EQE Paper A 2019 - Cell culturing device
Paper A of 2019 concerned a device for culturing cells. Different from the prior art, a gas-permeable membrane is used to form a cell culture chamber, which improves the exchange of gases and therefore increases cell growth.
Several issues were tested in this paper.
The paper provided two different ways of accessing the cell culture chamber: by way of an aperture in the frame or by temporarily opening and resealing one of the membranes. These two options should be covered by the main claim. The paper suggested the genus 'opening' to cover these two possibilities.
For some of the features it was mentioned that they were essential, and thus should be included in the claim. For example, that the membranes are liquid-impermeable is essential for all embodiments, and should thus be included in claim 1. Other features are only essential for some embodiments. For example, in the embodiment according to the figures, with an aperture through the frame, it is essential that the aperture is leak-proof.
The paper provided lots of features that could potentially be claimed. At the same time the client indicated that he did not want to pay additional claim fees, so that the candidates had to prioritize which features to claim and which not to. Some of these features were known from the prior art or obviously solve a problem. Such dependent claims will not provide a suitable fall-back position and should be omitted. For example, no claim should be formulated for: an optically transparent membrane, or adhesion coating; these are known features that bring their known advantages. Likewise, we think no claim should be formulated for the gas-permeability ranges for O2 and CO2. The ranges as stated are anticipated in the prior art, and no hint is provided how these ranges could be limited in an inventive manner. Also no claim seem needed for a rectangular frame. This is an obvious adaptation of the frame.
The gasket is a bit harder to decide. On the one hand it is a 'type of mechanical' seal, and thus presumably known in the art. On the other hand, the cited art does not mention gaskets, so probably their use in the field of cell culture chambers is not known. Furthermore, the gaskets provide a clear advantage. Accordingly, the use of gaskets in the field of cell chambers seems a good fall-back.
Another difficulty concerned the method of culturing cells. One could argue that all steps of such a method are known except for the use of the inventive cell culturing device. Accordingly, the method does not seem to protect anything that isn't already protected by the device claims. On the other hand, the method does cover the main use of the cell culture device and so may provide a fall-back position. The paper suggests that the cell culture device can be tilted, but does not explain why one would want to do so. If the intention is that tilting is beneficial for cell growth, then a method claim may be formulated that includes a tilting or shaking step. Probably, it is the intention however that this is an advantage of the full-filling of the chamber, and so no claim is required.
We find it conceivable that one would omit the cell-culturing methods and instead rely on the protection of the device claims. If one were to go that way, one may need to include a device claim in which the cell chamber is completely filled with cell suspension.
Below are the claim according to our solution:
Several issues were tested in this paper.
The paper provided two different ways of accessing the cell culture chamber: by way of an aperture in the frame or by temporarily opening and resealing one of the membranes. These two options should be covered by the main claim. The paper suggested the genus 'opening' to cover these two possibilities.
For some of the features it was mentioned that they were essential, and thus should be included in the claim. For example, that the membranes are liquid-impermeable is essential for all embodiments, and should thus be included in claim 1. Other features are only essential for some embodiments. For example, in the embodiment according to the figures, with an aperture through the frame, it is essential that the aperture is leak-proof.
The paper provided lots of features that could potentially be claimed. At the same time the client indicated that he did not want to pay additional claim fees, so that the candidates had to prioritize which features to claim and which not to. Some of these features were known from the prior art or obviously solve a problem. Such dependent claims will not provide a suitable fall-back position and should be omitted. For example, no claim should be formulated for: an optically transparent membrane, or adhesion coating; these are known features that bring their known advantages. Likewise, we think no claim should be formulated for the gas-permeability ranges for O2 and CO2. The ranges as stated are anticipated in the prior art, and no hint is provided how these ranges could be limited in an inventive manner. Also no claim seem needed for a rectangular frame. This is an obvious adaptation of the frame.
The gasket is a bit harder to decide. On the one hand it is a 'type of mechanical' seal, and thus presumably known in the art. On the other hand, the cited art does not mention gaskets, so probably their use in the field of cell culture chambers is not known. Furthermore, the gaskets provide a clear advantage. Accordingly, the use of gaskets in the field of cell chambers seems a good fall-back.
Another difficulty concerned the method of culturing cells. One could argue that all steps of such a method are known except for the use of the inventive cell culturing device. Accordingly, the method does not seem to protect anything that isn't already protected by the device claims. On the other hand, the method does cover the main use of the cell culture device and so may provide a fall-back position. The paper suggests that the cell culture device can be tilted, but does not explain why one would want to do so. If the intention is that tilting is beneficial for cell growth, then a method claim may be formulated that includes a tilting or shaking step. Probably, it is the intention however that this is an advantage of the full-filling of the chamber, and so no claim is required.
We find it conceivable that one would omit the cell-culturing methods and instead rely on the protection of the device claims. If one were to go that way, one may need to include a device claim in which the cell chamber is completely filled with cell suspension.
Below are the claim according to our solution:
1. A device for culturing cells comprising
- a frame (1),
- a first and second gas-permeable
and liquid-impermeable membrane (2a, 2b), wherein the membranes are attached to
the frame by means of a leak-proof seal forming a cell culture chamber (4) between the opposing
first and second membranes and the frame, and
- at least one
leak-proof resealable opening (3a, 3b) that allows substances to be introduced
into or withdrawn from the culture chamber.
2. A device according to claim 1, wherein at least one leak-proof
resealable opening (3a, 3b) is a leak-proof resealable aperture (3a, 3b)
provided through the frame (1).
3 A device according to claim 2, wherein the at least one leak-proof
resealable aperture comprises a gasket.
4. A device according to claim 3 wherein the gasket comprises an
elastomeric material.
5. A device according to claim 4 wherein the gasket further
comprises an antimicrobial agent integrated in the elastomeric material.
6. A device according to any one of claims 2 to 5, wherein the aperture
has a diameter of 1 to 2 mm.
7. A device according to any one of claims 2 to 6, wherein the frame
comprises two or more leak-proof resealable apertures (3a, 3b) allowing a user
to introduce a substance into the cell culture chamber via one of the apertures
while another substance is removed via another one of the apertures.
8. A device according to any one of the preceding claims, wherein at
least one membrane of the first and second membrane is a leak-proof resealable
membrane forming the at least one leak-proof resealable opening, wherein the at
least one membrane is attached to the frame with a pressure-sensitive adhesive.
9. A device according to any one of the preceding claims, wherein an
average distance of between 1 mm to 5 mm is provided between the first and
second membranes.
10. A rack for holding a cell culture device according to any one of
the preceding claims in an incubator, the rack being configured to provide a
space between the first and second membrane and the incubator to allow air to
circulate.
11. A method of culturing cells, the method comprising
(a) suspending the cells to be cultured in an appropriate amount of cell
culture medium to form a cell suspension;
(b) introducing the cell suspension into the cell chamber of a cell
culture device according to any one of the preceding claims
(c) incubating the cell culture device containing the cell suspension in
conditions allowing cell growth.
12. A method of culturing cells according to claim 11 comprising
filling the cell culture chamber completely with a cell suspension such that
there is no head space containing air.
13. A method of manufacturing a device
according to any one of claims 1 to 9, comprising
- providing a frame
(1),
- providing a first
and second gas-permeable and liquid-impermeable membrane (2a, 2b),
- attaching the
membranes to the frame to establish a leak-proof seal between the membranes and
the frame, so that the membranes oppose each other and a cell culture chamber
(4) is formed between the opposing membranes and the frame, and
- providing at least
one leak-proof resealable opening (3a, 3b) that allows substances to be
introduced into or withdrawn from the culture chamber.
14. A method of manufacturing a device according to claim 13 comprising
establishing the leak-proof seal using a pressure-sensitive adhesive.
15. A method of manufacturing a device according to claim 14 comprising
establishing the leak-proof seal by ultrasonic welding.
Thanks for your review.
ReplyDeleteMy claim follows the same structure but I went narrower and defined the resealable opening as either the aperture and/or the resealable membrane.
This is because I thought the paragraph that said "there are two possible ways of doing this..." could be read in two ways, i.e.
"there are *only* two possible ways of doing this..."
or
"two possible ways of doing this *are*..."
Thus, I went a bit narrow to be on the safe side. I think this paragraph could have been a bit clearer to suggest that there were other ways of achieving the opening.
JJ
Using 'and/or' does not seem to be a substantial limitation, provided that the formulation indeed covers all possible variants, e.g., in which there is both an aperture in the frame and a resealable membrane, or two apertures, etc..
DeleteHey Nico,
DeleteI think you should add the and / or limitation to the main claim, in addition with the pressure-sensitive adhesive for one or combination. The letter says that the invention only works with the described opening and therefore does not work with other openings. Therefore the two options are essential features. In your solution further openings are claimed, which are not executable. Therefore the claim is not executable in this broad version. For example you also claim a device, which has a hole within the membrane. But that is, according to the inventor, not a possible solution for the opening and should therefore not be claimed.
By adding the essential features / the only possible solutions, you do not narrow the claim! Those seem to be the only devices that can be protected, since no other openings can be combined.
Cheers!
Yes I opted for the and/or because of paragraph [11] final sentence in particular:
Delete"Therefore, *in order to carry out the invention* the frame of the cell culture device comprises at least one leak proof resealable aperture or/and at least one membrane is resealably atached to the frame in a leak proof manner".
This made it seem like the invention couldn't be carried out without one of these more specific features.
What about paragraph 19: 'using two opposing membranes and a frame for forming the cell culture chamber allows only the three embodiments above'?
DeleteSo you mean we shouldn't use opposing membranes and a frame? I couldn't see any way of going broader and still being novel. D2 disclosed two membranes next to one another.
DeleteUsually you need to use language provided by the paper, so I thought the frame and opposing membranes had to be there because there was no broader definition provided.
That said, I didn't notice the word "only" in the actual exam.
Hello UK trainee,
DeleteO-oh, there might be a translation flaw :-)
I agree with you: the EN version puts it in a clearer way.
However, the DE Paper says in the same sentence: "Folglich umfasst *zur (!) Ausführung der Erfindung der Rahmen... oder/und ist die Membran wiederverschließbar*, which I read according to the Guidelines F-IV, 4.13, first sentence as *a frame merely suitable for*. Moreover the formulation "zur Ausführung" leaves room for other possibilities to carry out the invention.
Best,
"AnonymousMarch 01, 2019 11:06 am
DeleteNico: I think this opening feature is only essential..."
This is brilliant and gets me on the idea that a device with no openings can be just a disposable one..
This comment has been removed by the author.
ReplyDeleteThis comment has been removed by the author.
ReplyDeleteI agree to UK trainee and also used the specific wording/ "and/or" definition which was presented in the description.
ReplyDeleteInstead of the method claim I went for a usage claim to claim to use the cell culturing and then added the described method steps.
Thank you Deltapatents for providing us with the proposal of the solution.
Thanks for your answer. I also went for the and/or combination for the same reasons, and specified the relative essential feature.
ReplyDeleteI also went for a manufacturing method and for a use claim.
With respect to the use claim, i merely claimed the use of a device according to claims 1-10 in a method of growing cell with the device.
The letter specified that the method was a usual method, thus i thought not really necessary to further limit the use claim.
I also went for a use claim as the client was a manufacturer and not a lab, thus i thought it was more intrested in the use of the device rather than in protecting a method of growing cells.
The method per se may be the 'usual' method, but when the method is performed using a device which is novel and inventive, this confers novelty and inventiveness upon the method. As such, it seems prudent to also claim the method.
DeleteOh no, I made the claim as you are suggestivt, them I changed it to be only permeable membranes arranged opposite to each other. This solves the problem with O2/CO2 exchange to the culture. Was it not inventive? Noone had thought about it before and it provided ground for a nice kit claim with the rack...alliwung air on borh sides of the chamber.
ReplyDeleteLinda
It also got me a nice method claim with completely filled chamber and use of the eack for this purpose.
DeleteSo you omitted the leak-proof resealable opening? This is explained to be essential in such a cell growing device, see [011].
DeleteYep, I certainly did! Removed I did!
DeleteWell I guess I will have the opportunity to add some necessary feature to my claims next year...
Hello Nico,
DeleteFirst of all thank you for providing a solution.
May I disagree on the essentiality? ;-)
I had a DE paper, so I will cite from there.
1. Para 001 to 007 are silent about openings.
2. Para 008 begins: "wir haben verschiedene Möglichkeiten zur Verwendung von Membranen in Vorrichtungen ... ausprobiert. Unser *wirtschaftlich vielversprechendster Ansatz* besteht in ... Fig. 1a - 1c. So there are other Ansätze whatever they might be.
3. Then it goes about openings and leads us to para 011. It says: "die Verwendung von 2 Membranen und einem Rahmen zur Bildung einer ...Kammer hat *den Nachteil*, dass ... nicht eingebracht oder entnommen werden können, *indem einfach* wie in D1 beschrieben der Deckel geöffnet wird. *Deshalb* is es wesentlich..." Hier it doesn't say *it is impossible to remove or introduce cells, if there is no opening* and period it says *the openings are there to make life easier*. Here I ought to say I'm not a biologist, so I have no clue what is possible or not possible with those membranes and the frame. The paper goes about needles, for example, so why not stick a needle in a membrane? According to the paper it might even work - see D1, which teaches openings in a lid and then says a lid could be a membrane (maybe with an opening or not). As I mentioned, I got no idea about the subject and I should not, because skill person knowledge is a NO-GO at the EQE. So, in my humble opinion, the Paper doesn't *explicitly* exclude a device with no openings, but puts it rather as potentially commercially not very interesting (see above) - an example we had last year with the pulsed laser btw. Not to mention that *implicit* features or their essentiality has no place at the EQE.
Then para 019 says: "Die Verwendung von 2 ... Membranen und einem Rahmen zur Building der Zustellkulturkammer erlaubt *nur die drei oben beschriebenen Ausführungsformen*." Meaning that there are only 3 possible ways to go about the openings. So if you put general openings into the claim, you actually get into Art. 83/84 sort of trouble and if you are ok with that why not to get rid of the openings at all? :-)
... to be continued.
4. In view of D1 and D2, I believe, two membranes do the job: New and inventive over D1 and D2 and achieve the goal, set in para 004: "...Austausch von Gasen zu erhöhen und Zellwachstumsrate zu erhöhen". Funny enough I believe that one of the three options for the openings that "mindestens eine der Membranen ist dicht wiederverschließbar am Rahmen befestigt" is not even a good fall back position in view of D1, para 003, which shows the usage of such membranes in Multi-Well-Thingies :-)
Delete5. To conclude, I believe that if EQE's motto is "Fit for practice" and if the claim should have openings in it, then I believe that this year's Paper A definitely something completely different from the Practice. Paper A para 001 states that a client flies to Japan to meet an interested party, and you cannot possibly get him on the phone within the next 12 hours. So tell me, what is in his interest? :-) I believe that you get him/her a claim or claims that has or have the most broad protection scope. Now omitting all those Art. 83 discussions about openings or no openings I would say that a claim with no openings that is new and inventive is better than a claim with openings, if of course you put the openings into the dependent claims and into the specs. This is because if you put the openings as an essential feature into the application and than, later on, would like to get rid of them because someone comes up with an a brilliant "commercially not interesting" idea to put the stuff in the chamber without the openings, I wish you a good luck getting rid of the openings :-) so far about the practice.
You see I put loads of thought into Paper A and the above is my line of thought during the exam yesterday :-) something doesn't feel right about the Paper A this year.
BTW after practicing C method you taught us in Munich last fall, I had loads of fun with the Paper C today.
Warmest greetings from Vienna,
Oleg
Hi Oleg, I concur with your analysis and do not have the opening feature in my claim 1 (only in claim 2). From reading the examiner's reports of the last two years, I believe this kind of thinking is appreciated by the EQE committee. The device may not only be used for cell culture anyway, just like the glass pane may not only be used in (VIZ-)glazing so the 100 um protrusion feature is not actually essential.
DeleteOn a practical level, aren’t some form of openings needed so you can insert cells into the device?
DeleteI do agree that the two opposing membranes was enough for novelty and inventive step, since the surface for gas exchange was greatly increased compared to either D1 or D2.
We considered the ‘Deshalb ist es wesentlich… ' ('It is therefore essential...') to indicate that the opposing membrane-based cell culture device needs to have an opening, essentially to still be able to function as a cell culture device. In fact, many if not most of the embodiments seem to define how this opening realized in various advantageous ways (implicitly indicating it belongs to the ‘core’ of the invention).
DeleteTherefore, its omission may be considered to contravene Art. 84's implicit requirement that 'all essential features must be included in the claim'.
Of course, we may be wrong, in that the Exam Committee expected the claims to be broadened beyond covering all explicitly described embodiments. I furthermore agree that when you omit the opening, the claims are still novel (and arguably inventive) over the prior art. Therefore, a possible point subtraction - either way - is probably not too large.
Nico: I think this opening feature is only essential in the context that the device is used as a cell culture vessel which allows substanced input/output. However, we may also assemble the device and introduce the cell suspension simultaneously. In this case it is not necessary to have any reseable openings, which may make the device more affordable. We can eventually break the device cells.
Deletesorry guys, but all this makes no sense. I should be biased by my biology background, but what are you saying is not possible in practice as you want be able to change the medium and put cells of interest in the suitable number for your experiments. This is also explained in the background of the invention. an opening is essential for a cell culture device.
DeleteKavi,
DeleteWould you please point me to the sentence in the paper that says that you have always to put cells? D1 para 003 tells for example that it might be needed to refill *single* cells, not all of them. As I mentioned above there is a reason why a paper should be formulated in a way that even a biology lay person like myself could understand it.
BTW just curious: is a thing such as a disposable cell culture device not possible?
Cheers,
Kavi, I also happen to be a biologist. I do not agree that growth medium must be changed during the culture. For example, you may introduce 1000 cells -which are not so many - and as much growth medium as possible when such a device is being assembled. In this case, the cells could proliferate without the need for replenishing any further nutrients.
DeleteMoreover, the device may also be used for other purposes. For example, you may put fruit flies together with sufficient food inside when the device is assembled.
Oleg,
DeleteD1 para 3 says single wells, not single cells, because it is a multiwell cell plate. you have to put cells because this is why a cell plate is intended for :)
Yes, I meant wells :-)
Deletea disposable, already filled well plate is possible for one shot experiments for instance. however, this means that you might not be able to "jnteract" with the cells in it if there's no way to open it. In the vast majority or biology experiments (if not all) this is not practical/useful.
Deletethe letter from the client states that "Our company designs and manufactures devices which are used for growing cells
Deletein laboratories." my understanding was that they are well plates manufacturers, not providing cell culture services. I have assumed then that they wanted to reach the highest number possible of clients involved in cell cultures, which is described for non biologists in D1. as I said, I must have been biased by my background.
Anonymous
Deletein the case in which you "put fruit flies together with sufficient food inside when the device is assembled" you don't need leak proof seal, water impermeable membranes, elastomeric gaskets, antimicrobial agents etc because you won't put any liquid medium in the device. I guess we should stick to the information provided, not trying to invent more than necessary...
Kavi,
Delete"not practical/useful" does not mean impossible and it was not an exclusion criterion last year. In A2018 the client suggested to use a pulsed laser and said that continuous lasers were not commercially interesting or smth. similar. Examiner's report says "it was not necessary to limit the lasers to the pulsed lasers.
Hi,
ReplyDeleteI've realized that I've forgotten the essential feature of "by means of a leak-proof seal". How much do you think it can affect?
Are the steps of "providing" really necessary in claim 13? Are they not implicit from the reference to the previous device claims? I think the "attaching" is the only real method step...
ReplyDeleteYeah I only included the attaching step in my method claim because I reasoned that there was no support for any of the other steps in the description provided. Maybe these steps are implicit but I had always thought never to invent my own claim features
DeleteMe too (not adding any significant information with this post here, merely that it seems a rational opinion, followed possibly by many).
DeleteThe 'providing' steps merely define the context to the 'attaching', and you may indeed argue that this context is already given by the reference to the previous device claims. So leaving away the 'providing' steps probably only attracts a minor point subtraction, if at all.
DeleteWhat do you think about two Independent claims given the wording ,two Alternative solutions‘ in the paper
ReplyDeleteIs claim 11 novel over D1? Personally, I also introduced the features of claim 12 in claim 11.
ReplyDeleteYes - because it is using the novel device
DeleteYes, you are correct, thanks for helping me understand it! I hope it is not considered a severe limitation then adding the features of claim 12...
DeleteI wouldn't have thought it would be a severe limitation - in DP's analysis above they discuss the value of the cell culture method as a whole, as it will be covered by the device anyway - so not a super valuable claim I don't think - like you say the newer bit is the feature of DP's claim 12.
DeleteThank you for providing a potential answer. The sentence in the description "[010] The frame can be made of any material that has the required structural integrity to keep the device relatively rigid and that is suitable for containing the cells", made me think that these 2 features might be essential. Aren't they? Is it a strong limitation?
ReplyDeleteIt is a bit of 'Fingerspitzengefühl' ('intuition') which features are truly essential. I agree that the adjective 'required' may suggest an essential feature. On the other hand, from an exam tactical perspective, the definition which is given ('relatively rigid') is not well-suited as a claim feature as it contains an undefined relative term ('relatively') and no better - broad - definition seems to be given. In addition, one may argue that there seem to be many suitable materials, and that the skilled person would automatically select a suitable material when designing such a cell culturing device (e.g., he/she would consider the rigidity and bio-compatibility to be implied, and select a suitable material accordingly).
DeleteHaving said (and speculated...) all of this, you make a fair point, but ultimately I expect that the feature is not required, at least not in the independent claims.
I do not think that it is necessary to have at least one leak-proof resealable opening, although it is indicated to be essential by the client, because the device may also for one-time use. For instance, we can introduce cells into the device before the membranes are sealed and culture cells in the chamber before the device is broken to harvest cells. According to the last several Examiner's reports I got the impression that we are expected to be more innovative.
ReplyDeleteSo my device only contains two gas-permeable and liquid membranes held to a frame by means of a leek-proof seal to form a chamber.
Hope so...I thought that a chamber alqays included a reasealable opening, as all mentioned Chambers have that, one ylar it was a patch with an adhesive later, but that was not to be included as D1 Said that pathes have an adhesive layer and there were points to loose on explicitly disclosing the adhesive layer. I am not sure about anything, lets hope for the best!
Deleteanyway such cell culture devices are usually disposable. If it is much cheaper and easier to manifacture, then why not just use such devices comprising two membranes? it appears to me that there is no need to have a reseable membrane.
DeleteHi, I didn't include the method of manufacturing the whole device ... just a method of manufacturing a cell culture device comprising irreversibly sealing at least one gas permeable/liquid impermeable membrane to a frame (so as to cover what I understood to be the new bits of the method of manufacture). And then a dependent claim to ultrasonic welding/hot melt adhesive - do you think this will be problematic?
ReplyDeleteHi - does anyone have any thoughts on the above?
DeleteHi Nico, I defined "opening membranes are attached to the frame by means of a leak-proof resealable seal" instead of the opening. In cl. 2 I included that the resealable seal is formed by:
ReplyDeleteat least one leak-proof resealable opening (3a, 3b) is a leak-proof resealable aperture (3a, 3b) provided through the frame (1)
AND/OR
at least one membrane of the first and second membrane is a leak-proof resealable membrane forming the at least one leak-proof resealable opening, wherein the at least one membrane is attached to the frame with a pressure-sensitive adhesive.
I think this also covers the invention. What is your opinion.
There seem to be two aspects related to 'sealing':
Delete- The opening (aperture in frame, membrane) should be resealable.
- A leak-proof seal should be used to attach the membranes to the frame.
Both aspects do interact in the second embodiment (resealable membrane) but are separate in the first embodiment (aperture in frame). As such, stating that the 'seal is formed by (...) the aperture provided in the frame' seems to be incorrectly mixing-up both aspects?
In our view, there always needs to be a leak-proof seal.
In addition, there needs to be an opening, which could either be an aperture in the frame or one of the membranes being leak-proof resealable.
Hi Nico, do you think that full points will be deducted if claim 1 included a resealable seal instead of a resealable opening?
DeleteWhen claiming a resealable seal you will exclude only one main embodiment (resealable opening). The resealable membrane OR Resealable membrane + resealable opening falls still under the claim.
What if claim 2 defines that the resealable opening is at least one resealable membrane attached to the frame and/or at least one resealable opening through the frame. How will the points deducted then?
Is there still a chance for passing the exam? Thanks!
claim 1 seems unclear and not enabling to me. It does not specify what kind of openings we should use. In addition, do the reference signs 3a, 3b just refer to the apertures when read together with the drawings?
ReplyDeleteThis comment has been removed by the author.
ReplyDeleteDo you know how many marks are lost when the claim has incorrect two-parts form?
ReplyDeleteI guess maximum 2 points.
DeleteRegarding: pressure-sensitive adhesive in claim 8, i believe that in D2 the membrane was some kind of self adhesive. Did anyone try to cover that?
ReplyDeleteThis comment has been removed by the author.
ReplyDeleteThanks for providing your model solution so quickly! It is highly appreciated.
ReplyDeleteRegarding the manufacturing methods, I read paragraph [015] as there being interest in protecting both 1) using an adhesive (in particular a hot-melt adhesive) and 2) using ultra-sound welding. The latter is said to be preferable, but the last sentence of the paragraph states that there is interest in protecting "these methods" (plural).
Any reason that you chose "pressure-sensitive adhesive" instead of "(hot melt) adhesive"? The "pressure-sensitive" feature appears to be related to the second embodiment, but the desire to protect the manufacturing methods is expressed in relation to the first embodiment.
Further, I read this as an "alternative solutions to a particular problem" situation (Rule 43(2)(c)) and drafted one independent manufacturing claim for each of 1) and 2) above. Any thoughts on that?
In [019] is says: using two opposing membranes and a Frame for forming the cell culture chamber allows ONLY the three embodiments above. Doesnt this exclude a Broad claim as suggested
ReplyDeleteWell, one could also interpret it the other way around: apparently the broad claim only yields a scope of protection which corresponds to these three embodiment as no other embodiment are possible. In other words, the broad phrasing and an explicit writing out of the options using an 'and/or' yields the same scope of protection. This means that there should be no support problem under Art. 84 even when using the broad phrasing.
DeleteA disadvantage of an 'and/or' is certainly that phrasing the dependent claims may be more difficult (although this could be addressed by careful phrasing).
Hi Nico, thanks for providing your solution so quickly!
DeleteWith respect to the and/or-issue, I tend to disagree, too. You say there should be no support problem under Art. 84. The main problem, however, is that the broad claim cannot be performed according to Art. 83 over the whole area claimed (T 727/95), because only the three embodiments are possible [019].
According to [011], the aperture and/or the resealable membrane is needed to carry out the invention. The broad claim should have a problem with Art. 83 and the "whole are claimed" requirement (GL F III 1).
You are right that the structure of your claims 1, 2, 8 allows for "sorting" the preferential features for the aperture directly to claim 2.
DeleteLegally, I think, a claim structure
1. Device with aperture and/or with resealable membrane
2. Device according to claim 1 wherein the aperture comprises a gasket
is just short for
1. Device with aperture and/or resealable membrane
2. Device with aperture comprising a gasket and/or with resealable membrane
Therefore, there should be no difficulty with respect to the phrasing.
Sorry for the typo: "whole are claimed" = "whole area claimed", of course.
DeleteI am also sceptical about such claim 1 without aperture and/or resealable membrane.
DeleteNico: you say such broad claim without aperture and/or resealable membrane would yield the same scope of protection. If this is the case, though, then why not mention the aperture and/or the resealable membrane in the first place?
Splitting it up in 3 claims would just be a waste of 2 independent claims which are valuable in this paper. As you said, there are a lot of features could potentially be claimed while at the same time we are limited to 15 claims.
Also, if the scope of protection is the same, and even if the broad claim would be somehow clear, why not use the *more* clear version including the aperture and/or resealable membrane. Art 84 not only requires clarity of whatsoever nature, but requires the claims to be as clear as possible (T 2026/09, etc).
Article 84 EPC also requires conciseness though. That being said, I also opted for the and/or variant to be on the safe side. In past papers insufficient disclosure was seemingly penalized more harshly than lack of clarity. Don't think it will make much of a difference in the end anyways.
DeleteThese claims are similar to what I had except I didn't specify "that allows substances to be introduced into or withdrawn from the culture chamber" in relation to the opening so am wondering now if I am missing an essential feature.
ReplyDeleteI think this functional limitation ('suitability') should be ideally be included in claim 1 since otherwise openings are covered which are too small (see, e.g., the suggested size of 1-2mm of the aperture) or otherwise not suitable.
DeleteHey, I have one further question according the independent claims. Paragraph [014] states, that *most of the clients* use a standard-size needle and syringe to access the cell culture chamber. This means, these products are commercially highly relevant. So, why not claim like:
ReplyDeleteKit, comprising the device according to any of the claims x to y (first embodiment), together with a needle and a syringe.
Writing this, I think about claim 14 of the Examiners' Report: Mock Paper A from 2016 for Part A 2017:
"A kit comprising a multi-layered patch according to any of claims 1-10 and 13, together with a container containing a perfume composition.
In his letter ([0011]), the client explains that perfume could be added to the patch, for instance shortly before use. D1, which also refers to perfumes added to a patch shortly before use, describes kits comprising patches and the perfumes and stresses that these products are commercially highly relevant ([0006]).
Candidates were expected to realise that such kits were perfectly in line with the client’s letter and to accordingly claim such a kit.
10 marks were available for this independent claim."
The difference with the 2016 paper is that there the perfume would be _sold_ together with the patch, but packaged separately from the patch in the container as the perfume could be applied to the patch only shortly before use. This makes a kit claim appropriate.
DeleteThere is no indication here that the cell culture device would likely be sold together with a needle and a syringe. That the cell culture device would be used together with a needle and a syringe is probably not a sufficient criterion to include them in the claim (otherwise, where would one stop?).
Hello,
ReplyDeleteI have the same set of claims as DP, except that claim 2 is in claim 1. In other words, I excluded the second embodiment of the client.
Do not ask me why I did that (exam stress, tiredness,...). I know that in mechanics, for the past paper, excluding one embodiment costs a lot of points, like between -10 up to -45. However, in mechanics, the independent claim was worth 50 points and there was only a single independent claims expected. We have here method claim and use claim (not required in mechanics). Do you have an idea if I may pass with this mistake?
Dear Nico,
ReplyDeleteThank you for your fast reply. According to this, I thought of the glass plane, claimed A2018. The examiners' report states: "Such a glass pane, _although not specifically requested by the client_ is not known from the prior art at hand".
The proposed kit is neither specifically requested by the client and neither known from the prior art at hand. Plus it is commercially highly relevant.
At least, I tried to combine the information from these examiners' reports.
Best regards
This post was for the kit claim.
Deleteso you tried also to protect a rack in an incubator?! I have turned this out as a method for culturing cells by providing enough space below the plate to allow air to circulate.
ReplyDeleteregarding the main claim, I have put no apertures (3a, 3b) but rather included the concept of leak-proof openings, then defined in dependent claims alternatives, either one of the membranes or apertures (3a, 3b). multiple dependency played for the several combination of embodiments. it is clearly stated in embodiment 2 that you can just have the two membranes and one of them as a resealable one: this must be protected as such in the first claim by providing all possible alternatives.
the "one or more leak-proof resealable apertures (3a, 3b) allowing a user to introduce a substance into the cell culture chamber via one of the apertures while another substance is removed via another one of the apertures" to me was more a method claim, as this refers to suitability of the aperture to do something, which is proabably not even new.
cheers
I also drafted a dependent claim for the method claim on providing enough space for air to circulate. Since no details of the rack were provided, I felt in the exam that I end up claiming result to be achieved if I claim a rack for holding etc.
Delete"so you tried also to protect a rack in an incubator?! I have turned this out as a method for culturing cells by providing enough space below the plate to allow air to circulate."
DeleteI did the same - hopefully we will get at least a mark for this!
Thanks for the solution! I don't see the logic behind claim 10 though. Ok, so racks per se do not form part of the prior art provided in this paper, but it seems likely that a rack suitable for holding a cell culture plate in an incubator is known to the skilled person.
ReplyDeleteI opted for a claim to a "system" comprising both a rack and the device of the preceding claims - this is unambiguously novel and inventive.
I agree and did the same.
Delete+1 !
DeleteWhat are your thoughts on unity of the rack claim?
DeleteUsually it would be required a technical relationship between the device of claim 1 and the rack of claim 10 involving one or more of the same or corresponding special technical features...
I believe the proposed claim 1 is too broad. Claims 2 (leak-proof resealable opening) and 8 (leak-proof resealable membrane) should be included into claim 1 as and/or combination.
ReplyDeleteFor current claim 1, the disclosure seems to be insufficient to enable the skilled person to carry out the device over the whole of the broad field claimed (although sufficient in respect of the and/or variants) - GL F IV 6.4.
It still puzzles me, because GL F-IV 6.4 talks about carrying out the invention. Para 004 states "It is the aim of the invention to increase the exchange of gases and therefore to increase the cell growth rate." It also states that "the invention overcomes these problems by providing a device for culturing cells comprising a first and a second gas-permeable membrane".
DeleteHow does the opening comes into play here? :-/
I agree, the problem to be solved seems to be "increasing the exchange of gases and therefore to increase the cell growth rate".
DeleteThis problem should be solved by the distinguishing feature "two opposing membranes such that cell culture chamber is formed in between". This feature makes the claim novel and inventive, because combining D1+D2 does not yield opposing membranes.
The aperture is known (in the lid as far as i remember) and the reasealble membrane is of course also known. These features, however, seem to be required for enablement.
I don't agree. in the description, a difference is made between definition of openings and that of apertures, the latter being those in the frame. I am convinced that defining a leak proof resealable opening in the preamble was necessary (being known from the prior art), but the embodiments presented by the client are just those imagined and developed: a gasket in one of the membranes would make the job, still being an opening but not an aperture in the frame. For that, I guess that limiting claim 1 with the and/or clause would overly limit the invention.
DeleteKavi, you are right that a difference is made between the abstract opening and the concrete aperture and/or resealable membrane.
DeleteHowever, the concrete aperture and/or resealable membrane are the only embodiments possible (see par [019]). Thus, in the theory of this paper, a gasket in one of the membranes is not a possible emobidment. In my view, this means that including the and/or clause in the claim is no limitation.
Rather, the and/or clause seems to be needed in claim 1 in order to carry out the invention (see par [011]). In other words, the and/or clause renders the claim 1 executable over the whole area claimed, which is a requirement of Art 83.
I absolutely agree with you, but only if you disclose it in the description... remember that you have received a letter from a client ; it is up to you then to seek the best protection for him in view of what he did. Of course, if you put in the description that the only the three embodiments are possible, you cannot claim broader. it looks to me that people here are more focused on articles and rules instead of how to best protect an invention, without being polemic.
DeleteThat is an interesting point. I agree that Art. 83 requires the description to disclose enough to carry out the claim. Consequently, I also agree that we cannot claim braoder if we include in the description that only the three embodiments are possible.
DeleteHowever, the reverse conclusion, that we *can* claim broader if we do *not* include this information in the description, is not true. Rather, in this case, the description still does not provide enough information to carry out the invention over the whole area claimed. Otherwise, the requirement of Art 83 could always be circumvented by not providing enough information in the description.
again, this is up to you, meaning that you are the one drafting the description and the claims. in my view, disclosing at least one leak proof resealable opening, then defining embodiments thereof to be claimed in dependent claims of particular openings still complies with the requirements of art 83. the client sends you a letter, not an already filed application.
DeleteIs there anyone who defined the resealable opening as a resealable seal?
ReplyDeleteI defined that the membranes are attached to the device by means of a resealable seal (i.e. resealable membrane and/or resealable aperture).
I however omitted omitted a seal beween the frame and the membranes. I probably wrongly understood that these sealings were the not same as the resealable sealings.
How many points will be deducted if an essential element is omitted?
Although my exam result is quite different, now, in retrospect, I think the expected claim is something like this:
ReplyDelete- a frame (1) [known from D1 as multi-well plate / lid]
- two membranes (2a, 2b) being gas-permeable and liquid-impermeable [known from D2 arranged in juxtaposition]
- the two membranes (2a, 2b) being attached to the frame (1) by means of a leak-proof seal [known from D2 + D1]
- the frame comprising at least one leak-proof resealable aperture (3a, 3b) [known from D1 as aperture in the lid] OR/AND at least one membrane (2a, 2b) is resealably attached to the frame in a leak-proof manner and with a pressure-sensitive adhesive [known from D2].
- CHARACTERIZED IN THAT the two membranes are attached to the frame in opposition to each other such that a cell culture chamber (4) between the two opposing membranes and the frame is formed [=distinguishing feature, novel and inventive over D1+D2 and solves the problem of increasing the exchange of gases and thus the cell growth rate].
This seems to me also the right solution. I agree
Delete+1
DeleteDear AnonymousMarch 04, 2019 7:21 pm;
DeleteWhat do you think about method claim?
14. A method of manufacturing a cell culture device according to one of claims ..., comprising
Delete- providing a frame (1)
- providing two membranes (2a, 2b) being gas-permeable and liquid-impermeable
- attaching the two membranes (2a, 2b) to the frame (1) by means of a leak-proof seal
- wherein the frame comprises at least one leak-proof resealable aperture (3a, 3b) OR/AND at least one membrane (2a, 2b) is resealably attached to the frame in a leak-proof manner and with a pressure-sensitive adhesive
- CHARACTERIZED IN THAT the two membranes are attached to the frame in opposition to each other such that a cell culture chamber (4) between the two opposing membranes and the frame is formed.
15. A method according to claim 14 wherein at least one membrane is attached to the frame by means of ultrasonic welding.
I drafted a similar independent claim; specifying that the at least one leak-proof resealable opening was one or both of (a) at least one leak-proof resealable opening and (b) at least one membrane being resealably attached to the frame in a leak-proof manner and with a pressure-sensitive adhesive.
Deletethis cannot be the right solution, as a second membrane is the characterising part of the device, not being discloded or suggested in the prior art and solving the technical problem of increasing gas exchanges.
DeleteKavi: a second membrane is already disclosed in D2 and therefore not sufficient as distinguishing feature. See par [004], last sentence of D2: "In the case of large multi-well plates, it is possible to use several films juxtaposed next to each other."
Deletea second membrane is disclosed, but not opposed to a first one.
DeleteHence, the claim reading "CHARACTERIZED IN THAT the two membranes are attached to the frame in opposition to each other"
DeleteMy difficulty was to find the distinguishing feature between embodiment 1 and the P.A. The only thing I came to think was that D1 was a multi-well plate, so the membrane, film , layer, whatever cover put on D1 would always cover multi -well, whereas the invention was directed to a single unit. The objective technical problem could be avoiding cross-contamination.
ReplyDeleteI would point to [004], last sentence, where it is stated that "the aim of the invention to increase the exchange of gases and therefore to increase the cell growth rate". This seems to be the problem. And it seems to be solved by the opposing membranes, because in [008] it is stated that "the use of two gaspermeable membranes on opposite sides of the frame increases the surface area available for gas exchange between the culture and the incubator".
DeleteEmbodiment 2
DeletePerhaps I was mislead by paragraph 3 of d1, talking about allowing access to single wells, which in fact is not possible in d1, if one uses such a device. (OR some insight from my "biology" background).
DeleteSeems, I’m quite late to the discussion and that the main concerns in the comments relate to the and/or issue. My try on summarizing the discussion so far:
ReplyDeleteThere appears to be consensus that both the broad claim 1 (proposed by deltapatents) as well as a claim which includes the and/or features (such as proposed by Anonymous March 04, 2019 7:21 pm) both would cover all possible (three) embodiments, because these (three) embodiments are the only ones possible [019].
Proposed claim 1 would thus not be limited if the and/or features would be included. Thus, the debate focuses on other reasons as to why the and/or features should be included or omitted from claim 1.
Arguments for including the and/or features are that these features are required to carry out the invention [011] and that including the features renders the claim executable over the whole area claimed, which is required by the EPC (Art. 83, GL F III 1, F IV 6.4, T 727/95) (Anonymous February 28, 2019 9:26 pm et. al.). Further, it is argued that including the and/or features - since not limiting - could only be advantageous to make the claim more clear (Skeptical March 03, 2019 9:42 am).
Arguments for omitting the and/or features are that by having separate claims 1, 2 and 8, the phrasing is easier (cf. Nico Cordes March 01, 2019 10:31 am). Also, it is argued that it is up to the drafter to avoid mentioning in the description that the and/or features are required to carry out the invention, and that by avoiding this information, the claims could be drafted in the broad way (Kavi March 05, 2019 7:14 pm).
Counter arguments are that phrasing issues would in fact not arise when including the and/or features (Mr. President March 01, 2019 12:22 pm) and that three claims 1, 2, 8 for the same scope of protection would be a waste of two dependent claims (Skeptical March 03, 2019 9:42 am). Further it is countered that hiding the information that the and/or features are required to carry out the invention would not help to circumvent the requirements of Art. 83 (Anonymous March 05, 2019 7:47 pm).
I strongly disagree with the 7 mark deduction for the broad wording used by deltapatents. It is the proper way to draft a claim rather than the "and/or" language. Worth an appeal?
ReplyDeleteWhy do you strongly disagree? I think this was quite expectable. In my view, from the discussion above it became more and more evident that the arguments for the "and/or" version are stronger. See nice summary from Papri.
DeletePursuant to Article 24(2) REE, the appeal fee shall amount to 600% of the basic fee.
DeleteI would say no...
Hi, this is probably a very late comment but I am sitting EQE 2020 in a month's time. I just wanted to know if we are allowed to cut and paste parts of the Exam paper into our answer sheets to save time for paper A (drafting) and paper B (example, the original claim set). I would be grateful for your thoughts on this...there doesn't seem to be a clear comment by the examination board in this regard and my colleagues seem to be unsure as well...
ReplyDeleteHi, yes it is allowed. cheers
Delete