Ariad v. Lilly: Federal Circuit Grants En Banc Request to Challenge Written Description Requirement

Ariad Pharmaceuticals, MIT, and Harvard v. Eli Lilly (Fed. Cir. 2009) (en banc)

The Federal Circuit has granted Ariad's motion for an en banc rehearing of its case. The motion boldly asks whether the written description requirement should be eliminated as a doctrine that is separate and distinct from enablement. The questions:

a. Whether 35 U.S.C. ? 112, paragraph 1, contains a written description requirement separate from an enablement requirement? and

b. If a separate written description requirement is set forth in the statute, what is the scope and purpose of the requirement?

Ariad's brief is due within 45 days, and Lilly's brief is then due within thirty days of that.

Briefs of amici curiae will be entertained, and any such amicus briefs may be filed without leave of court but otherwise must comply with Federal Rule of Appellate Procedure 29 and Federal Circuit Rule 29. The United States is invited to submit an amicus brief.

Value of Amicus Briefs: In its recent Cardiac Pacemaker decision, the Federal Circuit expressly indicated that it was "appreciative of these [amicus] contributions." To make one particular point in the decision, the court emphasized that Cardiac's extreme position was "not even supported by the lone amicus brief we have received in favor of including method patents within Section 271(f)'s reach."

Although the written description requirement is primarily raised in pharmaceutical and biotechnology cases, it is an increasing aspect of software patent litigation. This decision could have a significant impact both on how patents are litigated and on how they are prosecuted. The inventors here discovered an important biochemical pathway and broadly claimed uses of that pathway.

Notes:

75 thoughts on “Ariad v. Lilly: Federal Circuit Grants En Banc Request to Challenge Written Description Requirement

  1. Well said, Bruce Hayden, in putting his finger on something perceived as mischief, in any jurisdiction (belatedly, probably covetously, claiming an invention not perceived at the filing date). A tool is needed, to stamp out the mischief. In Europe it is called “added matter” and rejected under Art 123(2) EPC, and in the USA it is called an absence of written description. A rose by any other name, Willy Wobbledagger might have observed.

  2. However, when claims are so amended they recite something substantially different than when filed, it is possible they are not described in the text.

    Just a reminder – part of the rebirth of the Written Description prong of 112 P 1 was in response to Jerome Lemelson’s attempts to claim technology forty years after his priority date. They appeared able to overcome best mode, enablement, and new matter, but this arguably pretty much killed his submarine patents.

    Defensively, I like Written Description as a means of reining in overly aggressive post-filing claiming. A lot of times, enablement won’t help because how to implement the claimed invention is obvious from the claims. And, if you can find something to hang your hat on in the specification, then you can overcome the new matter problem. But it still comes down to the fact that in these cases, the applicant had no idea about those claims, when the application was filed. It wasn’t the invention as he saw it then, but rather, only later, when technology had advanced.

  3. 6,

    Still waiting for the results of your brilliant mind in using the tools you yourself provided on sentence sructure.

    Or did you lose yourself in your own analysis, buried deep in your own nonsensical explanations that you were grasping at? Did the actual letter of the law trip you on what you wanted the law to say? Reading comprehension just a bit much for you?

    Personally, I won’t hold my breath waiting for you to see any glimmer of a point emerge – you have not shown the capability of putting down your shield of persistent ignorance.

  4. Altering NFKB activity in cells such that certain influences are modified is undoubltely step + function language.

    Although means + function is well known to engineers, physicists and nowadays to those who write software, step + function is less commonly met with. Furthermore awareness of 35 USC 112(6)in the chemical and biochemical arts is low, but the same statute applies across all fields of technology. How it applies is simple: you have to have the supporting detail in the description and protection is given for the described detail and its equivalents.

    As to Malcolm’s point about how the invention was made, the following stories are told about William Thompson’s (Lord Kelvin’s) improvements to the mirror galvanometer (there is an interesting Wikipedia article about this instrument). The first version was that he wanted a long inertia-less pointer for his galvanometer, and with enormous insight he realized that a beam of light would provide just what was wanted. The other version is that after his tea he was falling asleep before the fire, and the firelight reflected from his glasses. As he nodded his head as he started to doze the spot of reflected light moved up and down the wall. Suddenly he awoke with a start, noticed the moving spot of light and so the invention came to be made. The benefit is there whichever the underlying fact pattern.

  5. “Is the “manner in which the invention was made” relevant?”

    It’s always relevant. It just can’t be the sole reason for invalidating a claim as obvious.

  6. “inequity is even greater when an applicant’s inference required little of applicant’s risk, sweat, or time”

    Is the “manner in which the invention was made” relevant?

  7. Just adding to what PC said:

    The only *step* in the method recited in Paul’s comment is “altering NF-κB activity in the cells such that NF-κB-mediated effects of external influences are modified”.

    In other words, the patentee attempts to claim ALL methods of modifying NF-kb that achieve a particular desired result, just as was done in Rochester. The proper questions is: what modifications are described in the patent that achieve this result and has the applicant provided sufficient evidence to show that he/she was in possession of the claimed invention. Such evidence should include, at least, experiments showing several different types of modifications that work.

    Without such an analysis, applicants may be granted patents that block fields of research merely because applicants were (1) the first to allegedly infer a relationship between a gene and one of its many “effects” and (2) the first to file a patent claiming the inference.

    It goes without saying that the inequity is even greater when an applicant’s inference required little of applicant’s risk, sweat, or time.

  8. How means-plus-function (not step-plus-function) language is to be interpreted in a method (as opposed to an apparatus) claim is an interesting issue.

  9. It seems from the distance of Europe that there may be a further problem with these reach-through claims.

    Consider 35 USC 112(6) which reads, as we all know:

    An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.

    Now consider the University of Rochester claim which read:

    “A method for selectively inhibiting PGHS-2 activity in a human host, comprising administering a non-steroidal compound that selectively inhibits activity of the PGHS-2 gene product to a human host in need of such treatment.”

    An element in that claim is the non-steroidal compound that has the defined functionality. Are the words “non-steroidal compound” sufficient to take that element out of the scope of 35 USC 112(6)? In the mechanical and electrical arts the answer has been “yes” in relation to e.g. a circuit, where there is a well known class of circuits for performing the specified function. But in the Rochester case the word “compound” covers almost every known compound that has ever been made and there is no well-known group of compounds for performing the relevant function, nor is any such group disclosed in the specification. When you read the word “compound” there is no implicit class of chemical structures that comes to the mind of the skilled reader. So there is a respectable argument that a claim of this class falls within the scope of the section.

    In Ariad the claims are even more purely functional, the following language being representative:

    A method for modifying effects of external influences on a eukaryotic cell, which external influences induce NF-κB-mediated intracellular signaling, the method comprising altering NF-κB activity in the cells such that NF-κB-mediated effects of external influences are modified, wherein NF-κB activity in the cell is reduced wherein reducing NF-κB activity comprises reducing binding of NF-κB to NF-κB recognition sites on genes which are transcriptionally regulated by NF-κB.

    Here we have a method step without even a postentially structural word such as “compound” to provide a potential avenue of escape from the provisions of paragraph 6.

    If no compounds are disclosed which will perform the specified function, then there is arguably no “recital of structure, material, or acts in support” of the specified function, and the relevant claim arguably does not comply with 35 USC 112. Study of the Supreme Court decision in Hallibuton Oil Well Cementing v Walker reveals that 35 USC 112(6) was enacted to prevent just the kind of speculative claim which is now in issue in the present case and which was then considered an undue obstacle to future research.

    It is impossible not to have sympathy for the proposition that institutions such as those which co-own US 6410516 should have a fair share of the rewards of fundamental research leading e.g. to the finding of new targets and the development of new pharmaceuticals in consequence. Such institutions, of course, enjoy donations and grants from the pharmaceutical industry. But if they are to be rewarded through the patent system, as they are now asking, it seems that legislative change would be needed because the relevant “reach-through” claims (at least as seen from a distant European perspective) probably cannot be supported as the law currently stands.

  10. The reason Plotkins argues for it is because he understands the issues against it. You should read it too Noise.

    As a preview I’ll tell you what he told me. He says that his argument is that there should be a special exception to the traditional rules around functional claiming carved out for software. Now, you can agree or disagree with him, but I don’t see any reason to carve out a special exception for them. They should die or live just like any other similarly worded non-software claim imo.

    He of course goes even further than software into “wish” patents. Which is where is “exception” line of logic inevitably leads. I doubt you are as pro “wish” patents as you are “software” patents, so you might want to take note that the most persuasive argument for the types of claims at issue leads to that outrageous result.

    “but I have no compunction about doing so.”

    Then go ahead and point it out jackas. Or stop being a jackas.

  11. The same Plotkins that said “In this article I will argue that not only should software be patentable, but that inventions that are even more “abstract” should be patentable” on IPWatchdog?

    - very funny 6.

    Notwithstanding your shield of persistence ignorance, your concession is blatantly obvious to anyone applying your “logic” to its conclusions. breadcrumbs may be too nice to slam you on the point, but I have no compunction about doing so.

    trainwreck reply in 5… 4… 3…

  12. “OK, so kill the obvious ones for obviousness – what’s the problem with the non-obvious cases that are fully enabled?”

    You should read Genie in the Machine. Plotkins tells me he laid out why the typical software claiming scheme is found lacking therein, and he laid it out for me, so I believe him.

  13. I don’t concede sht in this thread you idi ot. I said they may have a point. Buried deep in nonsensical explanations they are grasping at. I have yet to see any glimmer of a point emerge.

  14. That has to be one of the longest concession posts by 6.

    BTW, 6, it is improper to elevate one of the “of” phrases over the other “of” phrase in your boiled down sentence.

    Nice job breadcrumbs. Although 6′s shield of persistent ignorance will still prevent him from learning anything about the Law.

  15. TJ,

    The facts you present are not what happened in Liebel-Flarsheim. In LF, the patentee deliberately removed some limitations from their claim so that that their injection device was not limited to jacketed versions. They NEVER claimed an unjacketed version, which would not have been enabled. They just limited it to essential limitations.

    If I claim a braking system and the description shows it’s use for a truck. I file a claim to the braking system that is whole and complete that does not reference the vehicle in which it is used. If someone comes along and uses the same system in a train and they infringe all the elements of my claim, indisputedly, according to LF my claim can be invalidated for being overly broad.

    And by the way, LF appears to be a bad actor and the ultimate result is not one I have a problem with, it is just the route used to get there. Written description and prosecution history estoppel both would have been fine arguments.

  16. @ MM way upthread – “In the predictable arts (like software) where every embodiment is enabled simply by disclosing the functions to be carried out [agreed!], the use of a more stringent written description requirement serves to prevent applicants from grabbing large chunks of intellectual property simply because they were the first to use “novel” functional terms to describe the information transformations that take place (which are nearly always obvious in terms of the information transformations that took place earlier in the non-virtual world).”

    OK, so kill the obvious ones for obviousness – what’s the problem with the non-obvious cases that are fully enabled? Of course there’s best mode to contend with as well.

  17. “This can be seen as that clause applies fully to the description branch and is NOT applied only to one or to the other of the sub structures of that description branch.”

    I see what you’re saying, but that doesn’t lead to any “f(E)”, whatever that is supposed to be. WD2 is WD2. End of story. If you wanna call it f(E) or whatever you can, I won’t stop you. But it isn’t going to change anything. It still leads to there two seperate and distinct inquiries.

    If your point is that everything boils down to this:

    “The specification shall contain a written description of the invention, in such full, clear, concise, and exact terms as to enable any person to make and use the same,”

    Then I agree. The other stuff is basically meaningless for our purposes. In fact, I’ll go one more and say we can boil it down to this:

    “The specification shall contain a written description of the invention, in such terms as to enable any person to make and use the same,”

    Which states, in no uncertain terms, that there must be a written description, and the terms used in this written description must be of a certain type. That is, first and foremost, there must be a written description. That is the first inquiry. “Is there a written description?”. Then, you move on to say “what kind of terms did they use to put forth this written description, were they enabling terms?”.

    There is no “error” introduced by these inquries. No red apple errors, no errors at all. It works 100% of the time. Everytime.

    What kind of apple do you want? You want a red one.

    What kind of description do I want? I want a written one. And I also want this description to be in certain specified terms.

    Show me a claim where we have some error by making these inquiries and I’ll concede the entire point to you, hands down. Np.

    After all, you state that there will be error introduced if we do it any other way than your own. Go ahead. Show me some error.

    Btw, if you actually use the structure espoused in those articles you will get a pretty clear picture of the split. I’ll see about poastin a scanned copy tomorrow.

    In the end though it’s going to boil down to this. Perhaps Linn (or you) is right about an E2 existing, and perhaps it should all be lumped together, but he hasn’t convinced anyone, and he isn’t going to. Nobody but him and a few fringers want to use it. Perhaps he is 100% right, but there is 0 point in using his method, and everyone can understand the other method. In fact, if his interpretation is so complicated that only he, and a few select others can see it, it couldn’t have been the intention of the congress since there is practically no chance that the nitwits in congress could even craft such a statute if they tried.

  18. Let’s use the tool supplied by 6, realizing that this is not the only way to diagram sentences.

    In twelve easy steps, here’s how I see the overall picture unfolding (based on the example at link to geocities.com ).

    Please bear with me and follow the trail.

    Step 1) The specification
    Step 2) The specification shall contain
    Step 3) The specification shall contain a written description

    Since the best mode BM isn’t in question, we’ll finish off that section in one swoop, then omit it from the exercise until the last step. This will also add some clarity to the bifurcated predicate.

    Step 4) The specification shall contain a written description, and shall set forth the best mode contemplated by the inventor of carrying out his invention.

    Removing the BM returns the analysis to:

    Step 3) The specification shall contain a written description

    This is the critical step:

    Step 5) The specification shall contain a written description in such full, clear, concise, and exact terms as to

    Step 6) The specification shall contain a written description in such full, clear, concise, and exact terms as to enable any person

    Step 7) The specification shall contain a written description in such full, clear, concise, and exact terms as to enable any person to make and use the same,

    At this point we can approach either of the remaining sub structures to the description tree or to the person tree. However, the key point should be made that Step 5) with the structure of “in such full…as to” takes ascendancy over the prepositional phrases depending from the description branch. This can be seen as that clause applies fully to the description branch and is NOT applied only to one or to the other of the sub structures of that description branch. It is in this manner that WD2 = f(E) can be clearly seen.

    We’ll do the description tree.

    Step 8) The specification shall contain a written description of the invention, in such full, clear, concise, and exact terms as to enable any person to make and use the same,

    Step 9) The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person to make and use the same,

    Step 10) The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, to make and use the same,

    Step 11) The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same,

    We’ll now add back the bifurcated predicate BM, and have the complete first paragraph.

    Step 12) The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.

    Thanks 6, this tool complements the indented structure method I posted earlier and yields the same results. In fact, the strength of E2 actually shines more clearly with this tool. Perhaps Linn will be happy.

  19. MM I personally don’t need it, but if it convinces bread and Noise, and other similarly thinking individuals then so be it. In any case I’m practically done with it for our purposes, and I could scan it in.

  20. That syntax diagram is a great idea. I think every claim construction and statutory construction opinion I’ve ever read included such a diagram in the appendix as it is usually the most compelling evidence in the case.

    Or maybe the opposite is true?

    Whatever. Just a comment.

  21. bottom line, your diagram is way too simplistic and here is the resource showing you how to do it.

    link to geocities.com

    between all the examples we can piece this proper diagram together. I’m most of the way done.

    wd2 does not equal a function of enablement. At least in so far as I can tell what you are saying.

    When I get done with this diagram it will look something like this:

    link to geocities.com

  22. nm I found the proper way to do the “of and”‘s because this one shows how to do the branching implicit and’s and they did so in the context of “in and” instead of “of and”. But that’s fine it shows how it is branched.

    link to geocities.com

  23. curious “”I think the current tendency of certain CAFC judges to try to invalidate almost any broad generic claim in mechanical and elecrical cases on alleged 112 grounds is far more common and serious.”

    News flash: they are doing what the attorneys with the better arguments are asking them to do.

  24. TJ “This may well suggest that written description is redundant with enablement, but it also suggests that enablement might get significantly more stingy.”

    It really can’t get any more stingy in the biotechnology art unit than it already is. Of course, it can get a lot more stingy in the software art unit where claims are routinely issued on functionally-described pseudo-methods that were denied to biotech applicants years ago in the Rochester case.

  25. 6 states

    “… although I don’t really follow it throughout the middle portions.”

    and

    “Other than that your analysis looks pretty much correct You went further into depth than I need to to understand the sentence and I’m not really wanting to get in too deep.”

    Hang in there 6 and please try again. If you do, you will see that your other statement “because enablement simply has nothing to do with WD2.” simply is not correct and you will realize that WD2 = f(E). The linear separation you want to accomplish is not possible without introducing error (to keep it simple, think red apples). Without understanding the sentence structure, you cannot understand the law.

    I will set aside NAL’s admonition and trust that your diving into the deep may result in you learning how to swim in the law.

  26. “The voice of 6 is the voice of God”

    Message on the bottom of 6′s screen:

    “You have gained one follower.”

    Young minion, your point you are trying to make is non-existant and I’m not going to point out for you why. I’m going to leave this as an exercise for you.

    I saw this in mah yahoo news this morning:

    “Some of this wealth was based on real economic gains, like those from the computer revolution. But much of it was not, Mr. El-Erian said. “You had wealth creation that could not be tied to the underlying economy,” he added, “and the benefits were very skewed: they went to the assets of the rich. It was financial engineering.””

    From link to finance.yahoo.com

    F your financial engineering. Not only should patents not issue for it, it should be outlawed. This isn’t a WOW economy like in this article I also saw this morning:

    link to videogames.yahoo.com

    When you tinker with the market irl people pay consequences irl. In game people can swindle people out of thousands of “gold” by “financial engineering” of the market, especially when they have lots of startup funds. As a consequence, the swindled people making up the “market” couldn’t buy little trinkets and random nonsense. Irl people can’t buy FOOD and HOUSING when your “engineering” experiment goes a tiny bit awry.

    That sht makes me sick.

    Show your love for my fav mockumentary crowd.

    link to watchtheguild.com

    they like clicks and for you to spread the word.

  27. Wait, I get it – I’ll tell you how to make and use something but I’m not going to tell you what it is. I admit I’m not following this litigation, but how is this a relevant inquiry?

    Severability of WD and enablement aside, you need both to patent an invention so where are they going with this?

  28. Response:

    a. Yes.

    b. Assert an argument and do you own research.

    P.S. a. Is intent a separate requirement of a murder analysis? b. If so, what is the purpose of intent in a murder analysis.

    Give me a personal break. Why don’t we just dig up the framers of the Constitution for a sit down on these matters?

  29. “”Hint: think continuation.”

    Or did you mean “continuation-in-part”, 6?”

    Well, duh, 6 has overruled 37 CFR 1.53(b), In re Klein.

    Someone should have told these bozos: PowerOasis, Inc. v. T-Mobile, USA, Inc., 522 F.3d 1299, 1310-11 (Fed. Cir. 2008).

  30. “Please explain WHY 35 USC 132 wouldn’t effectively police new matter during prosecution. ”

    I would but we covered this in other threads already and I don’t like explaining more than I need to to nublets on the board who think they can just jump in mid discussion and demand explanation. Think it through, read the language, you’ll get it yourself.

    Hint: think continuation.

  31. “Judge Linn may be using an E2, which wraps up the E and the f(E) together. Equation 1) then becomes:”

    If he is then he needs to find some new wording to make his case, because he isn’t going to convince anyone the way he is talking right now. And speaking that way is very confusing because enablement simply has nothing to do with WD2.

    Other than that your analysis looks pretty much correct although I don’t really follow it throughout the middle portions. You went further into depth than I need to to understand the sentence and I’m not really wanting to get in too deep.

    “3. So, I still think you can’t use an enablement test to police the arrival of new matter.”

    Of course not, and if Linn is using those words then he is being misleading to people who aren’t as old school in their understanding of the statute. Of course a learned mind could say, “well, let’s just call all that enablement”, but that really isn’t very clear what is going on.

    “If the added claim per your hypothetical is not described in the specification, it simply cannot be enabled by the (missing) description.”

    Noise it is you who do not understand enablement. Added claims could be enabled by prior art, especially anticipatory prior art, but sometimes other art. They don’t require the specification to enable them except in the instance where the prior art already has not.

    I understand your take on enablement, where you live in a dream world where the spec is the only thing that can enable claims and enablement depends in total on the spec. And sadly I fear that is the same world where Judge Linn is living. While your distorted view of enablement is fine for most practical purposes and gets you through your day to day by allowing you to reach mostly the same decisions as your clear thinking brethren, it makes for rather confusing discussions amongst you, and leaves you without WD2 to consider in cases like this.

    I cannot say what the reach of WD2 is, and whether or not it should apply in these kinds of situations like the one on trial such that overly broad genus claims are not described unless there is a sht ton of species shown as well, but I will stand behind this as being the proper way to view the statute.

    And keep in mind, bread isn’t deferring to me, he did his own analysis and arrived at the same thing. Perhaps you should diagram the sentence and see if you don’t come to the same conclusion as well. Start by throwing out your misguided view on what enablement is and start from scratch.

  32. PHOSITASAURUS, I’m not sure your distinction with Liebel-Flarsheim works. I haven’t check the record, but it appears that Ariad enabled only one specific method–viz, using decoy molecules–to achieve the claimed effect. The court then says that, for “its own reasons,” Ariad insisted on a claim construction that was not limited to decoy molecules, and warns “beware of what one asks for.”

    I don’t actually know this, but the most likely reason for seeking the broad construction is that the infringing product does not use decoy molecules. If so, this looks exactly like a Liebel-Flarsheim case, except the court invokes written description instead of enablement. The underlying concern, it seems to me, is still that Ariad enabled one method of achieving a result but claimed all methods; just as Liebel enabled one method (jacketed) and claimed all methods. This may well suggest that written description is redundant with enablement, but it also suggests that enablement might get significantly more stingy.

  33. “However, it is widely expected that PTO Director Kappos will end the litigation by giving up on implementation of the proposed rules.”

    Sure, but he’d be crazy to end the litigation BEFORE the Federal Circuit chimes in with respect to the USPTO ruling making power. He at least needs to know what the en banc court says in order to make future rules.

  34. Section 112 requires a written description of the invention, but the measure of the sufficiency of that written description in meeting the conditions of patentability in paragraph 1 of the statute depends solely on whether it enables any person skilled in the art to which the invention pertains to make and use the claimed invention and sets forth the best mode of carrying out the invention.

  35. “I think the current tendency of certain CAFC judges to try to invalidate almost any broad generic claim in mechanical and elecrical cases on alleged 112 grounds is far more common and serious.”

    Examiners are doing the same.

  36. Just to keep the thread going:

    1. I think that “matter” gets “added” when a PHOSITA can derive some technical teaching from the app as amended that wasn’t clearly and unambiguously derivable from the app as filed. It’s a strict “novelty” test rather than an “it was obvious from the app as filed” test. I think that’s the “written description” standard too. there’s a very recent CAFC case on that.

    2. I think the subject matter of a claim is “enabled” when the app provides enough teaching to put the claimed invention into effect, over a range that corresponds to the ambit of the claim (Liebel-Flarsheim, no?).

    3. So, I still think you can’t use an enablement test to police the arrival of new matter.

    Ames, what’s your point. The EPO has 36 Member States, and the 3-member examining divisions are always international, so there’s no chance of a German member being paid by a German Applicant to allow a case. There would be no point anyway because the validity climate post-issue is even more torrid. The EPO examining division is your friend, tipping you off about what validity attacks lie in wait, after issue.

    Have you ever seen those natural history programs in which little turtles issue from their little eggs in the sand and then scuttle down the beach to the sea? A goodly number get picked off by the circling sea bird predators before they reach the ocean, right? Well, think of those little turtles as freshly issued EPO B publications. The beach is the 9 month post-issue opposition period, and what often skewers the little fellows is the “subject matter added during prosecution” provision of Article 100(c) EPC.

    And you can’t even amend, to remove the added matter, when that would have the effect of widening the scope of the claim (Art 123(3) EPC) so you’re in an inescapable, fatal trap. Dead patent, unrevivable. End of story.

    Will you be the one to explain that to your client (who has maybe just validated the patent, with translations, in 30 odd European countries) that the amendment you drafted (and insisted upon, over the reservations of European counsel) is now the thing that has destroyed the patent, all over Europe?

    So, it might be a good idea to listen to your European counsel, before you insist on your amendment at the EPO.

    You might also want to contemplate filing a few EPO oppositions of your own. Asian corporate applicants often insist on amendments at the EPO that are identical to those filed at the USPTO (you can imagine why).But it k1lls them, in EPO oppositions.

  37. Noise – sorry that my acronym got you wrapped around the axel.
    Re confusion about new matter v. written description … last time I checked, if new matter is added to a claim, that claim will be rejected under 112, first para as failing to comply with the written description requirement (MPEP 2163.06). Although I am sure you will point out that the MPEP is not the law, it is safe to say that it is the established practice of the PTO (sorry … USPTO).
    You note that “If the added claim per your hypothetical is not described in the specification, it simply cannot be enabled by the (missing) description.” This is wrong. It is possible for the claim itself to enable one skilled in the art to make and use the claimed invention.
    So I am back to my hypo above, which I agree includes an overly general statement re enablement, but cannot be summarily dismissed by saying “new matter,” at least in view of current examination practice.

  38. “Readers, now do you see why the EPO is so strict on admissibility of prosecution amendments? Posted by: MaxDrei”

    Perhaps the same strictness should apply to doctoral degrees. nein? unbelievable.
    BERLIN (AP) – German prosecutors are investigating about 100 professors across the country on suspicion they took bribes to help students get their doctoral degrees, authorities said Saturday. link to apnews.myway.com

  39. 6 blurted with regard to 35 USC 132: “That is a stretch and it doesn’t always apply.”

    Please explain WHY 35 USC 132 wouldn’t effectively police new matter during prosecution. And don’t rely on your typical stamp of “anything that makes getting or enforcing a patent easier is the suxxor.”

    Rather, just like MPEP 2163 requires, please explain WHY a person skilled at reading statutes would not recognize a new matter prohibition from the plain language of 35 USC 132: “No amendment shall introduce new matter into the disclosure of the invention.” Also, please explain WHY this prohibition “doesn’t always apply,” e.g., WHY 132 would not apply to the claims, which form a part of the disclosure (See In re Wertheim).

  40. Although never underestimating the ability of attorneys and judges to twist statutory language, I also do not see how or why the Sup. Ct. [if they get this after the CAFC en banc decision] would ignore the comma and the “and” in “The specification shall contain a written description of the invention, AND of the manner and process of making and using it..” and not would not also find that the “it” refers to “invention” ?
    Furthermore, as also noted, one can find examples, including attempted interferences, where there IS a “make and use” “enablement” buried in the spec among many others for some very different claims added much later in a “divisional” or “continuation”, but there is no description or suggestion anywhere in the spec that what is NOW being claimed was an invention or the invention of the named inventors.
    However, in any case, as noted before, I think the current tendency of certain CAFC judges to try to invalidate almost any broad generic claim in mechanical and elecrical cases on alleged 112 grounds is far more common and serious.

  41. breadcrumbs,

    Your deference to 6 will not result in any improvement in 6′s ability to understand the law. It’s humorous that 6 is offering lessons in Law and physics. That’s like the naked king selling his brand of non-existent clothes to the masses. Anyone dumb enough to buy that line of clothes deserves the outcome.

    And speaking of those buying…
    gman,

    You seem to have the same inane grasp of logic as the person you are agreeing with. Your understanding of what it means to be enabled is flawed.

    “Enabled” is NOT a state of whether the PHOSITA (not POSA), can easily make or use outside of the specification. Just because a claim with new matter can be understood by PHOSITA does not mean that the new claim is enabled by the specification. If a feature was not described in the originally filed application, it is NOT permissible to claim it. You have conflated the New Matter Rule with the current enablement discussion, which will undoubtedly only cause more confusion. Further, you may be confused about claims concerning inherent characteristics in something described, but inherency is a whole different topic.

    If the added claim per your hypothetical is not described in the specification, it simply cannot be enabled by the (missing) description.

  42. I agree with 6 – they are separate requirements.

    Generally, a claim is enabled if a POSA can make and use the invention without undue experimentation. If a claim is added to an application after the filing date, and that added claim includes a novel aspect that a POSA could easily make and use, then it is enabled. But if that feature was not described in the originally filed application, why should it be permissible to claim it? It shouldn’t. It is the separate WD requirement, not the enablement requirement, that prevents it.

  43. 6,

    Thank you for the additions to the argument. Had those additions been in place in your initial statement, you likely (?) would have not so invited NAL’s commentary.

    To paraphrase your position, and to use my own statement, enablement is a subset of written description. If you remove that enablement subset from consideration, you have some remainder that is the actual focus of the question that will be taken up en banc by the Federal Circuit. For clarity, I will refer to that portion remaining as WD2. I think we agree that the requirement in 112 para 1 can be reduced to the following equation:

    1) WD = (WD2 + E) + BM. (BM signifies Best Mode, and is currently not at issue).

    We both agree that the term “written description” applies to the specification, that is, WD. It is extremely unfortunate that the term “written description” has been used both for the over-riding requirement (including the subset Enablement) as well as the portion remaining if the E subset is removed.

    The question put forth for the en Banc Federal Circuit then, is not

    ***Whether 35 U.S.C. § 112, paragraph 1, contains a WD requirement separate from an E requirement?,

    but rather

    ***Whether 35 U.S.C. § 112, paragraph 1, contains a WD2 requirement separate from an E requirement?

    It is only in this sense that question b even makes sense.

    So let’s look at how the E part is integrated into WD. And perhaps more importantly, how E is integrated into WD2.

    L1 – “The specification
    L2 – (ID1) shall contain
    L3 – (ID2) a written description
    L4 – (ID4) of the invention, and
    L5 – (ID4) of the manner and process of making and using it,
    L6 – (ID3) in such full, clear, concise, and exact terms as to
    L7 – (ID4) enable any person
    L8 – (ID5) skilled in the art to which it pertains, or
    L9 – (ID5) with which it is most nearly connected,
    L10 – (ID4) to make and use the same, and
    L11 – (ID1) shall set forth
    L12 – (ID2) the best mode
    L13 – (ID3) contemplated by the inventor of carrying out his invention.”

    The lines of interest encompass L4 through L10. L7 through L10 makes up the direct portion of E. It thus appears that WD2 is the subset L4 through L6. What is left if L4 through L6 is looked at alone, or separated from L7 through L10?

    One problem is that this is not a clean or linear separation. Attempting this separation creates error. Specifically, L6, which explicitly controls L4 and L5, is merely the invocation of E. E applies completely to L4 and L5. Rather like a simple sentence “I want a red apple”, trying to remove red from apple will result in error. I do not want just any apple, I want the red one.

    It appears that WD2 = f(E), and thus equation 1) above, where the assumption is that we had separated E (completely) from WD2 is not as cut and dried, since the separation is not complete (and cannot be complete without introducing error).

    I believe it is in this sense that Judge Linn is stating his case. Further, I think that like WD and WD2, there is a possibility that Judge Linn is using a slightly different E. Judge Linn may be using an E2, which wraps up the E and the f(E) together. Equation 1) then becomes:

    2) WD = E2 + BM

    In which case, it is WD2 that is subsumed in the discussion.

    I will be interested in seeing how the En Banc panel determines the “what is leftover” when all E is removed from WD2, or if Linn impresses the others that E2 is truly the enablement requirement.

  44. Good thread so far. I should have liked Malcolm at 8.15pm to have added into his:

    …Party A narrows to cysteine during prosecution, from an originally filed (and novel)disclosure that makes no distinction between cysteine and all the other amino acids , and then produces data that reveal it to be a non-obvious patentable selection invention…

    the added spice that another party, B, with a slightly later filing date, but the advantage of an app as filed (long before the prosecution amendment was attempted by A) that already includes data that reveal the cysteine selection as the invention.

    Malcolm, what do you do then? Do you:

    1. Give both A and B a patent for the selection of cysteine

    2. Give A the patent and tell B she wasn’t the first (huh?)

    3. Give B the patent and decline to admit A’s prosecution amendment?

    If 3, what tool does one use, to shut out the amendment?

    For as long as you remain with First to Invent PTO filing dates don’t matter (until an Interference is declared). But in a First to File jurisdiction you must have strict control of the admissibility of prosecution amendments that allow Second Filer to misappropriate the rewards of the one who was in truth the First to File.

    Another reason to eschew a move to First to File?

    Readers, now do you see why the EPO is so strict on admissibility of prosecution amendments?

  45. “but rather, Enablement is a part of the written description.”

    EXACTLY. Enablement is part of the written desc. And that means that there is more to WD than enablement. Now, the court is saying that the part of “WD as a whole” which is “left over” if you subtract the part of “WD as a whole” known as “enablement” then you will be left over with a part of WD which is a “seperate” wd which the claims must meet.

    They are, in essence saying that there is a WD genus which has an “enablement” species and a “seperate WD requirement” species contained therein.

    That is, you followed the exactly correct analysis bread, but you don’t understand what the court is saying in its previous opinion. You agree with them in essence, you just don’t like they’re wording it. And in the manner in which they are wording it, the answer is yes. But the bottom line is, you both agree even though you think you don’t.

    Anyone still not understanding, simply take a piece of paper, draw a circle. Draw a line down the middle of the circle top to bottom. Write “enablement” on the right half, and write “seperate wd requirement” on the left half. Then write “written description” above the circle.

    That is how everyone on the court, bread, and everyone who is anyone, except for judge Linn apparently, sees the matter.

    “Actually, TJ, I think everyone agrees that 35 USC 132 has a written description/new matter doctrine.”

    That is a stretch and it doesn’t always apply.

  46. I have seen two people argue here that enablement is part of written description and therefore written description is not a separate requirement from enablement. Aren’t you missing the point?

    The language clearly states that the written description includes enablement and also includes a written description of the invention. A spec can enable a claim without describing it.

    Any of the enabled claims in the application as filed are of course supported. Couldn’t be otherwise as they are part of the written description or can be incorporated into the written description easily.

    However, when claims are so amended they recite something substantially different than when filed, it is possible they are not described in the text.

    I would rather see applications get rejected because the amended claims not are supported by the written description, rather than any extensions of Liebel-Flarsheim.

  47. Actually, TJ, I think everyone agrees that 35 USC 132 has a written description/new matter doctrine. I imagine the doctrine will remain the same, but 112 will no longer have anything to do with it.

    Also, I think your point about Liebel-Flarsheim is interesting. But this case may be distinguishable from Liebel and its progeny. Here, the plaintiff has not argued for a particular claim construction undisclosed in the specification, like Liebel did with the jacketted vs. jacketless syringe. That is, Liebel (and its progeny now) can be read to apply only in cases where the *infringing product* is not enabled by the *asserted patent.* Here, everyone agrees that the single disclosed fabrication method works, even if the patentees didn’t realize what it created.

  48. Ideally, the sentence would be diagrammed, but Typepad is not ideal for that purpose, so let’s try to rewrite the sentence in indented form.

    Alas, Typepad does not handle the tabs either and the tabs disappear when the following is pasted in, so we will try this path:

    Copy and paste the following into Word or an equivalent software package. Replace the number of indents with tabs (ID# = the number of indents that should be supplied.)

    “The specification
    (ID1) shall contain
    (ID2) a written description
    (ID4) of the invention, and
    (ID4) of the manner and process of making and using it,
    (ID3) in such full, clear, concise, and exact terms as to
    (ID4) enable any person
    (ID5) skilled in the art to which it pertains, or
    (ID5) with which it is most nearly connected,
    (ID4) to make and use the same, and
    (ID1) shall set forth
    (ID2) the best mode
    (ID3) contemplated by the inventor of carrying out his invention.”

    Now, by looking at the requirement in this manner, we can see that the requirement is, in essence, singular to the specification, and requires the specification to both contain a written description and to set forth the best mode. Enablement is merely a subset of the written description and actually describes the level and specificity of the terms required in the written description.

    When viewed in this manner, it appears that Enablement is not separate from the written description; but rather, Enablement is a part of the written description.

    The answer to a. appears to be NO.

  49. In a way, everyone agrees that 112 has a written description requirement. Even Judge Radar agrees with that, as long as that written description doctrine is confined to new matter rejections and not the Eli Lilly style rejection. But if the Federal Circuit collapses written description into enablement, will it then hold that the very broad claims at issue in this case are not enabled? Why and how? The patentee clearly enabled one means of achieving the claimed result. If the result of this case is an en banc decision that the patentee must enable every means of achieving a claimed result (a.k.a. Liebel-Flarsheim), then this will be a Phyrric victory for patentees everywhere.

  50. “Does the spec describe the best mode for the invention of Claim 1?”

    You have to describe the best mode for each of your claims???

  51. I agree 100% with James Bellie.

    Maybe the analysis is less confusing if we all remember that each claim is a separate “invention.” See 112, ¶2.

    So read Claim 1. Is there a written description in the spec of the invention of Claim 1? Does the spec describe how to make and how to use the invention of Claim 1? Does the spec describe the best mode for the invention of Claim 1?

    Go on to Claim 2, and repeat.

  52. “6 takes the approach of form over function. It makes for arriving at his preconceived notions easier.”

    This absolutely is not a form over function issue for me. If your spec actually describes what you want to claim to one of ordinary skill then that is fine. We’re talking about situations where the “form” is blatantly describing something entirely different from what was originally disclosed. You can’t just keep writing your spec as you go along.

  53. absolutely curious, it is applied across the board. There is nothing special about bio except that they regularly claim huge genii and that pisses some folks off since a lot of these huge genii really need to be fleshed out for them to be adequately described in full for one of ordinary skill. This is understandable, but the law simply isn’t against it. Congress might should pass another law to ensure that these kind of cases don’t issue, but that is a different issue from whether or not the court should invalidate them when the statute simply isn’t against that.

  54. “If something (let’s call it something number two) is a quality of something else (let’s call it something number one), then the two somethings are not SEPARATE (something number 2 is a part of something number 1).”

    Noise, the WD is the genus encompassing the species enablement. Does that boil it down for you in terms you can understand?

    Here, if I say “Noise, verify that the claim before you is not obvious” and point to a claim, what will you do?

    First, you will see, in the various pieces of art, whether or not all features are known, and you will record where they are found right? Following Graham.

    In so doing, you will have also noticed whether or not all elements were disclosed in one reference. So, as you were actually going about making sure the reference was non-obvious, you also would notice if it was anticipated.

    This is similar to the relationship between WD req and enablement. WD requirement requires a lot of things, and one of those things is enablement. So, if I say to you, Noise, make sure this claim passes WD, you will, in so doing, have to make sure that it meets enablement, and you will also have to verify that it passes what is being referred to as “a separate WD requirement”. Really it is all one big requirement, with enablement just being one aspect, or quality of the requirement. However, there is a part, separate from the enablement, that is whether or not there was, in fact, a written description of the invention. All of these aspects together make up the overall written desc. req.

  55. 6 takes the approach of form over function. It makes for arriving at his preconceived notions easier.

  56. 112 paragraph 1

    “The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.”

    It looks to me as if the first sentence says that the specification
    must have a written description, AND enablement. Besides, ruling
    that there is not a written description seems inconsistent with
    past rulings.

  57. some quick rope from 6:

    Q. Whether .. contains a written description requirement SEPARATE from an enablement requirement? ”

    …and then it goes on to say that one of the qualities OF THIS WRITTEN DESCRIPTION must be that it enables…

    If something (let’s call it something number two) is a quality of something else (let’s call it something number one), then the two somethings are not SEPARATE (something number 2 is a part of something number 1).

    Time for 6 to dance.

  58. “b. If a separate written description requirement is set forth in the statute, what is the scope and purpose of the requirement? ”

    by the by, the answer to this question is: I don’t know what the scope of it is, but its purpose is to prevent outright bulsht from happening.

  59. “Would it be fair to grant the claim?”

    No, they need to refile and take the later filing date. It took 2 years before that art showed up right? They need to refile and take the later filing date. They might still get a patent, but they can’t just have us toss out all the art that sprung up just because they got an anticipated/obvious genus claim in earlier.

  60. “I think he’d argue that it isn’t “new matter” if it’s enabled by the disclosure. ”

    Problem with that is though MM, many things are enabled BEFORE THE APP WAS FILED, and the app itself didn’t enable jack. It just claimed some already enabled things. This is the case in literally 99% of cases that come across my desk. Nearly everything in the first claims and in the new “new matter” claims was enabled PRIOR to the app even being filed. They contributed jack squat in terms of enablement. Literally jack squat, 0, nothing.

    Thus, the only thing they should be able to claim is the things they specifically state in the application wouldn’t you agree? Don’t you think Linn would also agree?

    “Does that seem like the proper result?”

    I couldn’t tell you because I don’t know wtf is going on in your hypo. You’re going to have to use something a bit more normal for an example.

    If I had to take a guess though, it looks like you’re saying they should be able to disclose a genus only, and then later when some prior art showing one of the species shows up, they should be able to include a different species in the claim that they didn’t even talk about in the app as originally filed.

    If that is the case, then that seems like precisely the WRONG result. They should have to refile and take a later filing date.

    That’s what this is all about. Not giving people an incorrect filing date just because they had a genus claiming/disclosing application wayyyyy before they actually found the right species to claim.

  61. 6: “I’d love to know what Linn’s position is on “new matter” situations and if they should be rejectable or not.”

    I think he’d argue that it isn’t “new matter” if it’s enabled by the disclosure. Thus, a specification that teaches only generically that “any combination of amino acids” could be used in a formulation would suffice to allow an applicant to amend a claim to recite “cysteine” to get around an otherwise identical prior art formulation that taught “proline, serine, or threonine.” Certainly the use of “cysteine” in the formulation is enabled by the specification. Does that seem like the proper result?

    Alternatively, one might argue that the better approach is to find that the claim reciting “cysteine” is obvious in view of the prior art. But what if the applicant comes back with data obtained after the filing of the application which shows that beneficial and “unexpected” are obtained with cysteine? Would it be fair to grant the claim?

  62. AD you can look at the previous articles about this case and see the other judges on the previous panel’s decision. I’m too lazy to do it for you. And I don’t think there is any other info on the other judges besides the ones on this panel.

  63. That said, sans the new matter issue I agree with you guys that perhaps there shouldn’t be a seperate “WD” requirement for applications where they’re just using it to make the claims be reasonably approximate to what was reduced to practice.

    The amount of scope I don’t give two hoots about. What I do care about is new matter and whether that scope was disclosed originally.

  64. “Q. Whether 35 U.S.C. § 112, paragraph 1, contains a written description requirement separate from an enablement requirement? ”

    A: Yes.

    Quite clearly the statute says that there is to be a written description, and then it goes on to say that one of the qualities of this written description must be that it enables one of ordinary skill in the art to make an use the invention. That doesn’t mean that you can just go hog wild and claim things that you never even brought up in the originally filed application after the fact.

    Impermissible. The court will so hold.

    I’d love to know what Linn’s position is on “new matter” situations and if they should be rejectable or not. He’s the spearhead of the “no WD” requirement movement wasn’t he?

  65. I tend to agree that a separate written description requirement is silly and “enablement should be allowed to do it job.” By the same token, 101 should be allowed to do its job. Properly applied, 101, 112 (enablement), and 103 should be able to exclude or invalidate broad claims to all methods of manipulating a newly “discovered” biochemical pathway, “correlation” or “relationship” (or any other pathway, correlation or relationship, for that matter — software applicants should be at least as concerned about overturning the earlier case as they should be about Bilski).

    The problem is that, in practice, the USPTO is rarely up to the task. Examiners simply lack the time or, in the case of certain art units, the creativity or training to address these claims in the “proper” manner. That only happens during litigation.

    The use of the written description requirement, then, to narrow claims in so-called “unpredictable” arts to something resembling the embodiments that were reduced to practice is a short cut to fairness. It’s too easy, otherwise, for the applicant to simply grab the world and cut away from the claim whatever parts the Examiner finds in the limited prior art search (because obviousness can be rebutted by the same arguments regarding unpredictability).

    In the predictable arts (like software) where every embodiment is enabled simply by disclosing the functions to be carried out, the use of a more stringent written description requirement serves to prevent applicants from grabbing large chunks of intellectual property simply because they were the first to use “novel” functional terms to describe the information transformations that take place (which are nearly always obvious in terms of the information transformations that took place earlier in the non-virtual world).

    The 101, 102, 103, and 112 are simply tools to prevent applicants from grabbing too much. At this point, eliminating the written description requirement and castrating 101 would be like throwing chum in the troll-infested waters of the PTO. Don’t do it, man.

  66. I haven’t followed this closely, but I seem to recall that Judge Linn is very adamant about there being no written description requirement beyond enablement. Does anyone have a break down of which judges have pretty clearly taken sides on this issue, and which ones have yet to do so?

  67. “…it is widely expected that PTO Director Kappos will end the litigation by giving up on implementation of the proposed rules. ”

    That would be a very smart course of action. Of course it would not settle any of the key questions that were raised, including the proper scope of PTO rulemaking authority.

  68. “it is widely expected that PTO Director Kappos will end the litigation by giving up on implementation of the proposed rules.”

    I thought that the Justice Department might have the litigation continued.

  69. Q. Whether 35 U.S.C. § 112, paragraph 1, contains a written description requirement separate from an enablement requirement?

    A. No

  70. If I understand it right (which I admit is very unlikely) it is the written description requirement of 35 USC 112 which is the only present mechanism to block the addition of subject matter to the application during prosecution through the USPTO. There are only three grounds on which to attack the validity of a patent at the EPO, after it has issued, namely a) patentability (101, 102 and 103) b) not enabled and c) subject matter added during prosecution. To Europeans, all three grounds are needed. Thus, I look forward with interest to an illuminating thread on this topic.

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