A 2025: first impressions?
To all who sat the A-paper today:
What are your first impressions with respect to this year's A-paper? Any
general or specific comments? Surprising elements in the client's letter and
the prior art?
How did this year's paper compare to
the papers of the last few years? Similar difficulty level? Or
harder/easier?
Was the subject-matter well
understandable, for chemists as well as e/m candidates?
Multiple independent claims? Functional features? Could you find the
wording for claim features in the clients letter and the prior art?
Did you have enough time?
How many marks do you expect to have scored? What is your expectation of the
pass rate and the average score?
What was the effect of doing the
paper online? Could you benefit from being able to copy from the exam paper
into your answer? And from copying parts of your answer elsewhere into your
answer? Did you struggle with the online format in any way? What was the effect
of the situation that you had to take the exam largely from the screen as only
a part could be printed?
Did you take the exam from your home
or your office? Or somewhere else? How did that work for you?
Did you experience any technical
difficulties during the exam? How and how fast were they resolved? Did you use
the widget to contact the invigilator?
Please be reminded that, if you wish
to lodge a complaint pursuant to point I.8. of the Instructions to Candidates concerning the conduct of the
examination , you must do so at the latest by the end of the day on
which the paper concerned takes place, by filling in the dedicated form on
the EQE website. The Form for paper A is
(only) available on 13.03.2025, 13:30 - 23:59, CET.
The paper and our answers
We aim to post the core our (provisional) answer shortly after the exam in a
separate blog post, as soon as possible after we have received a copy of the
paper, preferably in all three languages. Should you have a copy, please
send it to any of our tutors or to training@deltapatents.com.
Please be reminded that you can view
and print/download a copy of your exam answer after the exam, via the eye
below the "1. Paper"-icon in the bottom left part of the flow window
of the respective flow. (It may not be available immediately after the official
end of the (part of the) paper, but only 30-60 minutes later.) Apart from the
pre-printable parts, the paper itself cannot be downloaded (unless you copied
it in full into your exam answer).
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 13-03-2025
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Please post your comments as to first impressions and general remarks to this
blog.
Please post responses to our answer (as soon as available) to the separate blog
post with our answer. Thanks!
Anyone?
ReplyDeleteLateral flow test, plastic cassette, and a method of diagnosis using lateral flow test anyone?
Characterising portion being
spherical and less than 100nm for the coloured particle?
Anyone?
chartersised in that the colored particle is gold nanoparticle of size 20-100nm.
Deletethere is no basis for just spherical particle- too broad?
I did an ex vivo method of diagnosis, just to be sure. And the particle has to be the gold nanoparticle, between 20 and 100 nm. Less than 20nm could not give an accurate result.
Deleteis it inventive because of selection of 20-100 nm size of gold particle, contribting to increased sensitivity. D2 disclosed a broader range of 5-400, amd also not in lateral flow tests?
DeleteI argued that it was inventive because D1 teaches that you maximise sensitivity by decreasing the KD, and says nothing about changing the coloured particle, so the skilled person would try to improve the antibody rather than turn to D2.
DeleteI believe that the effect of the gold particle falls perfectly under "surprising technical effect" as a secondary indicator of inventive step. The person skilled in the art would have no reason to believe that changing the coloured particle would give a ten-fold increase in sensitivity since the known use of the gold particle is to produce bright colours, so there is no reason for them to combine D1 and D2 to solve the technical problem.
DeleteLateral flow test for detecting a target molecule in a liquid sample OR Lateral flow test for detecting a spike protein in a liquid sample ?
ReplyDeleteI settled on claiming the gold particles @ 20-100nm based on the bonus effect of increased sensitivity, but I feel like it might have not bene inventive enough. I'd certainly argue for the combination of D1 and D2, based at least on the "vibrant red" of D2 [002]. :(
ReplyDeleteSame, argued that inventiveness due to D1 being blue - technical effect of vibrant red is that the user is assisted in performing the task of reading the results of the device. The skilled person would not arrive at the invention since there is nothing in D2 prompting the skilled person to make it more easdy read the results by the gold particles, D2 does not even mention the red being vibrant
DeleteD2 does mention 'intense red' for <100nm, but i think person skilled in the art looking at D2 would replace blue latex particle with blue gold particles instead but not red.
DeleteI opted for a kit claim
ReplyDeleteAre you a UK trainee by any chance? My immediate thought was a "kit of parts" claim but I couldn't find anything in the guidelines or visser to support those being a thing in EP practice. I settled on adding a claim to a product comprising the device of any preceding claim and also the extraction solution. Which I /think/ counts as a dependent claim.
DeleteI opted for kit claim too, it came up in one of the EPI mocks papers
DeleteNo Thomas I'm not a UK trainee. I claimed the strip as main product and then a kit claim comprising the strip in a plastic cassette and an extraction solution
DeleteI also claimed kit of parts, seemed as if the exam pointed in that direction. I generally work with mechanics/computer implemented invention so I brought a "chemistry claims" template to the exam based on the material provided in deltas A-course. There it said kit of parts :) But I never written such claim IRL...
DeleteThis was an interesting (read: frustrating) paper for me. It seemed to contain much less direct input from the client than I've come to expect from past papers. E.g. the client did not offer any commentary on D1 and D2 other than that they were prior art. Further, the subject matter was very similar to D1, and the novel aspects were essentially taken directly from D2. The prior art didn't seem to really have any "problems" with it that we normally expect. The client invention was just an improvement over the existing offerings.
ReplyDeleteIn the end, I based my novelty on spherical colour particles having a diameter between 20 nm and 100 nm. I went back and forth on whether to have the range as 20-100 or 20-40 due to Guidelines G-IV, 12 and G-IV, Annex 3 for inventive step of selection inventions. G-IV, 12 states if the solution is connected to a particular technical effect and "if no hints exist leading the skilled person to the selection" then it is inventive. I wasn't sure if the mention of 100nm as red in D2 (and also specifically called out as the reason for using 100nm in the client letter) would render that non-inventive and therefore requiring the smaller range.
After many agonising minutes at the end of the paper I decided on 20nm-100nm on the basis that the 10-fold sensitivity increase technical effect was not hinted at in D2 at least and hoping that was enough for the GL G-IV 12 requirement.
I sincerely hope that was the right move as I wasn't sure whether to risk -10 for being too narrow or -30 for being non-inventive. That said, I hope this was the correct direction at all...
Thomas- did you mention the spherical colour particles as gold nanoparticles?
DeleteI did lateral flow device, system with device+cassette and device+extraction solution, and a claim for a composition comprising gold nanoparticles with 20-100 nm in a suspension for use in a lateral flow diagnostic method.
ReplyDeleteI read it as the client wants to sell tests not compositions, so stuck to the test with the gold 20-100 and the kit
DeleteAt least the field was easier for Chem/Bio people.
ReplyDeletePaper relatively short, D1 CPA, D2 less relevant, invention basically D1+D2 and why it was unexpected.
What was horrible is that it was not clear cut whether the 100nm max gold nanoparticle size was essential!
I opted essential because otherwise it would not be red. If its not red, then it is not inventive in view of D1 (which was blue) in combination with D2
Delete@Trainee forever, the 'red' limitation was described as necessary by the client.
Delete@Joel it may be described as necessary by the client, but it's still unneccesarily limiting. I don't see why the client would want to exclude other colours, but that's all the 100nm inclusion achieves. I therefore took out the 100nm upper limit, and just said sized to emit light on the visible light spectrum
DeleteI did not put the dimension of the gold particles in the device claim at all. This was not needed for the novelty or inventive step. D2 shows two different selections to made.
ReplyDeleteFor me, gold particles are nove just to D1, to be novel with D2 you have to narrow the known range 5-400 nm to 20 -100 to have vivid red color
DeleteIsn't Red color too limitating?
DeleteAnd for the test it has to be at least 20nm; so I am not sure if a upper limit is needed, as Goldparticle can be in other colors above 100 nm. Smelled like trap for me.
I think 20-100nm is also an essential feature, as there were issues above and below this range (I can't remember what they were now!)
DeleteAny gold particle include invisible ones, which would not solve the problem (one needs to see the result of the strip test).
DeleteFor me the question was either to limit to 20-100nm spherical gold nanoparticles OR from 20 nm and which generates visible light (because red would not be mandatory. why not blue, etc?).
In the end, I opted to limit to 20-100nm as the client TESTED and said that over 100nm did not work.
But this was unclear in the paper (on purpose!).
No, because the Client tested it and the vivid color which detect narrow concentration of target molecule oyu have just for particle size lest than 100 nm. I understood that.
DeleteI believe the size range is needed, because D2 teaches that with gold you can obtain all colours, including blue, and you may attach the gold nanoparticles to the antibodies, while D1 taught blue-coloured latex. Hence, D1+D2 would immediately give antibodies with (blue=different size) gold nanoparticles. However, with the red nanoparticles, the enhanced sensitivity effect is achieved, which would not be expected by D1 (which uses blue) or D2 (which simply lists all colours, but mentions nothing as to lateral flow chromatography).
DeleteGb - Exactly, I did the same. >=100nm needed for inventiveness.
Delete@Gb but the client does not say the colour needs to be crimson red in order to have the enhanced sensitivity. They just state that gold nanoparticles have to be used. So why limit to a diameter that only scatters red colours?
Delete@confused, I believe the limitation to red is needed for two reasons: 1. The client explicitly stated that the colour red was necessary in [0015] ("since larger particles do not have the necessary red colour"); 2, if other colours are covered, in particular blue, the claim would not be inventive over D1+D2. D1 uses blue latex. D2 teaches that gold nanoparticles may be provided producing any colour (including blue) and may be attached to antibodies. A skilled person looking for an alternative to the latex in D1 would consider use of the gold nanoparticles of D2, as D2 teaches that these can produce the same colour as D1 and be attached to antibodies.
DeleteSo, in my opinion, inventive step needs to rely on the fact that the enhanced sensitivity effect is achieved only for red gold particles (i.e., 20-100nm) - if the enhanced sensitivity effect is achieved also for blue gold, then I would not know how to get an invention out of the client's disclosure, because the enhanced sensitivity would be a bonus effect obtained by the use of gold (of whatever colour), which is obvious from the combination of D1 + D2. So, selection of red gold over blue gold would not be inventive, either. I explicitly added a discussion of inventive step along the above lines in my last paragraphs of the description, because I also find the inventive point rather weak.
[We are not allowed to take this into account in the EQE, but this is how gold nanoparticles colour changes with size: https://www.cytodiagnostics.com/pages/introduction-to-gold-nanoparticle-characterization?srsltid=AfmBOopYnqH3OqZetgMeJ_zGxe8XjTD0OsJEhH1FApiGDYv3P5RdbJBd ; I believe this information was conveyed in D2 by saying that 100 nm or less will result in red, thus implying that other colours (including blue) will be found at larger sizes than 100 nm] .
Is the wording "gold particle" clear? I used instead the ruby-red colour
ReplyDeletethis is the technical effect
Deletedo you think that "ruby-red colour" is more clear than "gold particle"? Jeeeeeesus
DeleteThe parts I found trickiest were the following:
ReplyDelete1. Was it important to claim "colloidal gold", i.e. a composition comprising the gold nanoparticles in a suspension, rather than just the gold nanoparticles? If yes, would "colloidal gold" have been sufficient? I opted for using "composition comprising a suspension of spherical gold nanoparticles with a diameter of 20 - 100 nanometers in a solvent" everywhere.
2. The usage of the word "specific to" with respect to the target molecules, as well as the more elaborabe version of "being able to specifically recognise and bind to". I opted for using the term "being able to specifically recognise and bind to" since the client expressly said that was crucial, even though I think the term "being able to specifically recognise" is not very clear. At first I only included the part about specifically binding to, but my lack of knowledge within the area made me too scared to not include the definition of the client verbatim, and also replacing the term "specific to" with the longer term when applicable.
Oh, and I almost forgot but was reminded by "Trainee forever's" comment - I also found it very difficult to determine if 100 nm was a necessary limitation. Conceptually it makes no sense to me that red is the only color that we can use, but since the client specifically said "necessary red color" I chose to believe that the client knew what they were talking about and that 100 nm was a necessary limitation.
DeleteI struggled with whether to claim "colloidal gold" as well. In the end, I decided not to as I thought, based on my extremely poor understanding of chemisty, that the presence of conjugants of gold nanoparticles and antibodies in the liquid sample once bound to the target molecule would be the de facto suspension in solvent needed to produce the light effect. Not confident this is correct though.
DeleteYeah, now I'm definitely having second thoughts about my version being needlessly limiting. However, the client specifically said that they ordered and used "colloidal gold", not simply gold nanoparticles, which made me think that without that distinction it might not actually be a working embodiment... that a definition of "colloidal gold" was provided in D2 pushed me more in that direction, and the final push was when I realized that my use claim could be formulated as "Composition comprising ... for use in X", which is probably too gamey but since medical use claims are not common for A papers I figured they would go with something where the phrasing is very close to examples provided in the guidelines. My first use claim of "gold nanoparticles with diameter 20-100 nm for use" just "felt" a bit worse than the composition phrasing, and I wanted to have the same phrasing in all claims.
DeleteGold nanoparticles provide a sufficient distinction from D1 and D2. There was no need to include the dimensions. The dimensions are unnecessary limitations.
ReplyDeleteWhat about inventive step?
DeleteI don't think dimensions are unncessary. The invention does not work if the gold is less than 20 nanometers. The question is whether the upper limit is necessary. it seems like the only "benefit" of being less than 100nm is that the colour is crimson red. however, this looks like a presentation of information, so wouldn't be considered technical imo
DeleteI'm afraid that this is probably incorrect, the gold nanoparticles required a limitation of the diameter being greater than 20nm to achieve the technical effect of increased sensitivity and the 100nm restriction was required by the client as it was 'necessary' to have the red strip.
Delete@confused , I think you're correct. I believe its why the less than 20nm was required.
DeleteDimensions are necessary. It is said in D2 that gold particles (in the range 5-400 nm) can attach to biological molecules, including antibodies. Hence, you can easily combine the gold particles of D2 with the test of D1. But in the client invention, size is restricted to the short range 20-100 and this gives a surprising technical effect of multiplying by 10 the sensitivity compared with latex particles.
DeleteIfig - the last paragraph of D2 has selection inventions issue. It’s not that easy to combine D1 with D2.
DeleteAt first, it seemed easy, but I always had doubts about the inventive step, due to the known range of the goldparticle diamieter between 20nm and 100nm — it felt almost too simple.
ReplyDeleteHowever, during the last 45 minutes while drafting the description, I realized that the tests the client conducted were ALL based on SARS-CoV-2. As a result, the increased sensitivity only applies when combined with the Spike protein of SARS-CoV-2. This made it clear to me that extending the scope of protection to other fields isn't possible at this point, even though the client had hoped for that.
do you not think it is unduly limiting to put in the spike protein into claim 1 though? Also, this means that D1 is basically pointless no? the reason why the sinsitivity increased was due to the way in which gold nanoparticles oscilate with light, meaning that the increased sensitivity should apply to some degree all the time. However, I do concede to you that the 10-fold example is just for SARS-CoV-2
DeleteI agonised over this, too. I didn't limit to SARS-CoV-2 in the end because somewhere in there they mentioned that any antibody can be used, so the increased sensitivity is a result of attaching the gold particle.
DeleteI took it to mean that any old antibody detecting any old target was fine, so long as you used a gold conjugate.
Well, it wasn’t clear to me what the (surprisingly) higher sensitivity actually causes—whether it’s just the light or some other effect. D1 mentions at the end that testing for viral molecules is possible too, which is where I thought it could easily be combined with D2. But maybe I was overthinking it and panicking towards the end. Since this goes completely against the client's wishes, I’m feeling very uncertain about it.
DeleteClient letter did say it can be used to detect bacteria and virus. Also that antibody specifc to target cam be used. But then also says- in case the spikr protien whicb they also tested witj gold partcles. Not sure How inventive step is to identified
DeleteIn couple of places the client says the target protein is spike protein in our invention. So I limited the first claim to spike protein but not to sars-cov or covid. I think as well that extending the scope of protection to other fields isn't possible at this point. I understood "any antibody can be used" expression as it can be any antibody with high affinity that targets spike protein. But I am not sure now :D
DeleteClient letter says - the number of COVID-19 cases has declined, the demand for these tests
Deletehas decreased and so we are looking into other markets for our products. So clearly not to be limited to virsues?
and that= We would like to protect the latest developments of our technology with a new patent application that covers testing for COVID-19 along with other possible uses.
DeleteI thought about this too but the client want to protect other uses so I foloowed him. It would be nasty from the EPO to have made it necessary not to obey the client.
DeleteI went for the later flow test, lateral flow test kit (+casette+solution), detecting agent, method of ex vivo diagnosis - all based on the gold nanoparticle of 20-100nm in some capacity.
ReplyDeleteGot there pretty quick but I agonized over details for ages, such as: do I need a control line, do I need a wick, do I need this many independent claims? haha - maybe I shouldn't have looked at paper 2022 last night, the 5 independent claims in that knocked my confidence and I want to make sure I at least tried to cover enough inventions that were unitary.
Still having nightmares from 2022...
DeleteI was pretty happy to keep the control line and wick out of the independent claim. D1 mentioned that control lines aren't always present in other tests. The wick was present in the test of D1 and wasn't essential in the client's view. Hope I didn't miss anything obvious there!
DeleteI continuously changed the idea until the last minute about a control mechanism, but I ended up not including it. It was definitely presented as optional in the client letter, but I am so convinced about D1.
DeleteD1 taught that some tests do not include control lines *and* include other means to ensure the test was correct. In the client letter, there was a definition of how to determine a successful test (confirm that the liquid sample with the detecting agent had reached and interacted with the test line).
A possible limitation could have been along the lines of "means to determine that the liquid sample comprising the detecting agent reached and interacted with the control line".
I decided to leave these means in a dependent claim in the end, because the control line is mostly needed to confirm negative results, but not really to detect positive results - if present, the target molecule will still form the test line, hence it can be detected. While on one hand I have never seen a lateral flow without control (so, in real life, would not have been horribly limiting), I am not sure how in EQE-world this limitation would have been read.
@Gb - thanks for your comments - luckily, I decided not to include the control one, and not to include the wick - but I do think I’ve cocked up a bit with the additional independent claims.
Delete@anon 1 - 2022 was horrific. I missed an essential feature and like 3 claim categories. Shocking. Not an ideal paper to do the night before, but hey it was a good wake up call
I opted for an lateral flow test wherein the coloured particles are spherical gold particles and have a diameter in the range of 20 to 100 nm.
ReplyDeleteI further included a kit-of-parts claim based on the clients comment to their commercial use and the lateral flow test for use in a diagnostic method for viral infection, bacterial infection or pregnancy (as Art 53(c) EPC does not exclude products for use in diagnostic methods).
What threw me off was whether or not the term "spherical" as relative term was sufficiently clear, or whether it did not meet Art 84 EPC. I only opted to include "sphericity" of D2 in a dependent claim.
BR
Lukas
I agree it was full of unclear terms. Sphericity, which was presented as essential without explaining why achieving a constant flow really matters, but even more the particle size, without any measurement method given, nor any mention by the client that one method would be used in that size range. Also the line being "across" the surface of the membrane, I was tempted to further define it (by logic, it should be perpendicular, also in view of the importance given to the sphericity/constant flow of the particles), but I refrained from doing so, for fear to introduce unnecessary limitations.
DeleteGood point on the particle size measurements, I did not catch that one.
DeleteRegarding the test "lines" I was very confused. The clients letter and prior art consistently used the wording "line".
However, limiting the test area to "lines" would - in my mind- lead to embodiments which are easily circumvented, as the test/control can easily have other shapes and still fulfill their purpose.
I phrased it as "test area" (or control area situated downstream relative to the test area in the dependent claim ) and included a dependent feature wherein the test/control area are in form of a line.
I hope I want trying to be overly clever by generalizing the "line" wording ...
Who claimed a lateral test strip as main product?
ReplyDeleteyes
DeleteMe
DeleteMe
DeleteI made a use claim for detection of the spike protein
ReplyDeleteI was near too, but I opted to claim the strip for pregnancy test which need lower KD a pore size range
DeleteUff from 13:56 pm - D1 at 010 talks about the pore size in microns. Not compatible with the golden nanoparticles from D2. Lateral flow test with all essential features and nanosized gold particles will provide inventive step. In any case, the range 20-100 nm is not relevant for inventive step becuase D2 discloses 40 nm example in the table.
ReplyDeleteHow about the reaction membrane having pore size from 5 to less than 9 or greater than 10 and less than 12? This would have technical effect of improving binding.
ReplyDeleteYes this was for the pregnancy use
DeleteI don't think the pore size was stated to have the advantageous technical effect of 'improved binding'. The ranges in the client's documents would not have been novel over D1 either.
DeleteI think somewhere the client letter mentioned about the natural affinity/binding... is improved and words best in these pore sizes. I don't remember that paragraph completely now.
DeleteThere were many essential features like spherical shape, downstream locations, antibody specifically recognises and binds to the target molecule which is spike protein, in the liquid sample, etc. I think I wrote too much but I felt like they were essential for clarity.This is what I wrote:
ReplyDelete1. A Lateral flow test for detecion of spike protein comprising:
-sample pad (1) suitable for absorbing liquid to be tested (5),
-conjugate pad (2) that stores the detection agent (11) for the test, which is located
downstream of the sample pad (1),
wherein detection agent (11) is a conjugate of an antibody (10) and coloured particle (9),
wherein the coloured particle (9) is attached to antibody (10),
wherein coloured particle (9) is gold nanoparticle with a diameter of 20-100 nm and have a
spherical shape to ensure moving at a consistent rate,
wherein antibody (10) specifically recognises and binds to the target molecule (6) which is
spike protein, in the liquid sample,
-reaction membrane (3) located downstream of the conjugate pad (2), having a test line
(7), comprising additional antibodies (12) that are specific for the spike protein and are
immobilised in a line across the surface of the membrane,
-a wicking pad (4) located at the downstream end of the test.
I did not say kit because I did not see the client mentioning it, but if it was mentioned then it is logical to say kit. I included the plastic casette as "wherein lateral flow test is housed in
a plastic cassett"
I did not write "control line (8)" in the main claim because in D1 it says it is not included in every test and client says "advantageously we added this". I also though not to write "wicking pad (4)" because it says in letter "We find it helpful to include wicking pad (4)". But then the effect of this pad (4) was mentioned as increasing sensitibility. So I added but I was not really sure:(
I also wrote the use of this test for testing COVID-19 as an independent.
You are right, I did not spot that control line 8 was optional
DeleteI didn’t include either the control line (8) or the wicking pad (4) in claim 1.
DeleteThe control line was advantageous, but I thought it wasn’t essential, especially considering the hint from D1.
As for the wicking pad (4), I also thought it wasn’t essential since it was just “helpful.” Even though it increased sensitivity, having a gold nanoparticle already enhanced sensitivity 10x, so it still exceeded the sensitivity of the test of D1.
I don’t know if this is correct, but that’s how I interpreted it!
I think 'spike protein' will be an unnecessary limitation, the wicking pad is also not required to achieve the technical effect.
Delete1. A lateral flow test for diagnosing infections caused by bacteria and viruses including SARSCoV-2, and pregnancy, comprising:
ReplyDeletea sample pad (1) for providing even and controlled distribution of a liquid sample (5);
a conjugate pad (2) comprising a detection agent (11), wherein the conjugate pad (2) is
positioned in the direction of capillary flow of the liquid sample (5) from the sample pad (1),
wherein the conjugate pad (2) rehydrates and mobilises the detection agent (11) when the
liquid sample (5) reaches the conjugate pad (2),
wherein the detection agent (11) is a conjugate of a first antibody (10) and a coloured particle
(9), wherein the first antibody (10) is specifically configured to recognise and bind to a target
molecule (6) in the liquid sample (5),
wherein the first antibody (10) is attached to the coloured particle (9) for providing visible test
result; and
a reaction membrane (3) comprising a test line (7) comprising a plurality of second antibodies
(12) that are specific for the target molecule (6) and are immobilised in a line across a surface
of the reaction membrane (3),
wherein the reaction membrane (3) is positioned in the direction of capillary flow of the liquid
sample (5) from the conjugate pad (2) so that the conjugate with the bound target molecule (6)
flows to the reaction membrane (3),
wherein the test line (7) is configured to develop a coloured line indicating that the liquid
sample (5) contains the target molecule (6) by catching and trapping coloured conjugates with
the target molecule (6) attached when the liquid sample (5) reaches the test line (7),
wherein the reaction membrane (3) further comprises a control line (8) comprising a plurality
of third antibodies (13), which are specific for the conjugate, immobilised in a line across the
reaction membrane (3),
wheren the third antibody is different from the first and second antibodies,
wherein the control line (8) is positioned in the direction of capillary flow of the liquid sample
(5) from the test line (7),
wherein the control line (8) is configured to change colour upon catching remaining
conjugates not trapped by the test line (7), and
wherein the coloured particle is not a gold nanoparticle with a diameter of less than 20 nm,
the lateral flow test characterized in that:
the coloured particle (9) has a spherical shape and has a diameter of 100 nm or less.
My claims look quite similar, however I am not sure about your feature of "is not a gold nanoparticle with a diameter of less than 20 nm"....
DeleteMy claim looks similar..Will I pass?
DeleteI opted for a method claim using the previously defined lateral-flow-test. However, in view of Art. 53c) I disclaimed the method by including "Method for detecting a target molecule in a liquid, except for the diagnosis of a pathological condition of a human or animal,....". Any thoughts on this disclaimer?
ReplyDeletemy view is that the method claim would already NOTfall under the art 53c exclusions because they aren't practiced on a human body. they're on samples extracted from a human body, so i don't think a disclaimer is necessary. however, i doubt including one would cause a fail. it should still be more than enough marks to pass the paper.
DeleteSurely the actual testing is outside the body. However, the collection of the sample, e.g., in the covid case using a device to collect target molecules from the nose, may comprise a step that is performed on the body. Therefore, I disclaimed it. On the other hand, pregnancy is not a pathological condition and thus a method for testing for it does not fall under Art. 53 c).
DeleteI was thinking about it too, but in this case, the one who infringes the method claim is the end user, not the producer
DeleteClaiming a minimum diameter size of 20nm was necessary. by why a maximum of 100nm? The only effect of that upper limitation is that the colour will be red, nothing else.
ReplyDeleteBesides, why limit the client to only having red colours? What if a competitor has gold that emits blue light?
In my opinion:
Deletethe client says that the 100 nm is "necessary". Necessary means essential. Essential means claim 1.
It doesn't matter whether you think the red colour is necessary or not for the claim. You should follow his instructions.
I think this means it is an essential feature.
Also, at some point D2 says that high particle size may lead to a colorless particle. So I think an upper limit is necessary.
Delete@LP due to that passage in d2, i said something like"the diameter/gold particle (cant remember) is sized to emit light on the visible light spectrum", in addition to mentioning that the diameter is greater than or equal to 20nm.
DeleteThat still managed to cover blue and other colours.
I know the client described red as essential, but i just refuse to believe the examiners wanted us to accept the clients demands of only producing a red colour. The increased sensitivity can be obtained without the red colour.
I didn't mention gold particles or its size in first claim, only "ruby-red coulored particle (9)". The technical effect of this technical feature (being red, that in this context is technical) is that the line is easier to read, improving the sensibility. D2 is suficiently far since the use of gold particles are described in general (all colors) for artists. So no pointers in red direction.
ReplyDeleteAnyone?
I think pointing to 'red' would be a result to be achieved. You needed to include the limitation of less than 100 microns which gave the effect of red light.
DeleteIn my opinion being "red" is physical property of an object that usually doesn't have a technical effect. So being red is general and golden particles 100-20nm specific.
DeleteIt is said that gold particles decuplate the sensitivity of the test. This is the technical effect you look after and this has nothing to do with the colour but with gold particles. I think.
DeleteDid you also consider control line and wicking pad as optional for a lateral flow test device claim?
ReplyDeleteOptional indeed.
Deleteyes, both optional.
DeleteBut I understand control means are still necessary (control means can be e.g. a control line) - see D1: "there are some tests available
Deletethat do not include one and rely on other means to show that the test has been
performed successfully"
I ended up claiming the wiking pad in a dependet claim because the client described the pad as "helpful" and because the effect of the gold nonoparticles does not require the wicking pad. Still in doubt though.
DeleteYes, as i considered both as optional, i claimed them in dependent claims, but was not sure bout control either. IMHO, the presence or absence of coloured line is essential for detection, the control is a nice to have, as other means are envisaged.
DeleteDid anyone make a covid-19 kit claim and also a pregnancy test kit claim? Would these not be construed as method of diagnosis claims?
ReplyDeleteNo, nowhere in the client's letter did they request that a pregnancy test be covered by the claims.
DeleteOnly Covid tests.
DeleteThey do say - we are looking into other markets for our products. seeking a new patent application that covers testing for COVID-19 along with other possible uses.
Deletehow about the novelty just standing out on the colour.
ReplyDeleteD1 particle is BLUE, invention particle is RED
> no size limitations, no material needed to make it novel.
I believe particles sizes were aiming to mislead candidates, they were somehow disconnected.
in my view and from a simple biochem perspective , the colour was the only needed distinguishing feature. From the common knowledge red colour outstands over blue colour. TO the human eye. The inventor also points this somehow.
Just colour would have been non technical and a result to be achieved. Needed the physical limitations which gave those effects.
Delete@GONZA I disagree. I actually think having red as the distinguishing feature will result in a heavy penalty.
DeleteFirstly, it's unclear. Are the nanoparticles gold or red? Or did you not claim the nanoparticle at all, and merely say that the test line can turn red? This would still be unclear as it's a result to be achieved.
Secondly, red is just a mere "presentation of information", thus it's not technical as far as the epc is concerned.
Thirdly, even it was technical, going from blue in D1 to red would be a standard change that doesn't require any inventive effort.
I think diagnostic method claim is allowed since the sample fluid is not returned to the body.
ReplyDeleteYes, i also double-checked the EP GL, its fine, still i claimed a Use of the lateral flow test for… should be a valid alternative. What do you think?
DeleteJ'ai eu une impression de déjà vu. L'épreuve semblait très classique.
ReplyDeleteLes questions que je me suis posé : est-ce qu'il fallait se limiter à revendiquer une bandelette ou bien est-ce qu'il fallait essayer de généraliser à n'importe quelle forme, la seule contrainte étant que l'écoulement capillaire passe d'abord de la zone échantillon à la zone test en passant par la zone de conjugaison ? J'ai revendiqué une bandelette, sans limiter à la zone échantillon placée à une extrémité. On a pas d'indication du client qu'il veut protéger autre chose qu'une bandelette.
Autre question : la nouveauté consiste à utiliser de l'or. Est-ce qu'il faut donner les dimensions des nanoparticules d'or. J'ai dit oui, en limitant à entre 20 et 100 nm.
Autre question : est-ce que le paramètre de Kd est nécessaire ou pas ? J'ai dit que non, j'utilise juste des anticorps spécifiques (en supposant que c'est clair) et j'ai une dépendante où j'utilise le paramètre Kd.
J'ai failli louper que les particules colorées doivent être de forme sphérique. je l'ai rajouté mais on voit aussi dans D2 que la sphéricité est un paramètre, qui est de 99%, pour celles du fournisseur. Est-ce que le paramètre de sphéricité est un paramètre nécessaire ? On verra.
Anyone added that "a reaction membrane (3) is a nitrocellulose membrane" ? It seemed to me from §10 of D1 that a nitrocellulose membrane is an important parameter"...
ReplyDeleteYes, actually I spent more time deciding whether to include this feature than the diameter of the gold particles.
Delete3rd time, did you finally include it ? :)
DeleteYes, I included it and mentioned the minimum pore size because it somehow said it only worked above that. I also included the affinity parameter Kd because it seemed that just mentioning antibody with "affinity" or even "high affinity" might be unclear?
DeleteLetter says - a pore size of at least 5 microns works well,. Doesnt mean it is necessary!
DeleteI also added two independent use claims of the test strip according to claims X to XXX for diagnosing infections caused by bacteria and viruses and for for performing lateral flow pregnancy tests. May I obtain full marks (if applicable) for these two independent claims of the same category ?
ReplyDeleteI believed that inventiveness based on the gold nanoparticles of 20-100 nm was really questionable, so I added another feature of :
ReplyDelete"the control line (8) comprises antibodies (13) different from the antibodies (12, 10) being specific to the conjugate (11) and being immobilized in a line crossing the reaction membrane (3), the control line (8) is configured to capture the remaining conjugates (11) which are not trapped by the test line (7)".
This feature is not disclosed by D1 since it seems in D1 that they are the same antibodies NOT SPECIFIC to the conjugate. However, no any particular technical effect associated to this feature... Probably increasing precision since allows to check one more time if all the conjugates were captured. I prefered to loose points on too limiting feature rather than not inventive.
They are different also in D1. Even on the figure, the color is different.
Delete@Alexandre, the control antibodies in D1 are also clearly disclosed as being different. I can't remember the exact wording but it describes the control line as being used to show the test has been completed, so they bind to the conjugate. This is so it acts as a control, letting the user know the test has been successful even if the sample doesn't contain any spike proteins/target molecules.
DeleteIt's interesting to see that the discussion here is centered around the gold particles, which does not seem that much of a challenge, and not about the features that really pose doubts, like the nitrocellulose membrane (essential or not? the paragraph about it in the letter gives confusing hints) or the affinity number Kd (just writing "antibody with high affinity" is clear enough?).
ReplyDeleteFor the nitrocellulose feature, the paragraph seems to hint to a preferable (and therefore non-essential) feature: "Various materials can be used for the reaction membrane, such as cellulose acetate or nylon, but we prefer to use a nitrocellulose membrane." I opted for a dependent claim for this feature.
DeleteFor the binding affinity, the paragraph also seems to hint to a preferable feature: " Ideally the antibody will have a high binding affinity for the target molecule." I nevertheless added it in claim 1, because it seems essential to obtain a good sensitivity based on D1, [011] "To maximise sensitivity of the pregnancy test it is important to use antibodies that will bind strongly to the hCG hormone". A higher sensitivity being the technical effect, besides the non-technical effect of red vs. blue.
In hindsight, this limitation was probably not needed.
I left both out of claim 1. If I recall correctly, the client said other materials could be used instead of nitrocellulose (although that was the best one and therefore suggested a dependent claim to me). I also left affinity out of claim 1 and used a Kd value instead of saying "high". I think "high affinity" would be unclear, but I do a lot of work with antibody inventions - I think this must have been a tricky paper for engineers!
DeleteI think just mentioning the gold nanoparticles with dimensions does not involve inventive step over d1+d2. I thought too much about it and then limit the claim nitrocellulose with dimension at least 5microns. Since in the letter, client says 5 works better and in d2 the
DeleteNitrocellulose is 9-10 microns. In the letter the tech effect is given as not fixing antibpdy to the reaction membrane, which d2 must fix.
It think it was an important thing to describe that the pads 1, 2, 3, 4 must be arranged downstream to each other
ReplyDeleteYep I think so too
DeleteI agree it was required for clarity, I added the it in the first claim. And explained what downstream means in the description.
DeleteAgreed. However, only pads 1 and 2 were essential. The pad with the control line and the wicked were not required for the invention, so their inclusion would be an unnecessary limitation.
DeleteQuestion to all: In your view, did D1 disclose coloured particles that were spherical?
ReplyDeleteWould this feature be sufficient to establish novelty over D1?
Not disclosed in the text of D1, but from the figures it seemed clear that they are spherical, so I thought that would struggle for novelty- let alone inventive step
Delete@Aaad there was a technical effect associated with the sphericity - it ensures that that the conjugates move at a more consistent rate through the test strip. this effect was mentioned in neither D1 nor D2.
DeleteI do not understand why so unclear and biology based document was given us. I still not convinced the solution. Let’s wait and see. Btw, every 10 min a pop-up came and ruined my concentration.
ReplyDeleteHi everyone, I have started a PETITION to urge the EPO to offer the EQE twice a year, thereby minimizing the negative psychological impact on our mental health when we fail one part of the exam (and thereby the whole exam!hence forced to wait one complete year to retake - as if lifetime is endless).
ReplyDeletePlease I urge you to sign the reasonable (vernünftig, raisonnable) petition and to share it with colleagues, friends, trainees, and whoever you think can accelerate taking a decision by the EPO.
Thank you DeltaPatents for allowing us to share our concerns about the exam. While many companies in this domain are very much profit and business focused, you are humain and quality focused. Thanks from the heart.
Petition:
https://chng.it/V29hwhJQ8n
I included the reaction zone. I did not include the test line in claim 1 since it is an implicit feature known to always exist in the reaction zones of lateral flow tests (LFTs) since the early fifties (Lateral flow test - Wikipedia). The test line is a well-established and common component in reactions zones of lateral flow assay devices and tests, which are widely used in diagnostics. This is part of the common general knowledge for a person skilled in the art of lateral flow technology. Not including the test line in claim 1 is clearly allowable in this case, as asserted by the Guidelines GL F-IV 4.5.4: “As detailed above, an independent claim must specify explicitly all of the essential features needed to define the invention. This applies except in so far as such features are implied by the generic terms used, e.g. a claim to a "bicycle" does not need to mention the presence of wheels”.
ReplyDeleteThe technical effect of the invention (i.e., improved uniform flow rate and constant movement leading to improved binding efficiency and test sensitivity for detecting the target molecule in a sample) does not depend on the explicit mention of the test line. The test line is a standard feature in lateral flow tests and does not influence the core function of the invention, which is the use of spherical gold nanoparticles for detecting the target molecule (e.g., the viral spike protein in the case of a COVID-19 test).
I also did not specify any range either (not 20 to 100 and not above 20) for the gold nanoparticles, since it is not “clearly and unambiguously” stated in the client letter that this is needed to generate a technical effect that enables an inventive step. My arguments:
The client letter states: “We have experimented with gold nanoparticles from other manufacturers and found that any type which has a diameter of 100 nm or less is suitable for our test, since larger particles do not have the necessary red colour”.
This text means that larger particles do not have the necessary red colour. It does not say that larger particles (i.e. > 100 nm) do not improve the sensivitiy or do not fulfull the increased detectabily function. That only say that larger particles do have the red colour. This sentence does not provide evidence that the test would fail for these larger sizes.
Furthermore, according to D2, LSPR results in a color shift depending on the size of the gold nanoparticle, with red colors appearing for spherical particles under 100 nm and a transition to blues, blacks, or clear/colourless for larger particles. The fact that larger particles do not produce the red color but still function in applications (even leading to color shifts) supports the notion that larger nanoparticles can still be used effectively in the invention, but with a different color. While the red color might be preferred for its visibility, the detection function itself (based on LSPR) is still valid, even with a different color. Thus, the technical effects of the spherical gold nanoparticles, namely the uniform flow rate, consistent movement, and hence improved binding efficiency and detection sensitivity still occur, just with a color variation, which does not invalidate the invention.
I also looked at the French version during the exam. There, it is even more clear that the limit >100nm is not needed: “Nous avons réalisé des expériences avec des nanoparticules d'or d'autres fabricants et découvert que tout type ayant un diamètre inférieur ou égal à 100 nm est adapté à notre test, les particules plus larges n'ayant pas nécessairement la couleur rouge nécessaire”. "N'ayant pas nécessairement" (par exemple dans "n'ayant pas nécessairement besoin de" ou "n'ayant pas nécessairement raison") indique que quelque chose n'est pas obligatoire ou évident, mais il y a une nuance qui suggère que ce n'est pas systématique. Cela introduit une idée de possibilité, sans certitude.
Now, let us talk about the second range limit (> 20 nm). The client letter says: “We also found that gold nanoparticles with a diameter of less than 20 nm cannot carry sufficient antibodies to give an accurate result”.
ReplyDeleteThis sentence clearly says that particles having a diameter of less than 20nm do not give accurate result, i.e. give inaccurate results. It does not say that said particles do not give any result at all or that said particles do not carry any antibodies at all, or that the detection fails, or that said nanoparticles cannot produce a detectable signal, or that the technical effect due to sphericity, namely the uniform flow rate and consistent movement does not exist anymore.
According to Webster, the term not accurate or inaccurate means: “Inaccurate (adj.) as in approximate not precisely correct. Example: the estimate is inaccurate, but will do for our purposes”. This is what I understood from this client sentence: diameter below 20nm generates inaccurate results, but will do for our test purpose, i.e. will still provide the technical effects of uniform flow rate and consistent movement, and hence improved sensitivity, even if not to the fullest extent.
In other words, smaller nanoparticles (<20 nm) may lead to reduced accuracy, but they still contribute to the technical effect, and the test can still detect the target molecule.
The same analysis applies to the corresponding German text, "Wir haben ferner herausgefunden, dass Goldnanopartikel mit einem Durchmesser von weniger als 20 nm nicht genügend Antikörper tragen können, um ein genaues Ergebnis zu liefern," similarly suggests that these particles may not carry enough antibodies for precise results, but it does not imply complete non-functionality or complete absence of uniform flow rate and consistent movement that contribute to the improved binding sensitivity.
It should be noted that binding in lateral flow tests is between the antibody and the target molecule. The gold nanoparticle itself does not directly participate in this binding process. Instead, it serves as a carrier for the antibodies and ensures that they are uniformly distributed and flow consistently through the test strip.
The primary role of the gold nanoparticles is to provide a visible signal and ensure uniform flow rate due to their spherical shape. The spherical shape of the gold nanoparticles ensures a uniform flow rate, which is essential for the consistent movement and binding efficiency in the capillary flow. This uniformity is critical for the overall performance of the lateral flow test, regardless of the nanoparticle size. Even if nanoparticles smaller than 20 nm carry fewer antibodies, the antibodies carried by these gold nanoparticles can still bind to the target molecule. The reduced antibody load may lead to weaker signals, but the binding and detection functions remain intact.
Conclusion:
The client letter does not clearly and unambiguously state that restricting the size to above 20 nm is necessary. It only highlights that smaller nanoparticles may not provide the highest level of accuracy.
The technical effect of the invention—improved uniform flow rate and constant movement leading to improved sensitivity and detection of the target molecule—is achieved by the use of spherical gold nanoparticles, which ensure uniform flow rate and consistent results, regardless of their size.
Any comments on my arguments above is very much welcome and helpful, since i am willing to file an appeal. Thank you.
Dear Ralf, you might want to add this argument: the range 20 to 100nm applies only for COVID target molecules. If it were included in claim 1, the target molecule must be limited to COVID, drastically limiting the protection scope. This is not what the client wants. The clients want new markets and uses: "However, as the number of COVID-19 cases has declined, the demand for these tests has decreased and so we are looking into other markets for our products". For other target molecules, no best performing sizes of the gold nanoparticles are provided. It is no one size (or range of sizes) fits all bazar. Smaller target molecules and larger target molecules require different sizes of gold nanoparticles, some beyond the interval 20 to 100nm, to carry enough antibodies....
ReplyDelete