Impax Labs v. Aventis Pharmaceuticals (Fed. Cir. 2008)
This appeal focuses on the question of when a prior art disclosure is sufficiently enabled.
An Aventis patent covers the use of RILUTEK (riluzole) to treat ALS. Impax filed an ANDA with the FDA (seeking to market a generic version of the drug). In subsequent litigation, Impax also alleged, inter alia, that the listed patent should be held invalid. In particular, Impax argued that an earlier Aventis patent (the ‘940 patent) anticipates the asserted Aventis patent (the ‘814 patent) by suggesting a class of compounds may be used to treat ALS. The district court, however found that the ‘940 patent “does not enable a person of ordinary skill in the art to treat ALS with riluzole and therefore does not anticipate claims 1-5 of the ‘814 patent.”
Burden particularly heavy: A defendant who hopes to use previously considered art to invalidate a patent has a “particularly heavy” burden.
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Thus, a party challenging patent validity has the burden to prove its case with clear and convincing evidence. When the examiner considered the asserted prior art and basis for the validity challenge during patent prosecution, that burden becomes particularly heavy. See Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1467 (Fed. Cir. 1990). |
In this case, the ‘940 patent had been considered by the examiner during prosecution of the asserted patent.
Enabled Prior Art: To anticipate, the prior art must be enabling – i.e., it must “enable one of ordinary skill in the art to make the invention without undue experimentation.” This enablement standard is different from the applicant’s 112 enablement requirement which requires enablement of both making and using the invention. That distinction becomes lost in cases like this, however, where the patent covers a method of treatment. Here, the Federal Circuit appears to require anticipatory prior art to enable practicing the claimed method.
Enablement of prior art is a question of law, but is based on underlying factual findings. In close cases, the important factual finding is the amount of experimentation that would have been necessary. Applying Wands factors, the Federal Circuit agreed that the prior reference was not enabling.
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As shown by the trial court, the [prior art] ‘940 patent’s dosage guidelines are broad and general without sufficient direction or guidance to prescribe a treatment regimen. The alleged prior art also contains no working examples. Finally, nothing in the ‘940 patent would have led one of skill in the art to identify riluzole as a treatment for ALS. In sum, each component of the claimed invention—identifying riluzole as a treatment for ALS and devising dosage parameters—would require undue experimentation based on the teachings of the ‘940 patent. |
Burden of Proving Enabled Prior Art: In judging anticipation, courts generally presume that prior art is enabled. That presumption may be overcome by a patentee by providing “persuasive evidence” of nonenablement. At that point, the ultimate burden of proof (with clear and convincing evidence) lies with the accused infringer. In this case, the district court did not explicitly follow this burden shifting framework. On appeal, the Federal Circuit held that articulation of the rule was not necessary. The burden was properly shifted because Aventis presented “sufficient evidence to overcome the presumption of enablement.”
Holding: Affirmed. Validity challenge defeated because prior art was not enabled.
Notes:
- The opinion did not focus on timing: As technology develops more and more prior art references become enabled. Thus, it is important to consider at what point in time the reference must be enabling.
Disclosure: My former colleagues at MBHB represent Aventis in this case. The district court case was ongoing while I was there.
“The “normal” rule of construction, of any document, by any court, is to construe it as of the publication date of that document. Why make patent law harder than necessary?”
It doesn’t have to be. You should use obviousness, which would adequately protect the public domain when a term changed meanings over time or if newly developed devices were covered by a term in the publication.
Ron:
Has the Federal Circuit addressed the “functional at the point of novelty” issue?
By boiling down the satellite claim to the sufficiently strong amplifier point of novelty, it looks a lot like the fuel efficient engine example mentioned in Lizardtech. It’s hard to believe that any claim that recites functionality that is nothing more than an increased efficiency or performance of a prior art device would be fully enabled. Given the recent trend at the Federal Circuit regarding the need to enable the full scope of the invention in mechanical and software arts, I think your best bet would be to challenge the claim on enablement, rather than on a “functional at the point of novelty” approach.
“Even if an applicant showed that the prior art reference was not enabled, the applicant’s own claim to a satellite with a sufficiently strong amplifier (without more in the claim) may not be fully enabled.”
Enablement is not the issue vis-a-vis the augmented claim suggested. A claim that merely adds to the original satellite claim “a sufficiently strong amplifier” is what we used to call “functional at the point of novelty” and would not be allowable, but non-enablement is not the reason. By hypothesis, the disclosure of the sufficiently strong amplifier now makes the original satellite claim supported by an enabling disclosure because the amplifier was the last piece of the technological puzzle. HOWEVER, adding “a sufficiently strong amplifier” to the original claim STILL recites nothing more than a known or obvious OBJECTIVE, since everyone knew that one would want Arthur C. Clarke’s satellite to have a sufficiently strong amplifier. That is what is meant by “functional at the point of novelty.” The novelty is in the disclosed amplifier, but the claim doesn’t say what that novelty is. The claim would have to recite whatever new and non-obvious thing it is that actually makes the amplifier “sufficiently strong.” So I agree with the conclusion, but not with the route through which it was arrived.
Ron Slusky
With the march of time, things that were obvious can (sometimes but perhaps rarely) cease to be obvious. For example, when early research papers show that some class of compound seems to inhibit restenosis when coated on a stent, but then later papers are published which show that those compounds appear not to stop it after all. Mooney’s “expectation of success” is relevant here. But anticipation is different. A prior publication X deprives a claim of novelty, or it doesn’t. The mere elapse of time, between the publication date of X and the emergence of the claim in suit, shouldn’t make any difference. SF, naturally the anticipatory document doesn’t have to be a patent. Let’s reduce the problem to an absurd example. Suppose your claim recites “transistor” and the allegedly anticipatory document (very old) shows the identical circuit, except that where the transistor sits there is a thermionic valve. The PHOSITA, if it’s at the date of the claim, inevitably “sees” a transistor where the valve is. Does the reference anticipate, or is it only an obviousness attack? We need to be clear on the date at which the novelty reference is to be construed. The “normal” rule of construction, of any document, by any court, is to construe it as of the publication date of that document. Why make patent law harder than necessary?
Thanks for your take, Mooney.
My poorly-worded spilling phrase had to do with where the line between (1) using extrinsic evidence merely to show a cited anticipation reference was enabled and (2) the extrinsic evidence morphing into–instead of spilling into–a secondary reference for obviousness. I think that you’re clearly in obviousness-land when you need the extrinsic evidence to add an element that isn’t expressly or inherently in the initial reference.
Sorry Mooney, laundry lists, prior art disclosures, and the like never read on anything. Only claims read.
Let me repeat that – only claims read.
More evidence that you don’t know what you are talking about. But don’t worry, you are not alone, there are many examiners that have the same problem. Examiners have a tendency to (improperly) read the prior art on the claims instead of the other way around. Its the main cause of poor rejections.
Its a subtle but important point. I thought you were all about nuances?
The mixed use of the terms “enabled prior art” and “enabling prior art” is very disturbing.
To me, enabled prior art is prior art that has enough details that one could practice what they describe.
On the other hand, enabling prior art is prior art that has enough details *about the claimed invention* that one could practice *the claimed invention*.
If a piece of prior art is enabled, but does not enable the practice of a claimed invention, it should not prevent the patenting of the invention by another.
The “enabling” requirement doesn’t seem to jive with Dippin Dots, where the customers of Dippin Dots were clearly not enabled to practice the secret technique Dippin Dots used to make his ice cream balls. Nevertheless, the court felt it okay to combine the secret technique with existing known techniques to make a 103 rejection.
“For the reasons I advanced in my first posting, my answer is NO, because the claimed subject matter was a known desirable objective. ”
Also 102f I believe bars him doesn’t it?
Ron, as a matter of fact your example is a highly relevant one. As you may be aware it was Authur C. Clarke that came up with the “idea” of the comm sat. It turns out that he was gyped out of getting a claim to it by an attorney who told him not to file. Of course he found out later that he should have and it would have made m/billions.
But, as to your question of who should get that claim it seems to me that none of them “should”. The one guy came up with something, the comm sat, that wasn’t achievable at the time. The first guy to think up FTL travel shouldn’t have been allowed a patent on it either because he couldn’t make a vehicle to acheive it. Certainly the guy that came up with the amp shouldn’t get it. We award inventors not the enablers of inventors so far as I’m aware. Moral to this story is, if you have a grand vision of something to do, either keep a lid on it and achieve it yourself, or be sure that you (or at least POSHITA) would know how to make it.
Though fyi, when Mr. Clarke came up with the idea IRL it was enabled, and would have been fair game for patenting. And in fact others started putting them up shortly thereafter.
SF “The issue I was wondering about is this: to what extent extrinsic evidence may be used to show that undue experimentation was required to practice what a reference teaches at the time of the patent’s filing date.”
For determining whether a prior art reference anticipates, the answer is: to the full extent, **assuming** that the elements that arose from the experimentation are recited in the claim.
Based on this case and Rasmusson, I would say that the bar for showing that an otherwise anticipatory prior art reference is non-enabling is still very very high. Somewhere between this Impax labs case (reference is a highly dubious generic laundry list of elements that barely reads on the claims at issue: no anticipation because undue experimentation required) and Rasmusson (plainly anticipating reference expressly states that the claimed method was tried and did not work: still anticipates!) lies the genuine standard.
SF “I don’t think extrinsic evidence showing the level of skill and level of knowledge, regardless of the time frame, spills into obviousness unless that knowledge is necessary to provide a recited claim element.”
It spills in via the “reasonable expectation of success” requirement for showing obviousness.
SF “The issue I was wondering about is this: to what extent extrinsic evidence may be used to show that undue experimentation was required to practice what a reference teaches at the time of the patent’s filing date.”
For determining whether a prior art reference anticipates, the answer is: to the full extent, **assuming** that the elements that arose from the experimentation are recited in the claim.
Based on this case and Rasmusson, I would say that the bar for showing that an otherwise anticipatory prior art reference is non-enabling is still very very high. Somewhere between this Impax labs case (reference is a highly dubious generic laundry list of elements that barely reads on the claims at issue: no anticipation because undue experimentation required) and Rasmusson (plainly anticipating reference expressly states that the claimed method was tried and did not work: still anticipates!) lies the genuine standard.
SF “I don’t think extrinsic evidence showing the level of skill and level of knowledge, regardless of the time frame, spills into obviousness unless that knowledge is necessary to provide a recited claim element.”
It spills in via the “reasonable expectation of success” requirement for showing obviousness.
“Accordingly, the previously published references are interpreted as of that filing date, regardless of when those references were published.” should have read “Accordingly, the previously published references are viewed by one of ordinary skill as of that filing date, regardless of when those references were published.”
Max:
Perhaps, I should be clearer. I did not mean to suggest construing the meaning of the cited reference differently. I was talking about what one of ordinary skill in the art could have done with the reference at the time of filing of a subsequent application. In Slusky’s hypo, the meaning of satellite and amplifier (I presumed) were not in dispute. The issue I was wondering about is this: to what extent extrinsic evidence may be used to show that undue experimentation was required to practice what a reference teaches at the time of the patent’s filing date.
Also, in the US, a prior publication need not be a patent and need not “plant the flag” on anything. But you raise an interesting issue: what if the meaning of a term in a publication changed? Would one of ordinary skill recognize both the earlier and latter meanings or just the latter meaning?
Tell me SF, when US law construes any other document, like a Contract, is it the document on the day it came into being (Contract signed, and so on) or is it a date 20 years after the Contract was signed. Is that not a relevant consideration, when considering in a patent litigation what a document means? A prior publication that on its publication date didn’t enable something didn’t “plant the flag” on that something either. End of story.
… in other words, I don’t think extrinsic evidence showing the level of skill and level of knowledge, regardless of the time frame, spills into obviousness unless that knowledge is necessary to provide a recited claim element. In Slusky’s hypo, the prior art reference included all the claim elements, but didn’t enable them.
In the US, anticipation of an application’s claims are determined “at the time the invention was made” which is presumed to be the time of filing of the patent application, unless the applicant proves an earlier conception date. Accordingly, the previously published references are interpreted as of that filing date, regardless of when those references were published. That’s still anticipation under US law. I’m pretty sure you’re allowed to use extrinsic evidence to show that the publication is sufficiently enabled at the time of filing, even though the publication was published years before the time of filing.
SF: in a logical patent system, novelty and obviousness perform two quite different and complementary roles. What is obvious at the date of the claim should not be monopolised. End of story, no?. So what’s “novelty” for? It’s superfluous isn’t it? No. Every patent system needs a mechanism for mediating between several independent Applicants, with different filing dates, but all of which were non-obvious relative to public knowledge at their respective filing dates. Novelty does this. It is right that the later filers can monopolise all that was still novel, at their filing date, over the art including all that disclosure in the earlier-dated filings. The European “whole contents” benchmark. Deadly simple. Novelty stops later inventors monopolising where an earlier inventor had already planted a flag. If you are doing novelty but construing a doc published in 1970 with the knowledge of a reader in 2002 then you’ve slipped into obviousness mode, because you are invoking the common general knowledge of the PHOSITA in 2002, in addition to the true disclosure of the doc, as such. You’re no longer doing novelty, but onviousness. At least, that’s it under English law.
See also Lizard Tech (“By analogy, suppose that an inventor created a particular fuel-efficient automobile engine and described the engine in such detail in the specification that a person of ordinary skill in the art would be able to build the engine. Although the specification would meet the requirements of section 112 with respect to a claim directed to that particular engine, it would not necessarily support a broad claim to every possible type of fuel-efficient engine, no matter how different in structure or operation from the inventor’s engine.”) Discussed at link to patentlyo.com
Even if an applicant showed that the prior art reference was not enabled, the applicant’s own claim to a satellite with a sufficiently strong amplifier (without more in the claim) may not be fully enabled.
“Is it very important for you to know the answer?”
No. It just seems that fixing a reference’s enablement as of publication seems arbitrary when viewed in the context of my hypothetical. One of ordinary skill could presumably revisit a reference at any point after publication and there doesn’t seem to be any reason for ignoring extrinsic evidence of advances of the state of the art after publication.
“So the question would still be whether the amplifier inventor could secure allowance of my postulated claim by aruging that on the day that he filed, the prior art was non-enabling and therefore not citable again him.”
I have no problem with that result, given the courts are beginning to demand that the full scope of the claim is enabled:
link to patentlyo.com (Sitrick)
link to patentlyo.com (Liebel-Flarsheim)
SF. I gve up. You’ve got me with that one. Don’t know the answer. Is it a trick question? Is your scenario one you often find yourself in? I can’t recall ever being in that situation. Is it very important for you to know the answer?
Mr Slusky, your hypothetical is bang on point for the UK House of Lords, as it squares up to a case called Lundbeck, which has just been the subject of an Appeal Court judgement. Molecule X, even when a highly desirable known objective, is nevertheless patentable as such (as of today) provided the patent owner has revealed for the first time a way of getting to Molecule X. I think that’s wrong but that’s the law as it stands, at least within chemistry. A claim should recite the solution to an objective problem, not the problem itself.
I think my hypothetical was misunderstood on the facts. As I intended to lay them out, as of the date of the filing of the amplifier patent application, the prior art was not enabled to do what the claim said because no one knew how to build an amplifier that could survive launch. So no one knew how to make a communications satellite that would work once it got into orbit.
Certainly, if the amplifier itself was in the prior art and every other piece of technology were known, then the combination of the 1948 disclosure PLUS the subsequent art including the amplifer would constitute a complete enablement in the prior art and would bar the claim at issue. That was a point Dennis made in the posting.
However, in MY hypothetical, the crucial amplifier was NOT known. It was invented by the present applicant, whose own invention couldn’t, of course, be used in formulating an obviousness rejection against him.
So the question would still be whether the amplifier inventor could secure allowance of my postulated claim by aruging that on the day that he filed, the prior art was non-enabling and therefore not citable again him. For the reasons I advanced in my first posting, my answer is NO, because the claimed subject matter was a known desirable objective.
Ron Slusky
PS If you enjoy these kinds of jurisprudential thinking about patent law, consider my CLE seminar http://www.sluskyseminars.com
“In the EPO and UK, a reference asserted as a novelty destroyer is to be construed as of its date of publication and NOT at the date of the attacked claim.”
So what happens if the reference is included in a first edition of a collection of works and then later republished in a second edition of a collection of works? What date would you use?
In the EPO and UK, a reference asserted as a novelty destroyer is to be construed as of its date of publication and NOT at the date of the attacked claim. Otherwise, the reference has a multitude of different meanings, each one set by the date of the attacked claim. What’s the Rule, in the USA, I wonder?
“In Europe at least, the concept of an “enabling reference” belongs to a novelty attack, but not an obviousness one.”
Even with an anticipation defense, I would think that you could use extrinsic evidence to show that sufficiently strong amplifiers were subsequently developed and because well known, that it wouldn’t take undue experimentation to use them as taught by the reference, and thus the primary reference was enabled at a date later than its publication. It’s easier, however, to just rely on the obviousness defense which is why we may not have many cases on point.
SF: In Europe at least, the concept of an “enabling reference” belongs to a novelty attack, but not an obviousness one. But with obviousness you raise an interesting point. In the present case, why wasn’t the 940 disclosure (see its c3, l7 for “ALS”) enough to reveal the claims of 814 as obvious? The EPO family member of 940 is 374041 and it was published as early as June 1990, nearly 2 years before the prio date of 814.
Also, in an obviousness defense based on a second reference that discloses an element missing from a primary reference, the primary reference likely does not enable the entire claim because it lacks the missing element. Yet we allow subsequently published secondary references to be combined with such “non-enabling” primary references all the time. Your hypothetical reference discloses even more than the typical primary reference because it actually discloses every element. There’s no reason to think that your hypothetical reference couldn’t be used as a primary reference in an obviousness defense.
Mr. Slusky wrote, “If the still-nonenabling 1948 disclosure combined with subsequent technology couldn’t be used as prior art, then the inventor of the amplifier in question would, by disclosing its use in the artificial communications satellite context, be entitled to the above claim.”
I don’t believe the courts are saying that the prior art reference must be enabling at the time of its publication and, if not, it can never be. A prior art reference may become enabling in view of subsequent disclosures, as of the time of those subsequent disclosures, providing one of ordinary skill would have looked to these other disclosures.
In such cases, I believe that you can at least assert an obviousness defense (one based on both the 1948 disclosure and the subsequent amplifier disclosure), if not an anticipation defense as in the case discussed in this post. The obvious combination of references would be enabled.
Mr Slusky, thanks for your thoughts on “protection commensurate with contribution”. For me, cases like this expose the “disconnect” between chemical cases and EE/Mech, the former being unpredictable, the latter predictable. When “Molecule X” cures disease Y, inventors claim “Molecule X” and if it’s new they get such a claim to issue. That claim stops anybody putting X in his gas tank to make his car go faster or the engine last longer. In other words, the protection they get is wider than their contribution. Take the case here in issue, where the follow up patent ‘814, did claim the use against ALS but Applicant’s earlier ‘940 patent reference had claims to “Molecule X” and a contribution only generally to do with glutamate inhibition and “ALS” (c3, l7). Some might argue that, in ‘940, they ought to have been given claims to a glutamate inhibitor, but not to the molecule per se. However, courts world-wide customarily give inventors “absolute substance protection”. BTW, the UK House of Lords has an interesting discussion on “Support for the Claims” where the claimed subject matter was biotech but the discussion invokes a fantasy non-chemical claim to “A heavier-than-air flying machine” invented by the brothers Wright. See Biogen v Medeva, from 1996.
Hickey:
Your hypo states: “treatment of X was difficult or even art-recognized as impossible. Prior art reference teaches treatment of X by administering Y (same disease, same drug) but is entirely prophetic.” You present a situation where you have opposing prior art conclusions.
On one hand, you have Ref A telling you that the claim is difficult or impossible. On the other hand, you have Ref B which is speculation by a patentee (or more likely the drafting agent/attorney). Why does a speculation carry more weight than an express statement? Does a prophetic example become transformed into an enabled example just because it was written down?
I try to look at it thusly, If the prophetic example were in a journal, would it survive peer review and criticisms from a PHOSITA?
My more cynical side says “Do you believe everything that you see, hear, read?”
The question that I’ve never seen adequately vetted is the application of this issue in a mechanical/electrical context: Suppose that the prior art said in 1948 that it would be great to have communications satellites, .e.g.,
A method comprising
a) putting a communications relay station into earth orbit and
b) using the station to communicate signals between two points on the earth.
This idea was obviously not enabled in 1948—no rockets, no appropriate electronics, etc. At some point later, somebody was the first person to be able to provide an enabling disclosure for this method by inventing and disclosing in a patent application the last necessary piece of technology—say the first amplifier powerful enough for the task and that could survive the rigors of launch. If the still-nonenabling 1948 disclosure combined with subsequent technology couldn’t be used as prior art, then the inventor of the amplifier in question would, by disclosing its use in the artificial communications satellite context, be entitled to the above claim.
That, of course, makes no sense. The philosophy of our patent system is that an inventor should be entitled to a claim commensurate with his/her contribution to the art. The amplifier inventor didn’t contribute the idea of satellite communications. That idea was already known as a desired objective. I have always taught that you can’t claim something that the prior art knew to be a desired objective, even if the prior art didn’t know how to do it. You must, rather, include in your claim your new and non-obvious contribution that enables the prior art’s known objective.
If the amplifier inventor were given the above claim, then he could assert it against someone who performs the claimed subject matter but using a totally different amplifier. Again, that is an illogical result. The fact that someone is first to enable something that everybody’s been trying to achieve shouldn’t, just because s/he was first, entitle him/her to a claim as broad as that objective.
The above claim, by contrast, WOULD be patentable to the first person to articulate the notion of artificial satellites if that person was so brilliant as to have been able to come up with all the required enabling technology and disclosed all of that in the patent application. But that’s a different set of facts.
I only once saw something in a case that I believe substantiates the above. It was a statement by Judge Rich in a concurring or dissenting opinion to the effect that “a prior art reference is valid for what it shows.” But I lost the cite have never been able to find it again.
I believe that that rule that prior art needs to be enabled only makes sense in the context where virtually all of the cases in this area seems to live—namely in the chemical/pharma area. In those areas, it does make sense; otherwise the entirety of those technologies could be put into the prior art simply by listing out every possible substance.
Ron Slusky
“Here, the Federal Circuit appears to require anticipatory prior art to enable of practicing the claimed method.
Enablement of prior art is a question of law, but is based on underlying factual findings.”
With all due respect it seems that there is some loose language in the article.
Prior art should be “enabling” as to the invention claimed in the application against which it is being applied. A prior art reference is “enabled” if it enables its own claimed invention. And I’ve never heard of anything being “enable of” anything.
In general, whether or not a prior art reference is “enabled” has nothing to do with its character as an enabling reference that forms an anticipatory disclosure of the claimed invention against which it is applied. Indeed, a claimed invention in a prior art reference could be determined to be inadequately enabled, yet the reference itself could form an enabling and anticipatory disclosure against claims in an application against which it is applied.
Am I missing something here?
“There might be situations where the list in a reference for an set of electrical/mechanical components might not be enabling, but I can’t think of any offhand. I expect it would be difficult to argue why a particularly listed component is somehow not enabled in electrical/mechanical systems.”
Must be nice.
“Someone show me the law/rule that says precedent is what is required to be performed. No, seriously, where does this come from? Let me guess: Commonlaw procedure based on principles from the 1830’s with no law actually stating it anywhere.”
It’s a bit older than that. To really understand the importance of this question, you might want to start by reading some Aristotle. You can skip Aquinas, but you’ll definitely want to read Hobbes (you and he would get along great). Then read John Austin. For an ultra-dose of legal realism, you’ll then need to see Karl Llewellyn.
A benefit of all this reading is that you’ll then understand (LOL) how intellectually impoverished Scalia’s “originalism” is. Even Thomas has a more coherent world view. In my humble opinion, that is.
Let me know when you’re done, and we’ll discuss.
“Great case. I wonder how this will work in prosecution in mechanical/electrical prosecution in light of Automotive Technologies.”
I do not think the case will significantly affect prosecution in the mechanical or electrical arts.
In the mechanical arts and electrical arts, I would expect an examiner having trouble making a 102 rejection because of enablement issues similar to the one in Imax v Aventis to be readily able to make a 103 rejection using the same reference. Note that the prior art disclaimed riluzole as already known, but did not teach away from using it.
In the more predictable arts, applicants and examiners should accept that disclosing properties of a genus is enough to infer and make use of the properties of particular species without undue experimentation.
In this case, the prior art clearly disclosed riluzole and how to make it, while disclaiming riluzole from formula I as being part of the invention. The use of formula I chemicals for treating ALS was also disclosed. How often is there a situation in the mechanical or electrical arts where it is unclear how to properly use something that is disclosed in that kind of detail. Essentially never IMO.
The difference in the enablement standard betwee prior art and claims can be distilled down to “Old broke stuff is still old stuff”. Learn it, know it, live it!
Random wrote “Someone show me the law/rule that says precedent is what is required to be performed. No, seriously, where does this come from?”
Umm, common sense and a desire for predictability in our courts? Of course, it does not have to be rigidly adhered to, but should always be addressed if not. For example, the judge has to exercise judgment and determine if the present facts are sufficiently distinguishable from the previous fact pattern. Prior cases can also be overruled.
What should not happen is that the decision you get is based primarily upon the panel you get.
Random wrote “Someone show me the law/rule that says precedent is what is required to be performed. No, seriously, where does this come from?”
Umm, common sense and a desire for predictability in our courts? Of course, it does not have to be rigidly adhered to, but should always be addressed if not. For example, the judge has to exercise judgment and determine if the present facts are sufficiently distinguishable from the previous fact pattern. Prior cases can also be overruled.
What should not happen is that the decision you get is based primarily upon the panel you get.
Thanks for the clarification,
I expect the list in the prior art reference would likely be considered enabled with a detailed argument/proof against.
I have seen references that have statements like “could use any display including, plasma, liquid crystal, CRT, etc.” as a display device. If the change from one display to another would be similar to plugging in a new television, then it’s probably enabled.
Or perhaps something like, “the switch could be a transistor, or other known type of electrical or mechanical switch”. Replacing a switch with another known type of switch is likely to be enabled for a PHOSITA.
There might be situations where the list in a reference for an set of electrical/mechanical components might not be enabling, but I can’t think of any offhand. I expect it would be difficult to argue why a particularly listed component is somehow not enabled in electrical/mechanical systems.
Of — I cannot think of more than a couple of cases I’ve done where it would even be arguable that the prior art was non-enabling, much less convincingly argued, — for examples of non-enabling prior art elsewhere look to the three re-exams requested by PubPat and FTCR (now ConsumerWatchDog) on the WARF stem cell patents. Additionally, the accompanying declarations were deemed conclusionary.
Dear Mr. Boy,
Re: “(BTW, thanks to JAOTroll for correcting me on ‘Arial.’ …”
Please explain what you meant by your offering above.
[PS. Bingo, Dennis. I think you’ve hit the perfect combination of fonts, columns, and colors. (BTW, thanks to JAOTroll for correcting me on “Arial.” Sharp eye, that guy.)]
CAFC: “This court reviews the ultimate question of enablement without deference while reviewing the underlying factual inquiries for clear error.”
What in the blue phooey does this mean? Reviewing a “factual inquiry” is different from reviewing the facts. An inquiry is not a fact, it’s the process one uses to determine the facts.
What part of “the ultimate question of enablement” is law; i.e. not factual?
In Wands, for instance, everybody agreed on the validity of the underlying data (i.e. facts) presented by the applicant. What was at issue for the court was whether those data were statistically sufficient to “enable” the broad claim to IgM Ab’s reactive to a specific antigen. The point of contention was what percent of fused cell lines produced the Ab’s. Was it 44% or 2%?
But that’s still a fact question. So where’s the question of law in these enablement cases?
BTW, Wands, which the CAFC relied on heavily in Impax, was an appeal of a 112 rejection, not an infringement case. Are there distinctions of deference the CAFC gives an examiner viz a viz a judge? I think this has come up recently but my memory is getting clogged up by all this Palin stuff.
“I did not mean in this particular case. I have seen a large number of electrical/mechanical cases in which laundry lists are thrown out in a reference, with no explanation of how items in the list are to be substituted. Automotive Technologies appears to stand for the proposition that even in these “predictable” arts, some level of enablement must be present for such an embodiment to be valid.
If enablement must be present, but isn’t in such a reference, is it still a valid reference for this purpose? The federal circuit would appear to say no combining these two cases, but would this be enough to convince the PTO if this rejection comes up? I don’t think so…
Of course, this may be especially problematic if a considerable amount of time/money/engineering has been expended to create a particular embodiment, which has been “disclosed” by the list.”
No, they’re not. No. 1 you gave no evidence. No. 2 the reason that list is there in the electrical/mechanical predictable arts is merely as a time saver. One of ordinary skill could tell you how to use x machine instead of y machine to cut some metal. Etc. etc. Could your POSHITA tell me that you could treat a disease with one of a thousand different compounds? Thought not.
I forgot to add: the patentee provided evidence.
Hecky’s, in your hypo you definitely have enabled prior art and should tank the 112 and go with 102.
Do not misunderstand the holding above. This was a holding where the prior art only “maybe”, or “speculatively” disclosed treating the condition with the compound at all, it did not definitively disclose it. It would have taken thousands of experiments to necessarily find the right combination of curse/diseases in the reference. Obviously shotgun disclosures in arts that are unpredictable does not lead to those refs being anticipatory references.
Fed Circ affirmed because they couldn’t find error, let alone clear error.
There is nothing to see here, move along.
link to uspto.gov
^Discusses operability of a prior art reference.
I have had Examiners ding me on Hecky’s example, but never actually got the chance to argue MPEP 2121.
In-house:
Really? Here’s the rub: the specific steps taught in the prior art (namely identifying patient and administering drug) are clearly within the skill of the artisan. So performing the actual steps of the method requires no undue experimentation. In some cases, the prior art even hypothesizes a mechanism of action of the drug. Clearly reduction to practice is not required for enablement, but only sufficient detail to make and use the invention as claimed. See MPEP 2121, esp. sections 2121(III) and 2121.01
-Hecky’s
This is an interesting case but I suspect one that will be limited to its facts. It appears that Impax was pushing the prior art reference for all that it was worth. The anticipation issue could have been decided on grounds that all the limitations of the claim were not disclosed by the prior art, without even reaching the enablement question.
From the opinion: “The district court also did not find the dosage information in the disclosure to teach a proper treatment. Instead the trial court noted that “the dosage guidelines are broad and not specific to any of the hundreds of formula I compounds of the claimed invention or to any of the listed diseases.” Id. at 433. Moreover, the ‘940 patent ties the dosing information to “the compounds of the invention” and **specifically excludes riluzole from the invention**. Id. at 432-33. Finally, the trial court also noted the absence of working examples.”
… but working examples are irrelevent if “anticipation does not require actual performance of suggestions in a disclosure” (as held by the CAFC the first time they entered this dispute back in 2006).
Two points: (1) there remains some tension between this case and Rasmusson v SmithKline. Remember in Rasmusson:
“…the Board found (1) that in light of the state of the art at the time of the publication of EP ’383 in 1988, there was ****no reasonable scientific basis for a person of ordinary skill in the art to conclude that the claimed method would be effective***** in treating prostate cancer, and (2) that given the lack of proof provided in the publication itself, ****a person of ordinary skill in the art as of the publication date of EP ’383 would not have believed that the method described in EP ’383 would be effective*****. Under the legal standard set forth in Hafner and the cases that have followed it, ****those findings are insufficient***** to support the Board’s conclusion that EP ’383 is not an enabling reference for purposes of anticipation.”
(2) this case is double-edged and could be used to argue lack of enablement of an asserted patent or pending claim where “no working examples” are provided and dosing information is generically provided.
Lyncoln,
I did not mean in this particular case. I have seen a large number of electrical/mechanical cases in which laundry lists are thrown out in a reference, with no explanation of how items in the list are to be substituted. Automotive Technologies appears to stand for the proposition that even in these “predictable” arts, some level of enablement must be present for such an embodiment to be valid.
If enablement must be present, but isn’t in such a reference, is it still a valid reference for this purpose? The federal circuit would appear to say no combining these two cases, but would this be enough to convince the PTO if this rejection comes up? I don’t think so…
Of course, this may be especially problematic if a considerable amount of time/money/engineering has been expended to create a particular embodiment, which has been “disclosed” by the list.
Hecky’s hypo:
Just because the art says (that is may be) so or uses the same words/terms as the claimed invention, doesn’t make it so. A POSA must be able to understand that it can be so from reading the art.
Otherwise, cold nuclear fission has been anticipated by a guy tinkering in his garage.
Interesting… I am an examiner and get situations like this often. We frequently get claims to a method of treating disease X by administering agent Y (wherein both are specifically identified, i.e. a method of treating headache by administering aspirin). At the time the invention was made, treatment of X was difficult or even art-recognized as impossible. Prior art reference teaches treatment of X by administering Y (same disease, same drug) but is entirely prophetic. No working examples, and no disclosure of dose (although that might not matter depending on actual claim language in application). If I were presented with the prior art reference as a patent application, I would write a 112 rejection for lack of enablement commensurate in scope with claims, as treatment is not exemplified and art recognizes it is very difficult or impossible. In many ways, one could consider that the prior art reference is not enabled. However, it does teach the identical steps to the methods claimed:
1) Identifying patient with disease X and
2) administering drug Y.
Thus all steps of the claimed method are taught by the prior art.
What do people think — is the prior art enabling or not? If so it is anticipatory.
Note this hypothetical case is different from that in the Impax case cited above, in that in Impax the prior art reference did not specifically teach administering the species of drug to patients with ALS, but rather disclosed a genus with many members and generally taught it was useful for treating many diseases, including but not limited to ALS. In my hypothetical example, only one drug and one disease are mentioned.
Hecky’s: It’s the Sauce!
srsly lyncoln, stoopid is apparently in la la land today.
“In judging anticipation, courts generally presume that prior art is enabled. That presumption may be overcome by a patentee by providing “persuasive evidence” of nonenablement.”
No. 1 this case does not seem to be directed to Ex Parte proceedings. No. 2 the day an applicant with a straight face presents me with actual evidence that the claimed invention was not “enabled” by the prior art I’m using to reject then I will withdraw the rejection. I cannot think of more than a couple of cases I’ve done where it would even be arguable that the prior art was non-enabling, much less convincingly argued.
Keep in mind: In judging anticipation, courts generally presume that prior art is enabled.
BTW, I’m keeping in mind that my work is subject to REVIEW by the courts. Someone show me the law/rule that says precedent is what is required to be performed. No, seriously, where does this come from? Let me guess: Commonlaw procedure based on principles from the 1830’s with no law actually stating it anywhere.
Stoopid, I don’t understand your comment about the PTO ignoring the precedent.
The article says the examiner considered the prior art and apparently still allowed the patent. Seems to me that the examiner came to the same conclusion the courts did: the prior art didn’t provide enough information to produce a rejection.
What do you think the PTO would ignore about this judgement that would affect prosecution?
Great case. I wonder how this will work in prosecution in mechanical/electrical prosecution in light of Automotive Technologies.
My guess is that this precedent will be ignored by the PTO, as at least a fair proportion of examiners (e6k) have decided that they do not have to follow the law…
As a special series illustrating the number of times an independent claim is invalidated by a simple word search in google I will be posting here whenever this occurs over the next month. I will try to compare the number to the number of amendments/counts done that biweek. Starting out in the middle of a bi week. The only ones listed will be ones with art that reads directly and undeniably on not only the claim limitations but that actual subject matter being referenced in the specification by the claim. Meaning, I will not “interpretlol” or “inherentlol” my way into skewing the numbers. Also, only 102b’s.
1. 10:00 10/06/2008 number of searches before reference found: 1.
Max,
AFOI is right. For example, under 112, first paragraph, “enablement” of a chemical compound requires showing how to make and how to use the compound. By contrast, “enablement” under 102 requires only showing how to make the compound (showing how to use isn’t required).
Max, the CAFC has clearly stated that enablement under 112 is different from enablement required for 102 references. While (the lack of) undue experimentation is the test for both, 112 requires more (like specific utility, best mode, etc.).
Great case for discussion. I look forward to the thread. Is the legal test for “enablement” the same , whether it’s enablement in a prior document alleged to take away novelty, or pre-issue examination in the PTO and the question is whether the app enables the claimed invention? If the PTO screws up, and the District Court screws up, so the CAFC has to sort it out, that’s a lot of fact-finding work for the CAFC, no? Or is it? Is the CAFC also avoiding that work, by falling back on phrases like “done enough to overcome the presumption”? In general, is enablement getting examined competently? How well-equipped is the PTO, ex parte, prior to issue, to judge enablement issues?
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