“Inherent Disclosure” in Priority Document is Sufficient to Satisfy Written Description Requirement

Yeda Research v. Abbott (Fed. Cir. 2016)

Abbott’s patent broadly covers Tumor Necrosis Factor α binding protein (TBP-II). U.S. Patent No. 5,344,915.  The U.S. application was filed in 1990, but claims priority to two German applications filed in 1989. A would-be anticipatory prior art reference (Engelmann) was published after the priority applications but before the U.S. application – and the parties have agreed that dispute turns on whether the claims get to rely upon the early priority date.

In the preceding interference proceeding, the Board sided with Abbott as did the district court – finding that one of the German applications sufficiently disclosed the invention.  (Yeda’s application was filed nine days after Abbott’s.)

A priority filing is only effective if the claimed invention was sufficiently described in the original filing.  This implementation of the written description requirement requires the invention “be disclosed in a way that clearly allows a person of ordinary skill to recognize that the inventor invented what is claimed and possessed the claimed subject matter at the date of filing.” Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc).  In the priority context, failure of written description does not directly invalidate the claims but instead effectively negates the priority claim.  Here, that date is critical because of the intervening prior art.

 

Abbott’s Claim 1 is directed to the binding protein with “a molecular weight of about 42,000 daltons” and that has at “the N-terminus the amino acid sequence Xaa Thr Pro Tyr Ala Pro Glu Pro Gly Set Thr Cys Arg Leu Arg Glu . . . .”  The problem though is that neither of Abbott’s priority filings expressly disclose the claimed N-terminus sequence.

Abbott was able to overcome the lack of express disclosure with an “inherent disclosure”:

Under the doctrine of inherent disclosure, when a specification describes an invention that has certain undisclosed yet inherent properties, that specification serves as adequate written description to support a subsequent patent application that explicitly recites the invention’s inherent properties.

Slip Opinion at 6 (citing Kennecott).

Here, the priority document described how to make TBP-II, but did not identify the actual sequence as claimed.  On appeal, the Federal Circuit ruled that the original disclosure “inherently discloses the remaining amino acids in the N-terminus sequence” and therefore “serves as adequate written description support for the patent claiming TBP-II.”

 

 

 

Dennis Crouch

About Dennis Crouch

Law Professor at the University of Missouri School of Law. Co-director of the Center for Intellectual Property and Entrepreneurship.

60 thoughts on ““Inherent Disclosure” in Priority Document is Sufficient to Satisfy Written Description Requirement

  1. MD The first, as here, is when X is the priority document. So does the claim have priority back to X, Yes or No.

    The second is when X is a prior art reference to the same claim. Can what is inherent in X destroy the novelty of the claim?

    And the third is when X is the patent application as filed. Can the text of an amendment to the independent claim during prosecution be vindicated by reliance upon what is “inherent” (rather than explicitly disclosed, in written words any symbols) in the application as filed?

    MD, the answer to (2) is yes — that’s just the garden-variety inherency we’re all used to. As I read them, questions (1) and (3) are basically two versions of the same issue. The holding in this case demonstrates that, at least in the context of claiming proteins, the answer to both questions is yes, i.e., you can rely on inherency to get away with a non-verbatim written description of your protein when you’ve disclosed enough objective information about the molecule (e.g., its molecular weight, charge, decay pattern when treated with proteases, etc) that its identity (i.e., its amino acid sequence) can be “clearly” determined by an ordinary skilled artisan. Per this decision, that kind of non-verbatim written description will suffice to allow you to later claim the inherently disclosed sequence (in the US) and claim priority back to the inherently disclosing application.

    I think this should be a relatively rare fact pattern, by the way, particularly in the protein context. They’re not too hard to sequence. On the other hand, I can imagine there are some applications out there disclosing hundreds of unsequenced proteins by their various objectively measurable properties. Whether there’s enough there to support an “inherent” disclosure of a specific sequence is a question we’ll leave to the mischief-maker who tries to assert the patent twenty years down the road.

    1. Also, MD, as I noted in my comment at 4, the CAFC seems to have put a limitation on this “inherent description” business, namely Hitzeman v. Rutter, 243 F.3d 1345, 1355 (Fed. Cir. 2001), which states (according to Yeda, and the panel here does not object to this statement of law): “in the context of priority determinations, the allegedly inherent limitation cannot be material to the patentability of the invention.”

      It’s a bit of an open question as to whether that limitation has itself been limited by the CAFC in this case. Maybe it should now read “the allegedly inherent limitation cannot have been solely relied upon for patentability.”

    2. As for suggestions downthread that this case will be used down the road by the CAFC as a crutch to keep a class of l0w-rent crippled s0ftware patents on its feet, that’s a possibility that would surprise nobody. It’s what the CAFC does best, after all. Smell the “essence” of that “electronic structure”! The code written by the infringer is “inherent”! Sure it is.

      1. code written by the infringer is “inherent”! Sure it is.

        LOL – the converse of a past question put to you that always saw you runaway:

        How is it that the [Old Box] could “all of a sudden” have some new capability (which would have to be inherently there) if NOT introduced (and hence change that [Old Box]) with the addition of the machine component and manufacture known as software?

        Smell that.

        1. How is it that the [Old Box] could “all of a sudden” have some new capability

          Because it was provided with instructions, which it was created to receive and follow.

          Keep up the great work, “anon.” This is spectactularly difficult stuff.

          1. That does not answer the question on inherency for [Old Box].

            Your “view” leads to a direct contradiction vis a vis the Morse case (your view requires ALL future improvements to the machine be INHERENTLY already “in there.”

          2. You are also “conveniently” forgetting your very own admission against interests of knowing and understanding the exceptions to the judicial doctrine of printed matter.

            Oopsie for you.

          3. …and not to mention that your “logic” here is exactly what is panned when I ridicule you with the Big Box of protons, neutrons and electrons (just as your “instructions” “concept”is too glib and you want the first computer that was able to use any software to make all future improvements “obvious” so too would the first application of putting anything together with protons, neutrons and electrons make ALL other such items “obvious”

            I won’t tell you to “keep up the great work” because what you do is not work, and it is at the opposite of the spectrum of great.

    3. Thank you MM. Rare for proteins perhaps but less rare in mech cases, to be debating what is inherent in the priority document or the application as filed. Europe would say “implicit” rather than inherent. England’s novelty test is that X has to contain “clear and unmistakeable directions” to do something within the scope of the claim, or that the “inevitable result” of following X’s teaching is that you end up with something inside the claim. But Paris gives priority when the invention of the prio doc is the “same”. Whether X discloses the “same invention” is not the same thing as whether X destroys novelty, but both depend on what X discloses.

      1. Not sure I understand what you mean by:

        Whether X discloses the “same invention” is not the same thing as whether X destroys novelty,

        Are you viewing an obvious variant as still being the “same invention”…?

        Elsewise, how are the two “disclosures” NOT the same thing?

        1. Consider a claim (construed peripherally) as a balloon that constitutes the invention. Everything inside the balloon is an embodiment of the invention. Your “Best Mode” you can think of as a diamond inside the balloon.

          Same invention means same balloon.

          But what destroys novelty? All you need is a disclosure of something within the balloon. Even something as small as a diamond, if within the envelope, destroys novelty. But that novelty-destroying reference doesn’t necessarily disclose the same balloon, the “same invention”.

          It’s perhaps easier to understand the difference when in the chem/bio space. It’s all about the degree of generality of the respective disclosures and claims.

          Obviousness is something else entirely. But, of course, that same reference that destroys novelty will also often succeed as the basis of an obviousness attack. It’s just that obviousness has no relevance to the “same invention” issue.

          1. Sorry but still not following you – you appear to be changing what the invention is from a ballon to a diamond, but you still have one claim – one invention.

            Also, I do not see how your “obviousness has no relevance” stance even starts. Of course it has relevance -as it must.

  2. Given that the facts in this case are so useful for exploring what “inherent” means, I’m disappointed that the comments thread is so quiet. Europe does not make use of any Doctrine of Inherency, so I’m interested in understanding how it works in the USA.

    In particular, I’m interested to know whether it works the same way, in all three of the legal situations where it might arise.

    What are those three situations, in which what is “inherent” in Document X, is decisive of the case?

    The first, as here, is when X is the priority document. So does the claim have priority back to X, Yes or No.

    The second is when X is a prior art reference to the same claim. Can what is inherent in X destroy the novelty of the claim?

    And the third is when X is the patent application as filed. Can the text of an amendment to the independent claim during prosecution be vindicated by reliance upon what is “inherent” (rather than explicitly disclosed, in written words any symbols) in the application as filed?

    In all three situations, what counts is what X discloses to the skilled reader. I’m not sure I understand whether what is “inherent” is part of X’s “disclosure” to its skilled reader.

    Anybody care to enlighten me?

        1. Firstly, may I remind you that Europe’s PHOSITA is not the same as the US’s PHOSITA.

          Secondly, may I remind you to respect the differences in patent law that any one sovereign may have decided upon.

          Thirdly, may I suggest that you perhaps seek answers with a mind not really open to understanding.

          Harder than drawing teeth…?

          Perhaps. And perhaps that difficulty can be laid at your own door.

          1. I’m not asking anything about patent law in Europe. I’m not out to compare jurisdictions. I’m not disrespecting any “sovereign”. My mention of Europe is only for the purpose of making it clear that the doctrine of inherency is difficult for me.because it’s strange for me.

            I just want to know whether, exclusively within the USA, the doctrine of inherency works, exclusively in the USA, in the same (sic) way (with the same single Definition, exclusively USA, of the PHOSITA) under 35 USC 112 of the domestic, exclusively USA, patent statute, as it does under 35 USC 102, 103, 119 and 120.

            is that so difficult, for you too?

            1. It is not difficult at all for me.

              On the other hand, YOU still seem to have problems.

              And yes, those problems do stem from the reputation that YOU have created for yourself as a shi11 for the “EPO way.”

              Sorry MaxDrei, but you have acted yourself into that situation.

      1. Sorry anon, while I know what ipsis verbis means, I nevertheless don’t understand your question. I’m simply not trying to compare Europe and the USA.

        The White Book of the Established Caselaw of the Boards of Appeal of the EPO makes it crystal clear that verbatim support is not a sine qua non.

        And the EPO is the toughest of all European jurisdictions, in this regard. Jurisdictions (like England, France or Germany) in which every participant has the same working language are always more relaxed about the importance of verbatim support.

        1. You keep on saying “I not trying to compare,” even as you continue to compare….

          Do you realize the mixed message that you are sending?

            1. There are NO “mess” involved in the conversation Malcolm, so this is just (yet another) of your empty mindless drive-by ad hominem postings.

              Yay “rules.”

    1. Max –
      I can only answer you by example. Lets say the application under examination discloses and claims an improvement to a known electronic device, say a tablet. The fact that a tablet computer includes a processor was obvious to the inventor, so the specification does not include a sentence that literally says the tablet includes a processor and memory, yadda yadda, yadda and the original claims don’t recite those elements either. However, during prosecution the Examiner pretends he claims are unclear or he cites a reference describing a pad of paper and calls that a tablet.

      One could amend claim 1 to add recitation of a processor and argue that this is not new matter and does not extend beyond the application as filed as a processor is inherent in a tablet (as that word is used in the specification, which describes using a touch screen to interact with the tablet). Yes, that argument would probably best include an assertion that one of ordinary skill in the art would have understood that the disclosed tablet includes a processor and should probably point out that without a processor, what would the user be interacting with and what would generate the displays, etc….

      1. that argument would probably best include an assertion that one of ordinary skill in the art would have understood that the disclosed tablet includes a processor and should probably point out that without a processor, what would the user be interacting with and what would generate the displays, etc…

        But displaying information about some artist’s music on the display … totally not obvious! Because … “investors” and their s00per serious”expectatations.” S00per techn0!

        You gotta love it when the truth leaks out.

      2. Les, I think your tablet example is helpful for exploriring what is “implicit” in any given disclosure.

        But I think there is a difference between what is implicit and what is inherent, especially in chem/bio. For example, it is inherent that the analgesic aspirin also has a blood-thinning effect but not implicit from the text you get with a packet of aspirin tablets.

        I think I know what “explicit” and “implicit” means, in the context of any given documentary disclosure. I’m still not sure though, that I understand the concept of inherency.

        1. But I think there is a difference between what is implicit and what is inherent, especially in chem/bio

          I think that you have contradicted yourself, as elsewhere you have indicated that the two are the same (with your comment that in EPO land you use “implicit” instead of “inherent”).

          You appear to be leaning too much on the “written word.” What the concept is about is not about the written word, but about the item that the written word carries with it (as an item).

          To this end, I think that your earlier statement about using “implicit” instead of “inherent” is simply not correct, and that you are indeed not understanding inherency and confusing it for what you are familiar with.

  3. disclosed in a way that clearly allows a person of ordinary skill to recognize that the inventor invented what is claimed and possessed the claimed subject matter at the date of filing

    Of course, if the identity of the amino acids in the tail were so “clear” to those of “ordinary skill”, it’s kinda odd that they weren’t recited in the first place. Must just been an oversight …

      1. Right.

        The application drafters thought “Should we disclose the clear identity of these amino acids… or … or ….. or should we not disclose them and create several hundred thousand dollars of additional expense for ourselves, not to mention the lost time we could be spending on other stuff? Oh, what the heck, let’s go with option two this time!”

        I’m sure that’s how it played out.

          1. Anon bro, this might be hard for you to hear, but most everyone can’t see your emoticons, they just show up as boxes usually. Once in a blue moon your emoticons actually show up. I’m guessing it’s the more complicated ones that don’t show up, and the more basic ones that might occasionally be seen properly.

              1. Hmmm,

                If 6 cannot see the emoticons because of the setup of the Office,..

                And others outside of the Office can easily see the emoticons …

                (another point 6, is that the emoticons are made by Prof. Crouch’s site – I merely type the “old world” equivalent and the site transforms them into the emoticon – the Winkie is actually typed as semi-colon, hyphen, close round bracket)

                And if Malcolm cannot see the emoticons…

                Perhaps Malcolm works AT the Office…

                Meh, I really don’t care after all.

    1. MM, both the reference in the priority application “inherently” disclosed the full sequence. One would think that the priority disclosure should be recognized regardless of what the applicant said about the reference because with the earlier priority date, the reference is avoided.

      Back in the day, I was taught by a good professor to argue against a reference first, and only then filed one’s 131 affidavit, or assert priority. After reading your comments here and begin to wonder whether that was good advice.

      1. One would think that the priority disclosure should be recognized regardless of what the applicant said about the reference because with the earlier priority date, the reference is avoided.

        It’s a bit odd, tho’, to make an argument about the prior art reference at all if one’s disclosure is so … “clear.”

        And I’m still unsure about what exactly was disclosed in the prior art reference I discussed in comment 4 (e.g., the prior art that disclosed a protein with the same source, weight, and function as the protein claimed in the ’915 patent — different from the Englemann reference). Does TBP-I weigh the same as TBP-II?

  4. From the decision: [W]hen a specification describes an invention that has certain undisclosed yet inherent properties, that specification serves as adequate written description to support a subsequent patent application that explicitly recites the invention’s inherent properties.

    Down below, AtariMan praises this case as providing “a bit of consistency in US patent jurisprudence.” Will that “consistency” be checked at the door when an undisclosed but inherent property of an obvious combination is at issue? Presumably so …

    Also, when I read the decision, this bit jumped out at me:

    Yeda asserts that the amino acids missing from the ’072 application are material [and therefore can’t be filled in by inherency] because Abbott relied upon their absence to distinguish the prior art during prosecution of the ’915 patent.

    The apparent basis for this argument is an earlier CAFC case, Hitzeman v. Rutter, 243 F.3d 1345, 1355 (Fed. Cir. 2001), which states (according to Yeda, and the panel here does not object to this statement of law): in the context of priority determinations, the allegedly inherent limitation cannot be material to the patentability of the invention.

    So here’s the summary of the facts:

    The prosecution history, however, does not support Yeda’s argument. During prosecution of the ’915 patent [the patent at issue here] the examiner rejected claims based on prior art that disclosed a protein with the same source, weight, and function as the protein claimed in the ’915 patent [i.e., TBP-II]. Abbott relied on the Engelmann article [Engelmann is the prior art reference that anticipates if there is no inherent disclosure in the priority apps] to argue that the cited art concerned only TBP-I, and that TBP-II includes a sequence of five amino acids not present in TBP-I that match the chain recited in the ’915 patent claims. Abbott’s response did not solely rely on amino acids missing from the priority applications; three of the five amino acids disclosed in Engelmann were disclosed in the ’072 application [the priority application for the patent at issue here] and were themselves sufficient to distinguish TBP-I from TBP-II. [emphasis added; my comments in brackets]

    Therefore (apparently) the inherent disclosure is “not material to patentability.” Can anyone follow the CAFC’s reasoning here? It’s perfectly opaque to me. What’s most mysterious is how it’s possible that the cited art could disclose a protein from the same source, with the same molecular weight and function as the claimed protein and not inherently anticipate, but reliance on the same properties to distinguish their claim isn’t “material” because … the reliance was only partial? What?

    Lastly, where does Myriad fit into this?

    1. where does Myriad fit into this?

      One requirement: WD
      Another requirement: possession

      Both satisfied through the inherency doctrine.

      1. I do not think that WD and possession are separate requirements. The whole point of the WD requirement is to make sure that the applicant had possession of the claimed invention (i.e., had really invented it) at the time of filing.

        How do we know whether the applicant had possession? Because the applicant provides a written description of it in the application.

        Possession and WD are just two sides of the same coin.

        1. I would think that most people would have agreed with you prior to (but not after) Ariad.

          I presumed Malcolm simply mistyped the case name…

            1. I think that he was – but switched when you pointed out the mistake. See below (some people simply cannot admit their simple errors – even when that simple error might just be a typo)

              1. I think that he was – but switched when you pointed out the mistake.

                ROTFLMAO

                It’s always a blast when we get the opportunity to glimpse the inner workings of “anon’s” awesome brain.

      2. Incidentally, I am also unclear why you are talking about WD in relation to Myriad. Myriad was about subject matter eligibility, not WD.

        I suppose we will never find out about the Myriad compliance of these claims, because they expired already, so unless Yeda was selling the claimed protein back during the patent term, there will not be an occasion for Yeda to defend against an infringement suit on the basis of ineligibility under Myriad

        To my mind, the Myriad holding was super narrow: “It is important to note what is not implicated by this decision… We merely hold that genes and the information they encode are not patent eligible under § 101 simply because they have been isolated from the surrounding genetic material,” (italics in original, boldface added). In other words, proteins were not in the case, so the holding does not reach proteins (as claimed by Abbott).

        I suppose that Roslin extended the Myriad holding to whole organisms, but technically the holding has not yet been extended to isolated proteins. In other words, it is not 100% clear that Abbott’s claims should be regarded as ineligible under § 101.

        1. it is not 100% clear that Abbott’s claims should be regarded as ineligible under § 101.

          I’m quite sure that the PTO would disagree with that.

          The eligibility of a naturally occuring protein distinguished only the basis of its being “isolated” seems highly suspect if you take Myriad’s reasoning on its face (which maybe you don’t because you didn’t put it in bold).

          Roslin extended the Myriad holding to whole organisms,

          Indeed. Kind of an obvious extension.

        2. I am also unclear why you are talking about WD in relation to Myriad.

          I was just asking an obvious question about some claims directed to an isolated naturally occurring protein.

          It’s a patent blog, with a comments section. For people to comment in. Basic stuff.

          1. Ah, so it was not a typo…

            The way that you asked the question was as if someone had already mentioned the case. Since you added zero context to your question as to clue anyone that you were discussing a new topic and all…

  5. So…

    Does the person who invented the first “general purpose computer” get to lay claim to all future improvements to the computer that come by way of software?

    (Why that’s rhetorical Dr. House, as Mr. Morse already answered that)

    😉

  6. Below is what I typed yesterday in the Bits & Bytes thread:

    “Paul, I’m curious. The notion of what any given document (X) “discloses”: does it vary depending on whether the document is i) a patent application (A) as filed, ii) a priority document (J) under the Paris Convention, iii) a US provisional (P) whose priority is declared or iv) a search reference (D1) cited against novelty?

    You see, to provide a level playing field on which rival filers in any FtF System sort out who gets what, the Definition of “disclosure” has to be identical four all of i) to iv).

    It is in Europe, but is it under the AIA? Perhaps not yet. But in the end it will be.”

    And then, suddenly, we have Yeda v. Abbott. Is this Decision a solid step in the required direction?

    Atari, you mention “Rasmussen” but Reyna does not. What is Rasmussen, may I ask?

    1. Max, it’s actually spelled “Rasmusson” (my mistake in my original comment), a 2005 CAFC decision that’s one of a line of cases that says “The standard for what constitutes proper enablement of a prior art reference for purposes of anticipation under section 102, however, differs from the enablement standard under section 112.” link to scholar.google.com

      Strictly speaking, I was premature (or in error) in comparing Rasmusson to this case, since the question in Rasmusson (enablement, and whether the same standard applies for enablement in a priority application vs enablement in a prior art reference) wasn’t the same question in the Yeda v Abbott case (whether or not the written description requirement can be met by inherent disclosure in the priority application). I am nevertheless relieved that the court did not create a similarly bifurcated rule with respect to written description.

  7. Imagine that! Instead of a double-standard (ala Rasmussen), something that would inherently anticipate also inherently meets the written description requirement. A bit of consistency in US patent jurisprudence? What’s the world coming to?

    Fortunately, thanks to SCOTUS, the PTAB/court dichotomy for claim construction will be around for a long time to keep the inconsistencies alive.

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