Guest post by Jeffrey A. Lefstin, Professor of Law at the University of California Hastings College of Law. Professor Lefstin’s forthcoming article, Inventive Application: a History, was cited by Judge Linn in his concurrence in Ariosa.
The Federal Circuit has issued its decision in a closely-watched biotechnology case, Ariosa Diagnostics v. Sequenom. The opinion clarifies several aspects of the patent-eligibility inquiry in the wake of Mayo v. Prometheus, and has significant long-term implications for patent-eligibility not only in biotechnology, but in other fields where invention is based primarily on discovery.
The invention in the case derived from the inventors’ discovery that the cell-free fractions (serum and plasma) of a pregnant woman’s blood contain surprisingly large amounts of DNA from the fetus. Based on this discovery, the Sequenom patents claimed methods for prenatal diagnosis of fetal abnormalities, the methods comprising amplifying paternally-inherited sequences from the cell-free fractions of the mother’s circulation.
Applying Mayo, the Federal Circuit held all the claims in suit ineligible. In step one of the Mayo inquiry, the court found that the claims were all directed to a natural phenomenon: the existence of paternally-inherited cell-free fetal DNA (cffDNA) in the maternal bloodstream. In step two, the search for an ‘inventive concept,’ the court invoked Parker v. Flook for the following proposition:
For process claims that encompass natural phenomenon [sic], the process steps are the additional features that must be new and useful.
Because methods of amplifying DNA were well-known at the time of the invention, the court determined that the claims disclosed only well-understood, routine, conventional activity beyond the underlying natural phenomenon. The claims therefore lacked an inventive concept sufficient to transform the natural phenomena into a patent-eligible application. So Ariosa makes clear that the test for patent-eligibility is whether a claim represents an ‘inventive’ application of an underlying natural phenomenon, at the time the invention was made.
Another notable aspect of the case is the court’s discussion of preemption. After Mayo and Alice, some district courts have treated preemption as an operative test for patent-eligibility, while others have regarded preemption as the underlying justification for the doctrine. In Ariosa, the Federal Circuit seemed to adopt the latter view, stating that once claims are determined to disclose only ineligible subject matter under the Mayo test, “preemption concerns are fully addressed and made moot.” However, the court also wrote that “[w]hile preemption may signal ineligible subject matter, the absence of complete preemption does not demonstrate patent eligibility.” So the Federal Circuit seems to be suggesting that arguments regarding preemption can be taxed against the patentee in the § 101 inquiry, but not counted in the patentee’s favor.
In Ariosa, the Federal Circuit has endorsed a highly restrictive interpretation of the test for patent-eligibility, one that was not mandated by Mayo itself. A test for ‘inventive’ application was only one of several possible analytical approaches set forth in Mayo. Mayo also suggested a test of non-generic application for patent-eligibility: that a claim must do more than state a law of nature or abstract idea, and append an instruction to ‘apply it.’ That was the aspect of Mayo stressed by Alice, which emphasized generic application far more than inventive application.
As I argued in a recent paper, under a test of generic application, the claims in Ariosa might fare differently than the claims in Mayo. The claims in Mayo represented generic applications, because they did no more than reveal the results of the underlying relationship between 6-thioguanine levels and therapeutic efficacy. Arguably, at least some of the Ariosa claims do more than that: rather than claiming the natural phenomenon (cffDNA in the maternal circulation) itself, they employ the natural phenomenon as a means to a achieve a different end (diagnosing a genetic condition of the fetus).
Moreover, the Ariosa opinion appears to endorse dissection of the claim to a degree not only contrary to Diehr, but beyond that suggested by Flook itself. While Flook explained that “the process itself” must be new and useful, Ariosa suggests that the individual steps of the process must be new and useful, and identifies the discovery of cffDNA as “[t]he only subject matter new and useful as of the date of the application.” Given that most inventions consist of rearrangements of old elements, it is difficult to understand how the court can refrain from addressing the claim steps as an ordered whole, as mandated by Mayo itself.
And that highlights what is perhaps the most puzzling (or disturbing) aspect of Ariosa. According to Judge Linn’s concurrence, the steps of the method were new: at the time of the invention, no one was amplifying paternally-inherited sequences from maternal serum or plasma, because no one thought that those fractions contained significant amounts of fetal DNA. That contrasts with Mayo, where the acts recited in the method were identical to those performed in the prior art. Yet Judge Linn believed that the Supreme Court’s “blanket dismissal of conventional post-solution steps” in Mayo left no room to distinguish the Ariosa claims on those grounds.
If the step of amplifying paternally inherited DNA from serum or plasma was new, by what analysis could the court could regard it as “well-understood, routine, and conventional activity”? One way would be to sub-dissect that step into the conventional step of obtaining a cell-free fraction, and the conventional step of amplifying a sample containing DNA. That approach seems to lead to the reductio ad absurdum that most biotechnology processes are patent-ineligible, because they consist of the conventional steps of transferring drops of fluid from one tube to another.
The alternative way would be to ask if the step of amplifying paternally inherited DNA would be obvious once it was known that there was cffDNA in the maternal bloodstream. In other works, assume the patentee’s discovery to be already known, and ask if the invention is obvious once the discovery is assumed away. If that is truly the interpretation of Mayo signaled by Ariosa, then the case promises to cast a long shadow on the patent-eligibility of inventions based on discovery in the future.
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Seems that Ariosa interprets Mayo in light of Alice. Mayo by itself makes sense (maybe?), but Mayo plus Alice leads to bizarre rules.
I don’t understand how “conventional” well-known features are being used to kill patents. The single feature cited in Alice that did “something more” was a thermocouple (in Diamond v. Diehr). But at the time of patenting in Diamond v. Diehr, thermocouples were very well-known as was the Arrhenius equation.
So what in god’s name is something more?
Claim 1 is difficult to defend as more than recitation of a newly discovered fact of nature plus the words “apply it”. But some of the detailed claims relate to potentially eligible applications of the discovery, for example determining the concentration of the foetal nucleic acid sequence in the maternal serum or plasma and using that determination to detect a foetal chromosomal aneuploidy e.g. Down’s Syndrome. Very arguably those steps go a considerable way beyond merely “apply it” and define a patent-eligible application of the principle with enormous new utility.
The problem with the decision is not the finding in relation to claim 1 but lack of attention to detail in relation to more meritorious dependent claims.
Paul, the problem probably was that the patent owner didn’t spend too much time on these claims. The page limit on the Fed. Cir. briefs (14,000 words) is a bit tight.
Disclaimer – I have an EE/CS background, so I’m not an expert in this technology area.
Paul said “for example determining the concentration of the foetal nucleic acid sequence in the maternal serum or plasma and using that determination to detect a foetal chromosomal aneuploidy e.g. Down’s Syndrome. Very arguably those steps go a considerable way beyond merely “apply it” and define a patent-eligible application of the principle with enormous new utility.”
No doubt these steps have enormous new utility. However, the claim would still be ineligible if those steps merely describe a known process, i.e., if foetal chromosomal aneuploidy is traditionally detected by determining the concentration of the foetal nucleic acid sequence.
I do not think that it could have been traditional to determine concentration in maternal serum or plasma because the presence of paternal DNA in serum or plasma was a new discovery. The fact that you could use concentration to determine aneuploidy was a further thought, giving very arguably eligibility for that feature.
However, there is a typo in the decision which is very misleading. Only a few of the claims were in issue formally before the district court and the Federal Circuit. However, the footnote at one point suggests that many more were in issue, whereas the reality is that a number of claims including those to which I drew attention were conceded as being on an equal footing with e.g. claim 1 as also explained in the footnote. It is wholly unclear why this concession was made, but its effects are far-reaching, and it is doubtful in view of the concession whether the case can go any further, which is to say the least unfortunate.
The real question to my mind is whether this would get through 103. This clearly should be eligible for patentability.
I find it too highly disturbing that Renya a judge without a science background with absolutely no foundation with which to even begin to understand the issues wrote the decision. Moreover, Renya was appointed in the era of Google influencing Obama. Clearly Renya was appointed as part of the Google bucks influence.
Contrast with all the bad mouthing of J. Rich’s reasoning. J. Rich was entrusted to re-write patent law based on his expertise and the Congress trusting him to reform our patent law. On the other hand, we have a judge whose appointment is highly suspect and whose qualifications are highly suspect handing down landmark decisions.
My but we have taken some big steps toward third world status.
There are some very good arguments that this would be obvious.
The patentable under 103 argument is akin to the: even if the solution is obvious once the source of the problem is understood, the claim is not obvious if the source of the problem was not obvious.
Here, no one knew you could get fetal dna from the mothers blood, which is much easier an safer than amniocentesis. So…. the source of the solution (if you will — and see what I did there?) was unknown….
This is clearly the kind of discovery the Constitution wants to promote and the related method is clearly patentable under 101 – 103.
This ruling and the Supreme Court rulings upon which it is based are clearly travesties.
Peanut Gallery: do you both (Ned and MM) agree that biotechnology claims for diagnostic applications are largely ineligible going forward?
That depends on what you mean by “biotechnology claims for diagnostic applications.”
Let me answer by making a couple points that will certainly be glossed over or completely ignored in most discussions of this topic, especially those written by the various patent-centric “sky is falling” pundits out there.
First, it’s always been the case that the typical diagnostic method claim, e.g., the “determine-and-infer” claim, was ineligible for patenting. Unfortunately at some point the Federal Circuit and the PTO both began dropping their guard and, as the patent bubble inflated and “patent monetizer” became a career unto itself, applicants became both more bold and more eager to obtain such claims. Simultaneously (and not coincidentally) so-called “personalized medicine” (previously known as “using information about a specific patient to determine the best treatment for that patient” — an ancient practice predating our patent system by a couple thousand years at least) began to inflate itself as the most important development in the history of medicine. Thus began the era of number crunching as a gateway to patent accumulation. Find a data set — it doesn’t even need to be your own data — then identify a correlation, and then file a process claim protecting the consecutive steps of (1) gathering information with an old method and (2) thinking about what that determination means (maybe toss in “on a computer” if you’re trying to be really careful!). Every one of these claims ever granted should is ineligible. They should never have been granted in the first place. As everybody knows, Prometheus was the party who finally attempted to shoot for the moon and ask the Supreme Court to uphold a patent that covered — literally — obtaining data using a public domain method and then thinking a proprietary thought about that data.
Prometheus’ theory was rightfully shot down by a unanimous Supreme Court in an essential and correct decision that ideally should have been rendered twenty years earlier. The problem many commenters in industry and elsewhere are dealing with is that in that intervening time a lot of speculators, wishful thinkers and/or self-deluding individuals convinced themselves that they could obtain medically useful information and protect it with patents. These people need to adjust their thinking because the wave that crashed over them in Prometheus was not a fluke. It was the furthest thing from that. See, e.g., the ridiculous, failed attempt by Advanced Biolabs to protect a computerized “knowledge base” for providing “ranked listings” of therapies in response to queries.
So that’s one answer to your question, Peanut. Infinite numbers of medical diagnostic “methods” — hugely important ones that affect your health and my health and our children’s health — are not only ineligible for patent protection “going forward” but also “going backwads”. In short, they’ve always been ineligible. This is a good thing. It’s the way things ought to be. Let’s try not to forget that.
The second major point is that “going forward”, “biotechnology” claims that do, in fact, protect new technologies for gathering useful diagnostic information (as opposed to protecting access to the information itself) remain as eligible for patenting as ever.
Just to clarify a few facts here, re both this article and the dissent, this is the subject claim 1 in its entirety:
“1. A method for detecting a paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample from a pregnant female, which method comprises amplifying a paternally inherited nucleic acid from the serum or plasma sample and detecting the presence of a paternally inherited
nucleic acid of fetal origin in the sample. ”
That is NOT “claimed methods for prenatal diagnosis of fetal abnormalities” as this author alleges! That desire may be broadly stated in one dependent claim. But at least one of the defendants was apparently not even doing that, since it was only doing mere paternity tests covered by this claim 1 and others!
P.S. No one is denying these scientists their shot the Nobel Prize, tenure, or any other lucrative professional awards, just clearly preemptive patent claims to any use of a discovery in nature.
PM That is NOT “claimed methods for prenatal diagnosis of fetal abnormalities” as this author alleges!
You are correct, Paul. I meant to specifically point this error out myself last night but I ran out of steam addressing other issues. Lefsin tries to make a distinction between this claim and Prometheus’ claim but in doing so he makes an error similar to that made by the Federal Circuit who characterized Prometheus’ claim (wrongly) as a “treatment claim.”
The claim is an information gathering claim. The information being gathered is the presence of a naturally occuring phenomenon. The information is gathered using conventional methods, described in the broadest, generic terms.
No one is denying these scientists their shot the Nobel Prize, tenure, or any other lucrative professional awards
This is another critical point that you can guarantee will be forgotten a million times before this discussion is over. Ineligible discoveries are made and reported all the time, every day, and in nearly every instance the idea of patenting them is not even considered. This is a good thing. Most people would like to keep it that way, for great reasons.
Note also that the “discovery” being protected here is exactly the kind of discovery that follows from the invention of new technologies for gathering information. That is where the patent system should be focused — promoting those inventions — instead of granting zillions of patents on specific (technically indistinct) uses for the old technology such that the old technology remains perpetually tied up in IP, decades after the patent on the new technology has expired.
I’m enjoying the debate on eligibility, watching how points that have been chewed over in Europe, in literally hundreds of inter partes cases, now come up again, for inspection at Federal Circuit level in the USA.
Here are two of the questions:
1. What does claim “dissection” mean and to what extent is it permitted?
2. What does (pace Flook) “additional” mean? How much is enough?
At the EPO, the “assume it was known” approach ran for some time but met with ridicule from the USA and has now been discarded, in favour of a more intellectually rigorous approach.
I do like the Lefstin treatment of the notion of pre-emption. It strikes me as eminently reasonable to say that an absence of pre-emption cannot validate eligibility whereas wide and heavy pre-emption is a pointer towards ineligibility.
I like this case because it strikes me as marginal, the outcome depending critically on what exactly is claimed, and the 102 and 103 patentability looking to be achievable, once the eligibility hurdle is cleared. The hard cases are those where anybody can see that the patent application discloses a contribution to the useful arts which is useful/valuable/meritorious but Applicant simply over-reached with his claim. Seems to me in such cases the proportionate way for the Federal Circuit to handle it is to invite the owner to come back with narrower proportionate claims. I guess that is what invariably happens and so, after a generation, the law of eligibility crystallizes. Just like in Europe.
But don’t take seriously anything I write. I’m not a specialist in chem/bio. Just a curious bystander, looking in.
Max, read my post, 6.2, about Judge Rich’s position. No dissection. If the claim includes eligible subject matter, move on to 102/103.
His views were cited with approval in Diehr even though at the time they were inconsistent with Benson. They have since been soundly rejected in Mayo and Alice.
The analysis today is that of Hotel Security, a case Rich “overturned,” at least some on the Federal Circuit tried to restore in Bilski, and which Stevens, Breyer, et al., relied on in Bilski in their “dissent.” Breyer made it the law of the land in Mayo. The whole court is now on board with the Hotel Security analysis.
Max, on preemption — this is where the subject matter claimed is claimed to the point of abstraction — no specific application. See, Rubber-Tip Pencil and Morse. The requirement for a specific application is common to both non statutory subject matter and “principles in the abstract,” ideas.
Math was deemed non statutory in Benson. The algorithm claimed in that case was deemed preempted because the only limitation was to the use in the generic computer, its only used in point of fact. Flook made it clear that “wholly preempt” is not the issue. The issue was whether the math was applied in a specific application. Diehr established that when math is used to modify a conventional process to improve it, that the claim as a whole was directed to patentable subject matter. Bilski established that well-known business methods were ineligible subject matter. Details about the mathematics or the methods of gathering data did not transform the subject matter into something otherwise eligible. Mayo established that using conventional data-gathering steps were not sufficient to transform the law of nature into a specific application. Alice established that a business method that employed only conventional computer hardware was not a specific application. Alice is really no different than Benson.
As to what is necessary to “transform” the claims subject matter into a inventive application, certainly the otherwise statutory subject matter must be improved as in Diehr.
But preemption also applies, as I said, in the Rubber-Tip Pencil case where the novel subject matter is claimed at such a level of abstraction as to wholly preempt all applications. In the claim there at issue, we had a pencil and a piece of rubber and the idea of attaching one to the other. The pencil and the piece of rubber were both statutory subject matter and old. The new part of the claim, the idea of placing the one on the other, was deemed too broad because there was no specific structure claimed for attaching the one to the other. All such methods of attachment that were covered. The claim was simply too broad. It was to a result, not to a specific means or method.
Thanks Ned, I was with you till I got to the pencil case.
Suppose the art includes i) free-standing erasers and ii) pencils devoid of erasers. Suppose I’m the first to conceive of the idea of mounting an eraser on the unpointed end of the pencil. That’s not only new but not obvious, and pre-empts only those who want an eraser mounted to the tip of their pencil. Nobody did, till I thought of it.
Why is my claim “simply too broad”? Why must I include in my claim the specific method of mounting and thereby render it useless? Why shouldn’t my claim “pre-empt” the new field of pencils with an eraser mounted to their non-pointed end? It ain’t fair!
“That approach seems to lead to the reductio ad absurdum.”
As do Alice, Bilski, Flook Diehr et al.
I agree. Maybe it has to do with the statues. As far as I recall, 103 is the only one that requires analysis of “the claimed invention as a whole.”
As to the “new and useful” requirement of 101, if 1 step out of 10 is well known, does that mean the entire claim is ineligible subject matter. Seein’s how 101 does not mandate a holistic analysis, if any part of a claim is not new is the 101 “new and useful” not met? Is 101 “new” different from 102 “novel?” Does 101 “new” include 103 “obvious?”
Under 102 each and every step has to be disclosed in a single PA disclosure in order for the claim to be rejected as not novel. Even if all of the steps are well known but only one is disclosed separately from the others, the claim is still novel. Under 103 even if each step of the process is well known or obvious, the claim in its entirety can still be non-obvious, even if examiners don’t get that fine point.
Does 101 require a totally different — line by line — analysis, wherein if one step is known the whole claim, although passing 102 and 103, is invalid under 101 “new?” This is, basically, the examiners’ approach to drafting FOAMs.
The problem here is the inclusion 2x of “new and” in 101. The requirement for originality is sufficiently set forth in 102/103, both of which are subsumed under the closing phrase of 101: subject to the conditions and requirements of this title.
Face it folks, the Patent Act was written by monkeys with typewriters. The only thing that changed between 1952 and 2011 was that the typewriters became keyboards.
Only if you pretend that statutory construction only happens in a vacuum.
(It does not).
Babel, a little history lesson might be helpful. In 1790, the analog of 101 did not require newness, just not known or used. In 1793, “new” was added at the same time as “composition” was added, but the requirements for not known or used was retained.
“New” is an absolute requirement, independent of whether the subject matter was previously known or used. The holding in Myriad determined that a human gene was not a “new” composition regardless that it was not previously known.
Regarding the analysis of the Supreme Court versus the analysis of Judge Rich:
Judge Rich was a 103 bigot. If the subject matter of the claim included patentable subject matter, he would move on to 102/103 in all cases, and give even the unpatentable subject matter weight in the analysis.
The Supreme Court flips this. They first determine whether there is unpatentable subject matter in the claim and then requires “invention” with respect to the otherwise patentable subject matter. In other words, the unpatentable subject matter must be applied to transform otherwise old, but otherwise patentable, subject matter into something new or improved.
Hope this helps.
And let me also add the Supreme Court is also concerned that the novel subject matter in a claim not be claimed to the point of abstraction. Supreme Court keeps relying on Rubber-Tip Pencil as a 101 case, a case that prohibits claiming mere ideas. In that case, the idea was attaching a piece of rubber to the tip of pencil without more.
Ned, you always write about J. Rich as if he wasn’t entrusted to re-write patent law. He was. He wrote the 1952 patent act. He meant to remove 102, 103, 112 considerations from 101. Alice is direct contravention of the law as passed by Congress.
Try to keep that in mind. J. Rich was entrusted to re-write our patent law by Congress—by Congress. Repeat that over and over and then re-read the Constitution about who is to make law for patents.
Judge Rich did not write the ’52 Act. Federico did – and most of it was a carry-over from 1790-1952. It declared purpose was to codify intervening case law. Federico, not Rich, was chosen by congress to do the statute. When he was done, 1500 copies were circulated to the patent bar associations for comment. Ashton of the APLA organized a steering committee to receive comments, and pass them on to Federico.
Rich had a hand in 112(f), originally from the Milwaukee Patent Law Assn. He was one of the crafters of 103. But is major contribution, for which he became a big wheel and the reason he was chosen to be on the steering committee by Harry Ashton, presided of the APLA, was 271(a)-(d).
should be “Harry Ashton, president of the APLA.”
Your “version” of history is an outright an unmitigated L1E Ned.
You’re not getting me there, Ned, but I appreciate the effort.
I think I would back Giles’ position, at least as your describe it, on this issue: I would basically ignore the “new” of 101 and considered it subsumed by the novel/non-obvious (NONO) analysis of 102/103.
The 101 “new” refers to subject matter; more specifically, an instance of one of the 4 statutory classes. NONO applies to a claim – “claimed invention.” But only claims are enforced, so what’s the point of a whole additional layer of “new” in the subject matter analysis? Ultimately, the 101 “new” eligibility has to be determined w/ respect to the claims, which is, of course, what Mayo says and what CAFC is doing here.
In the present situation, everyone agrees that human ccfDNA is, itself not new. In all likelihood it has existed for as long as humans have existed – now estimated at more than 1 myr. So in, say, 1996, an attempt to patent ccfDNA itself would have been 101-DOA as a natural phenom. But there was no PA literature about ccfDNA in 1996, so would a claim to ccfDNA have been NONO in spite of failing the “new” test of 101? If the answer is yes, then there is a distinction between 101 “new” and NONO. If the answer is “no,” then there is no distinction.
I would argue that the answer is “no” because although there was no PA, ccfDNA had been in “public use” for the entire 1 myr period during which pregnant humans have been sending husbands out for ice cream and pickles, which predates the US patent laws by about 1,998,220 years, give or take a decade.
IOW, I would argue that every natural phenomenon, whether known by man (and/or woman) or not, is in public use under 102. Now I haven’t gone back and reviewed the “in public use” case law, but I believe it has something to do with a surreptitious bra, as they all used to be. I believe “public use” does not necessarily mean in view of the public or acknowledged by the public. However, this suggestion may need a broadening of the meaning of “use.”
The courts don’t do this, but I think it’s a better point of view: all natural phenomenon are in the public domain and so 102 should apply so no human can have a monopoly on them. This goes for natural forces, processes, and laws regardless of whether or not they have been described by, say, mathematical equations.
What I’m trying to get at is that it would be easier for everyone if “new” were removed from 101 and that analysis deferred to the NONO analysis of 102/103. That would leave 101 analysis to utility and membership in one of the four statutory classes.
As I say, I’m with Giles on this one. Even after studying this opinion and the dissent and Mayo, I still struggle to see how subject matter that is NONO under 102/103 is deemed not “new” under 101.
BTW, had I drafted these claims, I would have claimed a method for using maternal blood to analyze fetal genetic characteristics, comprising the steps of isolating ccfDNA from the maternal blood and examining the isolated cffDNA to analyze the fetal genetic characteristics. Maybe such a claim would avoid a 101 fight and focus on 103, where the issue belongs.
I think Linn’s dissent was about right: the emphasis was not well placed in these claims. But I also think the courts are moving the US into a place where inventions having huge medical consequences are going to be all but impossible to patent. It’s one thing to pop a tire out of a vulcanizing machine at the right time, it’s something else to tie up basic research for a couple of decades that could save millions of lives.
My lasting impression of research labs in the basic medical sciences in the mid-1980’s is that they were filling up with smart, greedy people hoping to use public tax dollars to make discoveries that would make them filthy rich. I won’t mention any names.
BB: As to the “new and useful” requirement of 101, if 1 step out of 10 is well known, does that mean the entire claim is ineligible subject matter.
Of course not. None of these decisions come even close to suggesting that. On the contrary, the idea that identifying a single element of ineligible or eligible subject matter in a claim ends the analysis was soundly rejected in Diehr and that aspect of Diehr has not been criticized subsequently by the Supreme Court. There’s good reason for that: it makes senese.
Well . . . hang on. You might want to take this up with Prof. Lefstin:
As in “individual steps must be new and useful.”
Is this case not exactly analagous to Mayo/myriad?
Same thing happens in every one of these cases. Somebody discovers a marker that is correlative for something using routine methods and tries to patent the means of discovery rather than an application of said discovery.
I think we need to accept that certain things are outside the scope of patent law and in the realm of “pure science.” Scientists do not need incentives to apply known experimental methods to discover natural phenomena. This is what sane people refer to as “the scientific method” and it came in to being far before patent law ever existed.
Yes, just give them a pizza and they will work away and make all these discoveries with their homemade labs.
Apparently you have never been a grad student. Grad students will do almost anything in exchange for free pizza.
Apparently you have never been a grad student. Grad students will do almost anything in exchange for free pizza.
LOL! Indeed.
Grad students (in those “mature” bio arts) will be advised that they stand a better chance at a job delivering pizzas.
When you take people for granted, they will leave. Might take a while, but it will happen.
So basically
“Whoever invents or discovers any new and useful…”
is now
“Whoever invents any new and useful…”,
?
Discovery doesn’t mean what you think it does.
link to patentlyo.com
A wealth of (my) comments on that thread, Random.
Thank you for the trip down memory lane – so much wisdom I provided can now be enjoyed again by the new readers.
“Moreover, the Ariosa opinion appears to endorse dissection of the claim to a degree not only contrary to Diehr, but beyond that suggested by Flook itself. ”
“Gist” away any “scrivener’s attempt” at mere writing of elements, and stomp on the gas pedal.
What is the “eligible subject matter” in my Big Box of electrons, protons, and neutrons? Certainly not the elemental particles themselves. And certainly not the mechanism or process of configuring those particles together to make whatever.
So Ned’s own pet theory reduces to any and all things involving a mix of ineligible because basic matter itself is ineligible.
What “remains” is mere smoke, as “improvement” is simply another name for utility, as anything that provides utility is in a very real sense an improvement over that which does not provide utility, even if it is not as “good” as something that is already extant (anyone that knows anything about disruptive innovation knows that the innovation almost always is “worse” than the status quo at first, an under the “logic” (apparently) from Ned, would not be eligible.
This then (as the lesson of history again rings true) is the fruit of the “patent peace for our time” approach.
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You make a very good point anon. The lines are arbitrary and as such the burden should be reversed for finding something ineligible otherwise the court can merely find whatever it wants as being ineligible.
Question: could the fed. cir. find everything (in effect with some big words about some things not being ineligible) ineligible under the logic of this opinion? I think they could.
anon, please. You exhibit no understanding of my position.
Have you even read Hotel Security? Invention must be in the otherwise statutory subject matter. When non statutory and the statutory are mixed and the statutory otherwise old, the non statutory must transform the statutory in an inventive way — to improve it.
Ned,
You sadly confuse “understanding” with “agreement.”
It’s part of your “6-is-an-Einstein-because-he-agrees-with-me” motif.
In other news, have you subscribed yet to the daily email blast for which I supplied a link? He actually gushes over your IPR unconstitutional (thus the Titanic of AIA sinks) position and names you personally.
Yes, anon. I got my first blast this morning. Thanks.
The alternative way would be to ask if the step of amplifying paternally inherited DNA would be obvious once it was known that there was cffDNA in the maternal bloodstream. In other words, assume the patentee’s discovery to be already known, and ask if the invention is obvious once the discovery is assumed away. If that is truly the interpretation of Mayo signaled by Ariosa …
I believe that is the interpretation.
Genghis, close.
Look at Hotel Security as your guide. With mixed subject matter, some eligible, some not, the improvement must be in the eligible. If the sole novelty is the ineligible, it must be applied to the eligible in a way that improves the eligible. See Diehr.
Your use of Hotel Security is improper (as has been noted by Prof. Crouch and devastatingly explained to you by David).
Diehr does not dissect as your “version” would have it – and quite in fact teaches the opposite.
These are not new points. These are merely points that Ned (once again) shouts down internet style with his drive-by monologue.
Got it. Instead of the phrase “… ask if the invention is obvious once the discovery is assumed away …” I guess a better way to put it would be “… ask if anything new – in the 101 sense – is left in the claimed invention once the ineligible discovery is removed … “
Leftsin: If the step of amplifying paternally inherited DNA from serum or plasma was new, by what analysis could the court could regard it as “well-understood routine, and conventional activity”?
This passage badly misrepresents the majority’s analysis (which I agree with).
What was “well-understood routine and conventional” — and admittedly so — was using PCR to detect DNA in tiny tiny tiny amounts — wherever those DNA molecules happen to be. You’ll recall that a Nobel prize was given for the development of that method, a development which took place well before this discovery.
The eligibility problem here is distinguisable from the problem in Mayo but the distinction doesn’t solve the problem. The problem here is that the discovery that was made is a natural phenomenon; it was discovered by conventional methods and the claim does nothing more than state the use of those conventional methods to observe the phenomenon. The “meaning” or “relevance” of the phenomenon is, of course, meaningless to the eligibility analysis because that meaning is no more eligible than the phenomenon itself.
Also, do not ignore the fact that “paternally inherited DNA” is just DNA, just like “Zedekiah Unuguando’s DNA” and “fetal DNA of fetus that was conceived under bleachers at Disneyland.” PCR doesn’t care what name we give to the DNA, nor does it care about the history of that DNA. All that matters to the technology is: what conditions and steps are necessary to obtain (1) a reliable signal indicating the presence or absence of the DNA in question, and/or (2) enough amplified DNA for sequencing or some other form of identification beyond mere detection.
If there was, in fact, a problem to be solved beyond simply knowing with reasonable certainty that some tiny tiny amounts of fetal DNA were in maternal blood (and that does appear to have been the case prior to the “discovery” that the DNA was detectable by PCR) then the solution to that problem should appear in the claims. As far as I can tell, that solution does not appear in the claims.
Lefstin worries about this decision casting a “long shadow” but Leftsin has it backwards. The “long shadow” our patent system is just beginning to crawl out of was the shadow created by treating subject matter eligibility as a mere drafting hurdle. It’s the shadow created by a system granting 300,000 patents a year and growing exponentially. Had Mayo been decided differently we’d be looking at a shadow far longer and darker. Can you imagine the claims that lawyers would be drafting if all you needed for eligibility was the recitation of a non-obvious abstraction or correlation and some old conventional step? I can. So can every judge on the Supreme Court and so can an increasing number of jurists elsewhere.
The specific statement by Leftsin: If that is truly the interpretation of Mayo signaled by Ariosa, then the case promises to cast a long shadow on the patent-eligibility of inventions based on discovery in the future.
In fact, the impact of the analysis on any claim “based on discovery” depends on both the discovery and — far more importantly — on the subject matter being protected by the claim. Note: it doe not depend on the skill of the wordsmith. It’s the subject matter protected by the claim that matters.
I’d like Professor Leftsin to address the “shadow” created by armies of patent lawyers writing process claims that — separately or otherwise — cover all conventional methods of detecting newly discovered phenomena (including but not limited to the methods used to make the discoveries).
As someone who’s discovered a few phenomena myself over the years and who knows many people continuing to make such discoveries on a very regular basis, I can tell you that this “shadow” cast by the patent system is very easily recognizable. And it wasn’t always there. It’s a fairly recent development. Please try not to forget that.
MM. agreed.
Discovery of paternal DNA in maternal serum is like the discovery of a new star. If observing the presence of that paternal DNA using PCR and conventional techniques is patentable, the observing the star with a telescope is also. (This is your analogy, and it is a good one.)
I it is truly amazing that Professor Leftsin does not get this simple idea.
What the courts are looking for an an inventive application of the discovery, something new or improved in the conventional processes that are otherwise eligible to produce a new or improved conventional process as in Diehr.
So do you both (Ned and MM) agree that biotechnology claims for diagnostic applications are largely ineligible going forward?
Peanut, to the extent that diagnostic methods are conventional and what is being diagnosed is a law or product of nature, yes.
But, this is not new. This was the holding of Mayo.
I’m more than pretty sure that paternal DNA is more than “just DNA” for functionally related reasons (like attempting to use maternal DNA would not yield a useable result).
But why let such facts get in the way of fallacious spin?
Boys have a Y chromosome and girls do not, but DNA is DNA — it’s not “paternal” or “maternal.” The discovery is the fact that fetal DNA exists in a pregnant woman’s blood serum. Pretty sure nobody invented that.
Hans, you self FAIL as you point out that “boy” DNA is different than “girl” DNA, then err by saying DNA is DNA (implying that there is no difference, when you yourself just gave a difference). Importantly in the context of the present invention, that very difference is critical. Have you figured out why?
What invention, anon? There was only a discovery.
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