A 2025: lateral flow test - our provisional answer
Two DP-tutors (Nico and Nyske) sat paper A this year as benchmarkers. When comparing our answers, it turned out that we had largely the same solution, differing only in details of the wording.We both stuck closely to the wording of the paper, and incorporated some embodiments of D1 into our (dependent) claims. D1 turned out (again) to have some useful things in it.
A claim 1 according to our solution could read something like:
1. Lateral flow test, comprising:
- a sample pad (1) for receiving a liquid sample (5),
- a conjugate pad (2), which is arranged downstream of the sample pad (1),
the conjugate pad (2) containing a detection agent (11),
the detection agent being a conjugate (11) of a first type antibody (10) and a coloured particle (9),
wherein the first type antibody (10) is adapted to specifically recognise and bind to a target
molecule (6) in the liquid sample and wherein the coloured particle has a spherical shape,
- a reaction membrane (3), which is arranged downstream of the conjugate pad (2),
which
reaction membrane (3) comprises a test line (7),
the test line (7) comprising second types antibodies (12) that are specific for the target molecule (6)
and are immobilised in a line across the surface of the membrane,
characterised in that the coloured particle is a spherical gold nanoparticle having a diameter
of 20 - 100 nm.
As will be clear from a comparison with D1, the focus of the invention are the coloured particles. D1 does not explictly mention that it's spherical, however, according to par. [008] of the client's letter, the coloured particles must have a spherical shape to ensure they move at a consistent rate. Therefore, we assumed that the blue latex particle of D1 also would have to be spherical in order for the test of D1 to work.
D1 has a lot of features in common with the invention, but the final paragraphs [014] and [015] of the client's letter move away from the blue latex particles to replace them with gold nanoparticles. D2 mentions colloidal gold , which is a solvent with gold nanoparticles in it. However, the client's letter does not mention the solvent so there is no need to put the colloidal gold in the claim.
In par. [015], the clients letter says: "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." We learn from this that we don't need to limit the claim specifically to the nanoparticles of the manufacturer D2. The limitation of a diameter of 100nm or less appears to be necessary in order for the invention to work. Limiting to "the necessary red colour" seems to have risk of being unclear, because what is necessary"? Par. [014] mentions "intense ruby-red" but it will be hard and even subjective to determine which red would be "intense ruby-red" and which red would not be. Because the client's letter says "necessary red colour" however, we don't have a basis for extending the gold nanoparticles to any acolour. So, having an upper limit of 100nm diameter seems to make sense.
Similar considerations apply to the lower limit of the diameter of the gold nanoparticles. Paragraph [015] tells us that "We also found that gold nanoparticles with a diameter of less than 20 nm cannot carry sufficient antibodies to give an accurate result.". Apparently, the invention does not work with nanaparticles of a smaller size.
We both included at least one claim to a kit comprising the lateral flow test according to any one of claims .. and an extraction solution for suspending a test sample.
Also, we both had a claim to the combination of a plastic cassette and the lateral flow test (or test strip thereof), either in the form of a regular dependent claim or as a claim to the plastic cassette containing the test/test strip.
We did not see any use to include a use claim or a method for ex-vivo diagnostics. Such claims would not add any further scope of protection as the product is already claimed. In addition, there were more than enough embodiments for dependent claims.
We also both decided against a separate claim for the detection agent, as the technical effect seemed to be linked to the use in the lateral flow test.
For dependent claims, we saw for example the following options:
- gold particle 40 nm diameter
- control lime + associated features
- reaction membrane of nitrocellulose + optional pore sizes
- wicking pad
- the wicking pad (4) is made from cotton, cellulose filter or glass fibre
- first type antibody = second type antibody
- the conjugate pad (2) is made from non-woven glass fibre.
- the sample pad (1) made of cellulose fibre.
- the first antibody (10) has a binding affinity having an equilibrium dissociation constant equal to or less than 10 -7M.
- the first antibody (10) and the second antibodies (12) are specific for human chorionic gonadotropin.
- the first antibody (10) and the second antibodies (12) are specific for a spike protein of SARS-CoV-2 virus.
-the conjugate pad (2) stores the detection agent (11) in dried form.
- the plastic casette is labeled to indicate a position of the test line (7) and optionally a position of a control line
- the extraction solution is a buffered solution, such as phosphate buffered saline.
Curious to hear your thoughts!
I think the uniform in D2 was there as a link to par. [008] of the client's letter. Say as an extra indication that the particles of D2 are suitabel for use in the invention. I did not put "uniform" in the claim, as I thought that might be an unclear term. There's no definition given in the paper what "uniform" means in objective terms. The only thing we know is that D2 mentions less than 1 odd shape per 100 particles, and that that's considered to be "extremely uniform". And less than 1 odd shape per 100 particles seemed to be unnecessary limiting because of the "extremely" uniform. At least, these were my considerations when doing the paper, I'm also curious what the Exam Committe had in mind.
ReplyDeleteI think "uniform" in itself is a rather unclear term - I don't know where the boundary between uniform and non-uniform is. As for the drawings, they seem to be schematic, so don't read too much in them.
ReplyDeletei had the same question! Generally double penalisation is avoided, but i don’t know how much points they are going to give you in this cases. I read in the compendium that the dependent claims are considered in light with the independent claim that you made on a case-by-case basis.
ReplyDeletethe pad 1 is essential for absorbing the sample, otherwise the sample cannot be absorbed and the test doesn’t work
ReplyDeleteYes, I agree with ABC123, in real life, you would Never deduce from the picture of D1 to State that the particles have a spherical shape. So the spherical shape should be novel over D1. Since it is related with a technical effect, there is also some Space for reasoning inventiveness.
ReplyDeleteIs accuracy and sensitity the same technical effect? Why would you assume that? On the same note, why is 20 nm requirement is connected to the sensitivity? Sensitivity and accuracy aren't the same.
ReplyDeleteControl line was NOT essential. The invention was about improving sensitivity of the test by gold nanoparticles, not the indication that the test was done properly
ReplyDeleteJBH - Right, I'm so stupid. Of course a skill person is going to look at the figure of D1, see a circular particle, and deduce :" I must make this latex particle in the shape of a sharpie pen"
ReplyDeleteWhy do you find it so difficult to remain objective and respectful in technical discussions? The sarcasm is inappropriate.
DeleteI understood the upper limit of 100nm to be necessary. If you don't have it, then you claim a product where the particles are invisible (e.g. 250nm particles). The claim is therefore not enabled. We are not given any other limit of sizes, and 100nm is the largest that the client knows will work. If having larger particles was important to them, they should have experimented to find the absolute upper limit and told us in the letter to claim that.
ReplyDeleteAlso, the invention is about improving sensitivity of the test. This is achieved by the intense red colour of <100nm so that you need fewer brighter particles to attach to the test line to see a positive line. If you provide blue of black particles, will you still be able to see the test line clearly with fewer virus/target molecules? I don't think so.
Finally, this isn't real life where you need to ensure your client gets the best possible protection on filing, and then narrow and divide in prosecution. You want to get novel and inventive claims based on the information you are given (but reasonably broad).
Anonymous from March 17, 2025 10:50 pm:
DeleteYou are contradicating yourself, I am afraid. You say:
"If having larger particles was important to them, they should have experimented to find the absolute upper limit and told us in the letter to claim that."
If the Client has not experimented and found the absolute upper limit and has no told you that clearly and unambiguously, why did you include in your claim? Why do you consider red colour to be superior to blue colour? Personal preference? :-)
Anonymous from March 17 10:50 pm: The broadest possible protection is not to assume what the Client provides as the correct information. You should apply the broadest possible protection under exam conditions. There are broad hints at paragraph 015 of the Client's letter to stay away from 100 nm limit. For instance, the wording "other manufacturers" i.e., not covering GoldiLocks as well as the wording "any type" i.e., not restricted to spherical shape give away the intention that "suitable" outweighs the "necessary" red colour in the same sentence.
ReplyDeleteAnonym saying "Finally, this isn't real life where you need to ensure your client gets the best possible protection on filing.."
ReplyDeleteHere is Rule 10 (4)(b) of IPREE of 2019:
"Candidates will be expected to answer questions on the allowability of the claim(s) under the European Patent Convention (hereinafter "the EPC") and as to whether the claim(s) provide(s) the broadest possible protection under the EPC. When answering the questions, candidates shall bear in mind the requirements of the EPC, in particular regarding novelty and inventive step, and the recommendations contained in
the Guidelines for Examination in the EPO (hereinafter "the Guidelines")."
It does not say the "best possible protection", but the broadest possible protection satisfying, in particular, the novelty and inventive step. Here is the case law book excerpt:
"The essential features should in particular comprise those which distinguish the invention from the prior art (T 1055/92, OJ 1995, 214; T 813/03). Regarding the delimitation of essential from non-essential features, see also T 61/94, T 203/98, T 141/00, T 260/01, T 1573/12, T 2131/12, T 21/16." (see https://www.epo.org/en/legal/case-law/2022/clr_ii_a_3_2.html)
What you're saying is, include another limitation of 100 nm because the client says so. It does not work that way.
You’re right in considering 100nm limit. Since there is no conclusive evidence to determine that diameter beyond which it is colorless, I have to rely on the recent G decision G 0002/21. I don’t think deltapatents took it into consideration. Here is g2/21 Headline:
Delete„
I. Evidence submitted by a patent applicant or proprietor to prove a technical effect relied upon for acknowledgement of inventive step of the claimed subject-matter may not be disregarded solely on the ground that such evidence, on which the effect rests, had not been public before the filing date of the patent in suit and was filed after that date.
II. A patent applicant or proprietor may rely upon a technical effect for inventive step if the skilled person, having the common general knowledge in mind, and based on the application as originally filed, would derive said effect as being encompassed by the technical teaching and embodied by the same originally disclosed invention.“
This means 100 nm isn’t relevant for the inventive step in view of G2/21. Just for the lack of conclusive experimental data, it’s wrong to include 100 nm in the claim which violates the recent case law of the enlarged board.
I agree with ABC123. The spherical shape should be enough for novelty over D1. The figure of D1 can‘t be enough for the disclosure of spherical particles.
ReplyDeleteThe Exam looked nice this time with the right balance between chemical and mechanical subject matter.
ReplyDeleteI did not put that the reaction membrane us arranged downstream of the conjugate pad (2) since I could not find the sentence in the text (and did not want to be creative). Further instead of using "the target molecule" I used in claim 1 "a target molecule" twice. Any idea of how many points this could cost?
ReplyDeleteI disagree with you. The role of gold in the conjugate is just to act as a visible reporter. The improved sensitivity is due to the vibrant red color. Nothing in D2 suggests that other color are as vivid and would achieve the desired increased sensitivity.
ReplyDeleteAdditionally D2 already promts the person to use gold particles in the conjugate, so for inventive step you have to restrict the claim to the aspect for which you can support
You need to check the selection inventions part of the Guidelines. Conjugating the gold nanoparticles with the antibody involves two selections!
DeleteUh? The client letter explicitly said that the sample pad was really important, due to its main function of redistributing the liquid evenly, etc.
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 (i dealt with LTF for some time now). 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 ) 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 sensitivity or do not fulfill the increased detectability 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.
I also did not inlcude the test line, or that the antibodies in the reaction zone are immobilised in a line across the surface of the membrane. This is because this feature is implicit for the person skilled in the art of lateral flow "tests". This is an established test since the early 90s as known by the skilled person, and as also clearly indicated by the state of the art document D1: "The major breakthrough came in the 1990s with the development of lateral flow tests .... Since the 1990s, lateral flow tests have been developed for many different applications". I think that the Exam Committee knows that. But just in case, here are few granted European patents that do not mention in claim 1 (or in any claim) the test line or that the antibodies are "immobilised" in a line. You can use them to support your appeal if needed: EP2643696B1, EP3382395B1, EP3421995B1, ...
DeleteNow, 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 innacurature 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.
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.
Thank you for your comments on this.
Ralf, I agree with all your arguments. I happened to work in the LFT field for some time now.
ReplyDeleteThe thing that is missing from your argumentation is the simple fact that the experiments and ranges (20 nm to 100 nm) are specific and valid only for the COVID target molecules experimented upon in the client letter.
If the customer is asking in its letter to protect the LFT "for COVID-19 along with other possible uses", the range 20 to 100 or any other range should not be included in claim 1 at all! This is exactly what fit to Practice means...
Lea - You might be onto something really critical here. I went back to paper A text again. Here is what the client is saying about "their test":
Delete"In our test, the target molecule being detected is the spike protein from the SARS-CoV-2 virus." paragraph 004
"The antibody must be able to specifically recognise and bind to the target molecule (6) in the liquid sample, which in our test is the spike protein produced by the virus." paragraph 007
"This means that it is possible to show results even when the concentration of spike protein (target molecule) is very low in the sample. 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." paragraph 015
All these three paragraphs indeed refer to "spike protein" related at least to a virus, preferably COVID-19.
And I read this in conjunction with the following statements from paragraphs 001 and 002:
"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."
"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."
And voila! The answer pops, 100 nm upper limit was indeed not an essential feature. What a mischievous attempt at hiding their true intention.
Results? reports?
ReplyDeleteYou should try to give to AI the paper A text and your solution, then ask it to mark it from 1 to 100. It's interesting...
ReplyDeleteAs to why?
DeleteAnyone knows when the results will be announced? It is about time.
ReplyDeleteWhen will they be out??
DeleteThis is taking eternity. Any information on when the results will be announced?
ReplyDeleteThere is one helpful employee who was trying to explain and apologize for the delay, saying "within 1 week", and also another less helpful employee who seemed dismissive and said "by the end of July" So I guess no one knows. The problem seems technical though, which begs the question: is this the first time they release results?
ReplyDeleteI can't see the results yet, is this normal ? I feel they're running late
ReplyDeleteToday afternoon (i. e. during the maintenance) they have changed the resolution code to "Admitted" by me at the ECQ Portal main exam. But nothing else happened. Does anyone else experienced something similar?
DeleteYeah me too. What does this mean?
DeleteOther than someone is doing something with the database? I don't know. Hopefully success* ;-)
Delete*based on extrapolation from pre-exam code
What is the ECQ Portal? Is this Wiseflow? I do not have access to Wiseflow EQE now, only compendium.
DeleteMine is also admitted. What was it before?
ReplyDeleteWhat does "admitted" mean? Passed?
ReplyDeleteI don't think it can. I think it just means admitted to the exam (i.e allowed to sit it). I hope it does mean passed though. It is odd it changed.
DeleteWhat was it before?
DeleteDoes anyone NOT see "admitted"?
ReplyDeleteAdmitted means nothing. If you click you can see previous exams and for me it says admitted next to exams which I failed. So no, it doesn't mean anything for sure.
ReplyDeleteIf I do not click and see just underneath Requests, I see "admitted" next to pre-exam (which I passed) and the 2025 main exam. What does this mean?
DeleteWhat is going on? Why the silence?
ReplyDeleteToday is the day?
ReplyDeleteJust called the EQE secretariaat. They said "very soon in the course of this week"
ReplyDeleteanyone? when is it out
ReplyDeleteOne thing for sure: the results will be announced in 2025.
ReplyDeletelucky us!
DeleteWhile we don't have the results, you can consider yourself equally passed and not passed.
ReplyDeleteRelax and enjoy your time being in Schrodinger's exam :-)
the mail is out, but still, I cannot find the results, where do I need to click ?
ReplyDeleteWhat does the email say?
DeletePlease note that your results for the European qualifying examination (EQE) are now available.
DeleteYou can access your results and download documents in the European Qualification and Certification Portal under 'My requests'.
Please be informed that no further information concerning the results can be given.
Kind regards,
The results were out for about 10 minutes. I managed to download the pdf file, and have them saved, but when I went back later the document was gone!
DeleteThis is crazy, so some people get an email, others don't. Some people got results, and others got results that belonged to another candidate. Ugh...
DeleteDid you pass tho? :p
Did you also get the 2.5 points of compensation because the assignment didn’t open for 20 minutes?
DeleteI got 2.5 points of compensation for the D exam because the assignment didn’t open for 20 minutes.
ReplyDeleteNot even an email. Has anyone else received no email at all about the result?
ReplyDeleteNope, nothing here (UK based). It's long past 1700h. CET, so I don't imagine the rest of us will receive anything today. It is very frustrating, even a blanket email to everyone explaining they have technical issues and results will be delayed would be helpful.
ReplyDeleteResults are finally out!
ReplyDeleteI had the results available at the EQC Portal but disappeared.
ReplyDeleteNew message:
ReplyDelete"
Results EQE 2025: Due to technical issues the result letters have to be re-generated. Please disregard result letters dated 7 July. You will receive a notification as soon as the result letters are available. Please refrain from contacting the Examination
"
A new message pops up in the EQC Portal informing
ReplyDeleteResults EQE 2025: Due to technical issues the result letters have to be re-generated. Please disregard result letters dated 7 July. You will receive a notification as soon as the result letters are available. Please refrain from contacting the Examination
Does this mean that the results published were not valid?
Yes, I would understand their statement to disregard the result letters dated 7 July as not valid. The results wil be re-generated.
DeleteI got a first result letter that has since disappeared, there is now a message that the results have to be regenerated, and to ignore the previous results (it was a pass for me). Four months to produce these results, and then this. I am speechless.
ReplyDeleteI am sorry to hear that. Go out and get a beer to relax, if its possible! Results will come.
DeleteYeah, I know and you are right, but it's really hard to swallow. I mean, if any one of us candidates showed this degree of incompetence and shabbiness on the job, would we still have a job (or clients...) the day after?
DeleteI thought failing this paper A again, which is the last remaining one, would be painful. But going through the motions in the last two hours and the severe mental stress I receive while opening and logging into EQC portal is something else. At this point, I am prepared to receive any result. This moment is only matched by a 30 mark deduction for a feature I received in 2024 paper A, despite the claim being novel and inventive.
ReplyDeleteIt is unconscionable that the Secretariat have issued many people with letters, now knowing them to be false, and yet all they do is put a red banner on a f*****g website. It's as if they've no idea that there are people out there celebrating or distraught, making career plans, negotiating pay rises, accepting job offers. The very least they should do is send an email to everyone. I mean, if you're the only trainee at your firm, and you had your 'result letter' why would you bother to go back to the website to find a red banner?
ReplyDeleteThe Secretariat compound their incompetence with lack of care. But I bet they slept well last night because, as always, the EQE exams were a great success this year! We need a new professional body.
let's see how long before they will remove them again
ReplyDeleteOh wow, I passed with 62 points, despite I did not limit claim 1 to 100nm. Hope the result are valid this time and I finally passed the EQE!
ReplyDeleteHi Can you please post your claim 1 for our understanding on how they marked this? Since you have already passed, it should not be a problem I suppose?
DeleteDid you formulate the effect of 100nm in a different manner?
DeleteMe too I did not limit claim 1 to 100nm, but I failed. I will wait for the Examiner's report. In the meanwhile I will start preparing my appeal.
ReplyDeleteI strongly expected a fail tbh. I deleted the 100nm thing in the last minutes and was very anxious afterwards. Still received 50% of the points of claim 1.
DeleteReceived almost all points for the depentend claims. The examiners are a big riddle for me.
Best of luck for your appeal!
I passed with 67 points. I did not limit claim 1 to 100nm, I restricted it by the function of visibility. I finally passed the EQE after 3 years!
ReplyDeleteCongrats to you. Since you have already passed, can you please post your claim 1 and marking for our understanding? I am preparing for an appeal.
DeleteMy claim 1 is almost word for word (literally!) to deltapatents answer above. I got 0. Wow. Also, I had a new candidate No. on my results paper this year that isn't my EQE number - did they change this year because of the new system? Anyone else notice?
ReplyDeleteCan you post your claim 1 for our understanding?
DeleteThe number on the results letter is the same as the number in WiseFlow. You can see this number in your answer paper for the Technical Test that you did in WiseFlow. It doesn't seem to be related to the UNIN and nor does it claim to be.
Deleteyeah - I should have posted that earlier, apologies, here is my claim 1. I think it is incredibly similar to get a 0. I am a bit shocked by it. Also, yes, I agree that the number on the results letter doesn't purport to be my UNIN or my EQE Reg number; but in previous years every result letter came with my EQE reg - hence my confusion.
DeleteClaim 1 :
1. A lateral flow test, comprising:
a sample pad (1), located at an upstream end of the lateral flow test, configured to receive a liquid sample (5) comprising a target molecule (6);
a conjugate pad (2), downstream of the sample pad (1) comprising a detection agent (11),
wherein the detection agent (11) is a conjugate of a first antibody (10) that is specifc to the
target molecule (6) and a spherical coloured particle (9);
a reaction membrane (3), downstream of the conjugate pad (2), with a pore size of at least
5 microns comprising a test line (7), the test line (7) comprising additional antibodies (12) that
are also specific to the target molecule (6) and are immobilised in a first line across a surface
of the reaction membrane (3), and
characterised in that the spherical coloured particle (9) comprises a gold nanoparticle
with a diameter between 20 to 100 nm.
any help appreciated :)
Sounds harsh. 40 marks for one additional unnecessary limitation "with a pore size of at least 5 microns"? Wait for the Examiner's report. The Examiners have to justify deduction of 40 marks for one additional feature which has the following basis:
Delete"We find that a pore size of at least 5 microns works well, with the best results obtained using a pore size of 8-12 microns." I don't understand the rationale behind this extremely high penalizations.
Yeah this seems really harsh :( Definitely worth appealing!
DeleteDon't you think that the issue comes from specifying that your flow test "receive a liquid comprising a target molecule"? As your claim is written, your claimed flow test is necessarily used with a liquid sample comprising the molecule, and not with any liquid sample. But this is not a limitation mentioned in the Examiners report, so I'm not sure.
DeleteAlso, you write "the spherical coloured particle comprises a gold nanoparticle" whereas the coloured particle is a gold particle. But i am not sure at all.
DeleteOr do you have another device claim? Only the lowest scoring claim in each category is awarded marks.
DeleteI wonder how many marks scored the European Patent Attorneys who sat the pepers as observer
ReplyDeleteThe examiner's report and the candidate answer is taking a while to come out this year.
ReplyDeleteExaminer's report and candidates answer for Paper A are out now.
ReplyDeleteWith all my respect to the examination body, but in my humble opinion, the examiner report solution is flawed and at least 20 points must be neutralized since claim 1 specified the range 20 to 100 nm, without stating that the target molecule type is SARs COVID! This is in violation of R. 84 and 83 EPC, and an intermediate generalization that is not allowed. All paragraphs of the client s report talk about experiments they conducted on COVID, and the sizes and technical effect is valid only for COVID. Hence COVID must be in claim 1! Tremendously restricting the protection scope, and acting against the clients wish to covers other products and markets! This solution does not demonstrate a fit to practice conduct of an expected European patent attorney!
ReplyDeleteintermediate generalization in drafting stage?? Hm?🤔. This is paper A not B
DeleteHello T,
ReplyDeletePaper A tests real-world drafting under EPC constraints:
Even if the client letter is not a formal EP application, Paper A is designed to simulate real-world practice. The candidate must draft claims and a description that could be filed immediately at the EPO, and therefore must comply with all legal requirements, especially Articles 83, 84, and 123(2) EPC.
Even outside a filed application, the client letter is the only disclosure provided. Just like in real life, the practitioner must only claim what is supported.
Our Paper A gives no basis to conclude that the 20–100 nm range is valid for all analytes, and indeed the letter hints the results for other targets are inconclusive or unknown.
“[015] 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...”
But "our test" in that context is clearly the COVID-19 test. The client never indicates success with any other target.
Therefore, the generalisation made in the model solution is not only legally incorrect, but also factually unsupported, even as a matter of claim drafting.
After all, you are writing a patent application where all the data and effects and sizes (20 to 100) are related to COVID. You are not allowed to generalize the experimental results achieved by using solely COVID target molecule to all target molecules !!!
By generalising a range that is only described for COVID, the model solution would expose a real client to post-grant amendment problems (under Art. 123(2) or 84 EPC), oppositions, and invalidations. This is the opposite of Fit to Practice!
Please take a look at GL F-IV-6.2: "If it is reasonable to predict that all the variants covered by the claims have the properties or uses the applicant ascribes to them in the description, they are allowed to draw the claims accordingly." While it is not explicitly stated that you can generalize the test results to all types of lateral flow tests, there is nothing in the disclosure which states that you cannot, so I do not see any good argument why you wouldn't be allowed to generalize the claims to all types of flow tests.
DeleteYou say that generalizing such a range would expose a real client to post-grant amendment problems, which could hypothetically be true in case it is proven experimentally that the results cannot be replicated for other types of tests, but why would you go directly against your client's wishes of paragraphs [001] and [002] to generalize their product to all uses just because of some hypothetical scenario?
I had the same thought during the exam and limited the claim to the COVID virus, this is why i failed - so your comment immediately caught my attention. I agree that the information provided in the paper was misleading in that respect.
DeleteDear L, Thank you for your comment. I wrote the comment above.
DeleteYou cited GL F-IV-6.2, but said GL clearly states:
If it is reasonable to predict that ALL the variants covered by the claims ...
With all my respect, but “Reasonable to predict” requires concrete technical basis!
GL F-IV-6.2 permits broad claims only where a skilled person can reasonably foresee that All embodiment truly work within the claimed.
Here, the only experimental data (¶[015]) ties the 20–100 nm range to the SARS-CoV-2 spike-protein assay.
“We found that any type which has a diameter of 100 nm or less is suitable for our test … and that < 20 nm cannot carry sufficient antibodies to give an accurate result.”
No data or even teaching suggests those numerical limits apply to hormones, bacterial antigens, or other analytes!
A reasonable skilled person would therefore not assume a single 20–100 nm band works universally.
EPC sufficiency and plausibility demand support across the full scope
GL F-III 3.1 (and Art. 83/EPC) require that every embodiment within the claim’s breadth be at least plausibly enabled.
T 1329/04 and related case‐law confirm: unsupported generalisation beyond the demonstrated examples is not allowable.
By contrast, Claim 1’s sole requirement of “spherical gold nanoparticles” is fully enabled by both the COVID data and D2’s broad teaching (5–400 nm portfolio).
In conclusion, GL F-IV-6.2’s “reasonable to predict” test fails here, because no one skilled in LFT technology would reasonably extrapolate COVID-specific particle sizes to all targets. The only EPC-compliant way to secure both broad protection and legal certainty was to omit the 20–100 nm window from Claim 1 and relegate it to a dependent claim.
By the way, the same Guidelines you cited, also states: "A fair statement of claim is one which is not so broad that it goes beyond the invention". The invention report 20nm to 100nm 10 fold sensitivity increase only for COVID! everything else goes beyond the invention.
The Examining Division is reasonable and shall neutralize at least 10 points to avoid a torrent of appeals by the end of the month... Good reason should be rewarded not punished ... with all my respect.
Dear Ralph,
DeleteI think your arguments are well-thought-out but you are using knowledge for your arguments that is not cited in the A-paper. Where is it stated that the skilled person in LFT wouldn't reasonably generalize the antibody? As I said in my previous comment, there is no good argument either for or against the generalisation stated in the paper. Normally I would play it safe and thus not generalize the claim. But since the client explicitly requested in paragraphs [001] and [002] that they want to generalize the claims to all types of flow tests, you are kind of forced to do so, unless the prior art forces you to limit the claim to specific antibodies.
While I do not think your analysis, in that there may be not sufficient support to generalize the claims, is incorrect, I do think that ignoring the requests by the client to generalize the claims is a very critical issue. The client could have lost a lot of money because of your decision, and I think a penalty of only 20 points is very fair.
Dear L,
ReplyDeleteThanks for your comment. Here is my clear answer to your comment:
1. Client wishes ≠ EPC entitlement
Paper A rule: Candidates must draft claims that could be filed at the EPO under Articles 83, 84 and 123(2) EPC, relying solely on the letter and the provided prior art. Marketing desires—even if explicit in par. [001]–[002]—cannot override the requirement that every claimed feature be supported and plausibly enabled by the disclosure.
EPC principle: Art. 84 EPC (“claims shall be clear and supported by the description”) and Art. 83 EPC (“sufficient disclosure”) are absolute constraints. A wish to cover “all flow tests” cannot justify a claim that the specification does not enable.
2. No “magic” basis for universal 20–100 nm
Client letter ties 20–100 nm exclusively to the SARS‑CoV‑2 spike assay (par. [004], [007], [015]).
D2 [002] only teaches that colour shifts with size; it says nothing about sensitivity or antibody‑loading for non‑COVID targets.
Common general knowledge (from D1 par. [012] and membrane pore physics) shows that different analytes (hormones ∼4 nm, bacterial antigens >20 nm) often require very different nanoparticle sizes.
Conclusion: There is no reasonable basis in the provided disclosure to predict that the 20–100 nm window will “work” for every possible lateral‑flow target.
3. Real‐world EPC drafting must protect the client ....
Conclusion: In sum, while the client “wished” for broad coverage, the Paper A scenario requires strict adherence to the EPC enablement and support rules. Omitting the 20–100 nm window from Claim 1—and instead capturing it in a dependent claim—is not only fully justified by the disclosure but is the only drafting choice that yields a robust, defensible patent.
The 25‑point deduction (15 for the lower limit and 10 for the upper limit - or vice vesa) for not including this highly controversial feature into claim 1 should therefore be reversed,
or else a torrent of appeals will follow :). EQE candidates are not kindergarten kids ... they are practitioners, father and mothers fighting in the field. There is no magic in the EQE.
Par. 2 of the client's letter states that lateral flow tests can be used to diagnose infections caused by bacteria and viruses other than SARS-CoV-2, and are also used for home pregnancy tests. Thus there is a direct instruction that these tests work for other cases.
DeleteIf you read par. 15 of the letter closely, it states that the test works at low concentrations of spike protein, but highlights in brackets that this is the case for any target molecule.
It is the candidate's job to identfy the optimum scope from the letter to assist the client using the information, provided, there is no indication that the invention might not work for other target molecules.
Additionally the guidelines for sufficient disclosure are as follows:
GL F.III.1:
"A detailed description of at least one way of carrying out the invention must be given. Since the application is addressed to the skilled person, it is neither necessary nor desirable to give details of well-known ancillary features. However, the description must disclose any feature essential for carrying out the invention in sufficient detail to make it apparent to the skilled person how to put the invention into practice. A single example may suffice."
(...)
"With regard to Art. 83, an objection for lack of sufficient disclosure presupposes that there are serious doubts, substantiated by verifiable facts (see T 409/91 and T 694/92). If the examining division is able, under the particular circumstances, to establish, with supporting evidence, that the application lacks sufficient disclosure, the onus of establishing that the invention may be performed and repeated over substantially the whole of the claimed range lies with the applicant (see F‑III, 4)."
Thus no objection under Art 83 could be brought forward by the examining division in a substantiated manner, especially not using the information provided by the paper.
Additionally, if you include the dependent claims as suggested in the examiner's report, there will be no problems to later limit the claims to SarS-Cov2 should this be necessary.
Delete1. Yes, articles 83, 84 and patentability (ignoring 123(2) for paper A) cannot be overridden by marketing requirements for the EQE. But as I said, there is no evidence within paper A that the generalisation would not be allowed for art. 84 or art. 83. So there is no 'override' and thus there is no problem with the client's wishes.
2. "Common general knowledge (from D1 par. [012] and membrane pore physics) shows that different analytes (hormones ∼4 nm, bacterial antigens >20 nm) often require very different nanoparticle sizes."
I think we may be reading a different D1 par. [012] because it does not state that different analytes require different nanoparticle sizes. It simply states that certain flow tests require a suspension/extraction step. You are using your own knowledge about membrane pore physics to answer the questions which is not allowed. I don't think you should be punished for having more knowledge relating to the subject matter, but well it's the rules of the EQE.
3. We have been discussing about the generalization of the antibodies. The issue of omitting 20-100 nm is inconsistent to the issue of not generalizing the antibodies. You have to be consistent in your view of enablement/support, you cannot pick and choose for each feature what standard of support you will apply. It is logically impossible to defend the issue of not generalizing the antibodies without destroying your arguments for the issue of omitting 20-100 nm and vice-versa.
Dear Anonymous from 14:08 pm from July 15,
ReplyDeleteYou mention "It is the candidate's job to identfy the optimum scope from the letter to assist the client using the information, provided, there is no indication that the invention might not work for other target molecules."
The point was there is indication that the invention might work for other target molecules either. This was left unclear for the candidates to do guess work.
What I was referring to is firstly that I would read the letter as describing a lateral flow test with only occasional references to Covid and especially this line: Par. 15. "This means that it is possible to show results even when the concentration of spike protein (TARGET MOLECULE) is very low in the sample."
DeleteIn light of the way the whole letter is drafted I would interpret this sentence as meaning "spike protein or any target molecule"
This should be read in conjunction with this line from par. 2:
"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."
You're really stretching a thin argument. So basically because target molecule is mentioned in braces after spike protein, a candidate is supposed to assume the disclosed range works for bacteria and HCG hormone as well. Great example of alternative facts.
ReplyDeleteNot trying to present alternative facts at all, just my POV for reading the client's letter and interpreting the paper, which appears to align with what the examiners intended. In the end of the day, the 20 mark deduction for the limitation to Covid still means one could have gotten 67 percent of the marks for the independent claims.
DeleteDear Anonymous from 14:08 pm from July 15,
ReplyDeleteThat LFTs can be used in different applications is common general knowledge since the 90s and is not the problem here!
I mean this know from D1 not only client letter. D1 pa. 12:
Since the 1990s, lateral flow tests have been developed for many different
applications, such as detection of viral and bacterial molecules to diagnose infection.
The text you are referring to in par.15 of the client letter says: "This means that it is
possible to show results even when the concentration of spike protein (target molecule)
is very low in the sample".
Hence said reference in par. 25 directly and unambiguously says: the target molecule = spike protein, ie. COVID!
Accordingly, your reference to said target molecule in par. 15, plays directly and unambiguously against you!
Because this says that the 20 to 200nm limit is limited strictly to the target molecule called spike protein ie COVID!!!
The cited line above from par. 15 does not say for instance spike protein (OR ANY target molecule)!!!
You trying to change the client letter to fit the model solution :) I wonder why.
All the best with your appeals ... and with mine.
Anonymous from July 15, 2025 2:56 pm
ReplyDelete"In the end of the day, the 20 mark deduction for the limitation to Covid still means one could have gotten 67 percent of the marks for the independent claims."
Where did you get that information? It looks like you have not studied the report.
Missing 20 nm costs 15 marks out of 40; and Missing 100nm costs 10 more marks out of 40.
This means 63 percent out of 100 for missing upper and lower limits. This also means rest of the features have a value of 37 percent, assuming you have a perect claim otherwise.
Even if you combine kit and method indpendent claims, the resulting loss of percentage is 25/(40 + 20) = 42 percent.
So if you don't have these limits, you are doomed because you are expected to have a perfect method and kit claims. In a 10-mark claim, the Examiner's report provides 6 mark deduction for any major limitation (without specifying which exact set of features are major limitations and which are minor). All in all, the chances of passing goes to a negligible amount, for which paper A exam committee has background statistics, if you have upper and lower limits of the diameter of the coloured spherical golden nanoparticles in your independent claim. The report is designed to give as less a chance of success in an appeal.
The thing the target molecule binds to is the antibody the particle is conjugated with and not the gold particle itself. Once the conjugates bind to the target molecule, the gold particle increases the sensitivity because of its better visibility between 20 and 100nm even when fewer conjugates are mobilised. This means the improvement is independent of the type of molecule.
ReplyDeleteBecause the antibody is the thing providing the specificity to the test it would obviously work for different types of antibodies.
n essence, the Examiner’s point—that gold‐nanoparticle visibility improvements “between 20 and 100 nm” would equally enhance any antibody–target pair—rests on an incomplete view of how nanoparticle size, antibody loading and assay context interplay. A more nuanced picture, fully grounded in the client letter, D1/D2 and common general knowledge, shows why the 20–100 nm window cannot simply be divorced from the spike‑protein assay used in “our test”...
DeleteCritically, every statement about the 20–100 nm band in the client letter is tied to “our test”—the spike‑protein assay only (¶¶ [004], [007], [015]). There is no disclosure, even implicitly, that this window was found optimal for hCG, bacterial markers or future targets. To treat it as a universal “visibility enhancer” would be to generalise beyond any experimental basis provided...
Simply said, there is no justification whatsoever for including the range 20 -100nm in claim 1.