EN

EUROPEAN QUALIFYING EXAMINATION 2023

Paper B

This paper comprises:

* Description of the application 2023/B/EN/1-6

* Claims 2023/B/EN/7

* Drawings of the application 2023/B/EN/8-10

* Communication 2023/B/EN/11-12

* Document D1 2023/B/EN/13-15

* Document D2 2023/B/EN/16-17

* Client‘s letter 2023/B/EN/18-20

* Amended claims 2023/B/EN/21

2023/B/EN
0-1
 Inhalt (7 Seiten „Beschreibung der Anmeldung“ und „Ansprüche“)
nur auf dem Bildschirm während der Prüfung verfügbar

Content (7 pages „Description of the application“ and „Claims“) only

Contenu (7 pages „Description de la demande“ et

Drawings of the application

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 Drawings of the application / Page 2 of 3

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6
6
6

FIG. 2

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 Drawings of the application / Page 3 of 3

Light source Sample compartment Array detector

FIG. 3

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 Inhalt (2 Seiten „Bescheid“) nur auf dem Bildschirm während der
Prüfung verfügbar

Content (2 pages „Communication“) only available on screen during

Contenu (2 pages „ Notification “) uniquement visible sue l‘écran

Document D1: GB1234321

Description
[001] Easy and accurate measurement of glucose levels in blood is very important. A
5 person with diabetes needs to monitor their glucose levels up to seven times a day.
Based on this measurement, the amount of insulin to be injected is determined. The
measurement should be quick and accurate. As the measurement has to be performed
several times a day, it is impractical that such a measurement is performed by a medical
professional. The measurement should be what is known as a lay-operator
10 measurement, preferably performed by the patient.

[002] There are many systems currently on the market that can perform such
measurements. However, most of these measurements require several manipulations by
the user. However, in the last years a new type of system has taken over the market.
15 This is a system in which a disposable strip is placed in a measurement device. A
droplet of blood is placed on the strip and is analysed in the device. A droplet of blood
has a volume of at least 5 µl.

[003] Such a strip is illustrated in Figures 1A and 1B. Figure 1A shows the strip from
20 above, whereas Figure 1B shows the strip from below. The strip (1) has a reagent
part (2), which is attached to the strip using adhesive. Opening (3) is for access of the
light source to the reagent part. A droplet of blood is applied at (4), which is transported
to the reagent part by capillary action along a capillary (5). The strip is inserted in the
device with the side of the reagent part first. The shape of the opening (3) is chosen,
25 such that the strip clicks into place.

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[004] The device comprises an opening for inserting the strip, and a spectrophotometer,
which measures light intensity at 635 nm. The spectrophotometer comprises a light
source, a monochromator, a sample compartment, and a detector, as shown in Figure 2.

5 [005] The present invention concerns the reagent strip. On the one hand, this strip
separates red blood cells from the rest of the blood. The rest of the blood, mostly
plasma, reacts with two different reagents to generate a colour that can be analysed by
a spectrophotometer. The plasma first reacts with an enzyme called peroxidase, which
generates hydrogen peroxide from the glucose in the blood. The hydrogen peroxide then
10 reacts with a dye system to generate the colour. The colour intensity is linearly
determined by the amount of hydrogen peroxide and thus by the amount of glucose in
the blood.

[006] The reagent strip comprises a membrane that separates the red blood cells from
15 the rest of the blood and comprises reagents that react with the permeate to make the
sugar level visible. The reagents are as described above. The membrane is made of a
hydrophilic material. Preferably, polyamide membranes are used, such as nylon. The
membranes have a smallest pore diameter of 0.1 to 5 µm. At these pore diameters, a
good separation of red blood cells from the plasma is possible without too much lysis of
20 the cells.

Claims
1. Strip for measuring blood sugar levels, comprising a capillary and a hydrophilic
25 membrane having a smallest pore diameter of between 0.1 and 5 µm.

2. Device for measuring blood sugar levels for use with a strip as defined in claim 1,
comprising an opening for inserting the strip, and a spectrophotometer, which performs
measurement at 635 nm.
30

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Drawings D1:

Light source Monochromator Sample compartment Detector

FIG. 2

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 Document D2 / Page 1 of 2

Document D2: EP1234567 (Article 54(3) EPC)

Description
[001] This application is concerned with a membrane that is used in devices for the
5 measurement of blood sugar levels, mostly for people with diabetes.

[002] To mitigate the consequences of diabetes, people with the condition should
measure their blood glucose level two to seven times a day, depending on the nature
and severity of their individual case. Based on the observed pattern in the measured
10 glucose levels, the patient and physician together make adjustments in diet, exercise
and insulin intake to better manage the disease. The measured glucose levels should be
available to the patient immediately, through the use of a simple-to-use meter and strip
system that is rapid, inexpensive, and accurate.

15 [003] For such measurements to be performed, it is necessary that the red blood cells
are separated from the rest of the blood, so that the plasma is retained. The sugar level
measurements are performed on the plasma. GB1234321 teaches us to separate the
blood using a membrane. These membranes have a constant pore size. Good
separation of the red blood cells is reported. However, it was found that some cell lysis
20 takes place. This means that some red blood cells break apart. These parts will also
pass the membrane and influence the measurement of the sugar level.

[004] We have now found an improved membrane that avoids most of the lysis of the
red blood-cells. In addition, the improved membrane leads to a more accurate
25 measurement of the sugar level. Our improved membrane does not have a uniform pore
size, but has a gradient of pore size, from large to small. Membranes may have pores
that taper in diameter from 200 µm on the upper membrane surface to 0.1 µm on the
lower. On the upper surface, the pore size is preferably in the range of 30 µm to 100 µm.
On the lower surface, the smallest pore size ranges from 0.1 to 5 µm. The membranes
30 have a thickness of around 200 µm. The membrane should not be too thick, otherwise
the pressure drop through the membrane will be too high.

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[005] The membrane can be any kind of hydrophilic membrane, i.e. a membrane that
has affinity with water.

[006] The membrane can be used in known strips, which can in turn be used in
5 conventional devices for blood sugar measurement. In these devices, glucose level is
measured by measuring light intensity at a wavelength of 635 nm. The measurement is
performed using a spectrophotometer.

[007] The colour that is measured based on the light intensity is generated by an
10 oxidation reaction in the strip. The strip contains an enzyme, glucose oxidase, which
oxidises the glucose to gluconic acid and hydrogen peroxide. The hydrogen peroxide
then reacts with a dye to produce a colour. The colour intensity is a measure of the
amount of glucose in the blood.

15

Claims
1. Membrane for use in a strip for measuring blood sugar levels, which is hydrophilic
and which is characterised in that the membrane has pores that taper in diameter from
200 µm on the upper membrane surface to 0.1 µm on the lower.
20

2. Strip for measuring blood sugar levels, comprising a capillary and a membrane as
defined in claim 1.

2023/B/EN/17
 Inhalt (4 Seiten „Schreiben des Mandanten“ und „Geänderte
Ansprüche“) nur auf dem Bildschirm während der Prüfung verfügbar

Content (4 pages „Client‘s letter“ and „Amended claims“) only

Contenu (4 pages „Lettre du client“ et „Revendications modifiées“)