Written Description: Araid Petitions en banc Federal Circuit to Eliminate Separate Written Description Requirement

Ariad v. Eli Lilly (en banc suggestion 2009)

Ariad has petitioned the Federal Circuit for an en banc rehearing – boldly asking the court to eliminate the written description test as a distinct requirement of patentability under 35 USC Section 112, paragraph 1. The petition – drafted by Professors Duffy and Whealan – is essentially a well-formed collage of quotations from Federal Circuit dissents and 19th Century Supreme Court decisions.

The petition raises the following two questions:

(1) Whether this Court has erred by “engrafting . . . a separate written description requirement onto section 112, paragraph 1 …. ” Ariad Pharms., Inc. v. Eli Lilly & Co., 560 F.3d 1366, 1380 (Fed. Cir. 2009) (Linn, J., concurring).

(2) What is the proper test to satisfy the requirement in Section 112, paragraph 1, that a patent specification 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”?

Apart from the merits of this case, the brief notes that half of the Federal Circuit judges “have either voted to grant en banc review of this Court’s written description jurisprudence (Newman, Rader, Bryson, Gajarsa, and Linn, JJ.), or have expressly noted that future en banc review may be appropriate because this Court’s written description standards are unsatisfactory. (Dyk, J.).

Notes:

  • Ariad Brief: ariadrehearingpetition.pdf
  • Federal Circuit Decision
  • The original opinion was written by Judge Moore and joined by Judge Prost. Judge Linn wrote a concurring opinion as a reminder of his belief that the written description requirement should be eliminated and enablement be allowed to do its job.
  • Patent Docs has more.

58 thoughts on “Written Description: Araid Petitions en banc Federal Circuit to Eliminate Separate Written Description Requirement

  1. By itself, the change wouldn’t clarify anything *except* that it would remove any ambiguity as to whether one is properly arguing enablement versus written description, which seems to be a hang-up for many folks (an understandable hang-up, in certain instances, when case law is cited where the Federal Circuit itself has done its best to confuse the issue))

  2. Malcolm, you would like for 112 p1 to be called “written description ” requirement but have two separate tests: (1) a description requirement and (2) an enablement requirement. I am not sure how that clarifies things

  3. This seems to be a lot of hoo-haw over semantics. Whether the written description requirement is “separate” or not, the effect of the requirement (MaxDrei articulated it well at 5:04) must remain embodied in the patent rules somewhere, or we end up with a system that fails.

    The problem with the “separate” requirement as it stands is that, like certain other statements of the law by our beloved Federal Circuit, it’s clear as mud for typical jurists and fact-finders in most situations as to how to apply it and how (or why) it is to be kept distinct from the so-called enablement requirement. My preference would be for 112 to be referred to as the written description requirement, period, where the requirement includes a description of the invention, how to make it and how to use it.

  4. Now that I’ve read the Petition for Re-Hearing I’m reminded also of the Liebel-Flarsheim case. The Petition goes to the universal fundamentals of any reasonable patent system. Any patent system needs mechanisms to ensure the following:

    1) The app as filed must enable the claimed invention, at a degree of generality that is commensurate with the scope of the claim contended for. “The Telephone Cases”, Bell 1888, were wrongly decided.

    2) The Applicant should not be able, during prosecution, to shift the claim so that it is suddenly directed to an invention not already in the possession of the Applicant at the date of filing of the application.

    3) The Applicant should not be able, during prosecution, to rectify a disclosure that was non-enabling (for the invention of the instant claim) at the filing date of the application.

    I refer back to my comment at 7.16am on June 06. When in 1973 the Europeans wrote their European Patent Convention, brand new, on a plain white sheet of paper, they caught these fundamentals efficiently, and with the irreducible minimum of legal verbiage. In the USA, despite 200 years of ever more intensive refinement, the Statute has yet to encapsulate these very fundamentals.

    But stay with your Statute, by all means. I think the present one benefits the rest of the world more than it benefits the United States of America. As I always say, heaven help the ROW, once American inventors cop on, how to protect innovation everywhere else in the world.

  5. I disagree with your position. Just because a person is a PHOSITA, that does not mean that their invention is obvious. It just means that they are presumed to be in possession of the prior art relevant to the invention described. The invention may still be obvious or non-obvious in view of the prior art, but the inventor gets no special consideration for having greater or lesser levels of skill or knowledge of the P/A.

    One thing this could do is enable streamlined descriptions in that the P/A could be shorthanded in by reference instead of being expressly described in the current application to permit elements of the P/A to be recited in the claims. On the other hand, such US applications might then be more troublesome to port directly into a PCT application since the matter not expressly included in the application might be considered new matter in other jursidictions. At least, you might open the applicaiton up to more challenges and thus slow the foreign prosecution of US origin applications.

    ars

  6. Lighning50, Unless I’ve misunderstood you, I simply disagree with you.

    There are many countries that consider all unclaimed disclosure to be dedicated to the public domain upon filing. They prohibit broadening amendments or new claims. The U.S. is not one of those countries. Modern case law, especially Festo, even encourages Applicants to initially seek very narrow protection to avoid narrowing amendments, and then file continuations seeking broader protection.

    If you have a problem with applicants making broadening amendments or filing broader claims after the initial filing, then I think you are going to feel lonely in the U.S. It seems to me that what you want is a drastic change in the law.

    In any event, the written description requirement is not the appropriate tool for dealing with your issues. A written description requirement in addition to an enablement requirement simply imposes an artificial constraint that limits the words that applicants can use in adding and amending claims. It doesn’t just impact broadening amendments, it even hampers narrowing amendments. In fact, it hampers narrowing amendments a lot more than it hampers filing of broader claims. And a strict construction requiring that the wrodfs int he claims be found int he originally filed specification is inappropriate. The requirement is that the claims be supported by the text and drawings taken together. That’s really an enablement requirement, if you ask me.

  7. What about situations where an applicant brings in new matter through an argument? There’s no amendment to enter, so 132 is inapplicable.

  8. It depends on the “obvious mistake” made bread. And, in this situation, missing a new matter situation is not always an “obvious mistake”. Sometimes, the examiner may have simply decided that the amendment was not new matter. This would have to be the presumption in all cases where the amendment was accepted and we were actually using 132. (note that we do not currently use 132 for this purpose).

    I’m not attempting to use the same grounds for 1 and 2. I’m using 132 for 1 and I’m using 112 1st for 2. Of course, currently irl I only do 2 and I only use 112 1st. But, we could possibly use 132 for 1.

    The whole point is, that if I didn’t have 112 1st to use for new matter (i.e. situation 2) then only 132 is left (i.e. situation 1) and that is a problem.

  9. How are other obvious examiner mistakes corrected?

    Plus, please clarify “…it would be grounds for us to not accept an amendment, but I don’t know if it would be grounds to reject the claim after the amendment has been accepted.”

    How are you attempting to use the same grounds for
    1) not accepting an amendment and
    2) accepting an amendment but then rejecting the amended claim?

  10. Max, the reason is simple. Because 1. attorneys bich to high hell if you don’t accept their amendment (it shows off their incompetence for the client I guess) 2. not accepting amendments slows down getting to a final disposition. Simple as that man.

  11. One potentially interesting aspect of this case is that Eli Lilly, being a pharmaceutical company, probably would not be too heartbroken if the “super enablement” written description standard was tossed, especially since it is likely that the patent in suit probably would also be invalid for old-fashioned 35 USC 112 enablement.

  12. In the case I am thinking about, the amendment during prosecution (re-issue actually) removed a claim limitation that specified the relative location of parts. Amendments removing limitations don’t trigger the usual new matter objection. However, a PHOSITA reading the application as filed would conclude that the inventor considered the limitation necessary in order for the invention to work. After someone else began making a product with a slightly different structure that avoided that claim limitation, the inventor filed a broadening re-issue. The different structure was not an obvious variation. There is at least a prima facie case that the inventor never conceived of the possibility of a product that would not satisfy the limitation in question until he saw the competitor’s product. Why should that inventor be able to suddenly obtain the right to preclude the competitor from selling the product?

  13. Well thanks everybody, for the education but I’m still wondering why 35 USC 132 isn’t routinely used against all those claim amendments that get entered during prosecution and which contain new matter. For the time being I will suppose that the reason is as follows.

    If the Exr rejects claim under 132, the prosecuting attorney argues (and has caselaw on his side). But if Exr says “no written description” it is the Exr that has the caselaw helping him, and the attorney is not so well placed to argue.

    So, 132 falls out of favour.

    Years ago, those EPO Examiners doing IPEA work in PCT Chapter II, on apps prosecuted from a law office in the USA, often used to object that the independent claim was unclear. US prosecuting attorney then expressed outrage. “I’m an English native speaker Mr Examiner, and you’re not. So, don’t ever say that my claim isn’t clear”. EPO Exrs soon learned to write instead that the claim (on its widest reasonable construction) lacked novelty. Thus: “The way I see it, it is wide enough to embrace something old, namely, D1, col 6, line 17.” That, they found, immediately brings the attorney sweetly around to the action necesary, namely, amending the claim, to reveal for the first time its intended meaning.

    As many people continue to aver, there’s more than one way to skin a cat. I guess citing 132 brings a storm down on the head of the Exr that invokes it, 112 less so.

    But, if the USPTO want to clear the backlog, and better manage the workload, might not one long term solution be to step up the incidence of citing 132. Short term pain for longer term gain, maybe? If attorneys know that amendments having no counterpart in the app as filed are going to get rejected, will they not modify their behaviour?

    Or would that be futile, given the governing caselaw on 132?

  14. It’s also standard procedure that if you get a written description rejection on something that just appears in the original claims you can just add it to the spec. Any US patent counsel worth his or her salt knows that.

  15. It’s pretty apparent to me that section 132 was meant to address new matter and section 112, first paragraph was only meant to address enablement, in the minds of those that actually wrote the 1952 Patent Act. A decision that got us back to that and exorcised the ‘written description’ phantom would be no bad thing.

    It’s pretty common for a written description rejection to have the words “this is a new matter rejection” as a rider. I have also had “objections” for new matter under 35 USC 132. I was always led to believe that Examiners were supposed to write rejections under the statute and objections under the rules, so they should have been rejections.

  16. Dear Leo,

    Re: “…it’s theoretically possible to file an application consisting of only claims (and perhaps a figure), where the claims are self-enabling.”

    I’ll bet you’re right – Brilliant!

    It would depend a lot on the nature of the invention, of course. I had one recently where I would’ve tried that.

    Just thinking about it out loud, one could file a provisional with some disclosure for protection, but then file a utility (not incorporating the provisional) well within the year, say a day later, with only a claim(s) and perhaps a figure(s).

    I think this would work if a petition to make special based on age were also filed with the utility in case the timing of the first PTO Office Action put the invention at risk of not being patent-protected.

    * * * * *

    PS: What do you think of these sucky patterns?

  17. It’s not enough because nothing in 132 polices priority to a previously filed application. Section 120 does that, and it expressly requires disclosure “in the manner provided by the first paragraph of section 112.” If section 112 does not require a written description, but only an enabling description, then claims in a CIP requiring a “red wagon” could be entitled to the filing date of a parent application when all that the parent discloses is a “wagon.”

    The real issue is whether the separate written description requirement has been applied too rigidly in Lilly and its progeny so that even an original claim is not a “written description” of itself.

  18. Publius said…
    35 USC 132: “No amendment shall introduce new matter into the disclosure of the invention.”

    Isn’t that good enough, folks?

    It’s not enough because nothing in 132 polices priority to a previously filed application. Section 120 does that, and it expressly requires disclosure “in the manner provided by the first paragraph of section 112.” If section 112 does not require a written description, but only an enabling description, then claims in a CIP requiring a “red wagon” could be entitled to the filing date of a parent continuation when all that the parent discloses is a “wagon.”

    The real issue is whether the separate written description requirement should be as strict and rigid as Lilly and its progeny have interpreted it, i.e., whether the “super-enablement requirement” should be done away with.

  19. “I wrote it with something in my memory that was telling me that the European standard (that claims count as part of the “disclosure”) doesn’t come naturally to some US patent attorneys.”

    Max, I believe that something in your memory is wrong. The original claims are most definitely part of the disclosure in the US. Thus, a written description rejection of an original claim is unlikely to be sustainable, except in very unusual situations. The PTO can object to the fact that an original claim lacks any antecedent basis in the description, in which case the claim can simply be copied to the description. That would not be addition of new matter. I believe it’s theoretically possible to file an application consisting of only claims (and perhaps a figure), where the claims are self-enabling. Not that I’m recommending it…

  20. “I wrote it with something in my memory that was telling me that the European standard (that claims count as part of the “disclosure”) doesn’t come naturally to some US patent attorneys.”

    Max, I believe that something in your memory is wrong. The original claims are most definitely part of the disclosure in the US. Thus, a written description rejection of an original claim is unlikely to be sustainable, except in very unusual situations. The PTO can object to the fact that an original claim lacks any antecedent basis in the description, in which case the claim can simply be copied to the description. That would not be addition of new matter. I believe it’s theoretically possible to file an application consisting of only claims (and perhaps a figure), where the claims are self-enabling. Not that I’m recommending it…

  21. “WAXMAN: Look, I’m not a software developer and I have reason to believe that neither is Your Honor, and I — I can’t — explain specifically what this claims. It’s laid out very carefully in –”

    What is Waxman doing there, then?

  22. Lightning50 — I disagree with your use of the term “incremental material” since the new claims are fully supported, i.e., all elements were in the original disclosure.

  23. …………..it would be grounds for us to not accept an amendment, but I don’t know if it would be grounds to reject the claim………..

    6: that was the passage that threw me, and led me to write what I did. I wrote it with something in my memory that was telling me that the European standard (that claims count as part of the “disclosure”) doesn’t come naturally to some US patent attorneys. My remark was intended to tease out this point,in this thread, but for the time being it’s just you and me in the ring. Hopefully a US patent attorney will soon clamber up through the ropes, and join in the slugging.

  24. I don’t think that is a legitimate exception.

    I know for a fact though that many new matter situations, if missed by the examiner, would be far from an “obvious” examiner mistake.

  25. “He thought that an amendment to a claim could be responsible for adding matter. ”

    It can be. Yes that’s what I said, and we’re in agreement. None of that leads in any way to what you said in your comment way above.

  26. “CHIEF JUSTICE ROBERTS: Electric. I mean, it’s not like he invented the, you know, internal combustion engine or anything. It’s very vague, I think, and this is one of the considerations the district court mentioned.

    “CHIEF JUSTICE ROBERTS: I may not be a software developer, but as I read the invention, it’s displaying pictures of your wares on a computer network and, you know, picking which ones you want and buying them. I — I might have been able to do that.”

    President Obama was correct in voting against this idiot.

  27. 6: you write “wtf” about something I wrote. Looks like I didn’t understand what you wrote at 10.30, in reply to Publius. He thought that an amendment to a claim could be responsible for adding matter. You seemed to be saying that 35 USC 132 has become ineffective against such claim amendments. Are we agreed that, in principle, amendments to claims, in prosecution, can add matter to an application and that 35 USC ought to be available to deny such amendments admission to the proceedings?

  28. “A contribution to the state of the art is what we call “subject matter” isn’t it?”

    Let them file a patent application for it then. Their old application dies.

    “Thanks, Publius and 6, for pointing up another difference between America and Europe, namely, that a European can derive useful disclosure from a claim but, seemingly, an American PHOSITA can’t. ”

      wtf?
  29. Thanks, Publius and 6, for pointing up another difference between America and Europe, namely, that a European can derive useful disclosure from a claim but, seemingly, an American PHOSITA can’t. Suppose the invention is all about a special alloy composition, that enhances performance. During prosecution, Applicant amends the claim, to narrow the range of alloying element E, and argues that the amended claim delivers enhanced performance (surprisingly) and that the state of the art fails to render that claimed range either old or obvious. OK, there is no “written description” of the narrow range in the app as filed, but the amendment to the narrower range also added to the app as filed an announcement of what was the inventor’s objective contribution to the state of the art. A contribution to the state of the art is what we call “subject matter” isn’t it?

  30. 6, To answer your question, I do not think it would provide grounds to reject the claim after the amendment has been accepted, accept perhaps to point out that the eaminaer made an error as a matter of law that might challenge the validity of the patent (assuming that since your second question places the matter in litigation, that a patent has issued).

    How are other obvious examiner mistakes corrected?

  31. only a problem in that, if we presume the inventor to be Phosita, then the invention ipso facto was obvious to one of ordinary skill in the art – or, alternatively, any prima facie case of obviousness could be overcome by the inventor’s affidavit under 37 cfr 1.132.

    thus, taking the inventor as Phosita would undermine the entire logic (or at least the justiciability) of 35 usc 103. the obviousness inquiry makes sense only if the inventor is presumed *not* to be Phosita. really, if we wanted to get explicitly personal about it, the obviousness inquiry asks whether the inventor had greater or lesser understanding than Phosita at the time of the claimed invention.

  32. That has been brought up before. And at first you might think so, but that section is more of a command that the amendment shall not introduce new matter. In other words, it would be grounds for us to not accept an amendment, but I don’t know if it would be grounds to reject the claim after the amendment has been accepted. Then what happens in litigation, after the office has long ago accepted the amendment?

  33. 35 USC 132: “No amendment shall introduce new matter into the disclosure of the invention.”

    Isn’t that good enough, folks?

  34. It appears the subject of the seperate WD req is pretty well settled amongst everyone here. Excepting perhaps Max, who unfortunately seems to have missed the ship in his last comment.

    In any event, I was over at Baristas for some early morning lolz and I found a link to here:

    link to law.com

    An excerpt from the Ebay case is as follows:

    “But Chief Justice John Roberts actually mocked MercExchange’s “invention” from the bench during oral arguments:

    CHIEF JUSTICE ROBERTS: Mr. Waxman, you mentioned, in — in responding to the suggestion that we’re dealing with a troll, you described — what exactly is the invention here?

    MR. WAXMAN: The — the invention is a — it’s — it’s not a business method. It doesn’t claim methods. It claims a system, an apparatus for an electric market for the sale of goods via a network.

    CHIEF JUSTICE ROBERTS: Electric. I mean, it’s not like he invented the, you know, internal combustion engine or anything. It’s very vague, I think, and this is one of the considerations the district court mentioned.

    WAXMAN: Look, I’m not a software developer and I have reason to believe that neither is Your Honor, and I — I can’t — explain specifically what this claims. It’s laid out very carefully in –

    CHIEF JUSTICE ROBERTS: I may not be a software developer, but as I read the invention, it’s displaying pictures of your wares on a computer network and, you know, picking which ones you want and buying them. I — I might have been able to do that.

    (Laughter in the court.)

    MR. WAXMAN: Well — I’ll say respectfully that that is not a fair characterization of the innovation here, the actual innovation.

    When eBay’s lawyer mentioned patentees’ strong success rate in the Eastern District of Texas, Justice Antonin Scalia chimed in:

    JUSTICE SCALIA: You know, I mean, that’s — that’s a problem with Marshall, Texas, not with the patent law. I mean, maybe — maybe we should remedy that problem.

    MR. PHILLIPS: Well, I hope you do.

    JUSTICE SCALIA: But I don’t think we should write — write our patent law because we have some renegade jurisdictions. ”

    Is that not some hilariousness? If anyone can get me the full transcript, or tell me where it can be found I’d appreciate it. The last time I tried to find one of these things I could never dig it up.

  35. I don’t care if we call the requirement “written description” or “no new matter”. However, we clearly need some provision that prevents an applicant who has become aware of someone else’s invention after filing from broadening his claims to cover the other person’s invention. In our first to invent system, we assume that the date of invention precedes the date of filing. However, there are cases where the inventor does not appreciate the scope of the invention or think of some of the possible design arounds until later. In those cases, he should be forced to file a CIP and accept the later filing date for the incremental material.

  36. Here’s an argument for why we need both the written description and enablement requirements (taken from link to bc.edu ):

    It is possible for a specification to enable the use and practice of an invention as broadly as it is claimed, and still not describe the invention.In re DiLeone, 436 F.2d 1404 (C.C.P.A. 1971). The Court of Customs and Patent Appeals described this scenario in the following way:

    “[C]onsider the case where the specification discusses only compound A and contains no broadening language of any kind. This might very well enable on skilled in the art to make and use compounds B and C; yet the class consisting of A, B, and C has not been described.” Id. at 1405 n. 1.

  37. I always took the position that the reason for the dichotomy was that the inventor is not charged with having ordinary skill in the art while the POV of the person interpreting the claims is of one having this level of skill and knowledge. If we do away with the distinction, do we then assume the inventor is a PHOSITA? Would this be a problem?

  38. Mr McDonald I had thought the requirement to “fully explain” was synonymous with “enablement”. So what good does it do, to superscribe “written description” on top of “enablement”, to do the same job?

  39. 6: thanks. If you want to ever need to put uppity patent attorneys in their place, watch how many times their specifications recite “complimentary” when they should have written “complementary”. No attorney who considers himself educated should ever make that mistake.

  40. I am pretty sure that J. Rich didn’t mean for there to be two requirements in the quoted paragraph; however, I think it is probably better to have the two requirements. It keeps the prosecution process honest.

    The problem is how to deal with all that is known by a PHOSITA that can be put into the claims without a written description.

  41. Yeah, this is just what the Federal Circuit needs to do. At a time when the Supreme Court keeps jumping all over them for making it too easy to get a patent, let’s remove one of the 112 requirements so applicants don’t have to fully explain their inventions.

  42. Funny, I typed separate and then changed it to seperate. I’ve been having issues with that word (as well as exercise, I always want to write exersize, and a couple of other words) lately I always think I have it wrong. Gettin old I guess. Started about a year ago. I always second guess myself. Don’t even get me started on maintenance.

  43. I don’t want to be boring but Europe thinks a prohibition on adding matter during prosecution is important enough to make it one whole one of just three grounds of opposition to a patent granted by the EPO.

    The first ground of revocation is lack of a patentable invention (novel, non-obvious), the second ground is lack of an enabling disclosure in the app as filed, and the third is “no added matter”. These define the three essential hoops an Applicant has to get through, in any First to File jurisdiction, before the award of 20 years of monopoly rights is legitimate. It’s different, in First to Invent country, I suppose.

    6: your comment is much appreciated and I know its infradig to pull somebody up, in a blog, on their spelling, but “separate” is an awfully common word. Can you maybe write “separate” in future? I think some prosecuting attorneys would then give you more respect.

  44. “As I understand US law (plea to be put straight if I’m wrong) such an amendment would not attract a “new subject matter” objection at the USPTO but, rather, a 112 “written description” objection.”

    Indeed. I also have wondered about what these guys that want no seperate WD req have in mind for new matter. Perhaps they feel like it is A ok. Or perhaps they misunderstand the “enablement” requirement and feel like that would cover it. Obviously it does not, and I wouldn’t think a man such as Linn would be mistaken on this subject for 40 years. None the less, I don’t see what their answer is to the problem.

    “new matter rejection, and not just a 112 written description requirement rejection. ”

    New matter rejections are currently synonomous with WD rejections. Under which portion of the statute do you propose we reject them if not 112 1st?

  45. Max, depending on the technology, such a change might indeed be subject to a new matter rejection, and not just a 112 written description requirement rejection.

  46. I have skimmed the Brief and it leaves me curious about one thing. But I’m in Europe and not an American attorney at law, and I’m hoping for enlightenment from readers who are.

    During prosecution, there is scope to claim an invention that was not within the possession of the inventor at the time of filing. That often happens upon the arrival of closer prior art. Put most simply, that might be a new and inventive selection (intermediate limitation or generalisation) that was not within the contemplation of the inventor on the filing date and comes within that contemplation only when the inventor sees the belatedly arriving art overlapping with his/her conception of the invention at the time of filing.

    When an Applicant at the EPO files such a narrowing amendment to an intermediate generalisation, not in the app as originally filed, it attracts an objection that the amendment has had the effect of adding subject matter to the application. In our “First to File” landscape, that can’t be permitted, for then the patent might go to an inventor who wasn’t the first to file on the invention that really is patentable.

    As I understand US law (plea to be put straight if I’m wrong) such an amendment would not attract a “new subject matter” objection at the USPTO but, rather, a 112 “written description” objection.

    If the “written description” requirement is now to be downgraded, what is to stop applicants adding new subject matter to pending applications? If nothing, does that matter?

  47. How was this posted at 10:21 pm? It is currently 9:46 pm. Is the time wrong on your blog or do you for some reason use ESD even though you live in central time? Not that it actually matters.

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