATENTEE(S) 




71 


DISCOVERY HEALTH LIMITED 




APPLICANTS SUBSTITUTED: 






DATE REGISTERED 


71 










ASSIGNEE(S) 


DATE REGISTERED 


71 




* 






FULL NAME(S) OF INVENTOR(S) 




72 


1. GOODMAN, MAURICE RONAN 

2. MANSON, LORI 

3. NOSSEL, CRAIG 


PRIORITY CLAIMED 


COUNTRY 


NUMBER 


DATE 


N.B. Use International 
abbreviation for country 
(see Schedule 4) 


33 


NIL 


31 


NIL 


32 


NIL 


TITL 
54 


E OF INVENTION 

A METHOD OF INCENTIVISING MEMBERS OF A DISEASE MANAGEMENT PROGRAMME TO COMPLY 
WITH THE PROGRAMME 


ADDRESS OF APPLICANT(S)/PATENTEE(S) 




25 FREDMAN DRIVE, SANDTONGAUTENG 


ADDRESS FOR SERVICE 


DOR AND FISHER, SANDTON 


S AND F REF 


74 


SP< 


PA129488/P 


PATENT OF ADDITION NO. 


DATE OF ANY CHANGE 


61 






FRESH APPLICATION BASED ON 


DATE OF ANY CHANGE 







\ 



SPOOR AND FISHER 



REPUBLIC OF SOUTH AFRICA 
PATENTS ACT, 1978 

PROVISIONAL SPECIFICATION 

(Section 30(1) - Regulation 27) 



OFFICIAL APPLICATION NO. LODGING DATE 



21 


01 20004682 22 6 SEPTEMBER 2000 


FULL NAMES OF APPLICANTS 


71 


DISCOVERY HEALTH LIMITED 

• 


FULL NAMES OF INVENTORS 


72 


GOODMAN, MAURICE RONAN 
MAN SON, LORI 
NOSSEL, CRAIG 

i 


TITLE OF INVENTION 


54 


A METHOD OF INCENTIVISING MEMBERS OF A DISEASE MANAGEMENT PROGRAMME TO 
COMPLY WITH THE PROGRAMME 



1 



20004682 



BACKGROUND OF THE INVENTION 

This invention relates to a method of incentivising members of a disease 
management programme to comply with the programme. 

Known disease management programmes typically face the major problem of 
poor patient compliance with an enforced, funder driven programme. 

It is therefore an object of the present invention to provide a method of 
incentivising members of a disease management programme to comply with 
the programme in order to address this problem. This effectively changes the 
programme from a supply side "push" to a demand side "pull" programme. 



20004682 



-2- 

SUMMARY OF THE INVENTION 

According to a first embodiment of the present invention, there is provided a 
method of incentivising members of a disease management programme to 
comply with the programme, the method comprising the steps of: 

defining a plurality of general programme areas and a plurality of 
specific programme areas; 

associating each of the plurality of general programme areas with each 
of the diseases managed by the programme; 

associating* each of the plurality of specific programme areas only with 
those diseases managed by the programme to which the specific 
programme area is deterrhined to be of particular benefit to a member 
afflicted with the disease; 

awarding points to a member for each of the programme areas in which 
the member participates, only if the member is afflicted with a disease 
which is associated with that particular programme area; and 

allocating a reward to the member if the points awarded to the member 
accumulate to a predetermined amount 

Preferably, points are only awarded to the member if the member participates 
in all of the programme areas which are associated with the disease or 
diseases with which the member is afflicted. 

Alternatively, additional points are awarded to the member if the member 
participates in all of the programme areas which are associated with the 
disease or diseases with which the member is afflicted. 



20004682 

-3- 

The general programme areas may be diet, exercise, smoking and education. 

The specific programme areas may be blood pressure, flow volume loop 
measurement, influenza vaccine, pneumococcal vaccine, cholesterol and long 
term glucose control. 

According to a second embodiment of the present invention there is provided a 
method of incentivising members of a disease management programme to * 
comply with the programme, the method comprising the steps of: 

defining a plurality of general programme areas and a plurality of 
specific programme areas; . 

associating each of the plurality of general programme areas with each 
of the diseases managed by the programme; 

associating each of the plurality of specific programme areas only with 
those diseases managed by the programme to which the specific 
programme area is determined to be of particular benefit to a member 
afflicted with the disease; 

defining a measurable within each of the general and specific 
programme areas so that a member's performance within said 
programme area can be ascertained; 

defining a minimum level for each measurable, which minimum level 
indicates a minimum required level of member performance within each 
of the programme areas; 



- *?- 20004682 

-4- 

awarding points to a member if the member obtains the minimum level 
of a measurable for a particular programme area only if the member is 
afflicted with a disease which is associated with that particular 
programme area; and 

allocating a reward to the member if the points awarded to the member 
accumulate to a predetermined amount. 

Preferably, additional points are awarded to the member if they obtain the • 
minimum level of a measurable for all of the programme areas which are 
associated with the disease with which the member is afflicted. 

DESCRIPTION OF AN EMBODIMENT 

According to the present inventioh, people suffering from one or more of a list 
of predetermined diseases qualify to become members of the disease 
management programme of the present invention. 

For illustrative purposes, the invention will be described with reference to the 
following conditions: 

1. Hypertension. 

2. Diabetes Mellitus. 

3. Hyperlipidaemia. 

4. Asthma. 

5. Chronic Obstructive Pulmonary Disease (COPD). 

It will be appreciated that the method of the present invention could be equally 
applied to any other disease or condition, and is particularly suitable for any 
other type of chronic disease. 



^ 200046 82 

-5- 

_ According to the invention, a plurality of general programme areas and specific 
programme areas are defined. Each of the diseases managed by the 
programme are associated with each one of the general programme areas, 
while the specific programme areas are only associated with those diseases 
managed by the programme to which they would be of particular benefit to a 
person stricken by that disease. 

For the illustrative diseases of the present invention, the table below shows the 
general and specific programme areas: 



DESCRIPTION OF THE PROGRAMME 







General 




Specific 




r ^ 


r 














Diet 


Exercise 


Smoking 


Education 


Blood 
Pressure 


Flow 
Vol 
Loop 


Flu 
vaccine 


Pneumo 
vaccine 


Choles- 
terol 


Long 
term 
glu- 
cose 
control 


Hyper- 
tension 




•H '■* f 


" 1 . >- 1 ■ v 
.* . ) - - "■ 
















Asthma 


w V . *Z ■ ■ 


_^.. g , ; . . ...... 


















Hyper- 
lipidaemia 






















COPD 


■ ' ■ %■ ' : 




















Diabetes 
Mellitus 























It will once again be appreciated that the general and specific programme 
areas selected could include other general or specific programme areas if 
these were found to be particularly beneficial to a person stricken with a 
disease managed by the programme. 



-6- 



Furthermore, if it was found that one of the general or specific programme 
areas were not particularly beneficial to a person stricken with the disease, 
these could be removed from the programme, either altogether or for a 
particular disease only. 

It is obvious that these programme areas may be relevant even to a person not 
stricken with one of the illustrated diseases. However, a programme area is 
only linked to a disease if there is some particular advantage that the 
programme area would have for a person afflicted with the disease over and 
above the advantage the programme area would have for a person not 
afflicted with the disease. 

Referring to the above table, and.using hypertension as an example, all the 
general programme areas of diet, exercise, smoking and education are 
important for the disease management of a person with hypertension. 

Furthermore, the specific programme areas of blood pressure measurements 
and cholesterol are important to a person with hypertension. However, flow 
volume loop, an influenza vaccine, a pneumococcal vaccine and long term 
glucose control are not of particular importance to a person with hypertension 
only. 

For each one of the diseases managed by the programme, a member of the 
programme will be awarded points either for participating in a relevant 
programme area and/or for complying with a required level of performance 
within the programme area only if the member is afflicted with a disease which 
is associated with that particular programme area. The points allocation will be 
described in more detail below. 

Thus, a person afflicted with hypertension is awarded points for complying with 
a required level of performance within the programme areas of diet, exercise, 



• 



-7- 

. smoking, education, blood pressure and cholesterol, but will not be awarded 
points for participating and/or complying with a required level of performance 
within the programme areas of flow volume loop and long term glucose control, 
unless the person also suffers from another disease which may have these 
areas associated. 

It is obviously important that each of the programme areas have measurables 
by means of which it is possible to test whether a member of the programme is 
complying with a required level of performance for that particular programme • 
area. 

For the general programme area of "diet", three possible measurables are the 
body mass index, the percentage, body fat of the member or a goal weight 
certificate from an accredited weight organisation such as Weigh-Less ™. 

A minimum level of performance is achieved if a member's body mass index or 
percentage body fat result is within the acceptable range depending on the 
member's age and gender, or if the member obtains a goal weight certificate, 
for example, from Weigh-Less, at one point in the year. 

The cost of obtaining the body mass index measurement, the percentage body 
fat measurement or the goal weight certificate is typically borne by the 
member. 

The measurable for the general programme area of "exercise" is two fitness 
assessments per year, at least five months apart. The member will have 
complied with the minimum acceptable level if they maintain at least a 
predetermined level of fitness. If a member's disease prohibits them from 
obtaining the required fitness level, as may be the case with COPD or any 
another physical impairment, this should be taken into account by the fitness 
assessor. 



-8- 

The measurable for the general programme area of "smoking" is a urine 
cotinine test, with the obvious minimum level of performance being that the test 
must be negative. 

It is also possible to perform the urine cotinine test on a random selection of 
members. However, because it is essential that patients with hypertension, 
hyperlipidaemia, diabetes mellitus, asthma and COPD do not smoke, this test 
should be performed on all members with these chronic illnesses. 

The measurable for the general programme area of "education" is a 
questionnaire prepared by the managers of the disease management 
programme. Members need only complete the questionnaire once off and 
thereafter at the discretion of the managers of the disease management 
programme. The minimum level'of performance is merely that the member 
completes the questionnaire either on-line using a computer or together with a 
qualified person who can correct the member when the member gives a wrong 
answer, thereby educating the member. 

Turning now to the specific programme areas, the measurable for "blood 
pressure" is two blood pressure measurements per year, at least five months 
apart. 

A typical minimum acceptable level for the blood pressure measurements is 
equal to or less than 140/90 mmHg. 

The measurable for "flow volume loop" is 3 flow volume loop measurements 
per year, each at least three months apart. A typical minimum acceptable 
level for Asthma patients is as follows: 

FEVt > 80% predicted 



-9- 

. FVC > 80% predicted 
TLCO > 80% predicted 
FEVi/FVC > 80% predicted . 

As COPD is not reversible, there is no minimum acceptable level for a COPD 
patient. 

The measurable for the "influenza vaccine" is one approved vaccination per 
year between 1 March and 30 April when the programme is managed in the 
Southern Hemisphere. In this case, the minimum acceptable level is equal to 
merely performing in this programme area. 

The measurable for the specific programme area of "pneumococcal vaccine" is 
once every five years for high-risk patients. 

The measurable for the specific programme area of "cholesterol" is a 
cholesterol screening test or a fasting cholesterol test, once a year for 
members with hyperlipidaemia, hypertension and diabetes mellitus. The 
following are the minimum acceptable levels: 



Cholesterol 


Level 


Total 


< 5 mmol/L 


LDL-C 


< 3 mmol/L 


HDL-C 


< 1 mmol/L 



The measurable for the specific programme area of "long term glucose control" 
is an HbA1c test which is a glycosylated haemaglobin test which measures the 
patient's glucose control during the preceding three months. A member must 
obtain two measurements per year, at least six months apart. An acceptable 
minimum level is a test result of 7% or less. 



\ 



-10- 



Turning now to the points allocation, according to the present invention the 
points are allocated to members based on a multi-level system. On the first 
level, a. member. is awarded points for merely taking part in a programme area 
associated with their disease. Thus a member merely going for a fitness 
assessment will be awarded points regardless of the results of the 
assessment. 

Where a member is afflicted with more than one disease, they will be awarded 
points for taking part in a programme area associated with any of their 
diseases. Where a programme area is associated with more than one 
disease, the member will only be awarded points once for taking part in that 
programme area. 

The second level of the points allocation system is that a member will be 
awarded an even greater number of points for taking part in all of the 
programme areas associated with the disease with which the member is 
afflicted. This is because it is more important for members to take part in all of 
the programme areas than if they were only to take part in some of the 
programme areas. Thus, the points are awarded so that a member obtains 
bonus points for participating in all of the programme areas. It will be 
appreciated that the points allocation could be set up so that a member only 
gets allocated points if they participate in all of the programme areas. 

Where a member is afflicted with more than one disease, they will have to take 
part in all of the programme areas associated with all of the diseases with 
which the member is afflicted to obtain their level two bonus points. 

The third level of points allocation occurs if the member actually attains a 
minimum level for a measurable of a programme area associated with their 
disease or diseases. Thus, it is not merely the member's participation in the 



programme area which is required, but the member must attain an acceptable 
minimum level within that programme area before they will be awarded points. 

Once again, where a member is afflicted with more than one disease, they will 
be awarded points for obtaining an acceptable minimum level within a 
programme area associated with any of their diseases. Where a programme 
area is associated with more than one disease, the member will only be 
awarded points once for taking part in that programme area. 

For some diseases, the acceptable minimum level is more stringent than for 
others to obtain level three points. Thus a member afflicted with more than 
one disease must meet the most stringent acceptable minimum level to obtain 
these points. ^ 

The final level of points allocation is if the member attains the acceptable 
minimum level for a measurable in all of the programme areas associated with 
their disease or diseases. 

As with level two, where a member is afflicted with more than one disease, 
they will have to attain the acceptable minimum level for a measurable in all of 
the programme areas associated with all of their diseases to obtain their level 
four bonus points. 

It will be appreciated that the present invention can be implemented using the 
points allocation of all of the abovementioned levels, or the present invention 
can be implemented using a combination of only some of these levels. 

The prototype of the present invention was implemented using the first, second 
and third levels. 



For example,. a member who has hypertension earns first level points by 
participating in the general and specific programme areas associated with the 
disease. 

In the prototype, these points are as follows: 

Diet -5000 
Exercise - 15 000 
Smoking - 5 000 
Education - 1 000 
Blood Pressure - 1 000 
Cholesterol - 2 000 

For participating in all of the programme areas associated with a disease, a 
member will typically obtain the above points together with an additional 4 000 
bonus points. This is the second level of the points allocation system. 

On the next level of the points allocation, the member is awarded 600 points 
for achieving the minimum level within each programme area, as described 
above. Thus, a member with hypertension is able to earn 3 600 extra points in 
total on this level, while a member with Diabetes Mellitus is able to earn an 
extra 5 400 points on this level. 

Finally, if the member achieves the minimum levels for all of the programme 
areas for a particular disease, the member is awarded another suitable amount 
of bonus points. This level was not implemented in the prototype of the 
invention, but is an obvious extension of the prototype of the invention. 

Once the points awarded to a member accumulate to a predetermined amount, 
the member is rewarded in an appropriate way. The reward may be a cash 
payout, special options on services such as aeroplane tickets and/or car 



^ 20004682 



rentals or any other appropriate reward. The amount of the reward is related to 
the amount of points accumulated by the member, so the more points a 
member accumulates the more they are rewarded. 

Thus it will be appreciated that the present invention incentivises members to 
comply with the disease management programme. 

It will also be appreciated that the present invention could be applied where the 
members of the programme do not yet have a disease, but are identified as* 
being in a high risk group for a particular disease. In this case, by being 
incentivised to comply with the programme, the member's health is protected 
thereby hopefully preventing them from contracting the disease. 

Furthermore, the present invention could equally be applied to incentivise 
doctors to help their x patients Comply with the programme. Thus, a doctor 
whose patient obtains points for any of the various levels could also be 
awarded points, thus incentivising the doctor to further encourage the patient 
to comply with the programme. 

Dated this 6 th day of September 2000 

$y 

SPOOR AND FISHER ' 
APPLICANTS PATENT ATTORNEYS 



\