Association for Molecular Pathology v. Myriad Genetics, Inc. (SCOTUS 2013)
The Supreme Court has now set oral arguments for April 15, 2013. The petition for certiorari posed the following questions:
Many patients seek genetic testing to see if they have mutations in their genes that are associated with a significantly increased risk of breast or ovarian cancer. Respondent Myriad Genetics obtained patents on two human genes that correlate to this risk, known as BRCA1 and BRCA2. These patents claim every naturally-occurring version of those genes, including mutations, on the theory that Myriad invented something patent-eligible simply by removing ("isolating") the genes from the body. Petitioners are primarily medical professionals who regularly use routine, conventional genetic testing methods to examine genes, but are prohibited from examining the human genes that Myriad claims to own. This case therefore presents the following questions:
1. Are human genes patentable?
2. Did the court of appeals err in upholding a method claim by Myriad that is irreconcilable with this Court's ruling in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012)?
3. Did the court of appeals err in adopting a new and inflexible rule, contrary to normal standing rules and this Court's decision in MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118 (2007), that petitioners who have been indisputably deterred by Myriad's "active enforcement" of its patent rights nonetheless lack standing to challenge those patents absent evidence that they have been personally threatened with an infringement action?
And, the Supreme Court granted certiorari as to only question number 1. Although not announced yet, I expect that the US Government will participate in oral arguments along with the parties.
http://www.supremecourt.gov/Search.aspx?FileName=/docketfiles/12-398.htm
I had a few days away.
I was wrong with dictionaries and manufacture. I checked a couple online and a couple that I have at home – neither of which have a manufacture == a thing, then I remembered that merriam webster is quite US centric in it’s definitions and in my haste I didn’t read the definition they have there properly.
After checking with a couple of friends who are schooled in latin and other languages and etymology they did wonder whether it is an Americanised definition as they believe that it is incorrect in British English to have a manufacture = a thing.
Thanks for the discussion to all.
For what it’s worth, the Myriad patent was upheld in Australia by a single judge in the Federal Court:
link to austlii.edu.au
Genes are patentable in Australia:
link to techdirt.com
“If you don’t agree with him, he’s completely incapable of understanding or responding to the clearest and least controversial of statements.”
Coming from the number one person guilty of purposefully misstating people’s posts, IANAE, I find your comment disingenuous, duplicitous and offensive.
You, once again project a “incapable of understanding” position that is neither warranted, nor accurate. It’s a rhetorical tool that is like a lie – said often enough, you hope to impress upon the impressionable some semblance of truth.
Perhaps the scrutiny of removing personal comments will be applied to your post and perhaps not. But honestly, you are not the person to post about “understanding,” especially the asserted understanding of others.
bob says:
A manufacture = a process of making something
A manufacture != a product
But LB did get it wrong when he said “To be clearer, a “manufacture” as used in Section 101 is a product that results from a manufacturing process. See In re Nuijten.”
From Nuijten:
The term is used in the statute in its noun form, Bayer AG v. Housey Pharms., Inc., 340 F.3d 1367,1373 (Fed. Cir. 2003), and therefore refers to “articles” resulting from the process of manufacture.
From Merriam-Webster Online:
manufacture (noun) – 1: something made from raw materials by hand or by machinery
OK, I’ve supported “my” definition of manufacture with a statement made by the Court of Appeals for the Federal Circuit and with a dictionary definition. I’ve also pointed out that this definition makes more sense in the context of the statute. You disagree, supporting your argument with only an alternative dictionary definition.
With all due respect, bob, which of us do you think is likely to win this argument in a federal court interpreting 35 USC 101?
That’s O, bob – no offense taken.
I think we are both on the same page regarding “physical” and how the Nuitjen case simply misses the boat on reality for that term.
But to clarify (without trying to bog down in semantics),
to manufacture is a process as contrasted with
a manufacture is not a process.
Process and manufacture are different categories (and the invention is often [rightfully] cast and described in the different categories).
Sorry for the confusion, and any offence, if any.
You don’t have to apologize for the confusion or offense. They’re not your fault. Look at how anon engages anybody around here. If you don’t agree with him, he’s completely incapable of understanding or responding to the clearest and least controversial of statements.
You’ll generally get a fair bit of personal abuse along for the ride. And he’ll quite happily tell you that it will all stop, as long as you stop posting and/or agree with him. Because the way he acts is all everybody else’s fault.
You don’t have to say “if any”, either. If you’re talking to anon, it’ll be there in quantity.
TL;DR version: I wouldn’t bother engaging anon, if you’re looking for a good way to spend your time talking about patent law.
Sorry, anon. The problem arose because
NWPA said, “information is not being seen as a manufacture, but as abstract…” when talking about value
I said, “If a manufacture is defined as being something tangible, then information cannot be a manufacture because it is abstract” and then argued that value “is inherantly (sic) tied to…”
I then looked at Nuijten and a few hours later slightly confused myself when replying to LB when I said that the court defined “a manufacture” as “a product” – which they didn’t.
But LB did get it wrong when he said “To be clearer, a “manufacture” as used in Section 101 is a product that results from a manufacturing process. See In re Nuijten.”
When you said “Made by hand” is a term of art…
I thought you were in effect saying that “a manufacture” is a product that results from a manufacturing process as LB did. I thought you were wrong to be using that phrase in your comment, not that the comment was wrong.
This is why I went to the latin meaning of manufactus in order to state that a manufacture is a process.
Yes, “made by hand” is a term of art, as you say, and as a term of art it refers to a physical product.
Articles of manufacture can be made by hand or by machine. I wasn’t trying to say that that was not the case.
Sorry for the confusion, and any offence, if any.
“The Nuijten’s court definition is consistent with the text, with common sense, and the preceding 150 years of patent law jurisprudence.”
With its nonsense treatment (or rather mistreatment) of physicality/tangibility, recognition of its own ignorance in footnote 8 and the elevation of ‘persistence’ as the key to the decision?
LB, sorry, but there is no way I can agree with your statement.
“not sufficiently physical”
That’s just it. That is not what the court said (see my apology to Ned on that point, as I too did not remember the case correctly). They admitted that they were fully physical as that term means, but then turned and based the decision on “persistence.”
“but I’m not losing any sleep over it”
Whether or not anyone loses any sleep over any decision is relevant…. how?
I’m curious, where is the definition of a “manufacture” as used in section 101?
It’s not explicitly defined in Title 35, so far as I know. One clue from the statute is that the statute recites both a “process” and a “manufacture,” suggesting that the drafters didn’t intend the latter to mean the former.
The word “manufacture” when using dictionary definitions refers to a process or method or action of producing a thing.
The dictionaries I use also define “manufacture” as something made from raw materials by hand or by machine.
In re Nuijten the court was wrong to define “a manufacture” as “a product”.
I don’t think so. The Nuijten’s court definition is consistent with the text, with common sense, and the preceding 150 years of patent law jurisprudence.
I’d also like to see the argument that explains how an electromagnetic signal encoded (“structured”) to carry information can be manufactured – ie made by hand.
“Made by hand” works for me, so long as we’re not overly literal with that and understand it to mean “made by people.” (As anon has already suggested.) I don’t think the patent law has ever been intended to discourage the use of tools.
As to whether an encoded electromagnetic signal is manufactured, the radio transmitters that produce these signals are designed and made by humans, for the express purpose of making these signals. Those signals are “manufactured,” if you ask me. The court said they are not, because they are not sufficiently physical. I think they were wrong, but I’m not losing any sleep over it.
bob,
I do not understand your post and why you say that I “got it wrong.”
Are you saying that only directly made by hand items count as manufactures?
It is uncertain why you delve into the Latin at 5:27 AM and proceed to tell me that I am wrong. What exactly am I wrong with here?
Serious question.
More properly, since you got it wrong, “make by hand” is from the etymology of the word “manufacture” which is from the latin word manufactus – quite an old word. I thought you lawyerly types were into your latin. It is a word that had a meaning when it was created, which was many years ago, which was to describe the process of making something, quite literally, by hand.
Now the English language, whether Americanized or not, bastardizes the meanings of words as it evolves, but the fact remains that
to manufacture is to produce a physical item,
that an item of manufacture is a physical item
and a manufacture is a process to produce physical items.
Any other use of the word is either as a simile, metaphorical or figurative.
If you argue otherwise then you should be arguing with the dictionaries to change their definitions, or perhaps to congress to add a new definition in s100.
The issue resolved in defining what “thing” should be allowable.
The court decision resting on “persistence” is a farce if you understand anything about the physics involved (and is inconsistent with the treatment of non-persistent chemical inventions). The handwaving in footnote 8 is especially apalling.
“Made by hand” is a term of art and does not literally mean made directly by an individual’s hand.
This should be compared to “made by man” (as in, anything under the sun…) and contrasted with “made by nature” (i.e. product of nature).
It should also be kept in mind that even though man may be able to make the same thing (or effectively the same thing) as made by nature, that if that thing already belongs to the warehouse of men (and note that already does NOT include a time-dependency element – See Chakrabarty [though just discovered]), then such a thing is off limits to the patent world – not because of any notion of 102/103, but rather, through the implicit words of 101 and the judicial exceptions. Also note, that the process of making that thing may be patent eligible, so the ‘worry’ of dissuading innovation is but a red herring.
I read Nuijten and understood that. It is an issue I have with that decision. Please refer to my respond to LB above.
A manufacture = a process of making something
A manufacture != a product
I’m curious, where is the definition of a “manufacture” as used in section 101?
I’m looking at link to law.cornell.edu and, doing a search for the word “manufacture” I can only see 2 instances of the word which are duplicates and the terms consist of the following lines:
When used in this title unless the context otherwise indicates—
(b) The term “process” means process, art or method, and includes a new use of a known process, machine, manufacture, composition of matter, or material.
If I’m using the wrong resource please correct me. I did look elsewhere, for example, link to uspto.gov, and I cannot see any definition of manufacture to indicate that “a manufacture” is an item or product.
The word “manufacture” when using dictionary definitions refers to a process or method or action of producing a thing.
Etymology – From Middle French manufacture, from Old French, from Medieval Latin manūfactūra (“a making by hand”), from manufactus, a compound of manu factus, manū being ablative of manus (“hand”), and factus past participle of faciō (“I do, make”). (compare main, manual, facture.)
In re Nuijten the court was wrong to define “a manufacture” as “a product”.
I’d also like to see the argument that explains how an electromagnetic signal encoded (“structured”) to carry information can be manufactured – ie made by hand.
Is it that the examples are not realistic or is it simply the employment of the “you only use software” fallacy? You know, the deliberate concealment of the truth of case law (as captured in Alappat for example)?
There’ s a word for that type of misdirection and concealment of reality…
How do I get to obtain the coddled world of enablement where filing well in advance of the many years necessary to prove that enablement through clinical tests is allowed? I mean, without wasting years to obtain a phd, which would only make me envious and bitte.
“Following your logic,… Why fuss with the details about structure?”
Sort of like the magic word “isolated,” since that is “structural,” but ALSO needs claim-extrinsic help to actually figure out what that really means.
Hypocrisy is another well-worn item much lower (and thus much more easily obtained) item on certain people’s priority lists. Don’t you just love all that low hanging fruit grabbing?
Seriously, the words “controlling law” needs a bit more than your hand-wavy QQ to displace them.
It’s rather like pausing, smiling, and raising one’s arm to point to the scoreboard rather than hand waiving, but its easy to see how this confuses you.
“Sure it does. If they’re not in the car, I have a different user experience that is less enjoyable and fulfilling and, as a result, less useful. ”
Maybe you should read the book “A Thousand Poems” by Palin, in order to augment enjoyability factor and maintain the “utility” of inserting non-useful art into patent discussions.
Imagine a car with Barack Obama behind the wheel. You’re in the backseat. Then he gets out and Sarah Palin gets in.
Try to work with some realistic examples. The car has no functional relationship to either Barack or Palin.
Sure it does. If they’re not in the car, I have a different user experience that is less enjoyable and fulfilling and, as a result, less useful. The car is improved when they are in it, from my perspective and also from the perspective of other users with similar affinities.
Gosh, I hope you don’t fold so easy on the issue of “functional relationships” when your client’s claims are at stake. Are you really a prosecutor?
Seriously, the “functional relationship” exception to the doctrine of ignoring printed matter for patentability purposes is an extremely hand-wavey pile of judical deuxdeux. And that’s in its best incarnation, when it’s not being used to justify B-claims and other travesties.
Resally simple : The Examiner says “I have a breakfast cereal right in front of me that was on sale before you filed. Your claim is anticipated.” How do you respond? “No, it’s not the same cereal because that old cereal doesn’t cure cancer”?
Precisely. I can describe what makes my cereal different in the specification (i.e., enablement under 112, 1st).
Uh … no. Your claim isn’t enabled. It’s true that the specification can inform the skilled artisan and enable a claim that wouldn’t otherwise be enabled without the specification, but the scope of the claim needs to reasonably conform to what was, in fact, invented. Following your logic, why would you limit yourself to a “breakfast cereal” anyway? Claim a traffic light that cures cancer, too, while you’re at it. They’re both compositions and nobody has shown in the prior art they cure cancer. Why fuss with the details about structure? After all, all that matters is what you describe in your specification.
It sounds to me like you’ve spent a lot of time in the coddled world of software patent drafting. I’m sure it’s been a lot of fun.
I remember when my biotech buddy was asked to write a patent application for a (very simple) mechanical device. He struggled mightily
That’s a really compelling story. I’m sorry to hear about your “buddy”. I never had that problem, nor did any of my own “biotech buddies”. From personal experience, I can tell you it’s pretty easy to move from biotech downwards to, e.g., “device for receiving targetting ads” or “improved stent.” Boring as heck, but otherwise not terribly challenging.
You are confusing enablement under 112, 1st with 112, 2nd. If their modified sugar cures cancer, then it is covered by the claim.
No, I’m not “confusing the two sections”.
As stated by the Federal Circuit, “the purpose of claims is not to explain the technology or how it works, but to state the legal boundaries of the patent grant.
Right. And the legal boundaries of the patent grant can never be “all future solutions that achieve the desired result that was never before achieved” unless all such future solutions are disclosed.
A claim is not ‘indefinite’ simply because it is hard to understand when viewed without benefit of the specification.” S3 Inc. v. nVIDIA Corp., 59 USPQ2d 1745 (Fed. Cir. 2001)
I’m not talking about a claim being “hard to understand”. I’m talking about a claim being impossible to understand. Be careful about taking baloney like that out of g-rb-ge Federal Circuit decisions. Take your argument to its logical endpoint and everyone might as well just write pure nonsense in their claims. It’s “hard” for you to understand my nonsense, you say? Tough beans. Look in my specification then. There’s a couple judges on the Federal Circuit who think that sort of silliness is reasonable. I’m certain that there’s zero Supreme Court Justices on the court now who agree with them now and equally certain that a majority of Justices will never agree with them.
I hope you aren’t following this in your real life practice. If so, you are denying your clients some good claim language.
Best practice is to minimize prosecution history. If you think you can make a claim reciting an old composition plus some new function stick through the USPTO, then go for it. If you assert such a claim against my client, however, we’ll laugh in your face. Go ahead an file your lawsuit. Summary judgment exists for a reason.
it’s just this crazy claim that encompasses any 15mer from the full-length. If Myriad had a claim to any 20mer from the full-length, that claim might – MIGHT – be OK, at least prior art-wise (there was certainly support in the spec for this).
I wonder: why the keep up the pretense, then?
Never underestimate what a corporate patent attorney will do to save face, I suppose.
italics off
“It does not seem unreasonable (then or now) to have a rule which states that the mere existence of a genetic “correlation” is insufficient to confer specific substantial utility to a nucleic acid composition whose only credible use is to detect its complement.”
I like the idea of the rule you mention, but I don’t think it matters anymore, and certainly not in this case.
“Are there any composition claims pending which are not so easily demonstrated to be anticipated?”
No, it’s just this crazy claim that encompasses any 15mer from the full-length. If Myriad had a claim to any 20mer from the full-length, that claim might – MIGHT – be OK, at least prior art-wise (there was certainly support in the spec for this).
AC,
Just to be clear, when you say “isolated” for the non-Myriad claimed things, you are not saying the blood plasma with the isolated fragments and everything else, but you are asking for the difference between the very fragments within the serum compared to the Myriad claimed things, right?
For some reason, the discussion seems to be focused on a different set of goal posts.
Didn’t Alappat warn against this “I can use my eyes” mentality that I am hearing about?
I think it comes from your backyard (and what’s Not In My Backyard).
I wonder if I can get a patent for flakes of gold if I show all the hard work I had to do to isolate the gold from the muck that accompanies it in nature. All those impurities – if thrown into the purified gold processing I may want to do later would really mess things up, so I really really need to isolate and purify.
“A manufacture is a process which produces a physical product.”
This did not work for Nuitjen.
If “isolated” by itself is so uncertain and needs all these other extrinsic factors, isn’t any claim that uses the term inherently ambiguous so as to fail 112? And if so, does it not fail per se to distinguish in the claim?
The Examiner says “I have a breakfast cereal right in front of me that was on sale before you filed. Your claim is anticipated.” How do you respond? “No, it’s not the same cereal because that old cereal doesn’t cure cancer”?
Precisely. I can describe what makes my cereal different in the specification (i.e., enablement under 112, 1st).
That is, you can’t tell me what the necessary structural differences are between those two computers. All you can tell me is that they were “programmed” differently
A patent specification is written for a person of skill in the art, and such a person comes to the patent with the knowledge of what has come before. In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995). I don’t need to know how the programming impacts how the transistors in a programmable processor are arranged. I don’t need to know the works of a power supply that transforms AC into DC. I don’t need to know how the AC is transmitted to my home. I don’t need to know how a nuclear reactor is used to generate the AC power. I don’t need to understand how the bus interacts with the memory and the processor and the I/O devices of the computer. There are thousands of things (including the structural differences between the two computers) that underlay a computer-implemented invention. A specification need not describe all of them – only enough to enable a person skilled in the art to make/use the invention.
BTW – this is not solely the province of computer-implemented inventions. You can say the same about a transistor or an automobile engine. I remember when my biotech buddy was asked to write a patent application for a (very simple) mechanical device. He struggled mightily with it because he couldn’t wrap his head around all the things you don’t have to describe in the specification. However, he also struggled with the flip side, which is making sure you both broadly and narrowly describe what important bits.
Imagine a car with Barack Obama behind the wheel. You’re in the backseat. Then he gets out and Sarah Palin gets in.
Try to work with some realistic examples. The car has no functional relationship to either Barack or Palin.
A modified sugar, wherein said modified sugar cures cancer
That is perfectly fine language. Does it clearly distinguish the invention from the prior art? If so, it meets 112, 2nd.
The composition needs to be distinguished from the prior art composition based on its structure
The composition needs to be structurally different than the prior art, but you don’t have to recite that specific structural difference. 112, 2nd only requires that you distinguish the claim distinguish but it gives you wide latitude as to how the distinguishing is accomplished
It can’t be the case that examiners and competitors are forced to guess what the new ingredients and structures (or arrangements thereof) are that give your CLAIMED invention its recited desirable properties
You are confusing enablement under 112, 1st with 112, 2nd. If their modified sugar cures cancer, then it is covered by the claim.
They shouldn’t have to look in the specification and try to imagine what the actual invention is
Wrong. As stated by the Federal Circuit, “the purpose of claims is not to explain the technology or how it works, but to state the legal boundaries of the patent grant. A claim is not ‘indefinite’ simply because it is hard to understand when viewed without benefit of the specification.” S3 Inc. v. nVIDIA Corp., 59 USPQ2d 1745 (Fed. Cir. 2001).
The composition itself (not its desired properties) is supposed to be described in the claims
Wrong … see above. I hope you aren’t following this in your real life practice. If so, you are denying your clients some good claim language.
“He/she doesn’t have to use the composition for its intended purpose to determine how it differs from the prior art or whether it infringes.”
Are you talking about an intended purpose that is actually in the claim?
Yes.
And why would one need to “use the composition for its intended purpose to determine how it differs from the prior art”?
Because we’re talking about claims where the novel property/function is the only recited difference between the claimed composition and the prior art. Once again: I claim a “A breakfast cereal, wherein said breakfast cereal cures cancer.” The Examiner says “I have a breakfast cereal right in front of me that was on sale before you filed. Your claim is anticipated.” How do you respond? “No, it’s not the same cereal because that old cereal doesn’t cure cancer”?
if a patentee has a claim to: 1. A computer programmed to receive data inputs, sort the data inputs, categorize the sorted data inputs, and display the sorts
then if one can’t tell just by looking at any random computer, or if they have to actually use the computer for its “intended purpose” then it’s not eligible under 101? Or can’t be infringed?
I believe the claim you described is anticipated by old computers. Give me a better hypo. I can tell you this however: “programmed to receive X” does not structurally distinguish a computer so programmed from a computer that is “programmed to receive Y”. That is, you can’t tell me what the necessary structural differences are between those two computers. All you can tell me is that they were “programmed” differently.
Imagine a car with Barack Obama behind the wheel. You’re in the backseat. Then he gets out and Sarah Palin gets in. You ask them questions and you learn different useful things while you’re in the car with each of those two people. Different results, one superior to the other. But it’s the same car. You can’t claim a new car based on a recitation of that data processing that took place, no matter how much you enjoyed them, or how useful they were, or how much people would have paid for it, or how new the information was.
Tired: If the “improved” transparency is novel and non-obvious, why isn’t that enough to distinguish the invention from the prior art? It has a physical property or characteristic, i.e. a structure, that is novel and non-obvious.
You seem to be moving towards a position where claims do not need to meet the requirements of 112. Or put another way, you seem to moving towards a position where 112 is not applicable to claims (or at least certain types of claims). Do we need 112? Do we need claims at all? After all, if you invented something and it’s decribed in the spec, why shouldn’t THAT be enough? Why do we have claims?
112 requires that applicants distinctly claim the subject matter that they consider to be their invention. If you invented a novel method, the steps in the method need to be described. That is how the method is distiguished from the prior art method. You can’t simply recite an old method and tack on a new result. Do you understand why? The reason is that your invention is a novel method, not a “novel result.” If the “result” is an invention, then everyone would just claim the result they want. New steps? Let people figure that out on their own.
The same is true for compositions. You can’t simply recite an old composition and tag a new desired “result” on the end (e.g., “A modified sugar, wherein said modified sugar cures cancer.”). The composition needs to be distinguished from the prior art composition based on its structure, just like the method claims needs to be distinguished based on their steps. It can’t be the case that examiners and competitors are forced to guess what the new ingredients and structures (or arrangements thereof) are that give your CLAIMED invention its recited desirable properties. They shouldn’t have to look in the specification and try to imagine what the actual invention is. The composition itself (not its desired properties) is supposed to be described in the claims. That’s the invention that was examined (in theory) by the PTO and compared to the prior art (where identical compositions may have been disclosed in the absence of the original inventor being aware of the desirable property you recited in your claim).
[more to follow]
I notice the blocks have been augmented, but will every offensive phrase need to be pointed out (lines 15-16 of the 01:12 PM post) or is it just those that cut and past to use the same comment be censored?
And doesn’t this actually make my point that I am merely responding to the offenses already being perpetrated?
Will the censor be able to also block out the offensive mischaracterizations – which while they may not upset the delicate eyes of readers, are far more pernicious, and serve no valid purpose?
Smoothing out the rough edge of debate and submitting to the crybaby’s veto without taking these items into consideration is akin to censorship, but this is the Professor’s blog, and he can do whatever he wants to do (as well as whatever he does not want to do, like enforce already existing published policies).
C’est la vie
Yet you’ve continually ranted and raved about these “product by process” claims and what a plague they are.
I used to rant about them but I don’t need to rant about them anymore. The Federal Circuit sua sponte cleaned up the mess that Judge Newman made. Product-by-process claims are now treated as method claims. At the same time, if the product intended to be covered by the product-by-process claims is an old product, it’s anticipated and unpatentable. That’s all as it should be. See the old threads on that case (Apotex, right?) for further info.
I don’t think it‘s any different than inventions in which components are claimed as “extruded” or “cast” or “annealed” or any of the various terms used to describe a structure or microstructure or granular structure, etc. that one of ordinary skill in the art would immediately understand to be structurally defined.
By “it” you are referring to “isolated”? I don’t know what else to tell you if you are still hung up on it. I worked in the field for years and I told you that physical differences are implied by the term. The parties in this case agree on that.
The terms you recited are different. If dog-shaped iron objects are old in the art and I claim an “extruded dog-shaped iron object”, what’s the necessary physical difference between the object in my claim and the prior art object? “Extruded” means that the object was created by extrusion. In the context of DNA and biomolecules generally, “isolated” means that the claimed composition is relatively free of the contaminants and competing biomolecules found in cells. It does not mean that such relatively pure compositions infringe the claim only if they are obtained from cells.
GFY.
Really?
Hey suckie: you used to think that Dennis and me were the same person, too.
GFY.
hans: What Mayo did by challenging Prometheus’ patents was actually pretty amazing. Mayo had some patents just like this in its own arsenal. My understanding is that the tech transfer folks at Mayo were not exactly thrilled with the decision to make a 101 assault like it did.
Indeed, Mayo had its own tests that it could no longer protect as a result of the Supreme Court’s decision. They deserve kudos for understanding what had to happen. They did the right thing. I wonder which individual was primarily responsible for that decision? They’d make a great candidate for an IP award.
I just went back and looked at the patents, and there wasn’t even a function or activity disclosed, so even if one assumes that merely asserting that “the protein repairs double-stranded DNA breaks” is sufficient for utility purposes, in this case they didn’t even include that.
Which puts them very close to In re Fisher territory except for the finding that the presence or absence of the sequences could be correlated with an increased or decreased disposition for a particular type of cancer. It does not seem unreasonable (then or now) to have a rule which states that the mere existence of a genetic “correlation” is insufficient to confer specific substantial utility to a nucleic acid composition whose only credible use is to detect its complement.
it’s a failure on the part of the PTO to do its job, and it’s a failure on the part of potential competitors for either being intimidated by Myriad’s patents
No doubt about the PTO incompetence and the cowardice on the part of licensees. But obviously Myriad shares a huge portion of the blame. They could have pursued and enforced much narrower claims without raising the flags, and they could have quietly let their cr–ppy claims whither and die instead of shinging a light on them. Instead, they got greedy and went looking for trouble. And they found some big trouble, just like Prometheus did.
Thanks for the info regarding the claims and the reminder about the broad sequence space embodied by the chosen language. Now I vaguely remember identifying that problem myself early in this case’s history. Are there any composition claims pending which are not so easily demonstrated to be anticipated?
MM said in reply to Hans Blix…
I don’t have a problem with people using whatever alias they desire. But to talk to yourself under two different names is crazy. What’s next, a three way with Orly Taitz and Malcolm Mooney?
There are 1.6 million different 15mers encompassed by claim 5 of US 5747282. Kepler et al. searched for a subset of these 15mers on chromosome 1, and found 340,000. That was just a subset. They also looked at 714 GenBank entries representing complete coding sequences for human mRNA deposited in 1994, and found that more than 80% contained at least one of the 15mers.
I just went back and looked at the patents, and there wasn’t even a function or activity disclosed, so even if one assumes that merely asserting that “the protein repairs double-stranded DNA breaks” is sufficient for utility purposes, in this case they didn’t even include that.
I know that if I launched a BRACAnalysis-style test and I performed it exactly the way Myriad does, Myriad would not sue me for patent infringement (definitely now that we have Mayo v. Prometheus). The problem is that Myriad has a massive competitive advantage over me via its proprietary database of characterized mutations. This is probably the saddest part of the whole Myriad story: it built up this database on the shoulders of patent claims that were either invalid or would never be infringed by a competitive test. It’s not Myriad’s fault — it’s a failure on the part of the PTO to do its job, and it’s a failure on the part of potential competitors for either being intimidated by Myriad’s patents, or for not wanting to put its own patent portfolio at risk by challenging the validity of Myriad’s patents. What Mayo did by challenging Prometheus’ patents was actually pretty amazing. Mayo had some patents just like this in its own arsenal. My understanding is that the tech transfer folks at Mayo were not exactly thrilled with the decision to make a 101 assault like it did.
Tired: Didn’t you say, “[a]t one extreme (upper) limit, one skilled in the art would understand the term ‘isolated’ in this context to include a relatively short DNA molecule (or a collection of DNA molecules, all with the identical sequence, and each much, much less than a million base pairs in length), typically dissolved in a solution of water with stabilizers (typically salts and a chelating agent) and free of any contaminating proteins or other large molecules.”?
Yes, I certainly said that. Note the word “include”. That’s just one example of a composition that would fall within the scope of the claim, at the extreme limit) as I said. Also note the word “typically”. It’s also very common for DNA to be stored as a solid. And assuming the claim was limited to only this narrow embodiment, it doesn’t matter for infringement purposes how the salts got in there or whether the DNA was previously in an undissolved state. It’s a composition claim.
So don’t I have to know how the DNA molecule was “isolated” to know whether it falls within the scope of the claim?
No, you don’t. All you need to do is look at the composition with the tools that everybody uses, every day, all over the world and compare it to the composition described the claims.
More later after I get some other biz done.
“For example, if my invention is a new window glass manufacture with improved transparency, I shouldn’t be allowed to distinguish the invention from known windows in the prior art only by reciting a measurement of its transparency.”
Why not? If the “improved” transparency is novel and non-obvious, why isn’t that enough to distinguish the invention from the prior art? It has a physical property or characteristic, i.e. a structure, that is novel and non-obvious.
“That’s a clear 112 problem (at least, I think it’s clear; let me know if you disagree).”
I disagree. What’s the 112 problem?
“He/she doesn’t have to use the composition for its intended purpose to determine how it differs from the prior art or whether it infringes.”
Are you talking about an intended purpose that is actually in the claim? And why would one need to “use the composition for its intended purpose to determine how it differs from the prior art”? What does that have to do with whether the claimed subject matter is eligible under 101? Or whether it infringes some other patent claim?
“I think you can see how many ‘new programmed computer’ claims fail this analysis.”
So if a patentee has a claim to: 1. A computer programmed to receive data inputs, sort the data inputs, categorize the sorted data inputs, and display the sorts
then if one can’t tell just by looking at any random computer, or if they have to actually use the computer for its “intended purpose” then it’s not eligible under 101? Or can’t be infringed?
Thanks. It helps.
But I don’t think it’s any different than inventions in which components are claimed as “extruded” or “cast” or “annealed” or any of the various terms used to describe a structure or microstructure or granular structure, etc. that one of ordinary skill in the art would immediately understand to be structurally defined. Such structures also don’t have to be “used” in order to determine if they are structurally different from the prior art, and those structures are easily determined to exist using your eyes or other tools of objective observation. Yet you’ve continually ranted and raved about these “product by process” claims and what a plague they are.
“… and I don’t have to know how the composition was made to determine whether it falls within the scope of the claim.”
You don’t? Didn’t you say, “[a]t one extreme (upper) limit, one skilled in the art would understand the term ‘isolated’ in this context to include a relatively short DNA molecule (or a collection of DNA molecules, all with the identical sequence, and each much, much less than a million base pairs in length), typically dissolved in a solution of water with stabilizers (typically salts and a chelating agent) and free of any contaminating proteins or other large molecules.”?
So don’t I have to know how the DNA molecule was “isolated” to know whether it falls within the scope of the claim? If I “isolate” a DNA molecule by some process other than dissolving it in something other than a solution of water and the disclosed stabilizers, do I fall within the scope of the claim?
ToEM, it seems your question was posted twice. I answered upthread.
LB My only comment is that part of your analysis seems to suggest that there’s something illegitimate about distinguishing between two categories (e.g., infringing vs. non-infringing) of physical things by observing their functional characteristics, i.e., by observing their physical responses to physical inputs. I don’t understand where this comes from.
Well, I think you’ve correctly identified a fuzzy boundary in the analysis that may be difficult to shave perfectly smooth. There certainly are terms that straddle the structural/functional border. I think context is necessary to determine whether a term is properly structural or not, and that context includes all the usual facts: the claimed invention, the prior art, understanding in the field, the specification, etc., with the first two considerations (the invention and the prior art) being the most important.
For example, if my invention is a new window glass manufacture with improved transparency, I shouldn’t be allowed to distinguish the invention from known windows in the prior art only by reciting a measurement of its transparency. That’s a clear 112 problem (at least, I think it’s clear; let me know if you disagree).
In some contexts, a recitation of the measured weight or density of a composition could present similar functional claiming issues. In other contexts, however, these sorts of terms would be perfectly fine. For example, if my invention is not “a new window with [a specified transparency]” but “a new toothpaste dispenser comprising a glass window [with a specified transparency] (where such windows can be made by whatever available methods exist), then there isn’t a functional claiming problem. The skilled artisan knows exactly how to determine infringement, objectively, by avoiding the use of windows with that property in a toothpaste dispense and, likewise, the skilled artisan knows how to distinguish the invention from the prior art simply by studying the window’s objectively determined properties. He/she doesn’t have to use the composition for its intended purpose to determine how it differs from the prior art or whether it infringes.
I think you can see how many “new programmed computer” claims fail this analysis. I grant you that it’s possible that it’s not true of all such claims. I can’t think of a simple exception, but maybe you can.
anon: you mean like analogously to “configured” and what that term means to those of that art.
I agree that people use the term “configured to [achieve goal X]” to distinguish their claims from the prior art. I agree that in some circumstances such a term could have objective physical meaning to a skilled artisan (e.g., “configured to contact said A with said B and provide a container for said C”). I don’t agree that the term “isolated” in this context is analogous to the use of the term “configured” in the context of software.
I think you’re the only one commenting here who doesn’t understand my position on this subject yet. It’s not an unreasonable position at all. That is, I can explain the basis for each of those statements and I’ve done so in the past. If you want to disagree with me and explain why my statements are wrong, that’s fine. But instead you habitually ignore what I say and misrepresent my positions ten or twenty times a day. That’s why you’re a f—ing —hole who should be medicated into a quiet stupor for society’s benefit.
Hans: the fragment is anticipated under 102. Even Holman and Noonan agree with that.
Really? Cool. I was wondering about that. Can you direct me to where these two reached their conclusions on that issue?
The full-length claim has no substantial or credible utility, because it’s only useful to do further research.
I agree that in this respect it does seem similar to the cDNA claims found ineligible in In re Fisher (with Rader dissent) and similar cases. I suspect that this case could be distinguished if the applicants disclosed more information than was disclosed by the applicants in Fisher etc.
The fragment claim has utility problems too, because there may be (and certainly are) fragments encompassed by the claim that aren’t useful for anything
Yes. That age old question: at one point does the number of “inoperable embodiments” outweigh the operable embodiments such that the claim isn’t fully enabled?
That’s what’s so messed up about this case. The claims are difficult to defend on a number of grounds. Subject matter seems like it may be the least of Myriad’s problems.
Malcolm, what do I win for this?
I’ll ask Lord Soros what prizes he’s giving out this week and get back to you.
“We can be pretty sure that the term “isolated” means something, however, and that it was intended to distinguish the claim from compositions understood by the applicant (and the Examiner) to exist in the prior art”
Oh, you mean like analogously to “configured” and what that term means to those of that art.
Well, why didn’t you say so?
That seems pretty clear to me, MM. My only comment is that part of your analysis seems to suggest that there’s something illegitimate about distinguishing between two categories (e.g., infringing vs. non-infringing) of physical things by observing their functional characteristics, i.e., by observing their physical responses to physical inputs. I don’t understand where this comes from.
From the point of view of being able to determine whether something falls within the scope of the claim, I don’t see how observing functional characteristics of a thing is any less deterministic than observing static physical properties. (I also suspect that the line between the “direct observations” you mention and an indirect observations of something’s physical properties, e.g., by observing [functional] responses to stimuli, is less clear than you think.)
There certainly might be something wrong with any given claim to an apparatus that is claimed at least partly in functional terms, with respect to section 112, for example. But as you’ve acknowledged that’s also a potential problem for claims that use structural terms like “isolated.”
Are you seriously saying that you do not see that changing the claim that we started the conversation with (using the term “isolated”) into a claim that does not use that term (synthetic manufacture does not require the term “isolated”) changes the discussion?
Really? No, seriously.
Regarding the meaning of “isolated”, isn’t this a term of art with a well-defined meaning? Has it never been construed before? Does this term take on different meanings in different patents?
Term of art: yes.
Well-defined: not really.
It’s been construed before. It does take on different meanings in different patents, as you might expect given different definitions in the spec, different prosecution histories, different contexts.
Because you know, if you change the initial condition and no longer cite “isolated” then the inserted position of synthetically manufacturing has…
Huh?
Again, I’m left wondering: are you just ignorant or are you a f–ckwad clown who fights with people just for the sake of fighting? Or both.
A manufacture is a process which produces a physical product.
The manufacture of information is metophorical.
To be clearer, a “manufacture” as used in Section 101 is a product that results from a manufacturing process. See In re Nuijten.
But information is not a manufacture. A particular mechanism for carrying information might be. That’s partly what In re Nuijten was about, although the claims in that particular case were too broadly formulated and the arguments Nuijten presented weren’t presented very well. The important question in Nuijten was whether an electromagnetic signal encoded (“structured”) to carry information in a particular way could be considered an article of manufacture. The claim I have in mind (which Nuijten almost presented, but not quite) is not to the information itself, but to the “container” for the information, where the container is divided up into particular sub-containers that carry information chunks that are functionally related to one another. Such a claim would be agnostic to the specific information carried, but would specify how an information element having certain measurable characteristics would be encoded, divided up, and carried by the electromagnetic signal.
The court said that I can’t have such a claim. I was disappointed, but life went on.
anon: “Okay. So, if the composition is synthetically manufactured from monomeric nucleotides rather than isolated from a cell, then the claim isn’t infringed.”
Nice strawman.
It’s not a “strawman”, anon. I was discussing one of the implication’s of TOEM’s view that the term “isolated” is “product-by-process” claim language. If so, that has potentially dramatic effects on who infringes the claim. That, in turn, has dramatic effects on the ACLU’s arguments.
[continued from above]
Hopefully the answer to your question is already be clear. At one extreme (upper) limit, one skilled in the art would understand the term “isolated” in this context to include a relatively short DNA molecule (or a collection of DNA molecules, all with the identical sequence, and each much, much less than a million base pairs in length), typically dissolved in a solution of water with stabilizers (typically salts and a chelating agent) and free of any contaminating proteins or other large moleculess.
At the other extreme (lower) limit, one skilled in the art would understand the term “isolated” in this context to refer to relatively short DNA molecules (or collections of DNA molecules, all with the identical sequence, each much, much less than a million base pairs in length), existing outside of a human cell and substantially free of the proteins, chromosomes, fats and other interfering biomolecules that are found in a human cell or human serum.
These are structural differences. I can tell the difference between the claimed composition (the isolated DNA with a specific sequence of nucleotides) and the naturally occuring composition (the human cell comprising a chrosomome). I can tell that by using my eyes and other tools of objective observation. I don’t have to “use” the composition to determine if it’s different from the prior art (i.e., it’s not a functional distinction) and I don’t have to know how the composition was made to determine whether it falls within the scope of the claim.
Finally, just so there is no confusion, I understand that (according to some theories) the above discussion does not put the 101 issue to bed. I also understand that one can certainly complain about the possibly indefinite scope of Myriad’s claims, especially at the lower limit (again, it’s a claim construction issue). My purpose with this comment was merely to explain the structural differences between the claimed composition and the composition found “in nature.” Likewise, that was the purpose of my earlier hypothetical with the tubes of insulin. “Isolated” has a structural meaning to skilled artisans in this context. It’s not a vague indication that “something happened” (unlike, say, “modified” or “treated”) and it suggests nothing about the actual manner of synthesis of the claimed composition.
I hope this helps.
Tired: Aren’t you the one always arguing that in order to patentably distinguish your invention from the prior art, or in this case a product of nature, you have to be able to describe the structural differences?
Indeed. And by “structural” I mean a description of the objective differences between the composition in the prior art and the claimed composition.
So what are the structural differences between the “isolate” chemical composition and the non-isolated, naturally occurring chemical composition?
As I’ve already noted, the precise metes and bounds of the claim is a claimed construction issue. I haven’t gone through the prosecution history of this case with a fine tooth comb to determine what the applicant intended. Maybe Noonan has. Maybe the parties have. I haven’t. Have you? We can be pretty sure that the term “isolated” means something, however, and that it was intended to distinguish the claim from compositions understood by the applicant (and the Examiner) to exist in the prior art. I have read nothing to suggest that Myriad’s claims are “product by process” claims. Ultimately an expert (or two) will offer testimony as to how one skilled in the art would interpret the claim, assuming that hasn’t happened already.
The differences between the claimed “isolated” composition and the prior art compositions are acknowledged by both parties. I am not aware of a robust (or even a weak) anticipation argument proposed by the ACLU. But let’s run through the major differences again.
The “naturally occurring” composition is human chromosome 17, which is roughly 81 million base pairs long. A copy of that chromosome exists in each somatic cell of your body and every human being’s body. Everybody knew about this chromosome at the time Myriad’s application was filed. Everybody also knows that these 81 million base pair long molecules are absolutely useless as tools for diagnosing diseases because in their natural state, they exist only inside cells, they are enormous (as chemical compositions go) and they are wound up with tons of other proteins and cellular molecules. The problem to be solved by researchers who are trying to invent a nucleic acid with a specific substantial utility, then, is to create a molecule that is (1) much smaller and easier to manipulate, modify and manufacture; (2) that is relatively free of the sorts of contaminants and impurities that “pollute” human cells and human serum (particular nucleases and other interfering proteins); and (3) that is relatively free of nucleic acid molecules without the specific utility desired by the researcher.
[to be continued in next comment]
The final phrase at 11:39
Good to know that some speech is impervious to the Heckler’s (or is it crybaby’s) Veto.
c’est la vie
I am most certainly not trying to troll you.
Where is the forecast for rain? Well, it was made on the radio when I was listening to it. The forecast is now knowledge inside my head. It may also exist in a podcast or some other recording.
The forecast was (it was a radio broadcast), then wasn’t (the broadcast ended) but still is (something I know about).
A representation of information is just that. I would look at the meaning of the verb to represent. To present again. To give an account of, etc. I would argue that a representation of information is not the information itself.
Information is communicable knowledge.
As far as a manufacture being tangible or not, what does §100 say? I can’t see anything defining a manufacture. Would that not mean that the usual definition would be used?
link to merriam-webster.com
A manufacture is a process which produces a physical product.
The manufacture of information is metophorical.
What is the “structure” of an “isolated” chemical composition? Describe it to me. All I’ve seen from you is, “[f]or example, recombinant human insulin can be generated by expressing the protein in flasks of microbial cells.” That doesn’t describe any structure to me. It describes a process.
Aren’t you the one always arguing that in order to patentably distinguish your invention from the prior art, or in this case a product of nature, you have to be able to describe the structural differences? So what are the structural differences between the “isolated” chemical composition and the non-isolated, naturally occurring chemical composition? Describe them to me. And don’t just stick the word “isolated” in front of the chemical composition and declare, “It’s structurally different!”.
Regarding the meaning of “isolated”, isn’t this a term of art with a well-defined meaning? Has it never been construed before? Does this term take on different meanings in different patents?
Because you know, if you change the initial condition and no longer cite “isolated” then the inserted position of synthetically manufacturing has…
…what relation to the discussion we were having????
That’s right: none.
Funny, that’s the same level of intellectual honesty we see from you in this exchange.
And you want to QQ about postings?
“Okay. So, if the composition is synthetically manufactured from monomeric nucleotides rather than isolated from a cell, then the claim isn’t infringed.”
Nice strawman. No one ever indicated such, and to suggest that my position must lead to this position is a fallacy.
Nice to see that intellectual honesty is still top of your priority list. Any idea as to when you will actually get to the top of your priority list?
I might guess that one step would be to, um, isolate the product.
Okay. So, if the composition is synthetically manufactured from monomeric nucleotides rather than isolated from a cell, then the claim isn’t infringed.
You should let the ACLU know about your theory. I think they’d be interested.
“unless it’s functionally related to the thing.”
LOL – thanks IANAE. Worth noting for the archives.
I don’t think that a manufacture should have to be tangible.
Unless you’re speaking metaphorically (manufacturing evidence, manufacturing argument), that’s way beyond “broadest reasonable interpretation”. Everybody knows that manufacture means making stuff, putting stuff together. By hand, etymologically speaking. Typically in a “manufactory”, which might be more familiar to you as a “factory”.
The information is produced (taking time, space, and energy). The information must be represented somewhere. That representation of the information is tangible.
The fact that it can be written down on a physical thing doesn’t make it patentable. Actually, that pretty much makes it unpatentable, unless it’s functionally related to the thing.
I always love seeing you guys try to slither around the printed matter doctrine with your expanding and contracting metaphors. No, manufacture could be anything. It’s only “printed” that requires paper and movable type from the 1920s. What do you mean, computers can read paper now?
Please try to move past the 1920’s.
This from the guy who fixates on whether Ned’s humors are in balance.
Well, Bob, that is just it. I don’t think that a manufacture should have to be tangible. And, I don’t know what you mean that information is abstract.
What does that mean? Information is abstract? Tangible I grant you is tough issue to argue. I think I can argue, though, that information is tangible. The information is produced (taking time, space, and energy). The information must be represented somewhere. That representation of the information is tangible.
Sorry, I know you don’t like it, but those are the physical realities of information.
Please try to move past the 1920’s.
I don’t think claims in form simpliciter are ever used here in the States (but I could be wrong on that).
pressure of decades of setteld expectation => “such a high power” <=> “Stoffschutz is[t] absolut”
Also with the claims..? No.
The “nose of wax” comment has Supreme Court implications and onlyintersects with the “field of use” notion.
I’m glad you mention copyright. Somethings actually can earn both copyright and patents. Are you familiar with what each protects and why they are not mutually exclusive?
Molecule X simpliciter? Claim 1: Molecule X.
Field of use a nose of wax? Also with claims of the form “Molecule X”? I have in mind something along the lines of “Treatment for senile dementia, namely, Molecule X”.
BTW, I for my part have no idea what you mean by “such a high power” which you credit to me.
Dim bulb, if it is being rejected based on it not having utility then my arguments apply.
The rest of your red herrings I am not going to waste my time on.
I look forward to your response. Try splitting your post into multiple posts. I had a similar issue.
I did have a quick look at Nuitjen (sic) earlier.
I’m still reconciling what the court said about articles of manufacture. If I wave then I am causing signals (photons of electromagnetic radiation or the movement of air molecules) to be received by anything that can register my movement. Is my creation of these signals, which could be percieved as being an expression, patent eligible? Depending on whether you’re looking carefully enough, you may notice that I’m waving with an open hand with fingers outspread.
My opinion is that the thing creating the signals may be patent eligible but the signals are actually expressions which would, if they are new and original, often be copyrightable.
All that Nuijten did was add data (cleverly) to a digital audio file in a way that an observer would recognise. I have a secret wave to signal that I need a beer and I’m buying that I have where I fold my thumb towards my palm. My mates recognise the signal for what it is, but others just think I’m waving.
That has no utility? Why do people pay for it then?
Why do people pay for music? We all agree that music has no patentable utility, right?
Why do people pay for legal services? Acupuncture? Clothing for their pets? Because of their demonstrated patentable utility?
If your definition of the useful arts is “stuff you can get chumps to pay for”, you’ve got some ‘splainin’ to do.
Yeah, and I’m saying that merely asserting that the protein functions in a certain way is not a demonstration of a real world utility. This would actually kill most “gene” patents.
“but not so a claim to Molecule X simpliciter”
Not sure what you mean by this MaxDrei.
“and confining it to its field of use.”
Field of use is still very much a nose of wax.
I also would not place such a high power on “decades of settled expectations.” Prof. Crouch. (with the esteemed Hrick) pointed out that such will be reversed by the Court.
I assume that we want courts (including SCOTUS) to “do their job”. I assume that their job is to interpret the statute and lay down a clear ratio decidere so that our level of certainty about patent-eligibility after their Decision is higher than it was before their Decision.
Looking on the bright side, when the members of the Supreme Panel give their answers to Question 1, we will have a surer grasp on whether a claim to Molecule X is eligible.
It isn’t a trivial question. The valuable thing about Molecule X is its utility. Claims in engineering fields carry their utility with them in the claim but not so a claim to Molecule X simpliciter. There is a reasonable case for denying patentability to the molecule per se, and confining it to its field of use. Not that I am for one minute expecting that result here. The pressure of decades of settled expectations, that Stoffschutz is absolut, is too much for the court to go against.
“The value of information is inherantly (sic) tied to…”
All true bob.
“If you used the word intangible instead of abstract, would that colour your points above any differently?”
Possibly, but possibly not. “Abstract,” as undefined as it is, is a term of art in the patent world. Unfortunately, it is not defined in brightline terms. “Intangibility” as a concept is also an unfortunate and misunderstood item in the patent world. The badly mangled Nuitjen case exemplifies this, as physicality and intangibility collide with a very unsatisfying (if you understand the legal and physics involved) result.
ps – I have a lengthy reply to you on the other thread, but the filter is blocking it. When I figure out where the snag is, the post will show up.