by Dennis Crouch
The Supreme Court declined to hear an important patent eligibility case on October 2nd, denying certiorari in CareDx v. Natera. This leaves in place a Federal Circuit ruling that invalidated CareDx’s patents on its method for detecting organ transplant rejection.
The patents at issue covers breakthrough diagnostic technique using cell-free DNA to non-invasively detect organ transplant rejection. For over a decade, scientists had tried unsuccessfully to use cell-free DNA for this purpose. The key innovation was applying high-throughput DNA sequencing and identifying SNP thresholds to make the technique clinically useful. However, the lower courts ruled the patents invalid under the judicial exception to patent eligibility for natural phenomena.
The Supreme Court’s denial means this important legal issue remains unsettled. The Court’s Mayo/Alice framework for patent eligibility has been heavily criticized for over-invalidating diagnostic patents based on natural phenomena. But the Federal Circuit felt bound to apply it to CareDx’s patents. Justice Kavanaugh dissented from the cert denial, signaling his view that the Court should refine or reconsider its eligibility framework as applied to diagnostic patents.
For the medical diagnostics industry, the outcome is disappointing. These types of pioneering diagnostic techniques often require massive investment to develop clinically. Without reliable patent protection, investors may turn away from funding this research and scientists may avoid commercializing it. As a result, patients may never benefit from potentially life-saving tests.
Looking ahead, the eligibility framework will likely need to be addressed by the Supreme Court or Congress. Justice Kavanaugh’s dissent signals openness of at least one Justice, with four typically required to grant certiorari. Congress is also considering steps to revamp section 101 of the Patent Act, but action is unlikely prior to the 2024 election.
One eligibility petition is still pending in the case of ChromaDex, Inc. v. Elysium Health, Inc., No. 23-245. ChromaDex is asking the court to rationalize its natural phenomenon jurisprudence from Myriad with its abstract idea and law of nature jurisprudence from Alice/Mayo respectively. Does the same two part test apply to products of nature?
No matter what, my phone as in the message. All of it can be retrieved.
As Dennis knows, there is no “revisiting the eligibility framework” until the “framework” in the US for drafting claims is revisited. This is not a policy issue. It’s an issue of basic logic, so basic that ordinary people have little difficulty understanding the issue.
But keep pretending otherwise! Nobody can predict what will happen to pretenders who ignore basic logic in favor of their dreams, especially when those dreams are mainly dreams about non-inventor wealthy white dudes scraping the bottom of the barrel and ruining everything in order to line their own pockets (while they aren’t cheering on f a s c i st coups).
It is more than a fair assessment that your view of “logic” is not in accord with reality.
“those dreams are mainly dreams about non-inventor wealthy white dudes”
You really do have some serious Sprint Left cognitive dissonance issues.
MM bro how you feelin today?
? What current event drives this question?
By now a competent patent attorney can draft a claim that passes Section 101 muster. **Assuming the inventor actually invented a non-abstract invention (which is not always the case).
I agree. But that assumes that the application gets assigned to a reasonably competent examiner. That is no sure thing.
I don’t agree at all. Plus, the competent examiner issue is huge.
101 is simply a nightmare that has not ended and the new director has 101 creeping into other AUs and examiners are typically arrogant as F with 101 rejections because they know it is all just made-up nonsense.
I don’t agree either. The cases are all over the map, and there’s no way to determine what will be considered to be “so” abstract that outlining a problem, solving that problem, and putting the solution to that problem in the claims is useful or not.
There is also an “unstated” premise that “competent” would merely not attempt to protect innovation based on the illicit actions of the Supreme Court.
But this misplays the role of counsel as advocate for their clients, and seeking to overturn incorrect Justice (Supreme Court Justice) written (as opposed to actual interpretation) law is made to disappear without thought or understanding.
This would decidedly be against the ethical requirements of counsel.
This is not to say that every counsel MUST make that fight – the decision to make that fight is (and ever remains) a client choice – but the client making that choice needs to be making an informed decision.
. . . which is why it’s better to deal with the 101 devil that we know (Alice / Mayo), than with the one that we don’t (PERA).
Competency is not the focal point of fighting incorrect law — leastwise not in your view of abdicating to that incorrect “interpretation” of law.
If it were, we would still be embracing Dred Scott.
>>a competent patent attorney can draft a claim that passes Section 101
This is simply nonsense. A competent patent attorney knows if a claim is likely to run into trouble at the patent office and we have ways to try and get around it. But, in reality, there are many inventions that can’t be claimed without a decent chance of running into a problem 101. Lots of companies now regularly forego filing a patent application because it is just too likely that the application will run into 101 problems.
Plus, there are still many applications that are being abandoned due to 101 and there just isn’t a good way to write new claims in a continuation to get around 101 particularly when the application has landed in 36xx AU.
Reality. I deal with this every week and appeal 101 decision. I consult with huge international client who just say forget it. Let’s not file on this one. And let’s just abandon it. That is reality.
Correct — improper application of 101 (by the Court) does NOT dictate that “competency” be defined as kowtowing to the impropriety.
JurisIMprudence.
Plain and simple.
“detect this! and this! and that!” claims where the “innovation” is just specifically naming the thing to be detected or what detection of that thing “means”
In other words, the “invention” is some species of information. No chemical or mechanical change, no structure except the putative “structure” of information, which is just more information.
Wrong! Obtaining knowledge requires energy and time. Therefore, knowledge must be patentable. It must! It must! It must!
Obtaining knowledge is exactly like a cotton gin or an electric bulb! The stars in the sky are transient!
^^* the Tweedles are at it again.
In other words, the “invention” is some species of information. No chemical or mechanical change, no structure except the putative “structure” of information, which is just more information.
Just information?
Martin, do you want to know about that hurricane coming? Nah … it’s just information.
Martin, do you want to know that the wire you are about to touch is live? Nah … it’s just information.
Martin, do you want to know that the ground underneath you contains 10b barrels of oil? Nah .. it’s just information.
Martin, do you want to know that you have a disease that is curable only if you catch it soon enough? Nah .. it’s just information.
Martin, do you want to know that the inbound traffic to your computer indicates that you have likely been hacked? Nah .. it’s just information.
Martin, do you want to know that the oil temperature in your vehicle is unusually high? Nah .. it’s just information.
Collecting data, analyzing data, and reporting that analysis is not important — am I wrong?
Martin, do you want to know about that hurricane coming? Nah … it’s just information.
Can a patent be obtained on knowledge of an impending hurricane? A patent can be obtained on a better weather radar. Can one be obtained on a better forecasting model?
Martin, do you want to know that the wire you are about to touch is live? Nah … it’s just information.
Can a patent be obtained on knowledge a wire is hot?
Martin, do you want to know that the ground underneath you contains 10b barrels of oil? Nah .. it’s just information.
There’s gold in them thar hills. Can I haz a patent?
Martin, do you want to know that you have a disease that is curable only if you catch it soon enough? Nah .. it’s just information.
Gee, who told you I was sick? Did you find out via use of a new manufacture, composition, or machine?
Martin, do you want to know that the inbound traffic to your computer indicates that you have likely been hacked? Nah .. it’s just information.
Boy I couldn’t do Sh*t all if my computer were being hacked. But if some clever software on my machine knew it was being hacked, that sure could be useful! Maybe I SHOULD be able to get a patent on something like that, huh?
Martin, do you want to know that the oil temperature in your vehicle is unusually high? Nah .. it’s just information.
Golly if I invent an improved oil-temperature sensor, I sure hope I can get a patent on it!
Collecting data, analyzing data, and reporting that analysis is not important — am I wrong?
Those things can be very, very important. There are lots of very, very important things in the world for which no patent can- or should- be obtained.
Useful information that gains its utility inside a human mind should be out of the patent system’s reach.
Utility gained in a machine process, if meeting the other requirements of patentability, could conceivably- if not ideally- be protectable by patent as a policy compromise.
Better that no logic or information be protectable, but reasonable people could come to different conclusions on that.
There are lots of very, very important things in the world for which no patent can- or should- be obtained.
No patent should be obtained? You’ve been saying for years but I don’t recall you ever setting forth a policy argument as to why that should be the case.
Why does it matter where the utility is gained?
For me, if it is useful, then it should be protectable.
Why does it matter where the utility is gained?
Because the boundary of a human mind is a principled demarcation of an otherwise hopeless tangle; the area where a useful idea becomes a patentable invention, or where a useful item of information becomes a patentable invention. You cannot “protect” thought nor infringe by telling someone something in a free society.
The judicial insistence on some measure of non-abstraction (whatever that legally means) is recognition of that fact.
A human mind is the absolute arena of abstraction: no human mind, no abstraction.
You cannot “protect” thought nor infringe by telling someone something in a free society.
You are confusing the claimed invention and the utility of the claimed invention.
You have written “Useful information that gains its utility inside a human mind should be out of the patent system’s reach.” However, the ‘gain[ing] its utility’ is oftentimes (most of the time?) not even being claimed. In fact, I would wager that the ‘gain[ing] its utility’ part is almost never being claimed. As such, your justification does not match the reality of what is being claimed.
If you want to make a policy argument that “thinking” should not be an infringing act, then I’m fine with that. However, that limited goal should not restrict what is patent eligible since there are useful data processing inventions that are worth incentivizing and hence worth protecting.
There are useful data processing inventions that are worth incentivizing and hence worth protecting.
I agree. Our company obtained a patent this year on a data processing invention.
The utility of the invention is realized by the computer in disambiguating certain data. Cleaning up data is like a sharper knife: it’s intrinsically useful to the knife without regard to what is being cut.
It’s really quite easy to apply this test to every kind of information invention.
Sometimes you hit a subjective edge, but like obviousness, nothing human beings do can make law that does not eventually, sometimes, come down to the subjective understanding of a jurist or juror. A subjective edge is nothing like the free-for-all of the current Alice regime.
… and into the weeds again.
“The utility of the invention is realized by the computer in disambiguating certain data.”
No.
You mean “implemented by.”
The realization OF utility – like any and all such realization for the patent sense of the word “utility” is — necessarily — in the human mind.
This is why the simple notion of a traffic light (literally) stops your “ideas” d e a d in their tracks.
Further, your statement of, “Cleaning up data is like a sharper knife: it’s intrinsically useful to the knife without regard to what is being cut.”
Has already been debunked in regards to an unstated (by you) – but still required context.
Sharper edges are simply NOT universally of utility, as any such sharper edge requires a human (mind) directed purpose or application.
I will again repeat that you should discuss actual patent utility with your patent counsel, given as you refuse to accept the plain truth that I provide to you.
Caught in the George Carlin filter…
Your comment is awaiting moderation.
October 5, 2023 at 8:04 am
marty’s statement of, “A human mind is the absolute arena of abstraction: no human mind, no abstraction.” is a great example of someone simply not understanding the terrain upon which that person would do battle.
The claims in question simply are not — as a whole — directed to anything that exists entirely within a human mind.
That a human mind is necessary TO MEET the patent requirement of utility also runs 180 opposite of marty’s pet theory.
I am reminded of Wolfgang Pauli’s “not even wrong” in that marty insists on statements and theories that 1gn0re the legal landscape of patent law.
The worse part is not his “other universe” mental w @ nkery — it is his abject refusal to understand the terrain and insist that his w @ nkery is accurate.
anon: “marty insists on statements and theories that 1gn0re the legal landscape of patent law.”
Translation: Marty insists on ignoring my unintelligible gibberish when he should be making my arguments for me, even if those arguments were discredited and tossed in a cold heap in a lonely corner of the loony bin.
You are doing that projecting thing again Malcolm.
Could you imagine if I printed those ravings and brought them to our patent attorney (who actually gets patents for us) and paid the man to try to make sense of it, for the purpose of educating me.
It’s to laugh to even type it.
Then amp it by imagining being so delusio nal that you offer it as sincere advice.
And then the whole list of delusio ns about traffic lights (which have no structure) or the actual terrain of patent law (dancing figments in Thom Tillis’ noggin)….
At least it marks the years. I think about 10 now that I’ve been on this beat.
That you think them ravings and delusions is a YOU problem.
The point is not that information isn’t valuable. The point is that information as a category of “things” is TOO VALUABLE and TOO FUNDAMENTAL to lock it up with patents (and create strict liability for its use), in addition to it being abstract. While a natural phenomenon is not abstract, there is again the issue of preventing others from using EXISTING TOOLS AND METHODS to detect and study the phenomenon. Hence the ineligibility of claims to “looking at this new phenomenon with a telescope that someone else invented.”
Does this not make sense to you? If it doesn’t, probably you should find some other profession.
+1
The invention is in figuring out what information to collect and/or in how to collect it.
But for Martin (and, apparently, most of the people on scotus), it’s all just “information” so there’s nothing patentable.
Atari: “The invention is in figuring out what information to collect”
That does not sound like a patent eligible “invention”, or any other kind of invention.
“and/or in how to collect it.”
“or what detection of that thing “means””
Traffic light.
(And marty is dropped yet again)
¯\_(ツ)_/¯
“35 U.S.C. 101 Inventions patentable.
Whoever invents or discovers any new and useful process,
machine, manufacture, or composition of matter, or any new
and useful improvement thereof, may obtain a patent therefor,
subject to the conditions and requirements of this title.”
The discovery that DNA of fetal origin can be detected in maternal blood of a pregnant female, and that this can be used in methods to detect PATERNAL DNA, was groundbreaking in the field of fetal testing. Yet, the method for doing so was determined not patent eligible by the Federal Circuit, and the Supremes denied cert.
For starters, there is no patent law stating that every allegedly “groundbreaking” discovery must be eligible for patenting, no matter what the claim looks like.
Second, once it was known that stray fetal cells were in the maternal blood (a discovery that was not made by the patentee) it was obvious that there would be “detectable” amounts of fetal DNA in the blood because (1) fetal cells include fetal DNA and (2) PCR can detect the presence of single molecules of DNA. The real challenge was determining a way to perform the detection reliably, accurately, safely, quickly, and cost-effectively and NO INVENTIVE SOLUTION to any of those problems was recited in the claims at issue.
Is this difficult to understand? No.
“Why you always lyin’?”
“In 1996, Drs. Dennis Lo and James Wainscoat discovered cell-free fetal DNA (“cffDNA”) in maternal plasma
and serum, the portion of maternal blood samples that
other researchers had previously discarded as medical
waste. cffDNA is non-cellular fetal DNA that circulates
freely in the blood stream of a pregnant woman. Applying
a combination of known laboratory techniques to their
discovery, Drs. Lo and Wainscoat implemented a method
for detecting the small fraction of paternally inherited
cffDNA in maternal plasma or serum to determine fetal
characteristics, such as gender. The invention, commercialized by Sequenom as its MaterniT21 test, created an
alternative for prenatal diagnosis of fetal DNA that
avoids the risks of widely-used techniques that took
samples from the fetus or placenta. In 2001, Drs. Lo and
Wainscoat obtained the ’540 patent, which relates to this
discovery.”
Nothing in your comment contradicts what I wrote. Read what I wrote then read what you wrote. Then try to educate yourself on what was understood about the capability of “known detection techniques” as of the critical date for the absurd claims that were at issue in this case.
Dude, I hope your technological area is not biology! You think a stray fetal CELL is the same as CELL-FREE fetal DNA? Seriously?
Regardless, where is this stray fetal cell prior art of which you speak?
You think fetal cells are made of steel? If there are detectable fetal cells in the bloodstream, there is detectable fetal DNA in the bloodstream.
The prior art is discussed in the cases which you’d know about if you’d read them and paid attention to the discussions about them back when the cases were first published.
You do not understand how PCR or other nucleic amplification processes work. It is different than trying to find a few “stray cells.”
The prior art is not discussed in this decision. But, you may know better.
link to cafc.uscourts.gov
“Nothing in your comment contradicts what I wrote. Read what I wrote… ”
Ok.
“For starters, there is no patent law stating that every allegedly “groundbreaking” discovery must be eligible for patenting, no matter what the claim looks like.”
Nice strawman — no one, and I do mean NO ONE has ever postulated “no matter what the claims look like.”
You going to keep on slathering lipstick on such strawmen….?
“Second, …
once it was known that…. it was obvious that…
Great – the legal argument here is NOT obviousness. But you know that and this is not the first time that you have pulled this type of “Ends Justify the Mean / throw 103 at a 101 issue.”
“The real challenge was determining a way to perform the detection reliably, accurately, safely, quickly, and cost-effectively and NO INVENTIVE SOLUTION to any of those problems was recited in the claims at issue.”
What a POS you are – how duplicitous of you to want to assert “cost-effective” given your past views on that particular item.
Worse, and you should know this because I have told you this directly before, MANY innovations are initially worse off than one or more of your list AND those items may be indicators that a claim is non-obvious but those are just not (individually or as a group) legal requirements to establish non-obviousness.
“Is this difficult to understand? No.”
Level of “difficulty” is not at issue. You actually making legal sense – now that very much is an issue with what you wrote.
“ Nice strawman — no one, and I do mean NO ONE has ever postulated “no matter what the claims look like.””
LOL This discussion is about the eligibility of a claim that recited the use of a BROADLY GENERALLY DESCRIBED PRIOR ART DETECTION METHOD to detect a previously existing natural phenomenon. All of the whiners who don’t like this case are whining about THAT claim being ineligible but they go further and pretend that somehow every detection method is ineligible when nothing could be further from the truth.
Why not just admit it: detection methods are still eligible for parenting and the key is reciting novel non-obvious steps, not merely a generic description of an old detection method and a “new” phenomenon to be detected or a “new” location in which to do the detecting. Think you can handle that?
Read what I actually wrote — in direct view of what you actually wrote — and move the goalposts back.
My critique is spot on.
You may have wanted to write something else (especially after I heed your admonition to read what you wrote – and ripped it to shreds), and you are more than welcome to write a new post doing so, but please do not pretend that you wrote something else.
is it possible that claims could be drafted to cover the invention but no one has yet figured out how to word them? It seems there must be a way to cover this that meets all the legal requirements.
If the claim recited specific details about the steps (identifying critical reagents, volumes, concentrations of reagents, incubation times, etc) AND if the specific steps were non-obvious (because of unexpected results) then of course such a claim could be patented. Now cue up the whiners to argue that such a claim would be “worthless” because “people would just work around it.”
Your “exacting picture claim” mantra is simply not what the law dictates.
But you already know that, eh Malcolm!
“ Your “exacting picture claim” mantra is simply not what the law dictates.”
Depends on the invention and the prior art, Billy. You are an ignorant child.
No 1gn0rance on my part — you confuse your inability to obtain fittingly broader claims is a YOU problem.
Your mantra of painfully easy to design around picture claims is a disservice to your clients. But keep on thinking that you “have to” if that is what it takes for you to lower your cognitive dissonance to a level that you can stand (no matter how p00rly).
Today I buried my beautiful ten year old daughter who died tragically of Brownfelt-Sigmund disease. I am pretty sure she could have been saved if only liability for patent infringement had been radically expanded to include liability for thinking about “new” meanings for data collected using prior art detection methods. The monsters responsible for fighting that expansion should be ashamed.
If you would like me to offer my testimony in a patent case, please let know. I am friends with the Kavanaugh family (this should have no bearing on any Supreme Case that might arise as a result of my testimony). I know there are millions out there with identical stories and we are all equally credible and we are definitely not just shallow-thinking, self-absorbed, online patent-worshipping cranks.
I am sorry to hear that. I always thought when a person passed a quiet in this world came over us all, like a pin drop moment happened. I hope that you heard that pin drop.
Sadly, those moments of silence I have not expierenced of late.
Do you really think that Malcolm was being honest?
There is zero chance of that. He would have NO compunction to being false about such a topic.
Please provide a link for “Brownfelt-Sigmund disease”, when I googled it I found nothing.
Wait, let me guess, Malcolm is now using ChatGPT to write his posts. The fake case cites are coming next.
Malcolm never needed generative AI to be fake.
“ Please provide a link for “Brownfelt-Sigmund disease”, when I googled it I found nothing.”
Okay. Now look up “obvious sarcasm” and “parody.”
^^^ see sarah? No compunction at all – just a “rhetorical t001” from the t001.
DC: “For over a decade, scientists had tried unsuccessfully to use cell-free DNA for this purpose. The key innovation was applying high-throughput DNA sequencing, a powerful detection method that was INVENTED BY SOMEONE ELSE AND KNOWN TO BE WIDELY APPLICABLE.”
My goodness but it’s tiresome fixing these major (and intentional) errors of omission.
For the record, NOBODY is saying that new and non-obvious detection methods that are useful for diagnostic purposes (or any other purpose) are ineligible of should be ineligible. The issue being addressed is the broad claiming of widely applicable prior art detection technology (like PCR or high-throughput sequencing or microscopes or telescopes or antibodies) to detect some pre-existing phenomenon of the type that the prior art detection technology was designed to detect. The granting of such claims does not promote progress in detection technology (the kind of progress that SHOULD be primoted) but rather burdens the use of that technology by creating endless liability for people who wish to use it for its intended purpose. This is why eligibility screens exist in patent systems. If every development in detection technology is followed by millions of “detect this! and this! and that!” claims where the “innovation” is just specifically naming the thing to be detected or what detection of that thing “means”, then the system ceases to promote “progress in the useful arts” and merely promotes “progress in patent filing” and “progress in liability for patent infringement.”
When one of these judges has a loved one who might have been saved from some particular disease, had there been a diagnostic method to detect it, but the test wasn’t developed because no one wanted to invest in technology that you can’t patent, and when that causal link can be proved – THAT’S when SCOTUS will walk back its ridiculous 101 jurisprudence.
In other words, don’t hold your breath if you think SCOTUS is going to fix the mess it made.
Beyond parody. Thank you for the laughs, which I’m sure were not intended but … wow.
You and your warped sense of humor are the only ones who are laughing, Mooney.
… the larger din of laughter is not laughter with Malcolm.
These types of pioneering diagnostic techniques often require massive investment to develop clinically. Without reliable patent protection, investors may turn away from funding this research and scientists may avoid commercializing it. As a result, patients may never benefit from potentially life-saving tests.
I recall the extent of the cheerleading on this blog 10 years ago when it came to expanding the application of 101.
‘I never thought the leopard would eat MY face.’
Is there any evidence of a decrease in investment into diagnostic methods? (No snark, genuinely curious.)
I don’t know. These things take time to percolate. At the beginning, few really think “the law is going to take away my technology.” Moreover, if you have research/technology that has been in the works for years and years and years, you aren’t going to shut it down because you think that you might not be able to get patent protection.
Moreover, some researchers are so isolated from the world of patent law that they don’t even realize that what they’ve invented cannot be patented.
Eventually, however, the people who fund this type of research start putting more effort into vetting the technology and determining whether the technology is patentable and start weeding out more and more promising technology because it cannot be patented.
It all takes time. Eventually, you will come across researchers who will say “yeah, we could have gotten this funded 10 years, but not today.” Those stories aren’t told in the media because who really reports on highly-speculative technology that didn’t have a chance to come to fruition?
“ some researchers are so isolated from the world of patent law that they don’t even realize that what they’ve invented cannot be patented.”
Oh, the humanity! Will someone please think of all these researchers who aren’t aware that there are online patent crack addicts trying to patent methods of thinking about the meaning of data?
It’s still early on Monday but it’s going to be hard to top this unintentional comedy gold.
“the people who fund this type of research”
Right. The people who really, really, really care about improving healthcare but who are like “What? We can’t sue people who think about the meaning of data? In that case I’m going to just give my money to this gold course developer.” Those people. The best people! They are very serious and important and we must please them with absurdly expansive patent rights because there is no other way to fund research into disease causation and detection except to turn everybody into a patent infringer.