Integration Analysis Dooms Patent’s Written Description

By Dennis Crouch    

Novozymes A/S v. DuPont Nutrition Biosciences (Fed. Cir. 2013)

At trial, the jury sided with the patentee Novozymes on the issue of validity – finding that DuPont had failed to prove “by clear and convincing evidence that any one or more of the claims are invalid because the application filed on November 16, 2000 . . . does not contain an adequate written description.” Following the verdict, however, the district court judge rejected the jury verdict and instead held that, as a matter of law, the claims lacked written description support. On appeal, the Federal Circuit now affirms – finding that no reasonable jury could find the patent valid.

The written description requirement of 35 U.S.C. § 112(a) mandates that a patent application’s written description must ‘clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.’ Vas-Cath. The requirement questions whether the inventor was in possession of the claimed invention at the time the patent application was filed.

In this case, Claim 1 of the invention is directed to an alpha-amylase enzyme variant with a 90%+ sequence identity to BSG alpha-amylase, an amino acid substitution at serine 239, and increased thermostability at pH 4.5, 90°C, and 5 ppm calcium. The enzyme is used to make ethanol.

The original patent application describes each element of the claimed invention. However, the application does not particularly identify this particular combination of limitations. Rather, the application lists BSG along with six other types of alpha-amylase; lists the 239 position mutation along with 32 other potential mutation positions; and indicates broader ranges for thermostability of 4.5-5 pH and 85-95°C. U.S. Patent No. 7,713,723.

In considering whether the description was sufficient, the Federal Circuit considered the claimed invention “as a integrated whole” rather than merely element by element:

While the 2000 application provides formal textual support for each individual limitation recited in the claims of the ’723 patent, it nowhere describes the actual functioning, thermostable alpha-amylase variants that those limitations together define. Taking each claim—as we must—as an integrated whole rather than as a collection of independent limitations, one searches the 2000 application in vain for the disclosure of even a single species that falls within the claims or for any “blaze marks” that would lead an ordinarily skilled investigator toward such a species among a slew of competing possibilities.

The court makes clear here that written description is not satisfied merely by ensuring that each individual claim limitation is disclosed in the original disclosure. Rather, the written description requires disclosure of the patented claim as a whole.

Although strongly worded, this case is one in a spectrum of written description cases and thus only incrementally moves the law.

The majority opinion was written by Judge Schall. Chief Judge Rader wrote in dissent – arguing that substantial evidence supported the jury verdict.

72 thoughts on “Integration Analysis Dooms Patent’s Written Description

  1. It’s Really frustrating to read all of the nonsense posted by individuals who get this blog a day before the rest of us. It’s clear that you are all academics with no real experience in court. Or retired. Either way,how do you have the time to read the cases and make such extensive arguments?

    Liberty Lobby doesn’t apply because it considered a rule 56 motion for summary judgment brought before trial.

    In the case at hand, a JURY Received the evidence and made a decision on invalidity. The law requires that the court can countermand the jury’s decision -by a JNOV-only if it is clearly erroneous. Or should I say, that is a long acceptancd rule except in the rarefied cosmos of the Federal Circuit in connection with patents

  2. anon, of course you are so right about everything you stated above. No one in the anti patent crowd on this blog has ever accepted the challenge to apply “Integration Analysis” according to the USPTO Official Guidance, to Ultramercial’s claims.

    They fear the topic because it does toast their various anti patent agenda’s and theories, from mental steps test, MoT requirements, to Abstract idea/ Gist of invention hunting, and so on.

    None the less we continue to advance as they fall further and further behind.

  3. anon: “Prepare for the h@ters…”

    Let them come. In fact every since my interpretation of the Prometheus case as upholding an “Integration Analysis” and the subsequent restating of that interpretation by the USPTO, I have invited everyone to apply “Integration Analysis” to Ultramercial’s claims using the Office guidelines. I even invited the anti patent establishment in this blog to criticize, debunk, or discredit the analysis. To date none have dared to accept. Their silence speaks volumes.

  4. NWPA: “I wouldn’t be surprised if the CAFC clerks picked up on your analysis.”

    Indeed, I have been tracking the use of “Integration Analysis” since the Prometheus decision and pleased to see the analysis being used more and more in patent law as well as policy at the PTO. The doctrine of “Integration” is an important cornerstone in the foundation of the statutes broad eligibility provisions.

    Integration Analysis Table of Authorities 2012-2013

    All nine Justices of the Supreme Court of the United States:
    ” In Diehr, the overall process was patent eligible because of the way the additional steps of the process “INTEGRATED” the equation into the process as a whole. 450 U. S., at 187. These additional steps transformed the process into an inventive application of the formula. ) [MAYO COLLABORATIVE SERVICES v. PROMETHEUS LABORATORIES, INC 566 U. S. (2012) 3 Syllabus] (Emphasis Added) ”

    “The Majority Justices of the Court of Appeals Federal Circuit
    Taking each claim—as we must—as an “INTEGRATED WHOLE” rather than as a collection of independent limitations, one searches the 2000 application in vain for the disclosure of even a single species that falls within the claims or for any “blaze marks” that would lead an ordinarily skilled investigator toward such a species among a slew of competing possibilities.” Novozymes A/S v. DuPont Nutrition Biosciences (Fed. Cir. 2013) (Emphasis Added)

    Chief Judge Rader, and the dissenting panel of CLS Bank V Alice:
    “Here, the claim recites a machine and other steps to enable transactions. The claim begins with the machine acquiring data and ends with the machine exchanging financial instructions with other machines. The “abstract idea” present here is not disembodied at all, but is instead “INTEGRATED” into a system utilizing machines. In sum, the system claims are indistinguishable from those in Diehr. For these reasons, the system claims are not directed to patent ineligible subject matter.” 38 CLS BANK INTERNATIONAL v. ALICE CORPORATION (Emphasis added)

    Dennis Crouch, Associate Professor University of Missouri School of Law:
    Most Section 101 subject matter eligibility problems can be cured by “INTEGRATION” the ineligible subject matter with subject matter that is patent eligible. This works because the fact that an invention encompassing some ineligible material does not preclude patentability – as long as the invention also includes sufficient eligible subject matter. Following this theory, the Supreme Court in Diamond v. Diehr, 450 U.S. 175 (1981), agreed that a practical use of a mathematical formula was patentable even though the formula on its own would not have been subject matter eligible. [Patents Encompassing a Human Organism] Patently O, The Nations leading patent blog. ] (Emphasis Added

    
Andrew H Hirschfeld, Deputy Commisioner of Patent Examination Policy:
    “ D. INQUIRY 3: Practical Application and Preemption
    Does the claim include additional elements/steps or a combination of elements/steps that “INTEGRATE” the natural principle into the claimed invention such that the natural principle is practically applied, and are sufficient to ensure that the claim amounts to significantly more than the natural principle itself? (Is it more than a law of nature + the general instruction to simply “apply it”?) ……A claim that focuses on use of a natural principle must also include additional elements or steps to show that the inventor has practically applied, or added something significant to, the natural principle itself. See Mayo, 101 USPQ2d at 1966. To show “INTEGRATION”, the additional elements or steps must relate to the natural principle in a significant way to impose a meaningful limit on the claim scope. ….. It is not necessary that every recited element or step “INTEGRATE” or relate to the natural principle as long as it is applied in some practical manner. However, there must be at least one additional element or step that applies, relies on or uses the natural principle so that the claim amounts to significantly more than the natural principle itself. Elements or steps that do not “INTEGRATE” the natural principle and are merely appended to it would not be sufficient. In other words, the additional elements or steps must not simply amount to insignificant extra-solution activity that imposes no meaningful limit on the performance of the claimed invention. See id. at 1966” [link to uspto.gov ] (Emphasis Added

  5. Query said: “Claims are not evaluated as a whole but as old elements + mental steps.” Is that contrary to Ultramercial II?

    101 Integration Expert: Yes. Rader in Ultramercial basically adhere’s to the statute and takes the approach that Ultramercial’s process claims are presumptively “integrated”. There is no ignoring element or steps.The claims are evaluated as an “inseparable integrated whole”. Since the claims are a process under 35 USC 101 and meet the definition of Process under 35 USC 100(b) the claims are physical and not abstract. However this does not mean the claims pass 101 and are statutory subject matter. The Supreme Court has created exceptions, derived implicitly from the statute. Therefore me must ask 3 more questions as required by the Court.

    1. Are the claims a Law of Nature? The answer is, no

    2. Are the claims a physical phenomenon?
 The answer is, no.

    Are the claims a mathematical equation or formula representative of a Law of Nature, Physical Phenomenon, or other “scientific” truth? The answer is, no. In such a special case as when the answer is yes, in addition to the mathematical equation or formula, the claim would need at least one additional step that limited the process so that the claims as a whole (integrated) did not pre-empt the LoN, Natural Phenomenon, or “scientific” truth. Furthermore, if the additional step(s) were added and the LoN, Natural Phenomenon, or scientific” truth itself were still pre-empted by the claim as a whole, the additional steps would be counted as extra-solution activity, and the claims would still fail 101.

    3. Do the claims recite an intellectual concept of a fundamental truth; an original cause or a motive? The answer is, no.

    In which case we are now required by law to take the claims as an inseparable “integrated” whole and determine if they are new and useful, if so they pass 101 and we proceed to the other sections of title USC 35, to see if they those conditions and requirements are met.

  6. I wouldn’t be surprised if the CAFC clerks picked up on your analysis. That opinion may have come from you.

  7. Dennis wrote: “In considering whether the description was sufficient, the Federal Circuit considered the claimed invention “as a integrated whole” rather than merely element by element”

    Well, well, well. Look how far we have come since I first introduced the concept of “Integration Analysis” to the blog. At first I was attacked and ridiculed by the anti patent establishment. 6 called me a t-a-r-d for focusing on one word, “integration”. MM waved his hands and said it was simply dicta from Prometheus. Ned, for some time completely ignored it until he could find a way to twist it into his usual mantra of MoT. (Which he has failed miserably at I might add). Now we see “Integration Analysis” , just as I defined it, working it’s way into the mainstream judiciary and being used as arguments by the CAFC, just LIke I predicted. As we move software, and eventually another so called business method case back up to the Supreme Court I predict we will see the Court upholding one or more of these types of cases as statutory subject matter, because as the Court has repeatedly told us, that with the limited exceptions of a manifestly claimed law of nature, physical phenomenon, or abstract intellectual concept, a process standing alone is statutorily integrated. No one can refute that.

  8. anon: “maybe he needs a link to the Office interpretation of the Prometheus decision…Anyone have an extra one of those?

    Sure, link to uspto.gov

    Also, the Supreme Court is explicit and adamant that in the concluding analysis one must consider the claimed invention “as a integrated whole” rather than merely element by element.

  9. Didn’t go through, so I’ll try again:

    Wondering about how the jury could have come to the view that N “possessed” the invention in dispute, the thought occurred to me that the notion of “possession” as being something one possesses, ie, property. That would echo the idea of a patent as property, how much of it you’ve got being defined by the reach of your claim.

    So, if the claims filed by N right back at the beginning were wide enough to cover the invention that has come under consideration all these years later, then a jury person might be forgiven for concluding that N was already “in possession of” today’s subject matter ever since right back then.

    People often confuse commercial obviousness with technical obviousness. What to do to enhance technical performance in a device is often obvious to the PHOSITA but not to a product manager concerned only with commerce.

  10. Didn’t go through, so I’ll try again:

    Wondering about how the jury could have come to the view that N “possessed” the invention in dispute, the thought occurred to me that the notion of “possession” as being something one possesses, ie, property. That would echo the idea of a patent as property, how much of it you’ve got being defined by the reach of your claim.

    So, if the claims filed by N right back at the beginning were wide enough to cover the invention that has come under consideration all these years later, then a jury person might be forgiven for concluding that N was already “in possession of” today’s subject matter ever since right back then.

    People often confuse commercial obviousness with technical obviousness. What to do to enhance technical performance in a device is often obvious to the PHOSITA but not to a product manager who has to sell at a profit. So with “possession”. It means different things to different people.

  11. Wondering about how the jury could have come to the view that N “possessed” the invention in dispute, the thought occurred to me that the notion of “possession” as being something one possesses, ie, property. That would echo the idea of a patent as property, how much of it you’ve got being defined by the reach of your claim.

    So, if the claims filed by N right back at the beginning were wide enough to cover the invention that has come under consideration all these years later, then a jury person might be forgiven for concluding that N was already “in possession of” today’s subject matter ever since right back then.

    People often confuse commercial obviousness with technical obviousness. What to do to enhance technical performance in a device is often obvious to the PHOSITA but not to a product manager who has to sell at a profit. So with “possession”. It means different things to different people.

  12. That’s the safest approach, Stuart, from a judicial resources standpoint. If the jury had agreed with him, then the judge wouldn’t have needed to make his ruling at all. The jury didn’t, but since he got a jury verdict on the record, the judge ensured that no new trial would be need, regardless of the Federal Circuit’s decision. If the Federal Circuit had decided to reverse the judge, that would have simply reinstated the jury verdict.

  13. In the decision. why did the Trial Judge allow the case to go to the jury if he knew, upon closing, the claims were defective “as a matter of law” under 112?

    And, BTW, Dennis: this forum has become a venue for cranks posting daily childish insults. Or do you not care?

  14. Paul,

    I take it that you were not an actual engineer, but rather, were either a scientist or had the background training in science and engineering.

    duty to check, question, seek for workable variants do everything that a research supervisor, referee or independent examiner would do

    No. Again, not in the same way that the patent legal document is derived. Yes, the tools are similar, but the aim is different and based on the function of the job. IF there was no difference, THEN you would not need the team of both the engineer/scientist and patent lawyer.

    Other than that, it appears that we are just wrestling with semantics.

  15. What do you mean beyond good scientists and good lawyers? Obviously in context the law is patent law.

    The FIRST job of a lawyer is to find the facts on which advice is to be given and action taken. That requires the SCIENTIFIC or ENGINEERING enquiries that are mentioned in the earlier comment. We can only work on a sound factual base, and incorporation of arm-waving speculation, inadequately described embodiments and the like is valueless and insofar asd many of us are happy to go along with ane embellish this unfounded speculation it discredits the patent system as a whole and damages our entire profession. Is anyone proud that Bilski went to the Supremes?

    The facts are the primary responsibility of the inventor(s) but the patent attorney has a duty to check, question, seek for workable variants do everything that a research supervisor, referee or independent examiner would do. As I have said on numerous occasions, patent attorneys and inventors form a drafting team and both must contribute their maximum effort and skill.

    When we know the facts, we can carry out our legal analysis and produce the specification for filing. But a specification based on poor facts is noty litigation ready, and all the effort pout in later on during prosecution and litigation will be valueless if the underlying document is not of the required quality.

  16. >
    > 6: “analyze the claim as a whole, forbodin from ever analysing the
    > claim’s various parts for their effect on the whole.”
    >
    > The proposition of “Integration Analysis” which the Court held as law
    > in Diehr, is essentially that the claims MUST be considered as an
    > “inseparable whole.” Yes, you look at the individual steps and their
    > effects, in your analysis, but you are forbidden to strip away,
    > ignore, and essentially “read out” of the claims any steps, or
    > elements you deem to be ineligible subject matter in your conclusion.
    > The dissent in Diehr argued against adapting such an analysis as law.
    > The dissent of course lost. See the Court admonishing the dissent and
    > setting the record straight on the law:
    >
    > “In order for the dissent to reach its conclusion, it is necessary for
    > it to read out of respondents’ patent application all the steps in the
    > claimed process which it determined were not novel or “inventive.”
    > That is not the purpose of the § 101 inquiry, and conflicts with the
    > proposition, recited above, that a claimed invention may be entitled
    > to patent protection even though some or all of its elements are not
    > “novel.” [ Diamond v Diehr, Id. at 406 U. S. 521-522 (footnote
    > omitted).]
    >
    > Likewise you are not allowed to go on a witch hunt for the spooky
    > spirit, gist, or abstract idea of the invention. This was expressly
    > forbidden by the Court in Aro Mfg. Co., Inc. v. Convertible Top Co. -
    > 365 U.S. 336 (1961);
    >
    > And finally, you are not allowed to ignore “process” as an independent
    > category by applying “Integration” only to machines, or iron age
    > transformations, as Ned Heller has proposed. This was expressly
    > forbidden by the Court in Bilski. Inseparable whole, means
    > “inseparable” whole, Integrated.

  17. (sigh) 101 does not have this prior art ‘known-ness’ thing you keep on trying to insert.

    Go back and review my discussions on the Myriad case.

    As for ‘functional claiming,’ as I mentioned Ned, this is one of your canard-crusades.

    Please stop now.

  18. From earlier discussions here, I was lead to believe that those skilled in the art would know the structure of the isolated DNA from the protein

    That’s true in the case where the natural coding DNA for a given protein sequence does not include intervening or otherwise non-expressed DNA sequences (e.g., “introns”).

    the claim had many problems beyond 101

    Yes, and these problems were discussed at length by myself and many other people. In addition to the problems you mentioned, the problems include anticipation and obviousness. The anticipation issue, in fact, is closely related to the 101 issue, insofar as the impact of the composition claims on practitioners of the prior art methods for studying DNA compositions flows directly from the fact that the claims were broad enough to cover molecules necessarily created by researchers prior to Myriad’s “discovery” of the detailed structure of one or two sub-sequences.

  19. anon, if one claims structure by what it does, one is functionally claiming that structure. If the structure is the invention, not the function, then the claim is indefinite.

    The problem here, as I see it, is that the coding for BRC1 protein was the invention. If a person had gene that coded for that protein, that person was at risk. It really didn’t make any difference what the structure of the DNA was.

    So, the question really is, how do I claim the invention? Couldn’t I simply claim the protein? Or, what that known?

  20. “I’m not aware that method claims were at issue.”

    Indeed? Well I suppose they haven’t even come close to claiming what they subjectively believe the invention to be. Apparently it was the finding that was the “inventive step”.

  21. In reply to Anon, we owe it to our clients to be good scientists or engineers AND good lawyers

    Still NO, Paul.

    In reply, we owe it to our clients to be good patent lawyers.

    There is a difference.

  22. Paul, if I understand you, Myriad had claimed all isolated DNA that coded for BRC1 protein, while not disclosing even one example, or any method of obtaining that one example.

    From earlier discussions here, I was lead to believe that those skilled in the art would know the structure of the isolated DNA from the protein, but apparently my understanding was not correct. What they patented, it appears, was a research plan for finding the structure of isolated DNA, and for a process of isolating that structure.

    If this is the case, the claim had many problems beyond 101. These include issues relating to written description, enablement, and with definiteness because of functional claiming.

  23. LOL – good question Query.

    101 Integration Expert asked Malcolm long ago to apply the Office protocol resulting from the Prometheus decision to Ultramercial.

      1) yes, the very protocol that Malcolm danced a jog and was the first to post on this blog, the same one that ignores his now very burnt pet theory and instead reitereates 101 Integration Expert’s views
      2) Malcolm (along with the rest of his little circle club) flat out refused to approach the Ultramercial claims with the Office protocol.
      3) The only one(s) that ever postualted that nor burnt pet theory of Malcolm’s was Malcolm himself – and his dissembling svckpuppets – and yet, Malcolm QQ ed incessently about “svckies” on this blog – the hypocrite.

    Further, the same little circle members have no issue with getting on their QQ soapbox and spewing the same CRP without actually addressing the points raised against their views.

  24. “Claims are not evaluated as a whole but as old elements + mental steps.”

    Is that contrary to Ultramercial II?

  25. I have not had a chance to look at the specification in this case and see how it ties in with the earlier Myriad and Wyeth cases. But I strongly suspect that the same underlying fact pattern is common to all of them.

    If we go back to Myriad, the company had indeed isolated the cDNA for BRCA1 and had deposited it with a recognized depository. That may be a powerful reason why the Supremes were prepared to accept that claim.

    Why did the Supremes not buy the concept that cut chemical bonds were important? Possibly because Myriad had not reported cutting the BRCA1 native DNA from the surrounding DNA and had no way of actually isolating that native DNA. All they had was a computer-constructed partial sequence of the gene. Here is what Judge Bryson said about it in the CAFC:

    “Aside from Myriad’s cDNA claims, its composition claims are not defined by any
    particular chemical formula. For example, claim 1 of the ’282 patent covers all isolated DNAs coding for the BRCA1 protein, with the protein being defined by the amino acid sequence encoded by the naturally occurring BRCA1 gene. From a molecular perspective, that claim covers a truly immense range of substances from the cDNA that is 5,914 nucleotides long to the isolated gene that contains more than 120,000 nucleotides. And the patent does not define the upper end of that range be-cause the patent does not identify a unique nucleotide sequence for the 120,000-nucleotide-long isolated BRCA1 gene. Instead, the patent contains a sequence that is just 24,000 nucleotides long with numerous gaps denoted “vvvvvvvvvvvvv.” ’282 patent, fig. 10. An almost incalculably large number of new molecules could be created by filling in those gaps with almost any nucleotide sequence, and all of those molecules would fall within the scope of claim 1. Included in that set are many important molecular variations to the BRCA1 gene that Myriad had not yet discovered and could not have chemically described. Yet those molecules would share only one unifying character-istic: each would code for the same protein as the naturally occurring BRCA1 gene.”

    On the evidence Myriad no more had possession of a real BRCA1 gene than the University of Rochester had possession of a real COX2 inhibitor. In both cases what was claimed was no more than the result of a thought experiment – a truly reach-through claim. No wonder that two of the CAFC judges and all the Supreme Court judges did not buy into the proposition.

    So what should be our professional aims? In my submission to obtain soundly supported litigation-ready patents. In reply to Anon, we owe it to our clients to be good scientists or engineers AND good lawyers. We should strive to protect what is known or soundly predictable, we should not strive to protect what is merely speculative, and we need both to know the difference ourselves and to educate our clients about its importance. As Richard Feynman memorably said, nature is not fooled.

  26. MM, thanks for your posts in this area. I am educated.

    My take on this case:

    1. It is well known that if I disclose a range and the prior art is in the range, I cannot limit my claim to a sub range without a disclosure of that sub range. The sub range is new matter.

    2. This case takes point 1 one step further: if I later discover, after filing, that the sub range is really important, I cannot later add claims to the sub range without adding new matter.

    3. One can deduce that later claims to non disclosed species of any stripe violate written description.

  27. LOL – talk about lack of reading comprehension…

    Try again Malcolm (we are not discussing things going into deciding Myriad – even though you have spent tend of thousands of words trying to do that and evidently STILL are trying to come up with spin – we are talking about the fallout of the actual decision (you know, the decision – and reasoning – that I got right and you, well, still don’t get right)).

  28. “The jury heard expert testimony that “finding the position
    where you can make a beneficial mutation is, in fact, the inventive step,””

    I wonder if such a step was claimed

    I’m not aware that method claims were at issue. In addition, the facts cited by the majority suggest that at the time of the speculative provisional filing, the defendant had already identified the site of such a beneficial mutation and was selling an enzyme modified at that position.

  29. Was that facetious or srs?

    Serious. Also consistent with my many previous observations about said company. It’s a loathesome corporation and I look forward to its demise. It can’t happen soon enough.

  30. Sure do brosef.

    Though I do not apply it in the same manner as some people do where you are, in addition to having to analyze the claim as a whole, forbodin from ever analysing the claim’s various parts for their effect on the whole. Some such folk are known around here, integration expert and other tar ds of this ilk that have reading comprehension problems regarding Diehr fall into this category.

  31. “The jury heard expert testimony that “finding the position
    where you can make a beneficial mutation is, in
    fact, the inventive step,””

    I wonder if such a step was claimed, or if the applicant did indeed claim that which he subjectively believed to be his invention?

  32. “Although a separate written description requirement,
    and the vague notion of “possession” that it embodies, still
    troubles me, see Ariad Pharm., Inc. v. Eli Lilly and Co.,
    598 F.3d 1336, 1361 (Fed. Cir. 2010) (Rader, J., dissenting-
    in-part and concurring-in-part),”

    Rader is so hilarious sometimes.

  33. Meh, I’ve been applying the claims as a whole standard to WD determinations for years now. Nothing all that special.

  34. I usually agree with Prof. Crouch’s editorial comments, but I have to disagree with his “only incrementally moves the law” comment.
    I will need to check some precedent, but at first blush this seems to be a highly significant change in perspective.

  35. LB, this passage gets at the “predictability” issue:

    [R]ational protein design and random mutagenesis … identified thirty-three Bacillus alpha-amylase amino acid positions as targets for mutation in attempting to create alpha-amylase variants with enhanced stability. Of those thirty-three positions, seventeen were predicted using rational protein design techniques, while sixteen were identified via random mutagenesis experiments

    So DuPont was able to “predict” just half the number of amino acid “target” positions that actually existed (based on their definition of “target”). Note that those were just potential sites where stabilizing mutations could be inserted. That’s all that was disclosed in the provisional. Later it was shown (but not disclosed) that several target positions that were “predicted” were not useful at all or required very specific (but unknown to the applicant) amino acidsubstitutions at the “predicted” site.

    On top of that, the provisional disclosure covered modified enzymes that the defendant was already using! Too funny.

    Kudos to the judge in this case for ignoring the juries mindless conclusion. Of course, it’s probably the case that the jury was misled by the attorneys for the patentee who undoubtedly drilled them repeatedly about how many children were saved by their awesome “invention.”

  36. It is not that you are using the technical knowledge to which my post addresses, but to the ROLE to which the technical knowledge is being applied.

    Keep digging, anon. The ROLE to which Paul refers referring is the ROLE of “patent agent reviewing an invention disclosure.” Are you really still arguing that clients don’t pay patent agents to apply their technical knowledge when acting in this ROLE? Or are you just refusing (once again) to admit that you said something really silly as a result of your obsessive need to pick nits in even the most innocuous of comments?

  37. in this case the patentee made a big deal about how predictable this field was. Was this an accurate portrayal, or not?

    Well, a vast number (most?) of the molecules covered by that claim are not going to possess the recited functional property so in that sense it is “highly predictable”. ;)

  38. I’ll reiterate what I wrote above: in general, but especially in the unpredictable arts, be very wary …

    As I recall, in this case the patentee made a big deal about how predictable this field was. Was this an accurate portrayal, or not?

  39. As far as we know from the case, the application did a fine job describing what the inventors actually possessed.

    I’ll reiterate what I wrote above: in general, but especially in the unpredictable arts, be very wary about relying on functional limitations where the relationship between the recited structure and recited function is not 1:1 and where the specification does not provide ample and convincing evidence of that relationship.

    Some Examiners are very rigorous about ensuring that claims with the problems in this case do not issue. Others … less. As ever, you are likely to be pushed into a narrower (but valid) claim space that covers only the composition that was actually created and tested. At the very least, be sure that you have solid written description support for that composition.

  40. To what extent or under what circumstances would claim scope extend to the embodiment X(2), Y(2), and Z(2)? Under what circumstances would claim scope not extend to that embodiment because of a lack of written description?

    Written description would bite the applicant in circumstances where the prior art disclosed the generic widget (or rendered the generic widget obvious) and the specific widget is (argued to be patentable) because of unexpected properties that are not associated with that specific widget in the specification.

    Although the applicant’s hand may have been forced in this case by the prior art, the recitation of the specific functional limitations in this instance was a fatal error. The applicant might have been better off leaving those limitations out and arguing in a declaration that post-filing data showed unexpected results for compositions with the claimed structure. That practice (unfortunately) has been given the stamp of approval by the Federal Circuit and would have avoided the written description issues raised here.

    For those not skilled in the art, I will note that “90% sequence identity” for a modified protein (especially where that protein was previously known) is an unusually low number and most Examiners will refuse to allow such a claim absent an extraordinary amount of data showing that all the variants covered by the claim actually possess the unexpected properties that are deemed to render the composition patent-worthy. “At least 95%” is a more typical number to see in such cases but even that number is suspect and subject to challenge.

  41. rushing the filing may be quite lethal under FtF.

    Rushing an important patent application filing is always a risk and this has always been the case. It’s certainly more of a risk in the EP but it’s a risk in the US as well.

  42. There are in fact ethical considerations in outlining the scope of your representation (albeit your ‘jab’ rather ignores this fine point).

    Of course there are, but none of them are triggered by Paul’s advice to bring our full critical faculties to bear when we read an invention disclosure.

    Your comment that “Your client is not paying you to be a scientist, is he?” strongly suggests that you’re a hack, assuming that you actually practice patent law at all. My clients are most definitely paying me for my combination of legal and technical skills.

  43. He has a good point, no?

    I think he has a fine point. I do not think that he has presented his point all that convincingly.

    he doesn’t reveal in it, does he, how he would have decided it if he had been on that jury

    Why would (or should) he? Such speculation is not typically forthcoming from a judge, is it?

    Because he is the CJ and what he thinks matters, no?

    No more – and no less – than any other judge of the CAFC (he does not get extra ‘judge’ points in any made decisions).

    hint: Retired Chief Judge Michel stepped down expressly because Michel thought he could be more effective (and do so ethically) off of the bench than from on the bench

  44. Perhaps, perhaps not. Let’s let a trier of fact decide.

    Oh wait, that happened and was overturned…

  45. it’s unethical to bring all of your talents to bear for the benefit of your client.

    That’s why I always send my clients a registered letter informing them that I’m not a scientist. Haven’t had any complaints yet. Haven’t gotten any replies, now that I think about it.

  46. Your client is not paying you to be a scientist, is he? Have you made clear to your client that this is part of what you are charging him for ?

    Yeah, Paul, because it’s unethical to bring all of your talents to bear for the benefit of your client.

  47. This case was filed 12 years before the AIA went into effect. I’m just saying.

    Oh, I know. I was just expressing my agreement with MD’s belief that the written description requirement is going to become increasingly relevant in court under the AIA.

  48. I agree, Paul, especially with your “Don’t write what you don’t know” aphorism. However, I don’t think this case provides any lessons about drafting. The case is about claims that were presented 9 years after the application was filed. As far as we know from the case, the application did a fine job describing what the inventors actually possessed.

  49. the most important words in your post are “or otherwise suggesting“”

    So important that the suggestive language became typical boilerplate language in direct response to the courts’ actions (note that I am NOT commenting on this as a ‘best practice’ or not, but rather merely pointing out certain realities).

    ps, it is never wise to blindly use boilerplate in any legal document

  50. we should scrutinise the inventor’s disclosure with the same attention that a journal referee should scrutinise a contribution to a peer-reviewed journal or an examiner should scrutinise a PhD thesis.

    Not quite, as the purpose of what you are doing is what directs the effort.

    We do not cease to be scientists just because we are attorneys and represetn clients.

    Your client is not paying you to be a scientist, is he? Have you made clear to your client that this is part of what you are charging him for ?

    Otherwise, good comments.

  51. Paul I would say that the most important words in your post are “or otherwise suggesting”.

    That said, the enquiry about “written description” is more of a novelty than an obviousness enquiry isn’t it? So even a “Suggestion” of ABC in the appln as filed might not be enough to constitute a written description of it, right?

  52. Most patent attorneys started out as scientists or engineers and then graft on legal skills.

    So before we start drafting patent applications, we should scrutinise the inventor’s disclosure with the same attention that a journal referee should scrutinise a contribution to a peer-reviewed journal or an examiner should scrutinise a PhD thesis. We do not cease to be scientists just because we are attorneys and represetn clients.

    If there was no individial disclosure of the now claimed heat-resistant alpha-amylase then general pointers do not suffice. Myriad did not have the BRCA native DNA either as an individual molecule, nor did they even have the full sequence. If we go back to Wyeth v. Abbot Labs which was recently noted in this blog, there were no variants in existence at the date that the patent was applied for, so the attempt to prove that rapamycin represented a genus was doomed to fail.

    As was said to me in my student days: “Don’t write what you don’t know.” An excellent rule for patent practitioners as well as practising scientists. Foreseeability as established in Festo makes the same point. We can cover for our clients what is known and what is rationally foreseeable but no more.

  53. Good questions anon.

    Yes Rader dissents here but on what ground? That the appeal instance should not second guess the jury on a question of fact. He has a good point, no? I haven’t read his dissent thoroughly yet but he doesn’t reveal in it, does he, how he would have decided it if he had been on that jury.

    Why watch him? Because he is the CJ and what he thinks matters, no?

  54. Yes, more than 20 years ago I was told by our EPO firm head that a U.S. provisional [or other] application disclosing features A through Z but never claiming or otherwise suggesting the specific combination of A+B+C as being the subject invention would not be likely to get priority benefit for that combination.
    Furthermore, the 112 written description requirement was an issue that could be raised in U.S. interference practice long before the Fed. Cir. finally clairified its distinction from 112 enablement for patents in infrngement suits.

  55. One could track AskPatents for info about competing patent applications, and try to invalidate them. (With the added bonus of clearer knowlege of what to avoid when filling own patent aplication..)

  56. So, no surprises here for me, except that the CAFC’s incremental course correction is emerging so soon. But with a bang. eh?

    MD, I think the penultimate sentence in Dennis’s post is right on. There’s nothing new here – the patentee over-reached by trying to reach back and identify the invention well after the fact, and the court caught them.

  57. The conventional knowledge with respect to the AIA is that it makes a powerful incentive for earlier filings. However, as this shows, rushing the filing may be quite lethal under FtF.

    This case was filed 12 years before the AIA went into effect. I’m just saying.

  58. The worst case scenario, here, is one in which claim coverage is limited to examples, drawings and other descriptions of integrated embodiments. I don’t think we are there, yet but we very well could be.

    Suppose we claim a widget comprising: an X, a Y, and a Z. X, Y, and Z are generics. Examples show widgets having

    X(1), Y(3), and Z(2)
    X(2), Y(1), and Z(3)
    X(3), Y(3), and Z(3)

    Where X(n), Y(n), and Z(n) are species. To what extent or under what circumstances would claim scope extend to the embodiment X(2), Y(2), and Z(2)? Under what circumstances would claim scope not extend to that embodiment because of a lack of written description?

  59. Not snark MaxDrei, but what is keeping an eye on Rader going to do? You do realize that he was in dissent on this decision, right?

  60. LOL – maybe he needs a link to the Office interpretation of the Prometheus decision…

    Anyone have an extra one of those?

  61. Hello RC. As you say, rushing to file is indeed “lethal” everywhere else in the world apart from the USA. That exactly is the dilemma: file to soon and you let the cat out of the bag and get no rights of your own, but file too late and your competitor turns out to have filed earlier and thereby has a valid patent that it can use against you.

    Bring back interference proceedings? Is that the answer for you, RC?

  62. MM says: No this can’t be right. Claims are not evaluated as a whole but as old elements + mental steps.

  63. “First to File ratchets up the paramount importance of what is the content on the PTO filing date. I expected this, as soon as the AIA was signed into law.”

    Me too, but strangely, none of the US colleagues to whom I suggested this seemed to understand my point. Maybe I didn’t make it clearly enough…

    The conventional knowledge with respect to the AIA is that it makes a powerful incentive for earlier filings. However, as this shows, rushing the filing may be quite lethal under FtF.

  64. Written description (USA 35 USC 112) = adding matter is prohibited (EPC, Art 123/2).

    First to File ratchets up the paramount importance of what is the content on the PTO filing date. I expected this, as soon as the AIA was signed into law.

    So, no surprises here for me, except that the CAFC’s incremental course correction is emerging so soon. But with a bang. eh?

    Just keep an eye on Rader, CJ. He is often conferring, in Munich.

  65. “The court makes clear here that written description is not satisfied merely by ensuring that each individual claim limitation is disclosed in the original disclosure. Rather, the written description requires disclosure of the patented claim as a whole.”

    Oh dear,

    To me, this sounds a lot like the European Patent Office’s approach to extension of subject-matter. It seems to me that US patent applicants are about to discover the joys of “intermediate generalisation”.

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