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« Nautilus, Inc. v. Biosig Instruments, Inc. (2014) | Main | Consumer Watchdog v. Wisconsin Alumni Research Foundation (Fed. Cir. 2014) »

June 04, 2014


Wow. Just wow. Wish there was some leadership at the PTO. Or at least some OPLA attorneys with enough common sense to figure this out as well.

Thank you for your excellent writing and your work here!

Paul Cole writes: "To paraphrase the recent opinion in Nautilus v Biosig, a rule of law derivable from an opinion should be precise enough to afford clear notice of what is intended, otherwise there would be a zone of uncertainty"

As has been noted, the Supreme Court fails their own proposed test on many - if not nearly all - patent law decisions.

We do not have the luxury of saying the decisions "don't count."


The difference you seek to make has already been stated as:

Difference in kind rather than difference in degree.

I think perhaps one should also see the perspective of the scientists who were asking for eligibility requirements to be made stricter. The Supreme Court probably had the intention of making the 'commons' larger so that we have less 'dominant' patents, and none based on what is found in nature. From this policy perspective the decision and USPTO guidelines make more sense.

Great post. Thanks for your well-written insight.

This post is consistent with our amicus brief in Myriad where we argued that the key to understanding what Chakrabarty meant by "markedly different" is not structure but a function that is different from that in nature. Almost all new structures will have a function different from nature but isolated compounds may or may not have such a function. gDNA does not when it is used merely to obtain a person's genetic code but may be if used for treatment purposes. You can find our brief at: http://www.mcgill.ca/law/sites/mcgill.ca.law/files/gold_et_al_amicus_brief_amp_v_myriad_jan_2013_2.pdf

@ O'Sully

It is sometimes comforting to consider how well general lawyers do in the kind of skills that we have to use correctly every day.

I remember that some years ago the UK House of Lords attempted to define the tort of passing-off under UK law. There were three lead judgments, each listing five critical factors. Only three of the factors were common to all lists. So if the judges were being examined for having correctly identified the set of critical factors relevant to the tort, they would have all failed. It should be borne in mind that this was not something new, such as we are confronted with on a daily basis: the tort in question had been recognised in UK law for at least 100 years. In UK and Europe we have strict examinations to sort out those who can succeed in this kind of task and those who cannot.

@ Skeptical

There is a need for discipline in our approach to decided cases. We have enough trouble interpreting the rules of law as handed down to us by the judges: creating paraphrases does not help understanding. The rule is that the single reason of isolation will not serve, but two reasons will do, e.g. isolation + new utility will do.

I have just attended a committee meeting of an organization where some of its by-laws were recognised as being insolubly ambiguous. So the committee went on to consider the purpose of the relevant by-laws. In Myriad we do not need to do this because the rules propounded are very clear and straightforward. All we have to do is to apply them.


You may not be aware of this, but any such change in law to make requirements stricter is outside the province of the Court.

The Court does not have the authority to change the law as you indicate. That is the job of the Congress.

I hope the poster understands that the Parke-Davis applicant was able to convince the examiner to allow the claim to “Adrenalin” only by convincing the examiner that "Adrenalin" the medical product, was something different than a purified or isolated version of “adrenaline,” the hormone. In other words, the claimed "Adrenalin" was markedly different from the naturally occurring adrenaline.

My understanding is that such a claim would be just as eligible today - under the guidance - as it was back in 1911.

@ John Fythe

The whole point is that the purified adrenaline was something markedly different from what occurred naturally. The purified product was a useful medical product. The naturally occurring product was not. Judge Learned Hand completely understood the point.


I didn't know that. However my comment was about what I think might have happened. If the decision was a sort of policy one about redefining the commons it's something the Supreme Court judges could not explicitly say they did, if they did it. The reason why I say this is that here in the UK, House of Lords (now the UK Supreme Court) decisions seemed to be doing this. Pushing the system in a particular direction, and letting the Patent Office and lower courts just deal with it. Applicants will learn to live with the new USPTO eligibility guidelines and the system will readjust. Of course in the meantime uncertainty, and perhaps unfairness, unfortunately ensues.


To my "phrase," Paul Cole glibly replies "creating paraphrases does not help understanding."

And yet, to John Fythe, he offers the equivalent phrase "markedly different from what occurred naturally."

Which way do you lean this morning, Mr. Cole?


Thanks for the reply (and it helps to see your foreign nation basis).

Here in the States we have this concept called separation of powers, and it guides the proper rule of law based on the highest law of our land, the constitution.

It's a pretty important concept as it is meant to keep each branch of the government from coveting or obtaining too much power (explicitly or implicitly).

Early in our country's history there was a case that is often taught in our law schools to exemplify the power of the judiciary, and in a way, to show the separation of powers doctrine in practice, focusing on the separation between two of three branches, the executive branch and the judicial branch. That case was Marbury v. Madison, and it was a fight over a rather inconsequential political appointment to a rather inconsequential office.

Now take that fight and magnify it a thousand-fold. Take that fight and instead of the judicial branch fighting the executive branch, have the judicial branch fighting the legislative branch. Our constitution explicitly gives the legislative branch the power to write patent law. Our judicial branch is trying to write patent law. The problem is that that same judicial branch appears to be the branch deciding whether its own actions are legitimate.

Do you see the problem?

And this is not a problem over some silly little office appointment. This is a problem over a major source of power: innovation. And not just any type of innovation either. But innovation that permeates almost all art fields in the modern age.

Our system was set up such that this type of expansive-reach, intricate policy driven decision is not made by a cloistered and unanswerable few, but by a very specific branch of the government, that (in theory at least) is answerable directly to the people: Congress.

@ Skeptical

We over here are fully aware of separation of powers.

Section 101 provides patents for any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.

Jurisprudence provides exceptions for laws of nature, natural phenomena, and abstract ideas.

Where there is a statutory provision, separation of powers implies that any rule of law derived from a particular opinion and potentially expanding the exceptions should be construed narrowly. In particular, if there are several possible interpretations of such a legal rule, the narrowest one is the most preferable.

The point is made in submissions in advance of the 9 May USPTO forum:

- - - The task of a court in interpreting §101 is explained in the following passage from Diamond v Chakrabarty:

“Our task, rather, is the narrow one of determining what Congress meant by the words it used in the statute; once that is done, our powers are exhausted. Congress is free to amend § 101 so as to exclude from patent protection organisms produced by genetic engineering. Cf. 42 U.S.C. § 2181(a), exempting from patent protection inventions "useful solely in the utilization of special nuclear material or atomic energy in an atomic weapon." Or it may choose to craft a statute specifically designed for such living things. But, until Congress takes such action, this Court must construe the language of § 101 as it is.”

The task of the USPTO in interpreting the Mayo and Myriad decisions is similarly narrow. It is limited to making of a correct determination from those decisions of the rule(s) of law applied by the Court and then making a corresponding adjustment to examination practice (if needed). Either under-stating such rules and making too limited adjustments or gold-plating such rules and making unduly far-reaching adjustments strays outside the metes and bounds of that task." - - -

What has been said by many commentators is that the USPTO has indeed gold-plated the rule of lay derivable from Myriad.

Problem is, the hypothesis doesn't make sense doctrinally. Myriad was decided under the patent-eligible subject matter prong of Section 101. Specifically, the Court said that isolated DNA fell into one of the exceptions for patent-eligible subject matter--products of nature. The Court's rationale was that merely isolating DNA did not make it any less a product of nature. Utility is a different requirement under Section 101, and there is no evidence the Court intended to combine the two requirements into one.

@ Bill

I am not sure that there is any doctrine or that the Supreme Court intended to create one. As soon as it cited Hartranft and brought in tarriff cases the law entered a territory with a high degree of pragmatism where issues fell to be considered case by case.

Suppose you take the position that a change of shape suffices to make a natural product into a manufacture. You then have the problem of the copper disc moulded (I presume) with a raised rim to form it into a blank for a cooking vessel. That was held not to attract a tariff because it had insufficient new utility - the disc sold for its weight in raw copper and the raised rim add nothing to the commercial value of the disc. On the other hand pouring raw rubber into a mold and allowing it to harden into a shoe to give rise to a manufactured product because the product had a new name, new characteristics and a new utility. However, doctrinally every atom was unchanged or was changed by natural hardening in a way that was inherent to natural rubber. The dividing line was new utility - i.e. a change of shape can convert a natural product into a manufacture if sufficient new utility is created, otherwise not. In the context of the tarriff cases, it seems that the new utility has to be something that the customer is willing to pay for. Likewise an orange treated with preservative, even though it is a better product with a longer shelf-life, is still an orange because its utility (and presumably price) are that of an orange. Bringing Hartranft into the debate arguably does bring utility into the product of nature debate, and these two considerations are not isolated in the way that you suggest.

I know of no better interpretation of Myriad that both identifies a workable rule and avoids unintended consequences that the Court said in Mayo were to be avoided.

Mr. Cole,

Metes and bounds of the task...?

What are the metes and bounds of the judiciary being told that they are no longer permitted to use the tool of common law evolution to define what "invention" means under the then newly codified section 101 in the 1952 Act?

The word "exhausted" carries a slightly different tune then it did prior to the Act, in which Congress had acquiesced to the courts the ability to define invention with that same common law tool.

In other words, you misfire in your application of the separation of powers doctrine.

You misfire (as does the Court - other than the Chakrabarty Court which appears to be the sole Court recognizing the exhaustion imposed by Congress) by ignoring what happened to jurisprudence in 1952, that Congress 'exhausted' a certain power of the judiciary.

While what you otherwise say of the doctrine may be true, what you say is not on point to the doctrine's involvement here.

The Court CANNOT write a new rule of law (implicitly or otherwise) when it does not have the constitutional authority to do so. The Court's power of interpretation does not include the power of re-construction. Whether the Court missteps and does otherwise does NOT mean that the executive branch is free to follow that errant "rule of law" in its interpretations.

"Narrow but wrong" is still wrong.

The executive branch CANNOT use the "good soldier following orders" excuse. If there is NO "correct" interpretation, the Office is under duty to so state and under duty NOT to try to apply an incorrect interpretation. Metes and bounds indeed.

This is why a violation of the separation of powers doctrine is a serious thing, creating serious consequences.

You state that you are fully aware of the doctrine of separation of powers. Of that I remain...

@ Skeptical

There is no mileage whatsoever in trying to argue to the USPTO that a Supreme Court opinion is wrong or has no correct interpretation. We can, however, try to explain what the correct interpretation is and suggest how it should be followed. That is the most that we can realistically hope to do.

Your wider constitutional point may be right, but the USPTO is not the right forum to argue it.

I heartily disagree Mr. Cole.

Only a lamb accepts such as what you propose.

Congress acts to set the Court straight all the time - blind acceptance is simply NOT accepted.


Upon reflection, it appears that your last response misses the mark a bit. You have moved the goalposts (or at least the perspective of the discussion) from one of "what should the Office do in regards to the metes and bounds of its duties in response to the Supreme Court" to "what an applicant might do in response to what the Office may do."

That is a different discussion.

But nonetheless, the answer I provided may also pertain to that different discussion.

Blindly accepting even a wrong executive branch following of a wrong judicial branch view of the law offers NO chance to correct the law. Recent US jurisprudence shows that an applicant challenging the executive branch can work to make sure the law is correct. As evidence, I would submit the Taffas case for your consideration.

Separately, and for further consideration, let's say for the sake of argument that we allow the Court to have their way with patent law, changing what they will. A separate argument for constitutional violation surfaces in what the Court has provided as the law of 101: void for vagueness.

As (re)written by the Court, the law of 101 SHOULD BE determined to be void for vagueness. If the Court wishes to use its version - and continue to deny that they are actively writing the law in the first instance - how can any reasonable person claim that 101 is NOT critically vague and indeterminable as to what the law covers? Look at the seesaw battles of panel after panel at the CAFC level - one decision contradicting the next. Look at the en banc Alice decision: when the judicial body, explicitly created so as to bring order to patent law throws up their hands in disgust and says "We cannot make heads or tails of this stuff" - and "this stuff" is the mess of jurisprudence created by the Court, how can any reasonable person in the applicant's shoes know what the law of 101 covers on its face? When an applicant (and hence, the public too) must wait until the judicial process has run its course for each potential application to know whether or not the application fits under the law or not, then the law is critically - and perhaps fatally - vague.

I was disappointed, albeit not surprised that this "void for vagueness" was not an argument advanced in the Alice proceedings.

Disappointed, because the void for vagueness position is on point for the Court to consider, given that the case appears to present a pivotal moment in patent law; and not surprised, as I do not think either party to the case really wanted to go to the point that 101 as a foundation of patent law would be found void, and thus potentially bringing the entire system to a standstill.

As you may have gathered from the oral arguments, several of the Justices are seeking any option to avoid such a cataclysmic confrontation. And yet, to my view of the law, such avoidance is part and parcel of the mess that we find ourselves in.

Which brings me to another discussion point (and another metaphor). We may very well have a decision from the Court in the Alice case that further 'skirts' the issue and resolves nothing in the larger scheme of things.

Justice Breyer may find his road.

But any such road will NOT remove the vagueness that has been developed by the Court itself, and will likely lead to a road (a rule of law) that cannot be followed in the next case. Such a road so constrained as to be expressly limited to the exact facts in the immediate case will be useless for developing a rule of law for the next traveler.

And to end with another metaphor, will anyone be satisfied if the beacon of light created by the Court with a decision in Alice is immediately hid under a bushel? Or is clarity from the beacon what we all crave? Clarity, so that we can see the path forward, and not walk that path in darkness, blindly groping and bumping from one CAFC panel decision to the next?

This logic here is probably what the S Ct intended, and not the very broad interpretation embodied in the USPTO guidance document of March. One niggle. While Judge Learned Hand did indeed state the things quoted, Jonathan Harkness has persuasively noted that his statement about patentability of Adrenaline was in dicta; the case in hand was a priority dispute, and he simply missed the fact that the patent had been granted by a seasoned examiner only when the examiner was convinced it was a different molecule. Parke-Davis has indeed become cited as precedent, but Judge Sweet (in his District Court ruling in Myriad) and Jon Harkness have both noted Hand's dictum was a legal mistake. It may be good law, but it was nonetheless wrong at the time. While now ensconced in practice, this history may prove relevant, and Parke-Davis may not be the landmark it has been assumed to be. See Harkness's article: Journal of the Patent and Trademark Office Society, Vol. 93, No. 4, pp. 363-399, 2011 or through SSRN working papers site: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1881193

@ Bob

Many thanks for drawing attention to the Harkness article.

On the whole I think that the adrenaline case merely reinforces the aspirin case and neither of them have much to do with pine needles. Even if Learned Hand's proposition was initially doubtful, it has been followed for over 100 years, and the settled expectations of industry should not be ignored.

The point was raised in argument in Myriad, and counsel for the association expressly accepted the patentability of isolated medicament substances. The context was a discussion of "Amazonic acid", and in view of the concession it is surprising that an example written in a contrary sense appeared in the Office guidance.

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