Our attempt at e-EQE Paper B 2023 - Strips for testing blood sugar
Here's our attempt at this year's paper B. This year's paper concerned strips for testing blood sugar levels and devices that use them. The paper was not very mechanical, with the main feature for claim 1 being a range. Some hard decisions were expected from the candidates regarding the novelty of the claims in light of a 54(3) document.
You can find our solution by clicking on "Read more" below.
We look forward to your comments!
Comments are welcome in any official EPO language, not just English. So, comments in German and French are also very welcome!
Please do not post your comments anonymously - it is allowed, but it makes responding more difficult and rather clumsy ("Dear Mr/Mrs/Ms Anonymous of 15-03-2023 22:23"), whereas using your real name or a nickname is more personal, more interesting and makes a more attractive conversation. You do not need to log in or make an account - it is OK to just put your (nick) name at the end of your post.
The first objection of the Examiner that we need to address is the alleged lack of novelty of Claim 1. Comparing Claim 1 as filed with D1 shows that all features are disclosed there, so we'll need to amend. Fortunately, the client provides us with a proposal: strike the word 'hydrophilic', and incorporate claim 2.
Striking 'hydrophilic' from the claim is a broadening of the claim. This would be allowed if this passed the gold standard: could the skilled person have derived non-hydrophilic embodiments from the application? Although hydrophilic is nowhere explained as essential, there seems to be no indication that hydrophilic is optional either. Accordingly, this suggestion of the client seems to be added subject matter. Perhaps, Bad Sugar PLC, can file a new application for their hydrophobic strips, as none of the cited art discloses such strips either.
Incorporating claim 2 into claim 1 is not added subject matter, though one could wonder about striking the part 'the smallest pore diameter', but as the pore sizes tapers from large to small, this seems to be implied by the claim 2 text. When in doubt you could leave this part of claim 1, it should not make much of a difference.
The real question is, is the claim that we get novel over the cited art. For D1 this is not a problem as the tapering of pore size is not in D1. D2 however discloses all of new Claim 1 (note the capillary in D2's claims), except for feature (c) 'an opening for measurement and putting into place the strip, the opening being present in the reagent part'.
There are two spots in D2 where one could wonder if they disclose feature (c).
The first one is in D2, [03], which has a reference to D1. D1 does disclose feature (c). In principle, it is allowed for a prior art document to reference another document (gl. G-IV, 8), but this reference seems to have problems. First, it is not clear from D2 that this reference is even meant to fill-in the disclosure of their embodiment. Section [03] merely describes the prior art, not the new embodiments of D2. Second, the disclosure is specific for blood separation, not on the opening, or even blood sugar measurement. So, D2, [03], seems not enough.
The second spot in D2 is section [06]. Here it is disclosed that D2's strip can be used in 'conventional devices for blood sugar measurement'. All the conventional devices that we know of, and in particular, the one referred to in D1, have feature (c). So one might argue that feature (c) is implicitly disclosed in D2. However, the bar for implicit disclosure is a high one, it should be inevitable that a conventional device has the opening. It's not my technical field, but I guess other options are possible. So section [06] is also not enough.
This means that this amendment of the client makes Claim 1 novel. There was a small antecedent error in Claim 1, which we have also corrected.
Inventiveness needs to be argued, but as there is only one 54(2) document this seems straightforward.
For Claim 2, as it is now in Claim 1, the normal approach would be to strike the claim. But as the claim is there, we've opted to amend it to a fallback range, restricting the diameter on the upper membrane. This would make the claim novel over D2 even if the D2 as whole might be considered as incorporating feature (c) from D1. We don't think this amendment is needed.
Claim 3 contains an error which the client wants to have corrected. The legal basis for this correction would be R.139, second sentence. We need to ask if it is immediately evident that an error has occurred, and what the correction should be (gl. H-VI, 2.2.1). That an error has occurred seems obvious; drawing 3-5 ml of blood from a finger seems a serious injury. The examiner seems to agree with this. We'll argue that the units, not the values are wrong, using common general knowledge of a droplet as evidenced by an article in Blood Science and Technology, that we'll file with our letter. Auxiliary reference can also be made D1 as further evidence.
Claim 4 did not need amendments.
Claim 5 as filed is not novel, as existing devices are suitable for the new strips as well. In the application there a new device is disclosed specially suited for the new strips. Although the new device uses a known spectrophotometer, the combination with an opening for inserting the strip seems to be novel. As to the amendment itself one could doubt whether the 'array detector' needs to be incorporated in the amended claim 5. As the description seems to state that this is the only option, we've included it in the claim.
There are other ways to make claim 5 novel. For example, one could turn claim 5 into a use claim ('use of device for measuring blood') in this way the suitability becomes a hard feature. Alternatively, one could try a kit claim that has the strip and the device. But as both of these options get their inventiveness from the strip, the scope of protection does not appear to be improved for the client.
For claims 1 and 5 we also need to address R.43(2), and maybe unity as well. For the former, we'll argue that the claims fall under the exception of R.43(2)(a) plurality of interrelated products. This is an example, of a plug and socket claim (gl. F-IV, 3.2).
Our claim amendments are thus:
1. Strip for measuring blood sugar levels, comprising:
(a) a reagent part
comprising a membrane
(b) a capillary for
transporting a blood sample to thea
reagent part
(c) an opening for
measurement and putting into place the strip, the opening being present in the
reagent part;
characterised in that
the membrane is a hydrophilic membrane in
which the pores of the membrane taper in diameter from 30 to 100 µm on the
upper membrane surface to 0.1 to 5 µm on the lowerhaving a smallest pore
diameter of between 0.1 and 5 µm.
2. Strip according to
claim 1 in which the pores of the membrane taper in diameter
from 30 to 100 µm upper lower membrane surface to taper in diameter from 0.13 to 15
µm on the lower.
3. Strip according to
claims 1 or 2 that can perform a measurement on a blood sample of 3 to 5 µlml.
4. Strip according to any of claims 1 to 3 in which
the reagent is attached to the strip using adhesive.
5. Device for measuring blood sugar levels for use
with a strip as defined in claims 1 to 4, comprising an opening for inserting
the strip, and a spectrophotometer, which uses an array detector, which is able to detect light of several
wavelengths, including
a wavelength of 635 nm and
an additional wavelength to
perform the measurement.
Edit 15/3: removed duplicate 'uses' in claim 5
We look forward to your comments!
Sander, Jelle, Roel
(c) DeltaPatents
Annex - the complete paper - copied from Wiseflow "EPO – EQE Compendium" (added 16/3/2023)
NB: when copying, the line numbering, table and formatting of the amended claims got lost - we did a best-effort reformatting of the table and the amended claims. Please click on the figures for a full-size view.
EUROPEAN
QUALIFYING EXAMINATION 2023
Paper B
This paper
comprises:
* Description
of the application
* Claims
* Drawings of the application (pre-printable)
* Communication
* Document D1 (pre-printable)
* Document D2 (pre-printable)
* Client‘s letter
* Amended claims
* Description of the application
Description
of the application
[001]
Diabetes is a long-term condition that arises because of changes in the way in
which insulin is produced and used. Insulin is a hormone that facilitates the
uptake of
glucose by cells to produce energy and promotes the storage of glucose as
glycogen.
Lack of insulin causes the levels of blood glucose to rise, with potentially
life-threatening
results.
[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
glucose levels, the patient and physician can 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.
[003] The most commonly-used systems for determining blood sugar levels
comprise a
strip which is inserted in a device for the determination of blood sugar level.
The patient
puts a droplet of blood on the strip, which is then analysed in the device. The
blood can
be transported within the strip by several mechanisms. The most usual and
preferred
method is by capillary action. This mechanism is used in most devices on the
market
today. Capillary action is the drawing of a liquid into a narrow tube of the
strip.
[004]
Figures 1A and 1B show the strip, Figure 1A being a view from above, and Figure
1B a view from below. The strip (1) has a reagent
part comprising a membrane (2). An
opening (3) allows a light source to access 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 shape of the opening (3) is chosen such that the strip clicks into place in
the
measurement device. Figure 2 shows a detailed view of the membrane (2). Pores
(6)
extend through the membrane from the upper to the lower surface. The
representation
of the pores is schematic. The actual number of pores is much larger.
[005] Glucose cannot be measured directly but needs to be converted in the
strip.
First, the strip separates red blood cells from the rest of the blood. The rest
of the blood,
mostly plasma, reacts with two different reagents in the strip to generate a
colour that
can be analysed by a spectrophotometer. This works as follows. The plasma first
reacts
with an enzyme called glucose oxidase, which generates hydrogen peroxide and
gluconic acid from the glucose in the blood. The hydrogen peroxide then reacts
with a
dye system to generate the colour. The colour intensity is linearly dependent
on the
amount of hydrogen peroxide and thus on the amount of glucose in the blood. All
of
these reagents are well known in the art and can be obtained commercially, for
example
from Glucosic Inc.
[006] The colour is analysed by measuring the intensity of light that is
reflected when the
colour is exposed to the light source. The measurement is performed using a
spectrophotometer. A spectrophotometer is an instrument used to determine the
relative
intensity of various wavelengths in a spectrum of light. In the present case,
the relative
intensity is measured at a wavelength of 635 nm.
[007]
Before the reaction can take place, the blood needs to be separated so that the
red blood cells are separated from the plasma. The separation should take place
with as
little as possible cell lysis, which is the breaking of cells. Such broken
cells influence the
measurement in the spectrophotometer. Also, as few as possible red blood cells
should
remain in the plasma, because these red blood cells have a negative influence
on the
light measurement as well.
[008] We have now devised a membrane that separates the red blood cells in a
very
effective way, while at the same time almost completely avoiding cell lysis.
This means
that the analysis can be done with less blood. This is an advantage for older
people who
often release very little blood from their fingers and who often need, with
current
systems, a second or third try to release sufficient blood for a reliable
measurement.
[009] A membrane is a solid structure with pores. Some components of a liquid
mixture
can pass through the pores, whereas others cannot, thus performing the
separation. A
membrane like ours is able to separate red blood cells from a blood sample.
What
remains after the separation is the glucose-containing plasma. To achieve this
separation, the membrane needs to have suitable pore sizes. In general, the
smallest
pore sizes used have a diameter from 0.1 to 5 µm. In a preferred embodiment,
the
membrane does not have a uniform pore size, but a pore size that tapers in
diameter
from the upper to the lower membrane surface. For example, pore diameter may
taper
from 100 µm on the upper membrane surface to about 0.1 µm on the lower. On the
upper surface, the pore size is preferably in the range 30 µm to 40 µm. The
pore size on
the lower surface is preferably in the range 0.1 to 1.0 µm, with a pore size of
0.3 to
1.0 µm being preferred. Optimum results are obtained at a pore size in the
range of 0.4
to 0.6 µm.
[010]
The optimum pore size of 0.5 µm is a balance between separation efficacy and
separation speed. When the pore size is 0.1 µm the separation is best, but the
separation takes a relatively long time, which is disadvantageous for the user
of the
device. In the examples, we always use a membrane with a smallest pore size of
0.5
µm, but any pore size of between 0.1 and 1.0 µm can be used.
[011] The membranes are hydrophilic, which means that they have affinity for
aqueous
(water-based) media. They are preferably made of polyamides. A well-known
polyamide
is nylon. Most types of nylon are suitable for use in
the strip of the invention. The
membranes as such are known and are normally used in micro-filtration in
general. The
membranes are commercially available, for example from Permembrane Inc.
[012] Membranes where the pore diameters taper from the upper to the lower
membrane surface have several advantages. Most importantly, the red blood cells
can
be separated from the plasma with less breaking of the red blood cells, i.e.
the above
mentioned cell lysis. Cell lysis can be avoided by having a gentle
gradient of the pore
diameter in the membrane. The membrane may have a first pore diameter of 100 µm
that tapers to the smallest diameter of 0.5 µm. The gentlest separation, with
least cell
lysis, would be achieved when the diameter changes over a long distance, i.e.
across a
thick membrane. However, such a thick membrane would have a high pressure drop,
which also has an influence on the cell lysis. We have tested several membranes
and
have found that a membrane thickness of 150 to 400 µm provides a good balance
between pressure drop and separation efficacy.
[013] When using the membrane with a pore-size gradient, the sample contains
fewer
broken cells and, therefore, a new measurement device can be used that is
especially
adapted for strips using this membrane. This device uses a special
spectrophotometer
that uses an array detector, which is able to detect light of several
wavelengths. A
monochromator, as used in the prior art devices, is no longer necessary. This
makes the
measurement more accurate, because measurements at two wavelengths can be
compared, resulting in a more accurate measurement. The measurement is still at
a
wavelength of 635 nm, but an additional wavelength can be used to increase the
accuracy. Such a spectrophotometer is schematically illustrated in Figure 3.
These
spectrophotometers are known as such but have not previously been used in
devices for
measurement of sugar levels in blood.
[014] The strips using a membrane with pore-size gradient can also be used with
a
conventional measurement device, but in that case a little more blood is needed
for the
measurement, but still less than with a uniform pore-size membrane. The new
measurement device described here can only be used with the strips of the
present
invention.
[015] The table below shows how the density of the plasma produced after
separation of
red blood cells is influenced by the structure of the membrane. The presence of
red
blood cells in the plasma increases its density and so indicates less effective
separation
by the membrane. All membranes have the same thickness and when the pore
diameter
changes over its thickness, it changes in linear fashion. This linear change is
not
essential, however.
|
|
Pore
diameter (µm) |
Density
(mg/ml) |
|
Membrane A |
0,5 |
961 |
|
Membrane B |
4 |
1017 |
|
Membrane C |
100
to 0.5 |
920 |
|
Membrane D |
40
to 0.5 |
921 |
|
Membrane E |
35
to 0.5 |
918 |
[016]
It is clear from the table that membranes with a gradient of pore diameters
result in
plasma with a lower density, which indicates that very few of the red blood
cells
permeate the membrane.
[017] In operation, the test strip is first mounted in the device, prior to
application of the
blood sample. Then, a glucose-containing blood sample, typically obtained by a
finger
puncture (small prick in the fingertip) is applied to the test strip. The
amount of blood
should exceed that needed to saturate the reagent part comprising the membrane
in the
area where light reflectance will be measured. This amount is at least 3 ml, or
the
amount of one droplet. A droplet from a healthy adult is about 5 ml, but older
people
usually have less blood in a droplet. After the sample is applied, the
measurement starts
automatically when the fluid has permeated the membrane, and the device detects
the
resulting change in light reflectance of the testing surface.
[018] The test strips of the present invention can be used in conventional
instruments,
such as the Sugar Level Pro™ or the Glucexact™. However, when combined with our
improved instrument, as described above, we can achieve a reliable measurement
with
very small amounts of blood.
[019]
By using a membrane with a gradient described above, less cell lysis takes
place.
This means that the plasma that is obtained contains fewer impurities from the
red blood
cells that can influence the measurement. A more accurate measurement can be
performed on a smaller blood sample, especially when the strip is used with the
improved device.
* Claims
Claims
1. Strip for measuring blood sugar levels, comprising:
(a) a reagent part comprising a membrane
(b) a capillary for transporting a blood sample to a reagent part
(c) an opening for measurement and putting into place the strip, the opening
being present in the reagent part;
characterised in that the membrane is a hydrophilic membrane having a smallest
pore diameter of between 0.1 and 5 µm.
2. Strip according to claim 1 in which the pores of the membrane taper in
diameter
from 30 to 100 µm on the upper membrane surface to 0.1 to 5 µm on the lower.
3. Strip according to claims 1 or 2 that can perform a measurement on a blood
sample of 3 to 5 ml.
4. Strip according to any of claims 1 to 3 in which the reagent is attached to
the
strip using adhesive.
5. Device for measuring blood sugar levels for use with a strip as defined in
claims 1
to 4, comprising an opening for inserting the strip, and a spectrophotometer,
which uses a wavelength of 635 nm to perform the measurement.
* Drawings of the application (pre-printable)
* Communication
Communication
1.
The examination is based on the application as originally filed. Document D1 is
prior
art in accordance with Article 54(2) EPC. Document D2, which was pending on the
date
of filing of the present application, is prior art in
view of Article 54(3) EPC.
2.
The subject-matter of claims 1, 3 to 5 is not novel within the meaning of
Articles 54(1)
and (2) EPC because it is known from D1.
D1 discloses a strip and a device for determining glucose levels in a blood
sample. The
strip comprises a polyamide membrane with a pore diameter of between 0.1 and 5
µm.
3. The subject-matter of claims 1 to 5 is not novel within the meaning of
Articles 54(1)
and (3) EPC because it is known from D2.
D2
discloses a strip for determining glucose levels in a blood sample. The strip
comprises a membrane with pores that taper in diameter from the upper membrane
surface to the lower. The pore sizes vary from 200 µm to 0.1 µm. The larger
size is
preferably 30 to 100 µm. The smallest pore size should be between 0.1 and 5 µm.
The
membrane is a hydrophilic membrane. The strip can be used in devices for
measuring
sugar level based on light intensity.
4.
In claim 3 it is specified that the measurement can be performed on 3 to 5 ml.
It would
appear that either the value or the unit is wrong, or both. The same mistake is
made in
paragraph [017]. An explanation is requested.
5. Claims 1 and 5 do not fulfil the requirements of Rule 43(2) EPC.
Claims 1 and 5 are both independent device claims. Such a claims structure
having two
independent claims in the same category is not allowable.
6.
To maintain the application, new claims should be filed which take the above
objections into account. Care should be taken to ensure that the new claims
comply with
the requirements of the EPC in respect of clarity, novelty, and inventive step
(Art. 84, 54
and 56 EPC). Any amendments should not introduce subject matter which extends
beyond the content of the application as originally filed (Art. 123(2) EPC).
7. In the letter of reply, the problem-solution approach should be followed. In
particular,
the difference between the new claims and the prior art disclosed in D1 and D2,
the
objective technical problem underlying the invention in view of the closest
prior art, and
the solution thereto should be indicated. The basis in the application as
originally filed for
the amendments should be indicated (Art. 123(2) EPC and Rule 137(4) EPC).
* Document D1 (pre-printable)
Document
D1: GB1234321
Description
[001]
Easy and accurate measurement of glucose levels in blood is very important. A
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
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.
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
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,
such that the strip clicks into place.
[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.
[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
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
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
the cells.
Claims
1.
Strip for measuring blood sugar levels, comprising a capillary and a
hydrophilic
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.
* Document D2 (pre-printable)
Document
D2: EP1234567 (Article 54(3) EPC)
Description
[001]
This application is concerned with a membrane that is used in devices for the
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
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.
[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
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
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
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.
[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
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
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.
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.
2.
Strip for measuring blood sugar levels, comprising a capillary and a membrane
as
defined in claim 1.
(No Figures in D2)
* Client‘s letter
Client’s
letter
To:
Ms Cyrille Ringe
Dear
Ms Ringe,
We have reviewed the EPO communication and provide you in the following with
what is
hopefully a helpful basis for filing a response to that communication. We have
also
attached a new set of claims that we believe overcome the objections raised by
the
examiner. We restricted our claims to the membranes with a pore-size gradient.
However, we leave it to you to decide on the final wording of the claims, as
long as these
claims cover the strip and the device.
We
are currently testing membranes that are different from the polyamides of the
examples. Most of the promising membranes are hydrophilic, but some hydrophobic
membranes also show promise in the separation of red blood cells. The claims
should
preferably cover the possibility of membranes other than polyamides. We have
deleted
the term “hydrophilic” in claim 1. We believe that the fact that the membrane
is
hydrophilic is not essential.
Concerning
claim 4, directed to the device, we believe that further amendment is not
necessary as the claim refers to the novel strip of claim 1.
The
communication states that the claims are not novel over D2. We don’t think this
objection is correct, because document D2 is an earlier application from our
own
company. We don’t think we should be penalised in this application for a
previous
development of our own technology.
Finally,
the examiner noticed an editorial error in claim 3 and in the description. In
claim 3 and in paragraph [017], the amount of liquid is indicated to be in ml.
This should
have been in µl. This should be clear from the context in paragraph [017],
which refers to
the volume of a droplet. Also, document D1 as cited by the examiner shows that
the
amounts used in similar devices are in the range of µl and not ml. Also, D1
refers to a
droplet. In addition, we attach an extract from Blood Science and Technology,
which
shows that blood droplets are always in the range of 1 to 5 µl. This is a
well-regarded
publication in the technical field.
We
will be on our annual retreat on Bora Bora and will not have internet access or
be
contactable by phone. Please file a response reflecting the wishes we have
indicated
above.
Kind
regards,
Dr. Keith Richards
Bad Sugar PLC
2023/B/EN/19
Annex
to the Client’s letter
Blood
Science and Technology
Blood
droplets
The volume of blood droplets is relevant because blood droplets are often used
in
medical analysis. When the finger of a healthy adult is pricked, the droplets
have a
volume of 5 µl. Persons aged 65 and over often have less blood available when
pricked,
usually less than 4 µl or even 3 µl.
* Amended claims
1.
Strip for measuring blood sugar levels, comprising:
(a) a reagent part
comprising a membrane
(b) a capillary for
transporting a blood sample to a reagent part
(c) an opening for
measurement and putting into place the strip, the opening
being present in the
reagent part;
characterised in that
the membrane is a hydrophilic membrane having a smallest
pore diameter of
between 0.1 and 5 µm.
2. Strip according to
claim 1 in which the pores of the membrane taper in diameter
from 30 to 100 µm on
the upper membrane surface to 0.1 to 5 µm on the lower.
3.2. Strip according to claims
claim 1 or 2 that can perform a measurement on a blood
sample of 3 to 5 ml
ul.
4.3. Strip according to
any of claims 1 to 2 3 in which the reagent is attached to the
strip using adhesive.
5.4. Device for measuring
blood sugar levels for use with a strip as defined in claims 1
to 43,
comprising an opening for inserting the strip, and a spectrophotometer,
which uses a wavelength
of 635 nm to perform the measurement.
claim 1: I went for this exact solution! BUT:
ReplyDelete- I definitely felt extremely uncomfortable after the exam for not having made any additional amendments in view of D2. It seemed my whole novelty of the claim relied exclusively on the view of whether the opening was implicitly disclosed in D2 or not.
- In retrospect, it might have been much safer to include an (unnecessary) limitation and take the point hit, rather than the much bigger issue of having a non-novel claim...
claim 5:
- is it necessary to specify "which is able to detect light of several wavelengths" when you already specify you are using an additional wavelength?
- I changed the language to a more passive one: "a spectrophotometer comprising an array detector, configured to use a wavelength of 635 nm and an additional wavelength...". I don't know if this was necessary, but it seemed more appropriate.
- I was doubtful whether a *different* additioanl wavelength was needed, or whether that was applied by the additional (why would they be the same). I left it out and stuck with the wording of the application.
Thank you for your proposed solution. I generally agree with your comments, though I did not carry out the fallback position in claim 2 - it does seem likely to me though that it would be worth some points.
Oh, I did notice a small difference between my claim and yours. The membrane being hydrophilic should be in the pre-amble in your two-part form, because D1 already discloses this.
Deletegood to hear you agree. There are probably many wordings that boil down to the same thing and that will be accepted. The fallback for claim 2 is probably not needed but we wanted to include it show what your options were if you regarded D2 more broadly
Delete"a spectrophotometer comprising an array detector, configured to use a wavelength of 635 nm and an additional wavelength...".
Deletesame!
I mean I wrote the same.
DeleteThanks for your solution, Roel.
Good luck everyone for part C tomorrow! How it will be a bit friendler than B.
anonymous above is me. I admittedly ignored two part form, btw
DeleteSander, thank you for posting the solution so quickly :)
DeleteRegarding the hydrophilic membrane, before the paragraph where the membrane were discribed as hydrophilic, there was a paragraphs where the membrane was defined as rigid structures with pores where some parts of liquid can pass while other cannot pass. This feature also applies to hydrophobic membranes, so one can plausibly deduce that hydrophilic wasn't essential. Although I admitt that I would be using my own knowledge here.
While I get the argumentation regarding feature (c) of claim 1, it seems hard to believe that the Committee included D2 without it being relevant at all and all the fuss about the different membrane diameters in the description without the need to refer to them in our answer.
ReplyDeleteI think it's there because it's still a viable option to limit the claims by a range rendering it novel over D2, albeit a narrower one. You'd lose some points, but the rest of the story (inventive step) remains exactly the same. Seems very B-style to me to have this independency.
DeleteI wondered the same thing. Especially the table seems to suggest you'd use it.
DeleteThanks for providing your solution so quickly. Highly appreciated.
ReplyDeleteI agree with your assessment that D2 does not disclose a strip with all the features. Why are you not considering the thickness of the membrane as being an essential feature? D2 [004], last sentence is imho pretty clear that the thickness of the membrane needs to be limited.
Par [04] of D2 states that a membrane should not be too thick. However, too thick is relative and I am of the opinion that we do not know how to quantify that.
DeleteIn par 12 of the application it is stated: "the gentlest separation, with least cell lysis, would be achieved when the diameter changes over a long distance, i.e. across a thick membrane. However, such a thick membrane would have a high pressure drop, which also has an influence on the cell lysis. We have tested several membranes and have found that a membrane thickness of 150 to 400 um provides a good balance between pressure drop an separation efficacy." This to me discloses that the thickness is not an essential feature, as it appears to suggest that thicker membranes may also work, just not as good as the provided range.
I disagree, I think thickness is essential as not including range would also include non working embodiments, i.e. membranes too thick to work
DeleteI had not found this solution. Instead I put the range of your claim 2 in claim 1. I think this solution works though, and it is broader than mine.
ReplyDeleteHowever, even after reading your solution, I'm still wondering which solution was actually intended by the maker of the paper. Feels like 2021 all over again.
That was me by the way
DeleteDp’s claim is too close to the wire in my opinion, I would not have felt comfortable using it in the exam
Delete@Anonymous March 15, 2023 12:54 pm
DeleteAbsolutely. I did it and I can tell you yesterday was not fun! It seems much safer to include a small limitation and take a 5-10 point loss over doing this approach and potentially risking having a claim that is not novel.
One thing that makes me wonder is that I don't entirely agree with your second argument regarding novelty. It's not clear to me how the feature that the opening is "for putting into place" is structurally limiting.
Deleteyour = Sander's
DeleteTaking a small loss (range limit) to avoid the big loss (claim 1) seems like a good tactic. But as it is, D2 does not seem to meet the rules for references. Mind you it would not be the first time I have a difference with the official solution.
DeleteMy 2 cents on whether feature c is disclosed implicitly:
DeleteD1 mentions in [002] that ''a new type of system has taken over the market. this is a system in which a disposable strip is placed in a measurement device''. This is followed by the description of the conventional strip which has feature c (see also Fig 1b).
Then D1 goes on to improve the conventional strip by adding the membrane.
D2 mentions in 006 that its own membrane can be added in known strips. We know that known strips have the opening from the paragraph of D1 I linked above. Thus, the strip of D2 implicitly discloses it, the discussion on whether the D1 strip itself is implicitly disclosed is not relevant.
in other words, from 002, 003 and Fig 1B of D1 you can infer that all ''known'' blood measurement strips referenced in 006 of D2 have the opening in the reagent part. This is my interpretation.
DeleteThe discussion about the implicit disclosure of feature c) strongly reminds me to Paper C of 2022, where for a novelty attack the feature "rubber bladder" was implicitly disclosed in A6. Therefore, I am of the opinion that D2 discloses the features opening (required for measurement) and reagent part implicity in e.g., [006] [007]
DeleteSome additional (not strong arguments) on why it would be implicitly disclosed:
Delete1) if it is not, then the Examiner was wrong in the novelty assessment. Even though not impossible, it would be strange.
2) a lot of emphasis and time spent on ranges, which would not be needed at all.
In any case though, an argument in favor of it being implicitly disclosed is that it was not clear which range could be considered novel, as selecting a subrange is not a black and white thing.
This paper was not well drafted.
@Ioannis
Delete1) while the examiner was wrong in their conclusion, their reasoning did not include anything about the opening. In fact, the entire reasoning was focused on the membrane. I saw this actually as a hint that the opening may be relevant.
2) I think that was there because, if you don't consider the opening novel, then you have quite some options to amend, potentially losing some marks but the rest of the story is identical (because D2 is not relevant for inventive step anyway). The fact that there wasn't a clear best way to amend with regard to D2, made me also think that it was not necessarily intended (in line with your second to last sentence).
Reasons why I think the opening was the intended novel feature:
- D2 does not mention the opening at all in the description, even when talking about how the measurement device operates
- D2 claim 2 (= strip claim) only includes a capillary and a membrane, again, no opening
- D2 reference to D1 is to a very specific teaching, "GB1234321 teaches us to separate blood using a membrane.". In such cases, only the specific teaching and relevant content is considered incorporated by reference. This relevant content does not include the opening, in my opinion
- D1 claim 1 (= strip claim) also does not include an opening. If it was essential, it would have had to be there
- D2 reference to "known strips" is without reference to D1. There was no indication that the opening is the only way to allow light to access the relevant substance (e.g., maybe you can use transparent material?). It would not be fair for the applicant if a prior art can rely entirely on non-disclosed and arguably non-essential feature of such strips. Reasoning that known strips are in fact those mentioned in D1 is more akin to inventive step than to novelty, and D2 cannot be used for inventive step
- The office action remained completely silent how D2 anticipates the opening of claim 1, focusing instead only on the membrane (evidently for claim 2), but still directing a novelty attack to all 5 claims (including the adhesive for the reagent part! also not disclosed in D2 and only included in D1)
Regardless, I agree with your very last statement. This was a bad paper B.
As mentioned above my main argument has nothing to do with the incorporation by reference.
Delete006 of D2 teaches that the membrane can go into known strips.
003 of D1 shows you what these known (not D1's strip) strips contain. Feature c is there. You do not need to link these strips to D1, D1 is ''evidence'' of the presence of these strips in the art.
Known strips = no reference to D1 needed, they are CGK
This is my own interpretation.
@Ioannis
DeleteI understand, but D2 + CGK is also much closer to an inventive step reasoning than one of novelty. This is precisely why the bar for implicit disclosure is considerably higher than for explicit disclosure. Novelty is an absolute criterion.
Anyway, I'm very curious about the Examiner's Report for this case. I thought they learned their lesson in 2021, but apparently not.
A feature not being in the claims does not indicate much about its essentiality. Essentiality is all about the technical problem to be solved.
DeleteNo, D2 + CGK is not an IS discussion in this case because we are talking about implicit disclosures.
DeleteIf i disclose a sports shoe and we know that all the shoes in the art have rubber soles, then i disclose a sports shoe with a rubber sole implicitly.
The whole idea that the committee keeps testing implicit disclosures in a time-limited exam is beyond me.
It s a valid question to wonder whether other strips would have the opening somewhere else. However, this was not what was provided in the exam, which only discussed that the conventional strips have the opening in the reagent part (in D1).
DeleteIt is my understanding that the opening on the strip is essential, otherwise light cannot pass through the sample for a measurement to be taken.
DeleteI settled on claiming the thickness range of the membrane, and disclaiming the thickness of 200 micrometers (the only thickness disclosed in D2).
Narrowing the ranges of the pore sizes to gain novelty over D2 seemed to exclude a lot of the examples, whereas disclaiming a single thickness resulted in a claim with a broader claim scope.
As in, include the features of claim 2 in claim 1 to get inventive step over D1, claim the 150-400 micrometer thickness range, and use an undisclosed disclaimer to disclaim 200 micrometers (ie gain bare novelty over D2). There was a lot to talk about in the amendments section, as there are various criteria that have to be met for an undisclosed disclaimer to be allowable. There seemed to be no issues with this disclaimer against the standard tests (eg minimum to establish novelty over a 54(3) document, no impact on incentive step or sufficiency etc).
DeleteD2 said "The membranes have a thickness of around 200 µm."
DeleteDisclaimer such membranes is not possible, as both the disclaimers as well as the claim including the disclaimer need to be clear - which you cannot satisfy in view of the "about".
G 1/03, G 1/16
GL H-V, 4.2.1: "Art. 84 applies equally to the claim per se and to the disclaimer itself (see T 2130/11)."
Thanks for providing your solution. Regarding claim 5, do you think its necessary to add the feature of "an additional wavelength" to the claim? The array detector itself is enough to render the claim novel and this detector comes with the effect of not needing a monochromator, therefore enabling the possibilty to use more than one wavelength to get more precise results. Thus, I thought that just adding the array detector alone is sufficient.
ReplyDeleteI think the mere specifying that you CAN use multiple wavelengths does not mean that you actually do, so an 'additional wavelength' is in my view necessary, at least for attaining the technical advantage (novelty is established by the array detector itself already).
DeleteYes, I agree with Armin. Without the additional wavelength, you are still novel over D1 but might not be inventive, as the technical effect is not present in all embodiments.
DeleteI think its sufficient for novelty but not unity. I originally done the same as you, but when writing out the arguments for the products being inter-related I felt there needed to be something more to tie the products together (which wanst fully clear to me until I wrote out the OTP). On the flip side im sort of worried that its now too method-idy.
DeleteI considered doing what you propose, but in the end I went for functional language too, like in the dp solution, and even slightly more detailed. Your approach certainly seems plausible to me, but from the language of par. [013] it was not 100% clear to me whether the function was implied, and it's not my technical field.
Delete@ Armin and B taker:
DeleteIsn't adding an additional wavelength rather a feature related to a method instead of a device? The device-related feature enabling use of an additional wavelength is the array detector. Not sure about this argumentation
@Array
DeleteYou are allowed to have functional features in your device claims.
I formulated it as "a spectrometer comprising an array detector, configured to [...]"
I guess my problem with this was that I know from my technical background that an array detector would never be used with only one single wavelength, that just wouldn't make any sense (because in this case you would just use a single detector and not an array).
Delete@Array
DeleteI suppose you could measure the same wavelength with multiple detectors and take an average to improve the accuracy. Pure speculation, of course, but I don't see why it's impossible.
@ Armin
DeleteGood point, but wouldn't even in this case the array detector alone be sufficient to achieve a technical effect of improved accuracy over the generic detector of D1 and thus be enough for a reasonable inventive step argumentation?
@Array, I look at it like this. The measurement on a second wavelength is needed to obtain the technical effect.
DeleteIf it is the case that the presence of the array detector implies that a second measurement is taken at a different wavelength (which I don't think it does), adding functional language relating to measuring the second wavelength does not influence the scope of protection and merely makes the implicit feature of the array detector explicit.
If it is not the case that the presence of the array detector implies that a second measurement is taken at a different wavelength, the functional language relating to measuring the second wavelength is necessary to obtain the technical effect.
Thus, adding the functional language never hurts.
@B taker
Delete''@Array, I look at it like this. The measurement on a second wavelength is needed to obtain the technical effect.''
I disagree.
There are 2 effects.
One effect is using the second measurement which improves accuracy of the measurement (013).
Another effect is using the array detector in the first place, which enables the use of less blood for measurement (014).
So it is not as clear cut on whether you actually needed the second wavelength. Note that 013 mentioned that you ''can'' use a second wavelength, not that you have to.
Sounds like this was another messy paper like 2021
ReplyDeletehorribly drafted paper
DeleteAt least the client letter was very clear in 2021. This year, it wasn't even clear what the client wanted
DeleteI read item 6 of the communication as hinting that there was a potential clarity issue in the claims.
ReplyDeleteSo I phrased the amendment to claim 5 in more device-like language than the DP solution uses. It seems to me that "using" an array detector would be considered unclear about where this array detector suddenly comes from (is it part of the device or is it external, for example). Since there is no other language in the description, I used "comprising" based on figure 3, but to have proper basis, I added all three of the depicted components to the claim.
Does that make sense?
The phrasing of dependent claim 2 is reading a little bit weird.
ReplyDeleteThe subject matter of claim 2 is now a combo of pore sizes "30 to 100 µm on the upper" and "0.1 to 1 µm" on the lower.
Is this combo "30 to 100" and "0.1 to 1" unambigously derivable from the description?
I did omit "hydrophilic" from claim 1. As you stated, hydrophilic is nowhere explained as essential. As far as I can remember, the description contained a statement that only the right pore size is essential for achieving the desired result (and the pore size definitely is not dependent on the hydrophili/-phobic nature of a membrane). This, to me, implied that all other membrane-related features are not necessarily essential and thus, "hydrophilic" could be removed from the claim.
ReplyDeleteCould you please elaborate your thoughts on this?
Essentiality is a matter under art. 84 EPC. However, you also need to satisfy art. 123(2) EPC. What is your basis for removing hydrophilic? The application as filed explicitly stated that the memberanes are hydrophilic membranes
DeleteEh, I used the essentiality test for removing hydrophilic. Seems like I didn't get the memo that we now use the gold standard for this...
DeleteWell, guess I'll hope this doesn't cost too many marks
@Hydrophobic Candidate
DeleteThis has been in the guidelines for quite some time alread, GL H-V 3.1 defines the essentiality test first:
"If the amendment by replacing or removing a feature from a claim fails to pass the following test by at least one criterion, it necessarily contravenes the requirements of Art. 123(2):
(i) the replaced or removed feature was not explained as essential in the originally filed disclosure;
(ii) the skilled person would directly and unambiguously recognise that the feature is not, as such, indispensable for the function of the invention in the light of the technical problem the invention serves to solve (in this context special care needs to be taken in cases where the technical problem is reformulated during the proceedings, see H‑V, 2.4 and G‑VII, 11); and
(iii) the skilled person would recognise that the replacement or removal requires no modification of one or more features to compensate for the change (it does not in itself alter the invention)."
The paragraph right after states:
"However, even if the above criteria are met, the division must still ensure that the amendment by replacing or removing a feature from a claim satisfies the requirements of Art. 123(2) as they also have been set out in G 3/89 and G 11/91, referred to in G 2/10 as "the gold standard"."
Regarding the marks, removing hydrophilic is completely independent from any other aspect of the paper (novelty, inventive step). Keeping it in does not require any basis reasoning either (since you didn't amend it). So it probably only costs a few points in the claims itself.
DeleteYep, and I stopped reading after (iii)
DeleteIn real life I would surely have given it a shot. Especially if your client almost instructs you to do it! But for the exam I would have expected at least any hint the application that I could base the non-essentiality on.
DeleteFor me, hydrophilicity of the membrane didn't appear as an essential feature per se, because it didn't seem to have any technical effect. On the other hand, it was unclear how the invention was supposed to be modified to compensate for the change, because it wasn't really described as an optional feature and there was no alternative given in the description. So I decided to keep it, as even though it didn't appear to be essential for the invention, the removal wouldn't pass the essentiality test.
DeleteD2[006] discloses the membrane used with known strips (i.e. strip from D1 with an opening). Could that inevitably lead to a membrane with tapered pores (0.1 - 5 um) used on a strip with an opening?
ReplyDeleteIt just says known strips. You cannot consider all known strips to be incorporated by the mere statement of 'known strips' for the purpose of novelty.
DeleteIf this was an inventive step issue, then yes, because you would just combine D1 and D2 to get the opening. But D2 is art. 54(3) EPC so it is not relevant for inventive step.
I don't think there was any disclosure of a known strip without an opening though. Same with all spectophotometers described using light going through the opening to perform the measurement, so I assumed that all (or at least most) known strips had an opening.
Delete@Anonymous March 15, 2023 1:25 pm
DeleteIf "at least most" known strips have an opening, how can you argue that it is directly and unambiguously derivable from D2 that there is an opening in the strip?
Yes, there was only one example, namely that of D1. But that reasoning more akin to inventive step. That is, you would combine the device of D1 with the membrane of D2 (which can be used with known strips) to arrive at the solution. However, D2 is an art. 54(3) EPC document so this reasoning is not allowed anyway.
In my opinion, it would not be fair for the applicant if simply referring to "known strips" in D2 renders all known strips in the prior art disclosed in D2. That does not seem to align with the well-established "directly and unambiguously derivable" principle.
In real practice, I completely agree that "known strips" wouldn't disclose an opening unless further evidence is found that all strips use an opening.
DeleteHowever, all known strips disclosed in the exam had an opening (unless I missed something?) and the exam wants use to only use information given in the exam, so it feels like they wanted us to believe that all known strips have an opening.
If they didn't, I feel like they would have given us something saying that the opening is optional, or a way of using the strip without an opening.
Document D1 mentions that conventional strips have been in the market for "years", said strips comprise, inter alia, an opening. D2 says that their membrane can be used in known strips (which for the exam are those described in D1). So it is actually implicity (or even explicity) teaching at least an embodiment comprising a conventional strip (with an opening) and the membrane of D2 (maybe there is an embodiment not comprising a opening which is not even mentioned but indeed the embodiment wherein the strip with a opening is used is actually clearly disclosed). How could you say claim one is novel over D2 by the opening if D2 tells you that their membrane can be used in known devices which all comprises an opening (at least by the facts given in D1).
DeleteIm not convinced by dP solution this time.
I am not convinced that going against the client's wishes by keeping hydrophilic is the right thing to do (the client is king :)). Instead, it seemed more logical to me to substitute (with Dir H-V, 3.1 and T331/87) the membrane "hydrophilic", implicit in the definition of a membrane "with pores" based on par [9]. As hydrophilic is defined in the application as "having an affinity with an aqueous medium", there is no broadening of the scope if it is stated instead that the membrane is pore-filled. Paragraph [9] says in black and white that some components of a liquid mixture can pass through the pores, while others cannot, so the feature (essential to the operation of the invention) is indeed present as an alternative equivalent to the hydrophilic character of the membrane, which is permitted under Art 123(2) EPC.
ReplyDeleteWould your interpretation not rule out that a hydrophobic membrane is not covered by the claim? If you consider pore-filled and hydrophilic to be alternative wordings, then pore-filled would not be hydrophobic. Or am I misinterpreting your reasoning?
DeleteI don't understand this reasoning. The strip is and must be pore-filled in any case, because that's how blood is filtered.
DeleteAll the description details are already far in my memory, but I couldn't see how replacing "hydrophilic" by "spore-filled" would make the invention "hydrophobic" (or exclude this). I guess this is another difficulty of this very particular B paper - reading too fast, 'phobic' and 'philic' were easily confused ...
DeleteWhat do you think how much points I will lose with "35µm - 40µm" and "0,4-0,6 µm"?
ReplyDeleteWhat do you think how many points for inventive step as there was not sooo much to write?
A B paper where the examiner is wrong in his novelty assessment? That's odd
DeleteI'm sorry, what do you mean?
DeleteI claimed: "in which the pores of the membrane taper in diameter from 35 to 40 µm on the upper membrane surface to 0.4 to 0,6 µm on the lower"
That might be novel over D2, but it is really narrow. So I wondered about the penality.
I can imagine that going for 35 - 45 µm for the upper surface will be considered as an unnecessary limitation.
DeleteAnoynmous' comment above appears to refer to the DP solution regarding claim 1.
As far as I remember, the examiner stated that claims 1-5 are not novel over D2, and I doubt that the fact that D2 does not explicitly mention feature c) is enough for novelty of claim 1 over D2 (as this feature is implicit in my opinion). Therefore, I have limited the pore diameter on the lower membrane surface to 0,4-0,6 µm (this range being novel over 0,1-5 µm as mentioned in D2).
ReplyDeleteExactly. I also went for 0,4 - 0,6 µm, because from the broader range 0,3 - 5 µm, the 0,3 µm might be considered as not sufficiently far removed from the 0,1 µm disclosed in D2.
DeleteDid the examiner not raise novelty objections against claims 1-5? I feel like if this must be an unintended solution to a paper which was already very messy to begin with.
ReplyDeleteThe range stuff was an absolute nightmare for me. Couldn't decide which would be both novel and had basis.
not that I done it, but I feel like the 0.4-0.6 range for the lower part of the pore was the intended solution. Whether this would be deemed as novel is another matter. My gut tells me its to close the lower end of the disclosed 0.1-5 range. May be just going for 0.5 flat was the best as it was defo supported...
OK, I understand your reasoning, but went for the range, 0.3-1 below (and the device for measuring including the bandelette of claim 1). So, looks like I'm a cautious guy ;-)
ReplyDeleteIf I'm not mistaken, there was no limitation this year that we should not add any dependent, so I added some ranges:
2. Bandelette selon la revendication 1, le diamètre de pore étant de 30 μm à 40 μm sur la surface supérieure.
3. Bandelette selon la revendiaction 1 ou 2, le diamètre de pore étant de 0,4 μm à 0,6 μm, préférablement 0,5 μm sur la surface inférieure.
At least I feel on the safe side. I would be surprised that the model answer relies on a "It's not my technical field, but I guess other options are possible.". Papers should be done for people without specific field knowledge.
In any case, as a computer guy, I was very happy not to have a mechanical thing like previous years. In particular, I'm still not sure to get how the snowshoe is moving.... I'm waiting for the paper about ChatGPT and Bitcoin with small algorithms as figures ;-)
Thanks for the model answer !
I don't think you need field knowledge here to evaluate whether the opening is disclosed or not. It is an absolute criterion, and D2 does not satisfy it, because reference to "known strips" does not immediately mean that you get all those features for free when evaluating novelty. Had it been possible, inventive step would have been another discussion entirely, since D1+D2 would get rid of most options.
DeleteYou should get those features for free when evaluating novelty, only if the document is prior art under Art. 54(3) EPC. That is the situation here, and the features of D1 are relevant to D2's subject-matter as D2 also relates to membranes and strips.
DeleteWhy should you get those for free specifically in art. 54(3) EPC documents?
DeleteGL F-III 8, second to last paragraph:
"If, for the disclosure of the invention, a document is referred to in an application as originally filed, the relevant content of the reference document is to be considered as forming part of the content of the application for the purpose of citing the application under Art. 54(3) against later applications."
So a reference to D1 COULD perhaps be considered incorporated for the purposes of art. 54(3) EPC. However, the last paragraph:
"Because of this effect under Art. 54(3), it is **very important** that, where a reference is directed **only to a particular part of the document referred to**, that part needs to be clearly identified in the reference."
The emphasized part is the case here. GB1234321 (D1) is only referred to in a specific context, and that part is clearly identified in the reference to D1.
Therefore, you cannot consider the whole disclosure of D1 to be incorporated in D2 for the purposes of novelty.
To be honest I'm not really sure how the last two paragraphs of GL F-III are used in the case law. My interpretation is that without these two paragraphs, it would be exceptionally easy to overcome an objection under 54(3) with a trivial modification, or a trivial feature that is already in the claim, and this exception is used to prevent that.
DeleteIf this is how these paragraphs are used in practice, I would say that an opening is implicitly disclosed, because D2 clearly refers to "known strips", and D1's strip is the only "known strip" as per D2's teachings. I'm not sure whether the last paragraph would not contradict this, because as you said D1 is referred to in a specific context, which is not really related to strips. However, the fact that it says "known strips" in one of the following paragraphs might render this view invalid, because the only known strip according to D2 would be D1's strip, and it has an opening. It's really impossible to reach a conclusion, because both arguments have some basis to rely on.
A trivial modification is exactly the point of art. 54(3) EPC. On the date of filing, the applicant could not have become aware of the earlier application because it was not yet published. To account for this, the lawmaker put in art. 54(3) EPC and the exception of use of such documents for inventive step in art. 56 EPC, so that the applicant is not severely penalized; as long as the application is novel, it is okay.
DeleteI know from my training how incorporation by (cross-)reference in prior art works in practice, but I cannot cite any case law other than those already given in the guidelines in support, because I very very rarely deal with it.
Novelty remains an absolute criterion, and the features of the claim must be directly and unambiguously derivable from D2. A simple reference to "known strips", where it is not inevitable that this opening is always there (there is no essentiality mention in D1), is insufficient and requires a supporting document --> inventive step, which is not allowable for D2 because it is an art. 54(3) EPC document.
Could you use that argument in this case though, as D2 also belongs to the applicant? It's a weird situation.
Delete@Anonymous March 15, 2023 3:50 pm
DeleteI admit that's a weird additional piece of information. I don't see why the same argument would not apply; the guidelines do not refer to the applicant/proprietor of the prior art being relevant. The only relevant part for prior art is the publication date and, for the application of art. 54(3) EPC the filing date (or potentially even priority date).
It may have been there as a red herring for someone to think that because it's your own earlier application, it cannot harm you (which is what the client thinks), which evidently is not true if priority is not claimed.
Nevertheless, very unusual. I feel more confident about my approach now that the tutor's proposed solution is in line with it, but you never know with the Exam Committee.
For completeness, I do not think this paper was well-drafted. Clearly, it has divided people to argue both ways regarding the opening. It's inconclusive if anything, and that is not good for an EQE paper.
Armin, what do you think about this? It explains a similar situation.
Deletehttps://www.epo.org/law-practice/case-law-appeals/recent/t112259eu1.html
This decision (T 2259/11) is actually in line with my reasoning; see points 3.1, 3.2 and 3.5 below.
Delete"3.1 D1 does not disclose the feature of claim 1 that the bristles are made of polyester or nylon. For this reason, the subject-matter of claim 1 is novel over D1."
"3.2 Although the skilled person reads the prior art while relying on common general knowledge in the field, no evidence has been provided that only nylon or polyester were the materials used for tufts of bristles in conventional toothbrushes, albeit the Board and the appellant accept that these materials are the most common."
"3.5 The respondent's argument that the skilled person inevitably considered nylon as the mainly used material in view of the historical development of bristles for toothbrushes is not denied. However, in view of the possibility to select other materials, and D1 not referring to any material at all, nor a requirement to inherently require those particular materials, no clear and unambiguous disclosure of nylon and polyester is present therein."
Not entirely. It mentions that other possibilities were posible and that was proven and indeed document D9 was submitted as evidence of a different possibility before the filing date. Aditionally, no materials at all were mentioned in application as filed. In that case, in my opinion, it is clear that you cant assume that common general knoledge emcompassed all possibilities of materials when materials werent even addressed at all.
DeleteIn paper B they gave us a unique possibility for "conventional devices", no other possibilities were mentioned or given. The client strips comprise holes, D1 prior used (market device) comprise holes, D2 is a membrane and it does mentions to be used with additional devices (not like T 2259/11) it even refers back and cites D1.
3.5 The respondent's argument that the skilled person inevitably considered nylon as the mainly used material in view of the historical development of bristles for toothbrushes is not denied. However, in view of the possibility to select other materials, and D1 not referring to any material at all, nor a requirement to inherently require those particular materials, no clear and unambiguous disclosure of nylon and polyester is present therein.
3.3 In this regard, the appellant referred to D9 (which document had already been cited in the opposition proceedings for different reasons), which document was published in 1981 and discloses a toothbrush having bristles made of a core which is made of a hard thermoplastic material such as nylon 6 or high-density polyethylene and of a sheath which is made of a softer material such as ethylene vinyl acetate co-polymer, polyethylene or poly-vinyl chloride, or of natural or synthetic rubber. Accordingly, D9 provides evidence for synthetic materials other than nylon or polyester being applied for the same purpose before the priority date. It should be noted that the respondent made no objection to the appellant's reference to D9 in this regard. The Board also considered it appropriate as it was not complex and served the purpose of clarifying whether further bristle materials could have been considered in the context of D1.
sorry, "openings" not "holes".
Delete> In paper B they gave us a unique possibility for "conventional devices", no other possibilities were mentioned or given.
DeleteThey gave one example. Unless it is evident from the facts as given that it is the only possible way, I don't see how you can assume that all known strips automatically comprise an opening.
It is never stated that openings are always present in every possible strip and this is the only way to use the measurement device on the reagent part.
> [D2] even refers back and cites D1
Only with very specific reference to the teaching of D1 to use a membrane for separating blood. Such a case is discussed in the guidelines, in particular GL F-III 8, as well as GL G-IV 8 and G-IV 5.1.
There is no "general" incorporation by reference of a document that can take away novelty of a claim by virtue of it being disclosed in the document that refers to it; such a statement would not be accepted when considering novelty.
You need to refer to a specific part of another prior art for that *specific part* to be considered under novelty in the document that refers to it. This is what D2 did, so the membrane of D1 could be considered part of the disclosure of D2. However, the opening? I don't think so (in line with the tutors' opinion).
I fully agree with Armin and DeltaPatents.
DeleteWhat other possible ways (conventional strips) do you have to adapt the membrane on for measuring glucose? Please refer to the Paper B facts given because that is all you are suppose to know and abide by that. Please also note, they mentioned explicity what a conventional strips apparatus and no other possibility was mentioned or suggested. In my view, thinking that there might be more is using your own knowledge and assumptions. For example in Paper C that is cero points, all the facts are given, you need to abide by that.
DeleteBut I also agree that they should have drafted the paper in a more clear way. For example, stating that the conventional apparatus (with the opening) is the only known strip by the time that works with the membrane. But their intentions to do it by mentioning in another document what they mean by a conventional apparatus and the [not valid] crossreference (maybe to make you think what they mean by a conventional appatus to be used with the membrane), I think was there.
DeleteI think T 0279/89 is more relevant for this specific case.
Deletehttps://www.epo.org/law-practice/legal-texts/html/caselaw/2019/e/clr_ii_e_1_3_3.htm
DeleteIt is an implicit disclosure of the opening, even a very clear one.
See also GL G-VI, 6. "In the case of a prior-art document, the lack of novelty may be apparent from what is explicitly stated in the document itself. Alternatively, it may be implicit in the sense that, in carrying out the teaching of the prior-art document, the skilled person would inevitably arrive at a result falling within the terms of the claim"
Compare to C-Paper 2022 C-II: Novelty attack with A6
B-Paper 2023:
D1, [003] Opening is for access of the light source to the reagent part.
D1, [004]..spectrophotometer comprises a light source
D2, [006] The measurement is performed using a spectrophotometer.
--> thus the stripe needs to have an opening, (otherwise no measurement with a spectrophotometer possible). The opening must also being present in the reagent part (otherwise no measurement possible) [007]
@CL
DeleteI agree 100%. It could be possible to argue that maybe a transparent cover would work but from the information given that would not be encompassed in a "conventional strip with years on the market" which is the one meant to work with the membrane of D2, that would be something else that as far as we know is not "conventional". In adittion, all of this thinking would be assumptions and use of own knowledge out of the scope of EQE purpose.
Aditionally, the paper would have been so easy with not much to say on basis, on selection invention (novelty) and with only one document for inventive step. I dont believe this is the solution they were looking for.
@Anonymous March 15, 2023 8:08 pm
DeleteI don't have much more to add on the opening-discussion. I think the points on both sides are clear and in my opinion it is rather inconclusive and ambiguous. I lean towards my own solution but obviously this being an EQE paper I understand everyone is expecting an 'expected' solution and it's simply not clear, even if you ignore the opening issue.
But do you really think dealing with sub-ranges is more trivial and straightforward than dealing with the implicit disclosure? Especially considering recent case law, it's more difficult now than ever to determine whether a sub-range is novel or not, what is narrow and far removed (old way), what meets the gold standard (new way), and so on. Just like implicit disclosures, sub-range novelty is *also* determined on a case-by-case basis and has ambiguity at least to the same degree as DP's solution - neither seem suitable for an EQE B paper.
So, honestly, I don't know what they were thinking when drafting this. That's the only thing I can conclude 100%.
I do not agree that implicit disclosure is case-by-case different. See GL G-VI, 6: "it may be implicit in the sense that, in carrying out the teaching of the prior-art document, the skilled person would _inevitably_ arrive at a result falling within the terms of the claim."
DeleteSubranges is indeed more subtle, but the Guidelines are very clear in their test - despite the inconsistency with the case law book (which describes, in C.I.6.3.1 that "[T]he principles applied by the boards of appeal on novelty of selection inventions were initially developed in particular in T 198/84 (OJ 1985, 209). They are summarised briefly in T 279/89...." which still includes the purposive selection test, but which also indicates that "several decisions consider that purposive selection is relevant for assessing inventive step but not novelty) and the very recent T 1688/20 () of 19.10.2022 (reason 3.4 'In light of the above, the Board concludes that in cases where, under application of the "gold standard", it can be established whether the skilled person, using common general knowledge, directly and unambiguously derives a claimed sub-range from a particular disclosed range of the prior art, no supporting test or criteria is necessary to reach a conclusion and thus none of the principles set out in decisions T 198/84 and T 279/89 needs to be applied.").
The unclarity with the ranges could maybe be a pointer that the expected answer shall not be based on sub-ranges (at least not where they are not clearly narrow and far-removed), but on something else (the opening?)?
W.r.t. novelty of sub-rangers, also note that the 2022-edition of the Guidelines G-VI, 8 gave:
Delete"A sub-range selected from a broader numerical range of the prior art is considered novel if both of the following two criteria are satisfied (see T 261/15 and T 279/89):
(a) the selected sub-range is narrow compared to the known range;
(b) the selected sub-range is sufficiently far removed from any specific examples disclosed in the prior art and from the end-points of the known range.
The meaning of "narrow" and "sufficiently far removed" has to be decided on a case by case basis."
Whereas the 2023 edition of the Guidelines, which you had available online during the exam, gives:
"A sub-range selected from a broader numerical range of the prior art is considered novel if both of the following two criteria are satisfied (see T 261/15):
(a) the selected sub-range is narrow compared to the known range;
(b) the selected sub-range is sufficiently far removed from any specific examples disclosed in the prior art.
The meaning of "narrow" and "sufficiently far removed" has to be decided on a case by case basis."
i.e., the reference to T 279/89 was deleted and the far-removed requirement is not longer referring to the end-points of the know range but only to any specific examples.
What about generalising by supressing the 30-100 range for upper surface (since the description discloses thé général tapering), and keeping in claim 1 the lower 0.3-1 range?
ReplyDeleteI went for this considering it is novel over D1/D2 and allowed according 123(2)
This is something I did and then change it. I was wondering if we can consider this as intermediate generalisation or not. I was thinking of very big holes above as not disclosed and the limitation to 30-100 as being quite broad as I had the lower one in a dependent claim. Not sure !
DeleteI went with this intermediate generalisation and put the 30-100 range on a new dépendent claim
DeleteI went for this also
DeleteWe will see if you won some points, or lose a lot of points with this !!!
DeleteYeah, I thought the description referred to the prior art pores as tapering too... For example, I thought that the *tapering shown in Fig 2* was a picture of the *prior art* because it was referred to in the description before the any reference was made to the actual invention disclosed in the application? (unless i missed that it was a picture of an embodiment - let me know) Also, client did not hint that D1 didn't disclose tapering, which is the usual format for paper B?
DeleteFor those reasons, just to be on the safe side, I pushed my amendments to refer to specific ranges, rather than rely on the tapering aspect as being novel over D1.
@anonymous 2:53pm ; it seems the tapering was not in D1, as stated by the arguments of the tutor above in the novelty against D1. I considered the tapering was not disclosed in D1
Delete@Yoshi - I read the arguments above, but I'm not convinced. For example, D1 refers to the "smallest pore size" in exactly the same manner as for the tapering pores explicitly disclosed? Additionally, the relative term "smallest" does imply there is a relatively larger pore size, wherein there is nothing in the prior art or description to say that D1 includes irregularly sized pores which are not tapered, so I assumed it was in reference to the tapered pores described using the same language. I guess I thought the disclosure of a taper is *implicit* in D1?
Deletesuch dodgy wording!
@yoshi - me again. I can't think of what the purpose of Fig. 2 is otherwise? If you can, do let me know!
DeleteOk, Starting to prepare B 2024….
Delete@Anonymous March 15, 2023 3:30 pm
DeleteIt is not directly and unambiguously derivable from D1 that the pores are tapered. Smallest pore size X could mean many things. Perhaps some pores are bigger than others, and they're not all identical. However, this in no way implies a tapered pore.
@yoshi don't worry! I don't think that I'm right, I'm also expecting to resit. I'm mainly just pointing to an area I couldn't resolve within the time frame, which led me to a narrower solution.
Delete@armin I appreciate that it's not explicitly disclosed, and that I am probably wrong, but it seemed unclear what the intention behind Fig 2 was, especially as it was not a picture of an embodiment. Additionally the examiner didn't go to length to explain exactly why D1 didn't disclose calim 2. I couldn't tell. If it was because of the feature "taper" or the specific numeral range (namely upper pore)
So I didn't have confidence to go for the broader claim, despite first considering it *shrugs*
I very much doubt this is the expected answer. The paper was clearly set up to test our knowledge on amending ranges. Given that hydrophilic couldn't be removed, what would you actually write in the basis section of your answer if you've made barely any amendments to Claim 1?
ReplyDelete@you cant B serious : whom are you answering to?
DeleteNa Ja, in his model answer, he has to write the reasoning for claim 2, then you simply get the "range reasoning" points on claim 2 and get some more points for "insisting on D2 implicit disclosure" with claim 1. I'm trying to find in the case law what a "far removed" range limit is. Looks like its independent on how broad the range is....
DeleteThe DP model answer. There's just no way the exam committee wanted us to argue that the opening feature was novel. For all the reasons mentioned above and in the other thread, this feature was clearly implicitly disclosed.
DeleteLove your name and summarizes my feelings. Did not think it could get worse than 2021 but was surprised yet again
DeleteThis comment has been removed by the author.
Delete@Gui, what reasoning do you mean? Incorporation of claim 2 into claim 1 finds basis in the claims as filed. It is 1 sentence reasoning
DeleteSorry you are right of course, if you argue novelty with claim 1, you do not have to do it with claim 2.... So you're argument is a good one in favor of "You can't B serious", they probably wanted a "narrow and far removed" discussion.
DeleteHi Delta Patents - Are you able to publish the content of the paper?
ReplyDeleteHi Monifa, it's available on the EQE compendium on wiseflow
DeleteEarlier today, we added the paper at the end of the blog post for easy reference.
DeleteAt the end of the day, paper B is an amendment paper. It's designed to test our ability to make supported amendments which address the examiners objections with consideration of the client's wishes. It's not a paper about making dodgy novelty arguments which are in direct contradiction to the objections. The EQE is a game and you have to play it.
ReplyDeleteThere are always multiple ways to overcome a novelty objection under 54(3), unless the description is extremely limited and doesn't disclose any feature that could be novel over the document. So they have to accept a lot of different answers in this paper
DeleteFrankly, arguing that the opening is novel is not one of those ways, much less the expected way.
DeleteI agree with this, I've never seen a past paper where you were not supposed to take the objections in the communication at face value, and it seems particularly strange if it was expected for something as marginal as an arguable implicit disclosure. Then again, I don't understand why they didn't just make the implicit disclosure in D2 even a little bit more clear-cut to avoid this. I agree with some of the comments above that this was a poorly-drafted paper either way.
DeleteI am also not aware of any past paper in which the Examiner was wrong with the novelty assesment in the communication. I also think that the DP solution is not the intended solution, as this would make the whole document D2 irrelevant. BR, Lucas
Delete@SH
DeleteI do remember one paper (can't remember which year) where the examiner in the communication objected to a dependent claim for lack of inventive step, which turned out to be incorrect. There's probably more examples, but that's the one that immediately comes to mind. I would not take objections from the communication at face value, especially if they clearly don't address all the features of claim 1.
Having said that, I completely agree that paper B took a wrong turn here by introducing a high amount of uncertainty. I took the same approach as Delta in my exam but it did feel quite shaky and, seeing all the comments, almost inconclusive, rather than being a well-drafted and objective paper.
It would've helped if any of the documents stated that the measurement always *requires* an opening, or that there are other means to get light to the reagent part (no need to even specify how, that would be sufficient).
Despite my solution, I still feel frustrated, because I feel it could just be turned around by the Exam Committee, causing me to lose a lot of points.
I dont agree with that reasoning because they are explicity telling you that their membrane work in conventional known devices, and D1 (earlier document) tells you that known/conventional devices in the market have openings. Otherwise they would have tell somewhere in the paper that CONVENTIONAL DEVICES can optionally have openings (or something else) but they didnt. It is similar to C or D2, you have to assume that what is given on the paper are all the facts, and conventional devices known at the time of D2 have openings. in my opinion D2 discloses an embodiment of their membrane in a conventional strip which all comprise openings.
DeleteIf the solution was like the dP, the exam was intended to be a piece of cake, discard D2, and you only have D1 alone for inventive step, and you dont have even to write too much on novelty or basis in the description because there is not much to say.
I dont agree on this one.
personally i m just praying for 45
DeleteThat would be something like disclosing a special engine specially suitable for cars (and not mentioning any other purpose) and then trying to disclaim wheels.
Delete@Armin you are probably right, and I didn't necessarily mean that the objections should be taken without any question. I do think it's a highly unusual scenario in this exam to have an incorrect novelty objection against a main independent claim, especially on what seems to be a contentious point. Knowing that lack of novelty is often penalised quite harshly, I think they could have anticipated that many candidates would go down the 'safer' route of amending to include a narrower range, so hopefully that choice gains a reasonable number of marks anyway.
Delete@Anonymous March 15, 2023 5:17 pm
DeleteYour reasoning is still akin to inventive step rather than novelty. Novelty is an absolute criterion, to be evaluated from the perspective of a single embodiment of a single document. D2 does not go into detail what known strips are. At best, we can look at claim 2 of D2 which is a strip with a capillary and a membrane - no opening.
D1 is an example of a strip that was known before the filing date of D2. Clearly, it is not the only one out there. The client is also making 'known strips'. However, that does not mean that you can simply use anything known in the art as 'part of the embodiment of D2'.
Strips with openings are known in the art, but not from D2. You can refer to conventional devices all you want; D2 still gives no indication that it has holes and there also is no indication in any of the documents at all that strips MUST ALWAYS include an opening. For implicit disclosure, it must then always be the case, otherwise it is not directly and unambiguously derivable from D2.
@SH
DeleteI would not fear too much for the marks given to the claims. If you opt not to defend the opening and choose another limitation, you would (in my opinion) lose some marks for unnecessary limitation.
However, the rest of your reasoning remains exactly the same, whether you limited more or not. This is because inventive step here is independent from your limitation, because D2 is art. 54(3) EPC.
You also don't lose out in the basis marks, because 'not limiting' does not require any basis (so there is also no points for 'not limiting').
Even in novelty, you would not lose points, because your claim is also novel by virtue of the extra limitation.
Don't worry if your claim is narrower than the DP solution. I would think you can still pass quite easily with good reasoning. Those extra 5-10 marks (my guess) shouldn't matter.
So Armin, what exactly will you get points for in your answer seeing as there's no basis to give? You're not going to get 5-10 marks in the amendment and basis section of the mark scheme for making the amendment suggested by the client and giving the one liner basis required to incorporate claim 2 into claim 1.
DeleteI dont agree. In EQE world, similar to paper C or D2 you have to assume all possibilities (facts) are given in the paper. They are telling you that their membrane is suitable to be used with conventional devices (in fact they dont mention any other enabling embodiment), they even refer back to D1 (maybe for other purposes), but the embodiment of their membrane using the most common conventional strip is explicity described and the only "conventional strip" we know of in the paper is given in D1. Otherwise, it would be like an engine for use in cars, and then say that wheels are not disclosed.
Delete@You can't B serious
DeleteYou will get points extra for the claims, because that's where the limitations occur.
If you include an unnecessary limitation, some marks are deducted from the total available for the claims.
Sometimes, mistakes in the claims bleed into the letter too. If claim 1 is not novel, then you get 0 marks for the claim and also for novelty, since then apparently that reasoning was not correct.
In my opinion, both my claim and your slightly narrower claim are novel. Hence, there's no bleeding into the paper. Only the claims are affected (or basis if you didn't argue properly how your limitation is supported).
@Anonymous March 15, 2023 5:42 pm
DeleteI'm afraid we will have to agree to disagree, since we've both made our points already. We'll have to wait for the Examiner's Report.
Armin, my point is I can't believe you will get full marks for Claim 1 for simply making the amendments proposed by the client. The client's claims are always wrong and our job in the exam is to figure out why they are wrong. In this case they were wrong because they were not novel and because there was no basis to remove hydrophilic. It's unreasonable to expect to get the 5-10 marks for basically doing nothing.
DeleteThat was me above
Delete@You can't B serious
DeleteDon't forget there's also leaving in the hydrophilic, and the amendment to claim 5 which is actually *not* novel despite the client's reasoning. It's not just the claims as proposed by the client.
^ and antecedent basis for the reagent part in feature (b) of claim 1, the correct use of two-part form (hydrophilic should be in the pre-amble), and reference signs in parentheses R. 43(7) EPC
DeleteI'm not saying I would get 5-10 marks added. There is a total number available (usually about 30) and every mistake (unnecessary limitation, forgot reference signs, incorrect two-part form, lack of novelty, lack of clarity) results in a deduction of points based on the severity of the mistake. Typically, unnecessary limitations can be a deduction of about 5 points or 10 if severe.
DeleteI believe that the fact that document D1 stated that the strip (including the opening) was known and on the market for several years, and then D2 refers back to D1, it is to be understood that even if the opening is not included by reference it is actually common general knowledge because this strip (with opening) had been selling for years and they are even citing it as suitable. So if the distinguishing feature of your claim is the opening, said of claim is still not novel over D2.
ReplyDeleteIn T 786/00 the board stated that, according to established case law, when considering the question of novelty, a prior art document must be interpreted in the light of common general knowledge available at its publication date. Common general knowledge which did not exist at this date, but which only became available at a later date, could not be used to interpret such a document (cf. T 229/90, T 965/92)
You can not simply combine a prior art disclosure with elements from common general knowledge, as you suggest, also not to determine wehat is implicitly dsiclosed.
DeleteSee also GL G-VI, 6: "[...] it may be implicit in the sense that, in carrying out the teaching of the prior-art document, the skilled person would INEVITABLY arrive at a result falling within the terms of the claim."
E.g., it is common general knowledge than 200 is in between 10 and 100000. But a prior art disclosure of "in a range of 10 to 100000" does not disclose 200.
The use of common general knowledge to determine what is implicitly disclosed is not at all changing the technical disclosure. If it is, then you add technical teaching (which, if it would be an amendment, would violate Art. 123(2)).
E.g., if it is described that there are three planes, the second being described as being parallel to the first, the third being described as being parallel to the second, then it is -based on common general knowledge - implicitly disclosed that the third is parallel to the first.
Thanks for your thoughts on this, Roel. I am just wondering whether GL G-VI, 6 can be argued the other way. As you state, for an implicit disclosure, the skilled person would inevitably arrive at the result falling within the claim by carrying out the teaching of the prior art. Would claim 2, read in light of paragraph [006], fulfil this? Claim 2 was directed towards a strip comprising a capillary and membrane and [006] teaches that a known strip can be used (in the world where we only have information in this paper, we only know of strips with openings). Does that not suggest that when trying to work the teaching of claim 2, the skilled person would inevitably end up with a strip with the membrane of D2 and the capillary and reagent portion with an opening?
Delete@Tia
Deleteabsolutely. openings are needed to let the light pass through for the spectrophotometer to work. As D2 strip is configured to work with a spectrophotometer, it cannot be anything else.
The paper lacked clarity in my opinion, and this shows by the DP model solution. It needed a clearer stir on what was 'far and removed', novel (what was implicitly disclosed) and arguably, what had basis.
ReplyDeleteWith this much uncertainty, I believe its fair the committee takes a more lenient view on marking the claims.
Considering how many alternative answers I've seen on this blog alone, they kind of have to assume a more lenient marking approach, else the pass rate will be at an all time low
Delete
DeleteI doubt they will. Deltapatent’s solution feels wrong to me. I agree the paper is unclear. I went for a narrow claim because the ranges felt like a massive gamble and there’s no way of knowing which one was correct 🤷♂️
Just have to look at the Number of comments of this year compared to previous ones to see how foggy this year’s B paper was !
ReplyDeletefrankly, it seemed too easy to me, and not gone through the solution proposed above. So I expect a massive mess.
DeleteI doubt they will. Deltapatent’s solution feels wrong to me. I agree the paper is unclear. I went for a narrow claim because the ranges felt like a massive gamble and there’s no way of knowing which one was correct 🤷♂️
ReplyDeletehttps://www.epo.org/law-practice/case-law-appeals/recent/t070230eu1.html
ReplyDeleteSome folks here argued that 0.3 is not far removed from 0.1. This is apparently not the case and it's enough that the other endpoint is far removed from the prior art's.
I don't think you have read the decision properly. The patent in suit wanted to claim the sub range 2-12 when the open ended range of "at least 1" was known. For such an open ended range of course the claimed range was narrow with endpoints sufficiently far removed because there are infinite divisions in the known range.
DeleteFurther, I think DP's answer is wrong because of this decision relating to citations and implicit disclosures
Deletehttps://www.epo.org/law-practice/case-law-appeals/recent/t112259eu1.html
The meaning of the expressions "narrow" and "sufficiently far removed" has always to be decided on a case-by-case basis.
DeleteIn the present case, I think one could fairly assume that '0.4 to 0.6' is a "narrow range" out of the prior art range '0.1 to 5' (49 x 0.1 units)
However, given that the 0.2 units (distance between '0.4 to 0.6') are considered as "narrow" it follows unequivocally that the distance between 0.1 (of '0.1 to 5') to 0.3 (of '0.3 to 1.0'), which is also 0.2 units cannot be considered as "far away". I also highly doubt that the "sufficiently far removed" criterion applies for 0.4 (0.3 units) or even 0.5 (0.4 units). Although I guess, this depends on your arguments and potential case law supporting your arguments.
It would be madness for the exam committee to expect an answer that relies on case by case interpretation of such an ambiguous part of the law. This is why I believe the expected answer was to limit the lower range to 0.5.
DeleteThat's not the point. Read the board's reasoning behind accepting 2 as the lower endpoint when at least 1 was disclosed in D5. Obviously, it has to be decided on a case by case basis as CL mentioned, but saying that 0.3 is not far removed, but 0.5 is, doesn't make much sense to me.
DeleteReciting a single value from a known range is novel. Reciting a sub range is not. So reciting that the lower diameter is 0.5 is novel and covers all the embodiments. It doesn't need to be far removed because it's not a sub range.
DeleteRegarding the decision cited above: The numbers in those ranges relate to molar ratios. For the lower limit, a ratio of 2 (i.e. 2 to 1 = ca. 66,7%) was compared to a ratio of 1 (i.e. 1 to 1 = 50,0%), see sec. 1.4.5 of the decision. Looking at the associated percentage values, ratios have to be evaluated differently than absolute numerical values.
Delete@You can't B serious
DeleteWould 0.5 not be interpreted with scientific notation, i.e., 0.45 - 0.54, and thereby constitute a range too?
Asking because I'm not too familiar with ranges.
by the way, even though a purposive selection is no longer a requirement for novelty, whether your selection of a range is associated with an improve technical effect is still in practice considered on whether you are sufficiently ''far removed'' from the end points of the known range
Deletein general ranges are not an easy topic.
keeping that in mind, 0.4 to 0.6 was a ''relatively safe'' range since it was performing significantly better (according to application)
Delete@IP March 15, 2023 6:04 pm, but since D2 is 54(3), you only need to be novel. The technical effect over D1 is already present due to the membrane tapering in diameter.
DeleteAs i said, for novelty, sometimes they check the effect of the subrange to decide on whether it is sufficiently far removed (even though technically that s in IS analysis according to the current guidelines). They do it because the sufficiently far removed criterion is vague; it s used to help them clarify
Delete0.5 could be interpreted as a range such as 0.5-Δ,0.5+Δ, where Δ is measurement error margin and/or customary tolerance, but this depends on the invention.
Delete@ AnonymousMarch 15, 2023 5:04 pm
DeleteYou wrote: "Further, I think DP's answer is wrong because of this decision relating to citations and implicit disclosures.
https://www.epo.org/law-practice/case-law-appeals/recent/t112259eu1.html"
Please explain.
I have gone for the 0.4-0.6 range as it seemed to me a range (which is better that a single value) providing optimum performances for the membrane. Though it was not a criterium for novelty, the optimal performances was probably expedient to justify novelty and inventive step of the device of the invention.
DeleteThe solution by DP seems to be tooooo easy, why D2 is prior art according Art. 54(3). The Exam Committee wants to reduce our typing working for problem-solution approach?
ReplyDeleteI do not think its easy. It takes balls write such a claim imo. It does raise doubts about whats derivable from D1 starting with D2. For example, why would the window be implicitly disclosed but not the polyamide material???
DeleteWhy would you assume that polyamide is not implicitly disclosed? Imo, it is.
DeleteIt does takes balls LOL. D1 tells you that conventional strips all have openings, D2 refers back to D1 and says their membrane is suitable for using with conventional strips and does not give any further possibilities, and then you try to say that D2 does not discloses a feature which is known and included in the strip that D2 said it could work with. For me it doesnt make sense, that claim is not new over D2.
Deletetbh, I cant remember if it was in D1 or not. I basing it on being the un-preferred option in clients letter this year. In many past papers, an option for novelty is presented in the clients letter but is penalised heavily for marks. I assume it to give candidates a 'fail safe' to get to novel claim in difficult papers so they can start the letter (which usually has 70% of the marks).
DeleteFor example, last year the client gave you the option of claim 6 into 1, this carried a 10 mark deduction (as well as the marks you lost for not putting the correct solution).
Deletean opening is implicitly disclosed as it is needed in any strip to let light pass through for the spectrophotometer to work. as the strip of D2 is used with conventional devices such as those of D1, it cannot be anything else.
DeleteSander, I wasn't able to read the whole decision, but I think T 0279/89 contradicts the solution you've posted. The board assumed that teachings of the cited document is incorporated into the document by reference, even though the document that is prior art under 54(3) did not explicitly say so, and they are considered as a single disclosure for the sake of novelty assessment of the application. The apellant argued that the combined teaching of the 54(3) document and the document it referred to is not explicit, and thus the claim is novel. Nevertheless, the board disagreed with this view, as can be read in 6 (ii) and 6 (iii). The board concluded that the 54(3) document gives clear and explicit directions for the skilled person to arrive at a result falling within the terms of Claim 1.
ReplyDeleteNow obviously, the situation in B paper slightly differs from this, because D2 refers to D1 for a specific teaching, i.e., the separation of blood using a membrane. However, it's clear from both D1 and D2 that these membranes are intended to be used in a strip, and D2 mentions that the membrane can be used in known strips ([006]), and further, D2 also relates to said strips. In view of this, I would say that D2 gives clear and explicit directions for the skilled person to arrive at a result falling within the terms of the claim you've posted and the claim is not novel over D2.
There's probably case law that seemingly aligns with this solution, and case law that seemingly contradicts it. It's difficult to argue that the cases can be equated.
DeleteStill disagree with the implicit disclosure of an opening in D2, but clearly as shown by case law this is not a trivial thing and is to be determined on a case-by-case basis. That's exactly why most people find it strange they included this ambiguity in an EQE exam in the first place.
Maybe there is no 'right' answer and you're just expected to choose something and defend it. Or perhaps including a (small) limitation only loses a mark or two.
B 2021 had a situation where there were several options for amendment (none of them based on the client's proposal), and the Exam Committee seemingly picked one at random as the 'right' solution, the others losing a few marks.
DPs solution may be right but I think it seems very unusual for EQE to provide so much information for no use. Providing som much Information on the diameter and different ranges, just for making us come with an argument relating to the strip.
ReplyDeleteIn reality, the strip itself does not seem like the real invention of this application. D2 is also an application of the client and it covers a tapered pore membrane and a strip including the same.
DeleteThe real invention in the application in my opinion is the new device. However, since this device can only be used with a strip that has a membrane with tapered pores, you need to define that in the claim (either directly in the device claim or independently if possible).
That makes it extra strange. Whether you defend claim 1 in view of D2 based on the openings or based on a further limitation, both would be inside the scope of the claims in D2. Seems rather arbitrary to include any limitation (whether it is the opening or any of the ranges) for the sake of getting rid of D2 when the strip is nothing innovative compared to D2.
In a real life case, I agree, but in this exam format, I cannot remember any other year (or A, C, D exams) where so much information is provided without any use, if the DP solution is true.
DeleteI do not fully agree: most information is not without use - it is relevant for novelty w.r.t. D1.
DeleteAlso note that we indicated in the blog post that:
"There are two spots in D2 where one could wonder if they disclose feature (c).
The first one is in D2, [03], which has a reference to D1. D1 does disclose feature (c). In principle, it is allowed for a prior art document to reference another document (gl. G-IV, 8), but this reference seems to have problems. First, it is not clear from D2 that this reference is even meant to fill-in the disclosure of their embodiment. Section [03] merely describes the prior art, not the new embodiments of D2. Second, the disclosure is specific for blood separation, not on the opening, or even blood sugar measurement. So, D2, [03], seems not enough.
The second spot in D2 is section [06]. Here it is disclosed that D2's strip can be used in 'conventional devices for blood sugar measurement'. All the conventional devices that we know of, and in particular, the one referred to in D1, have feature (c). So one might argue that feature (c) is implicitly disclosed in D2. However, the bar for implicit disclosure is a high one, it should be inevitable that a conventional device has the opening. It's not my technical field, but I guess other options are possible. So section [06] is also not enough.
This means that this amendment of the client makes Claim 1 novel."
as well as:
"For Claim 2, as it is now in Claim 1, the normal approach would be to strike the claim. But as the claim is there, we've opted to amend it to a fallback range, restricting the diameter on the upper membrane. This would make the claim novel over D2 even if the D2 as whole might be considered as incorporating feature (c) from D1. We don't think this amendment is needed."
Some may have amended claim 1 to incorporate the feature of our claim 2, i.e., those that considered the whole of the disclosure of D1 to be included in D2 due to the reference. That may have been the intention of the committee, but we believe that the only that part of D1 that is specifically referred to is to be considered included when applying established case law.
It may also be that the committee intended our solution for claim 1, but had a kind of plan-B solution (=incorporating also the range of our claim 2) to allow candidates to create a novel ad inventive claim 1 so that the knock-on effect of a non-optimal solution for claim 1 on the rest of the paper is limited (as is the usual practice in paper D when it it foreseen that candidates make a specific, but common, error).
Further, the paper must have information that is not needed for the correct optimal solution, as there must also be information that allows you to go wrong.
DeleteHi Roel, what do you think about essentiality of "hydrophilic"?
DeleteI refer to our blog post. Please do not just rad our claims, but also the discussion in our blog post.
DeleteHi Roel. If the opening (feature c) was not in D2 and the original set of claims was novel over D2 already, then it has to be assumed that the whole content of item 3 of the communication is wrong. We have been trained to assume that the content of the communication should be fundamentally right in these aspects. I tend to agree with previous posts that this was a limitation of ranges case.
Delete@Roel
DeleteRegarding this "'s not my technical field, but I guess other options are possible. So section [06] is also not enough."
Respectfully, you are guessing other options are possible (using your own knowledge, assumption and creativity), from the facts the paper tell us, the only conventional strip is the one D1 mentions which "have been years on the market", you don't have to assume that others options are possible that's out of the scope of EQE and they (in my opinion) put it there for a reason. It's implicitly discloses, claim 1 is not novel over D2.
@Rea
DeleteIt is true that the only example of strips given are those of the application and those given in D1. However, neither state explicitly that openings are strictly necessary, they just have one for the purpose of allowing light to access it. Neither state that these are the ONLY strips imaginable. As a result, I think you are definitely allowed to argue against the implicit disclosure of D1, as the reference is quite weak and merely stating "known strips" does not automatically render the strip of D1 incorporated by reference.
@Roel
> "plan B solution"
I do truly think this is the case. Regardless of whether you defend novelty over D2 with the opening, or you amend to create (further) novelty, the rest of the story remains identical. They made a nice separation between novelty and inventive step in this way.
Besides that, everything in the paper seemed to point me towards defending the opening, as I've made abundantly clear in other comments. Nevertheless, the vast majority seems to disagree quite strongly.
I'm just baffled as to why they would make you rely on:
(i) implicit disclosure, which is very much a case-by-case, ambiguous and inconclusive concept; or
(ii) sub-range novelty, which has exactly the same issue.
We have added a copy of the complete paper at the end of the blog post .
ReplyDeleteNote: as the formatting got lost when copying from Wiseflow, we had to reformat the table and the amended claims (best effort attempt, but any overlook is not excluded).
Regarding R43(2), "we'll argue that the claims fall under the exception of R.43(2)(a) plurality of interrelated products." I have been wondering whether a mere "for use with a strip as defined in claims 1 to 4", i.e. a suitable-for limitation, is enough to fulfil the exception of R.43(2)(a). I haven't found any decision with such a case; do you know one?
ReplyDeleteSuch a mere "for use" does not provide novelty to the claim.
DeleteSo an Rule 43(2) discussion is not necessary nor appropriate for the claim as it stands, but you will need to discuss Rule 43(2) when you amend it (if still in the same category).
I still do not get why undisclosed disclaimer is not proposed as a solution. It gives the broadest scope of protection to the client!
ReplyDeleteI agree. this is the best solution for restoring novelty and provide a good new product protection to the client, as new useful membranes have been claimed in D2 by the client. Unfortunately I did not go towards that direction... I still believe however that this is the best solution to the client, but not the only solution for replying to the objections.
Deletestrongly disagree. the invention of D2 is about improvements in the MEMBRANE. Membranes are part of strips, that shall comprise an opening for letting the light pass through for optical analysis. conventional analysis uses conventional devices with a spectrophotometer with a single lightwave. so opening is implicitly disclosed.
ReplyDeleteMoreover, opening for letting the light through the strip is present in both D1 and the invention at stake. How could a strip comprising the membrane of D2, claimed in claim 2 of D2, cannot include an opening if it is used with a spectrophotometer?
DeleteI agree
Delete@DP: die Begründung zum fehlenden impliziten Merkmal c) in D2 scheint grundsätzlich plausibel zu sein. Wenn das allerdings tatsächlich die intendierte Lösung ist, schlage ich vor, die DP Methodik für Teil B zu anzupassen. Im deutschen Kurs wurde uns beigebracht, dass der Prüfer mit Neuheitseinwänden immer Recht hat und dass es im Sinne des Zeitmanagements effizient ist, die Neuheitseinwände nicht im Detail nachzuprüfen. Dieser Ansatz hat bisher immer funktioniert, müsste dann aber in Anbetracht der heutigen Prüfung adaptiert werden.
ReplyDeleteI have the same solution. After reading the blog, I an not sure anymore whether it was the intended solution, but our task as candidate in the EQE is not to find the intended solution to the intended paper, but the correct solution to the paper as it was presented to us.
DeleteSure, but in light of the exam paper, I think it is also possible to argue in favor of the implicit disclosure of feature c) in D2. I think there are arguments for both options (implicit and not implicit disclosure), as presented in this blog.
DeleteWhat about the original claim 3, the strip can perform a measurement on a blood sample of 3 to 5 μl, being patentable? It is stated in D1 that 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.
ReplyDeleteHi,
ReplyDeleteWhy is this claim 1 novel over D2? D2 specifically discloses ", the upper membrane surface may have pore size of 30 to 100 µm, while the lower membrane surface may have a pore size of 0.1-5 µm" (D2 §4).
Dp have provided there reasoning above. In short, they are saying the window is not disclosed by D2
ReplyDelete