From October 2016 to March 2017 the team is joined by Guest Kats Rosie Burbidge and Eibhlin Vardy, and by InternKats Verónica Rodríguez Arguijo, Tian Lu and Hayleigh Bosher.

Monday, 27 April 2015

Why things are as they are in patent law: forgotten principles and histories, and the role of complexity

In my previous post ‘Subject Matter Relationships: the need for strictness, complexity and fuzziness’ (here) I considered the different tests that are used to compare subject matter for priority, added matter and infringement. That post generated many interesting comments from readers which led to me think about why things are as they are.

Here are two of those comments:

‘When you lack the discipline to make any single court decision binding, you necessarily create the possibility of the "rule of law" completely arbitrary and vacillating from one decision to the next.

It is easy to see that such a vacillating and uncontrolled driver is simply no way to set the path for what examiners (already a bit wayward given that they will tend to put their interpretation on decisions) can use as "takeaways" from court decisions.’ 
So case law must be consistent, presumably centred on certain principles.
‘Of course in the patent world there is no such thing as an absolute. While the EPO does claim to use a novelty test, the guidelines do indeed stress that an explicit disclosure is not necessary, and, especially in priority questions there is a body of case-law that talks about having the same idea, i.e. again not quite explicit disclosure. Thus it's not quite as black and white. But then, nobody said this job was easy.

I think a good part of the problem is the US history of disclosure mainly being aimed at "possession of the invention" rather than the "able to be carried out" in EPO history. Rather then [Sic] two pairs of lenses, perhaps we could talk about meeting in the middle, but coming from different sides?’
Was this the framework to decide
patentability that eluded Bilski?
So perhaps history acts as a guiding principle as to how we approach patent laws and legal tests.

What went wrong in Bilski? Was it a failure to develop new principles?

In the US case of Bilski [noted briefly on the IPKat here] the Federal Circuit and the Supreme Court disagreed on the minimal requirements for a ‘method’ claim. The Federal Circuit decided that the ‘machine or transformation’ test should always be met and the Supreme Court said that was too strict a test.

I recently came across a paper by Peter Menell (here) which gave an interesting perspective on Bilski, viewing it as a missed opportunity to lay out a framework for determining the patentability of business methods. The paper accuses the Supreme Court of ‘superficial textualism’ in the way it carried out its analysis, and it says:
‘The solution lies in recognizing that patentable subject matter cannot evolve to meet the new challenges of the information age without integrating 18th, 19th, and 20th century sources of patentable subject law into a flexible and evolving body of common law that is sensitive to history, statutory evolution, constitutional constraints, and understanding of modern science and technology.’ 
So according to this paper US patent law has failed to evolve in a way where Bilski could have been decided on principles derivable from centuries of jurisprudence. The ‘machine or transformation’ test is ultimately very simplistic and does not take into account that many inventions cannot be classified or analysed in this way. The Supreme Court was clearly aware of that, but perhaps did not feel it had the expertise to define an appropriate new test. Both Courts seem to have failed to extend existing patent principles in a way which would be relevant to assessing the patentability of new business methods.

Does complex technology mean we can no longer apply historical lessons?

Complex technology
requires complex
patentability tests
This Kat is a practitioner in the field of biotech/pharma patents. Much of my time is taken up in understanding how patentability tests are applied to complex technology. As an example if one considers how inventive step was assessed in Teva UK Limited & Teva Pharmaceuticals Limited v Leo Pharma A/S & Leo Laboratories Limited [2014] EWHC 3096 (Pat) (see Katpost here) one sees that for a pharmaceutical formulation the following criteria may be relevant:
* obvious to try 
* reasonable expectation of success 
* prejudice 
* inventive selection 
* the Technograph test (Technograph v Mills & Rockley [1972] RPC 346) 
* synergy
Mr Justice Birss discussed some of these criteria in more detail than the parties, who perhaps had started to suffer ‘test fatigue’.

In Human Genome Sciences Inc v Eli Lilly and Company [2011] UKSC 51 (see Katpost here) the UK Supreme Court identified 15 different principles from EPO case law on the patentability of new genes.

If the patentability of complex technologies is going to be determined by the application of many different tests, then perhaps it is simply not possible to have a historical perspective, and perhaps it is difficult to derive over-arching principles to guide the development of patent law.

Which principles are we now following in Europe?

The second comment I have quoted above takes the view that added matter is assessed in the US based on the principle of ‘possession of the invention’. Clearly we don’t follow that principle in Europe. Here added matter is more centred on the actual text that has been provided in the specification. However that may not be the best reflection of the purpose behind the added matter test which limits the extent to which the Applicant can improve its position after filing and provides certainty for third parties.

The first comment I quoted mentions the possibility of the ‘rule of law’ being ‘arbitrary’ in the sense of case law changing from one decision to the next. Clearly there need to be ‘fixed’ tests in case law. However how do we know that case law is going in the best direction? It seems to this Kat that the facts of an important case or the events of the day can determine how the law develops, without any overarching principle being followed.

Patent law is clearly highly functional. It allows Patent Offices to process a high volume of cases concerning many diverse inventions, and in this Kat’s opinion provides a good level of certainty for users of the patent system. However this Kat wonders whether patent law has failed to consider properly the principles that should guide development of patent law.

How should economics affect patent law?

Even if you are filing an embroidered
patent application you need to ensure lots
fallback positions for amendments
The patent system necessarily has economic underpinnings. It is a tool to promote innovation which in turn helps the economic system. However in their everyday workings Patent Offices and courts pay little attention to the economic effect of their policies and decisions. Their concern is to deal with the immediate issues in front of them, rather than worry about the wider implications of what they do. As a practitioner I see how that happens, and how difficult it would be to do anything differently.

However this Kat does wonder whether the patent system appreciates how it impacts the technology sectors that it serves. In the biotech sector patentability tests are becoming ever more complex and unpredictable. In an EPO opposition 30 to 50 documents can be cited by opponents attacking inventive step. The problem solution approach normally copes admirably under these conditions, but such proceedings too often seem to be deciding the fate of huge amounts of research based on a fortuitous interpretation of a paragraph in the patent specification or in the prior art. Many years of patent law jurisprudence seems to have led to a system where valuable patents are lost simply because the specification did not recite a narrower range or a higher temperature. Surely this is not how it was meant to be?

28 comments:

MaxDrei said...

In a jurisdiction with Binding Precedent the Supreme Court should shrink from handing down decisions that render the law more complex rather than less. Leonard Hoffmann in the UK Supreme Court handed down decisions that made the law less complex. bravo.

Under the EPC, bad patents are revoked on one or more of a list of grounds much shoirter than those under the UK Patents Act 1949. Back in the 1970's people thought that the EPC had less grounds of invalidity than the minimum needed to do justice. But they were wrong.

Suleiman under obviousness you don't mention the simplest and fairest way to do it, namely what the Americans call TSM and what the EPO calls PSA. I think it a great pity that approach is not binding on the courts, for then they would refine the Approach to do justice every time and boy would it render simpler, more elegant and more harmonious the jurisprudence of obviousness.

MaxDrei said...

Sorry about that Suleman. I got your name wrong, and typed before reading to the end your final para on "economics".

In too much of a hury, this Monday morning. There's a lesson there for me!

Suleman Ali said...

Thank you MaxDrei. I think if there is clarity of thought in a decision it can help to create new principles or extend existing principles in a way that helps things to make sense even as technology gets complicated. I think in Bilski there was 'simplistic' approach which is what made it a bad decision by the Federal Circuit.

In the case of obviousness for pharma cases I think this is genuinely complicated, and whilst the Courts seem to often reach the correct decision I have yet to see them developing a guiding principle which could provide a proper framework. In the specific example I gave Birss applied lots of different tests, but I think there was a level of arbitrariness in the tests that were chose, and to a certain extent how they were applied.

However I do think there is something wrong with the system when a patent is rendered invalid because the spec referred to 10-20% rather than 10-15%.

MaxDrei said...

Thanks. Two thoughts:

First, you shouldn't blame EPO-PSA and Art 56 EPC for the loss of the patent because it said 10-20, and not 10-15. Insrtead, blame the Art 54, 87 123(2) EPC jurisprudence on what a document discloses.

Second, the Birss casting around for a convincing line on obviousness rather makes my point, I think. If PSA were compulsory, both sides would present their Art 56 case within the same framework of argument. Both sides would be competing on the very same "Playing Field". One can then look forward to i) success of the team with the better of the evidence and the better of the argument and ii) steadily increasing levels of legal certainty, with future litigation involving Art 56 EPC.


But I agree with you, on what constitutes "disclosure" there is still a great deal of heat in the argument. How can there ever not be though.

Anonymous said...

However I do think there is something wrong with the system when a patent is rendered invalid because the spec referred to 10-20% rather than 10-15%.

Why do you believe that an applicant should be allowed to narrow 10-20% down to 10-15% in a case where exactly that is sufficient to overcome an objection on inventive step? If 10-15% is "the invention", do you not think it should have been in the application as filed?

If the idea is "if one claims 10-20% and only part of what was claimed is inventive, then one should be allowed to get that part", then I will claim a television today and in response to documents showing that a television is not new I will, say 5 years from now, narrow down to a particular television that was inventive in 2015.

MaxDrei said...

While agreeing with yesterday's anon I suspect the issue was 54 and 123(2) rather than 56.

Personally, I do not like any jurisprudence which encourages chemical drafters to indulge in writing an infinite number of incrementally smaller ranges, just so they have verbatim basis, in their application as filed, for a narrowing amendment that is just enough to get novelty over the art, and no more. It makes patent applications indigestible and absurd. It makes applications unwieldy and absurd. This is dangerous because it brings the patent system (and our beloved profession) into disprepute.

THE US anon said...

Perhaps knowingly (or not), MaxDrie's lament at 08:44 has been pointed out on many a blog:

Patent profanity.

Scriviners will continue to react to court rulings, no matter how objectively inane those rulings are. Near infinite sets of ranges? So it is written, so shall it be done. Be wary of blaming the applicant of the natural result of the actions of the courts.

Suleman Ali said...

Thank you anon of 21:06. If we consider an invention which is a composition with many different chemical components and one is limiting the claims until one has novelty and inventive step, there may be many similar compositions in the prior art, and it may come down to the right ranges being available in the specification to obtain a novel and inventive composition. Some prior art will be relevant (mostly) only for novelty and other prior art will also be relevant to inventive step. In such situations it seems to come down to good luck as to whether the right numbers are there in the specification. MaxDrei disapproves of drafting an infinite number of incrementally smaller ranges, but for certain subject mater that must be done. Your TV example is helpful, but does not reflect the situations where ranges are important in defining the invention.

Millions of dollars of research might have gone into making the invention. It seems wrong for that to be put in jeopardy by not enough numbers being present in the specification.

THE US anon said...

Dr. Ali,

There was a Canadian case (if I recall correctly) that had the permutations well into the billions of possibilities.

When does such "necessary" listings indicate more of an actual lack of possession and less of merely some research plan to obtaining what might be present?

This circles back to a gripe I have with pharma patents in general in that in all other art fields in patent law, possession of actual utility at the time of filing is required, and yet possession in pharma is (generally) not even verified until years and years and years after filing through the mandated (at least in the States) FDA process. One only has to look at the immense number of items failing to survive that FDA process to throw a rather serious doubt as to the notion of possession at time of filing.

The fact that the innovation process may involve many millions of dollars in up front expenses is simply not a valid reason for the wink-wink nudge-nudge lack of enforcement of possession at the time of filing that pharma enjoys.

MaxDrei said...

Suleman if you were at the EPO, with your 10-20% range case, could you not have simply disclaimed 15-20? Is there not an on-point Decision of the Rennie-Smith Board that took such a pragmatic approach?

Suleman Ali said...

Thanks US Anon. Yes, pharma patents do stretch the system a little.

MaxDrei, I like your 'lenient' approach to added matter, but normally the EPO would want disclosure of '15%' somewhere in the spec in the situation where the amendment was relevant to novelty and/or inventive step.

In the old days (around 2000), I think one could occasionally introduce a number without basis to limit claims, but I would be very surprised if that could happen now. I don't know the Rennie-Smith decision you are referring to.

Anonymous said...

@MaxDrei:
While agreeing with yesterday's anon I suspect the issue was 54 and 123(2) rather than 56.

You might be right. But if it was novelty and 18% was known, then still I'm not sure why one should be able to go from 10-20% to 10-15%. In many cases 10-15% won't be inventive over 18% (and with 54(3) or accidental novelty one can disclaim). If going to 10-15% does make it inventive, we're back at where we were.

Personally, I do not like any jurisprudence which encourages chemical drafters to indulge in writing an infinite number of incrementally smaller ranges, just so they have verbatim basis, in their application as filed, for a narrowing amendment that is just enough to get novelty over the art, and no more. It makes patent applications indigestible and absurd.

I completely agree.
But at the same I don't like the idea that an applicant should be allowed to narrow a range (after the date of filing, without a basis) to a subrange where he can show a particular effect. (Maybe you agree? Certainly you will agree that allowing an applicant to limit 10-20% to 10-15% will allow the EPO or an opponent to argue that a prior-art document disclosing 5-40% thereby discloses 15%.)

So it seems to me that artificially listing long lists of ranges in the application just so that there will always be one that fits well with a later discovery by the applicant should not be rewarded. Art. 123(2) is an insufficient tool for that (unless a one-list principle is introduced). So it seems the tool should be Art. 56 / 83. The applicant can pick any range from a long list of ranges, but can't argue inventive step based on an effect that does not occur in all of the ranges, or (if the effect is in the claim) can't argue that the claim is enabled if the effect does not occur in all the ranges. That way that artificial list isn't going to bring anything.

The invention should have been made at the filing date at the latest...

@Suleman:
I will first admit that I'm not terribly familiar with inventions where ranges are all-important. So it is almost certain that my view is too simplistic. But...

If there is prior art that is only relevant for novelty, then it should be possible to disclaim that prior art.

It there is prior art that is relevant for inventive step, then I have trouble understanding the justification for allowing the applicant to overcome that objection on the basis of essentially meaningless values or ranges that were inserted in the application only to have room for manoeuvre. Such mechanical manoeuvring is not inventive, it seems to me.

Of course a subrange might exist where surprisingly some other technical effect occurs, or where surprisingly the original effect is particularly forceful. Such a subrange is a patentable invention, but the applicant should have made that invention already when he filed the application, and it should be disclosed in that application.

I'm sure that in many practical cases applicants succeed in getting a patent thanks to such a meaningless range being present in the description, and for that reason a good attorney should of course make sure that such data is added to the application before it is filed. But in my view this is a problem of Art. 56 jurisprudence/practice and not of Art. 123(2) jurisprudence/practice.

MaxDrei said...

Thanks for the responses to mine at 14:27.

I was thinking of a case where Suleman discloses a surprising and useful effect coinciding with the range 10 -20% and now some prior art D1 discloses a range down to 18% (but not the effect). To get novelty he wants to shrink back to 10-15% but can't find "15" in his appln as filed.

If he could find a verbatim 15 he would be through on all of 54, 56 and 123(2) EPC. In its absence he fails, but only because of 123(2). Being the first to contribute the effect to the art, he ought to get a patent, I think, even though he has no verbatim "15". It is 123(2) that treats him unfairly. But:

He could disclaim the overlap with D1, I suppose. Or, he could argue that no D1 reader would seriously contemplate the range 18-20. Or, he could extrapolate from the Rennie-Smith decision I had in mind. It wasn't a number range, now I think a bit harder. Rather, it was deletion of nearly all members of a list of molecule variations, to leave just a few. Was that an undisclosed intermediate generalisation? The Board thought not. If you can delete nearly all members of a class without offending 123(2) why can't you crop the top of the range down from 20 to 15?

THE US anon said...

I am struck by how much MaxDrei's post at 23:58 sounds like a "product by process" claim interpretation in that the emphasis is on the contribution of the effect ("process") without the verbatim 15 ("product").

Ought to get a patent...?

The last paragraph is difficult to follow. Are you saying, MaxDrei, that it is OK to add new matter now? Or are you saying that we should look at an implicit inclusion of the very "infinite number of incrementally smaller ranges"...?

Suleman Ali said...

Anon at 23:11. I agree with much of what you say, but from experience amending claims in situations where there is a lot of prior art then the numbers do matter. There will be documents that are relevant to novelty and inventive step, but the inventive step part is arguable and does not need amendments, so you need to get novelty by amendment, but you cannot use an accidental anticipation type disclaimer. You use the word 'invention' in the way you discuss this, but one could say it's better simply to refer to subject matter which is novel and inventive, without trying to look for an 'invention'.

MaxDrei - disclaiming a fully citable doc without basis in the spec is a now very high hurdle in terms of it being completely non-relevant for inventive step (accidental anticipation). Your argument about being able to 'crop' the range sounds reasonable, but of course the EPO will only allow this for specific discrete features, not ranges (at least with present case law!).

maxdrei said...

For me, the hard thing for DG3 is to reconcile 123-2 strictness with fair protection for what the inventor has contributed to the art. Think back to the genesis in DG3 of non-medical use claims. Back then, it found a creative solution. I nurture hopes it can do something equally creative on number ranges, when the invention justifies it.

Anonymous said...

@MaxDrei:
I was thinking of a case where Suleman discloses a surprising and useful effect coinciding with the range 10 -20% and now some prior art D1 discloses a range down to 18% (but not the effect). To get novelty he wants to shrink back to 10-15% but can't find "15" in his appln as filed.

But would getting to novelty help him?

D1 discloses 18%. The inventor has discovered an effect occurring in the whole range 10-20%, including at 18%. Compositions in the range 10-15% do not achieve an effect that was not already achieved by the prior art. So anything in 10-15% arguably is not more than an obvious variation of 18%.

One counter-argument is that the prior art did not teach the effect at 18%, so that the problem solved is achieving that effect. I would not consider that relevant, but I might have the case law in this field against me (I don't know).

A better counter-argument might be that I'm too quick in concluding that 10-15% is an "obvious variation" of 18% merely because it does not achieve any new effect over 18%. But let's formulate the problem as "finding an alternative composition still having the effect". Would it, normally, not be obvious to realise that values around 18% probably still achieve the effect so that the skilled person with some experimentation will find out that it occurs everywhere in the range 10-20%?

(Maybe D1 is an accidental anticipation? Then 18-20% can be disclaimed. But I have always found it curious that something falling squarely within the scope of a claim could be irrelevant for inventive step.)

The Rennie-Smith decision probably used G 2/10.

Suleman Ali said...

Anon at 18:16, also remember for inventive step there may be 'prejudice' arguments or 'teaching away from the invention, etc, which may make determining whether 10-15% is inventive over 18% quite complicated. If 17% did not work for example, then 10-15% is going to look inventive.

Anonymous said...

@Suleman:
I agree that if 17% does not work, starting from 18% the range 10-15% is likely to be found inventive.

But in our example the application states that 10-20% works, so if 17% does not there might be a problem. Clearly non-working or non-inventive embodiments cannot be simply disclaimed (G 1/03), so there would need to be a basis for 10-15%. Now the question (at least for me) is whether it is right to still take into account the effect that is achieved in the range 10-15% but was originally disclosed as being achieved in the range 10-20%. Apparently the information in the application was based on speculation that proved to be false. The information that it does work in 10-15% therefore seems to be new (for the first time not based on mere speculation). I'm starting to see why ranges are so interesting ;-)

Regarding your earlier post:
There will be documents that are relevant to novelty and inventive step, but the inventive step part is arguable and does not need amendments, so you need to get novelty by amendment, but you cannot use an accidental anticipation type disclaimer.

I might be misinterpreting (and in any case lacking expertise in this area), but this seems to suggest that an ED or OD normally insists on novelty, but not so much on inventive step provided one argues. Narrowing down ranges a bit without achieving new effects in my understanding should normally not help too much to establish an inventive step.

Of course an attorney should simply act in the interest of his client, insert extra values and ranges as safety measure, and argue that nothing in the prior art suggests that 18% could also be 17 or 16 or 15%, etc.

Suleman Ali said...

Also anon at 21:19 more than one 'effect' may be happening. For a drug efficacy, toxicity, stability, etc may all be relevant to inventive step and may independently vary over concentrations. Over which ranges the composition is inventive over the prior art is then potentially very complicated. Defining what the invention is is very complicated, and so the extent to which it was originally disclosed at which ranges starts to become quite an artificial exercise. As you say the attorney simply has to put lots of numbers into the spec and argue it as best as possible. However coming back to the point I was making in the original article, is this really the best way of doing things?

THE US anon said...

Dr. Ali,

Where do you stop?

If you are willing to give the wink-wink, nudge-nudge "close enough" to pharma (and the clear lack of actually having possession at the time of filing), why should ANY and ALL other art fields want "ameliorating" easements of any perceived "difficulty" of obtaining patent coverage?

Anonymous said...

As you say the attorney simply has to put lots of numbers into the spec and argue it as best as possible. However coming back to the point I was making in the original article, is this really the best way of doing things?

It is not, but what is wrong is that the artifical exercises apparently do help to get a patent.

In an ideal patent world the EPO would deny inventive step where it is based on artificial exercises. If the EPO were strict and predictable on that point, there would be no benefit to be had from such exercises and thus no need for the attorney to prepare the application correspondingly.

(The alternative approach, i.e. that the EPO becomes more 'flexible' on added subject-matter, should not be of any particular help to applicants, since that would also force the patent office to become more 'flexible' in interpreting the prior art. If 10-20% can be amended to 10-15%, then 5-95% discloses 12%.)

Anonymous said...

Although this comment comes a bit late, I will look at your approach from a German vs. EPO perspective.

The German Federal Supreme Courtwas adopted your appraoch in the decision "Chrom-Nickel-Legierung", wherin the FSC concluded that a range such as 10-20% discloses each and any intermediate value.

While this approach may be helpful under Art. 123(2) EPC, it essentially precludes selection inventions. Even if your application teaches that the range of 10-20%, in comparison to 1-100%, is asscociated with a favorable effect, it will lack novelty. I.e. it is not possible to argue that the range of 10-20% is narrow and is sufficiently remote from the Example in the prior art (e.g. 50%).

Turning back to your example, I wonder why, for patentability purposes, your do not resort to the effect of the range of 10-20% either in the form of a non-medical use claim or a medical product for use claim. This approach of course requires that there is direct and unambiguous support for the effect in the application.

If this is not the case, it seems o.k. that you will not be able to claim possession of the invention based on this effect.

If the effect is disclosed, you may even be able to rely on an Example to limit your range because this seems one of the cases where only the feature in the claim is responsible for the effect.

Regards
Patent Attorney

Suleman Ali said...

Anonymous of 12:59, thank you for that. As you say, perhaps it's better for inventions to always be limited to utilising the 'effect', and in that case we could have a different policy on ranges (in terms of their prior art effect or when considering Article 123(2)).

MaxDrei said...

It looks to me as if the last two comments reveal a GB-DE misunderstanding. When your range as such is not new but an effect within the range is, then why not claim the use of the range to get that effect (instead of the range, per se)? It is not an "always" thing, just a way of claiming that is commensurate with one's contribution to the art. And a way that goes all the way back to Exxon's "friction-reducing fuel additive".

Anonymous said...

MaxDrei,

Is there not an inherency problem?

If a prior art item is a claim to an actual item, is not ALL uses (uses that are inherent without more) a "natural by product" as it were of the first patent?

I am thinking of exhaustion as an example. I buy an item covered by a first patent, paying the asked for price for the item.

Am I not cleared to use that very item for any and all uses of the item? How is it that a second patent can limit me?

Note that I am not saying that a new use requiring more than just the item is curtailed - just that, without more, an "use" inherent in the item itself (and only itself) should not be able to gain additional patent protection, as that would appear to render the first Quid Pro Quo short of its full effect.

Anonymous said...

@Suleman

"Is there not an inherency problem?"

At least in EPO practice, there is no inherency Problem. There is case law where novelty and inventive step were acknowledged although the effects were very Close (e.g fertilizer vs. growth accelerator). The EPO is basically looking for whether the particular effect was explicity described in the rior art.

"Am I not cleared to use that very item for any and all uses of the item? How is it that a second patent can limit me?"

In principle, infringement will depend on whether the particular use is specified on your product or in your Marketing material.

Even when looking at your first example, there will be dependency between the older and the later patent. If the older patent claims 1-100% and your later patent claims 20-30%, your product having 25% will be covered by the older patent. The same applies when comparing generic vs. specific Terms, e.g. sugar vs. lactose as an excipient in a pharmaceutical composition.

Regards, Patent Attorney

Anonymous said...

Thank you Patent Attorney, but your view of whether the item is exhausted being limited to the marketing material is expressly wrong.

Anything in the item IS in the item regardless of the marketing materials.

That's like selling a hammer with marketing materials limiting use to roofing nails and then suing someone for using the hammer for a different use (for example, smashing a wooden box, or even hammering a different nail not listed on the marketing material).

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