Upcoming Oral Arguments in Myriad

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

136 thoughts on “Upcoming Oral Arguments in Myriad

  1. 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.

  2. 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.

  3. 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?

  4. 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).

  5. 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.

  6. 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.

  7. 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< ?i>”

    Whether or not anyone loses any sleep over any decision is relevant…. how?

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. “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.

  13. 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

  14. 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.

  15. 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…

  16. 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.

  17. 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?

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. “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).

  25. 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.

  26. 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.

  27. 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?

  28. 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.

  29. 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.

  30. “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.

  31. 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]

  32. 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

  33. 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.

  34. 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?

  35. 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?

  36. 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.

  37. 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.

  38. “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?

  39. 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?

  40. 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.

  41. 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.

  42. 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.

  43. 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?

  44. 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.”

  45. 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.

  46. 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.

  47. 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.

  48. 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.

  49. 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.

  50. [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.

  51. 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]

  52. 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

  53. 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.

  54. 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!”.

  55. 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?

  56. 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?

  57. 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?

  58. 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.

  59. 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.

  60. 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.

  61. 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.

  62. 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?

  63. 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.

  64. 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.

  65. 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.

  66. 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.

  67. 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.

  68. 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.

  69. 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.

  70. 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.

  71. And the better way to get publicity is to take down thousands of patents under a categorical ineligibility theory

    As it is with any of the anti-patent 101 agendas…

  72. Hans, what you say about utility would be true if Myriad had identified a bare sequence with no information about the protein it encodes, and the function of the encoded protein. The patent spec will show you that there’s substantial and specific utility.

    More to the point, the ACLU is not interested in making a utility or anticipation argument, because that would only invalidate the particular claims in this case. Why spend time on just a few claims that aren’t even infringed by diagnostic testing? These guys were sitting around one day, looking for something to be outraged about, and of all the things that bug them they picked “gene patents.” Supposedly they could have picked something else, like, oh, an actual civil rights issue. But no matter – we all have to do something with our time. And the better way to get publicity is to take down thousands of patents under a categorical ineligibility theory instead of striking down just three or four for lack of novelty or utility.

  73. The value of information is inherantly tied to the person that is valuing that information.

    The information with regard to impending rainy weather in London to a farmer in Iowa is of no value to that farmer but it is of value to umbrella sellers in London and their suppliers. The information of impending rainy weather to a farmer in Iowa may be either good news, during an extended period of dry whether or bad news if the harvest is due and he needs it to stay dry.

    If a manufacture is defined as being something tangible, then information cannot be a manufacture because it is abstract. But having no value? (Where relevant) information is highly valuable and I don’t think that anyone, whether pro- patent or anti- patent would be able to disagree.

    Just because something is abstract does not mean that it doesn’t have value. What of goodwill? Monetary values are put on goodwill all the time? Is goodwill abstract?

    If you used the word intangible instead of abstract, would that colour your points above any differently?

  74. So, if I was a company and learned all of this and keep everything a trade secret and then had a product send in a swab and we will tell you likely hood of getting breast cancer for a fee.

    That has no utility? Why do people pay for it then?

    The manufacture here is a information product. And, then invention is taking some giant thing inside of us and figuring out how a portion of it can predict whether we will get cancer.

  75. All this gesticulating, and for what? This case is easy. The full-length claim has no substantial or credible utility, because it’s only useful to do further research. 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 . Oh, the fragment is anticipated under 102. Even Holman and Noonan agree with that.

    Done.

    Malcolm, what do I win for this?

  76. 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 “isolate” 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!”.

  77. I took your “and then tell me” as a question.

    Was that too difficult for you to figure out from the context of our discussion, or are you really that thick?

    Either way, my post as I just time stamped for you “answers” you with the explanation you wanted (and indicated that you wanted after I had already provided it).

  78. You do like to wait when answers to your questions are already present, don’t you?

    Which questions are those, anon?

    Like I said, have a nice day.

  79. MM–

    You do know that this is before the USSC, a non-technical institution, don’t you?

    I repeat what I’ve been saying here, and elsewhere, for years: we need a specialist patent court.

    And no, the CAFC isn’t sufficient, nor will it be sufficient if Chen is appointed, although it might improve.

  80. Can anyone identify what’s wrong with this statement:

    “the presence in humans of sequences identical to the sequences of the claimed nucleic acid compositions”

    Why don’t you identify what’s “wrong” with the statement, anon? Maybe first you can carefully re-read what I wrote.

    After that, it should be easy to identify what’s “wrong” with this statement: “the presence in humans of a complex molecule consisting of seven hundred atoms, 13 of which are identical to the 13 atoms in the claimed synthetic chemical.”

    Please tell us all what’s “wrong” with my statements, anon. See if you can explain yourself clearly and convincingly instead of just launching into your usual insulting inuendo. Suprise everybody. Throw Dennis a bone because frankly you’re making him look a f–ing m0r0n for not banning you a long time ago when your sockpuppetry got out of control.

  81. What steps are required to infringe this product-by-process claim?

    Gee, I might guess that one step would be to, um, isolate the product.

    MF retort FAIL

  82. That’s not an answer MF.

    Oh wait, you don’t do answers, is that it? Those are not on your narrow script, are they?

  83. Sorry, LB, I don’t have that digging ability you have and haven’t been able to dig my way through the first load from MF.

    But, it is amazing that you see “anon said” and all else seems to fade into shades of grey. Now if you could steel yourself and read my comments and then match them to what MF vacusously posted, we’d be humming.

    I am touched, really.

  84. Right, anon. Keep telling yourself how superior your comments are. But how about you go read the thread initiated by “Anonymous Coward” above, and then come back and explain to me which parts of MM’s comments in that thread are “crrp.” And then tell me how many sentences of “substance” that you contributed in that little discussion.

    Go ahead, I’ll wait.

  85. “‘Isolated’ is a physical description of the composition.”

    It is? Sounds like a product-by-process limitation to me.

    I’m not aware of an isolated chemical composition claim (i.e., “An isolated chemical, wherein said chemical is X”) ever being construed as a product-by-process claim. What steps are required to infringe this product-by-process claim?

  86. Yes MF , your QQing about “this shouldn’t be a 101 question” was noted above.

    Hmmm, there’s a phrase I have heard for this (no, not one of the cuss ones):

    WHATEV

  87. Your head, sir.

    (And I have given you plenty of advice on how to reduce my postings – advice you are determined to ignore)

  88. Phhffft.

    Nice that you have embraced your nature and single me out from the even deeper pile of effluent from MF.

    Well, your ability to resist your obsession seems to be the master of you yet again. I admire the way that you can go about blindly ignoring the crrp that is MF and focus on me. Touched, really.

  89. All you did was tell me it was a label indicating structure.

    You didn’t tell me what that structure was.

    (as for the unearned and unecesary insults, well, that’s just MF being MF)

  90. Can anyone identify what’s wrong with this statement:

    the presence in humans of sequences identical to the sequences of the claimed nucleic acid compositions

  91. “‘Isolated’ is a physical description of the composition.”

    It is? Sounds like a product-by-process limitation to me.

  92. Also – analogously to Prometheus, if the change is not enough, then So Sorry – no patent for you

    Prometheus was a 9-0 decision because adding an abstraction (a “novel” mental step) to an old conventional step is effectively a patent on the ineligble abstraction. Why is that so? Because practitioners of the prior art become literal infringers when they otherwise lawfully practice the prior art and think about the abstraction.

    That issue is not presented here. The claimed composition did not previously exist. Nobody is prevented from thinking about anything as a result Myriad’s claims. You and I don’t infringe Myriad’s claim merely be practicing the prior art and thinking about the BRCA genes. Those method claims were correctly tanked by the Federal Circuit following Prometheus, exactly as I predicted they would be.

    As I noted above, there is a question as to whether Myriad’s claimed compositions read on the prior art. That’s an anticipation issue and very straightforward one to answer …. after Myriad’s claims are construed.

  93. I was hoping to actually learn something from the comments on this post, but anon is already well on his way to burying anything useful in his usual 3 feet of effluent.

    What a surprise.

  94. Maybe MM you would agree with some of what I am saying about information in that it appears to be devalued in their analysis

    In my view, the interesting issue regarding “information” in nucleic acid composition claims relates to the utility requirement under 101. Recall that in In re Fisher (CAFC 2005) it was determined that merely identifying a nucleic acid composition as an expressed gene was insufficient to meet the utility requirement for 101 eligibility. In other words, a nucleic acid composition that was known at the time of filing to be useful only as a subject for further research into its cellular and/or other non-cellular (ex vivo) functions was not eligible for patenting.

    The facts here are different from In re Fisher because Myriad included a crucial piece of information in its specification: the presence in humans of sequences identical to the sequences of the claimed nucleic acid compositions could be correlated with a likelihood of breast cancer.

    Note that Myriad did not need to express the BRCA1 gene and prove its function in the human body or anywhere else (indeed, some roles of the expressed protein are still being determined — cells are complicated that way!). To overcome the utility hurdle, the only additional information Myriad needed to provide (relative to In re Fischer) was information about this correlation in its specification. To be clear, the information about the correlation is not claimed. But the correlation was enough to grant a patent on what would otherwise be considered an ineligible “object for further research.”

  95. Also – analogously to Prometheus, if the change is not enough, then So Sorry – no patent for you.

    Again, if (and I grant that the Court may decide in this case that that “if” may be enough), “isolation” is simply not enough to make the item different in kind from it’s unisolated state, then So Sorry – no patent for you (no matter how much is costs to isolate).

    And MF – I explained this many times now – why don’t you employ that great archive ability of yours to find the times you previously ran away from my explanations, with your eyes closed, your hands over your ears and you chanting “na-na-na-na” as loud as you could?

    This time, try to actually open your eyes (in the metaphysical sense, as well as the physical sense) and allow yourself to understand what evidently the Amicus Brief writers of the governemtn and the AMA had no difficulty understanding.

    Or are you still intent on trying to paint my comments with a false or misleading appearance as to some English-as-a-second-language basis, or conceal the truth or real nature of what I actually tell you?

    Since your ability to search the archives, seems effectively disabled, let me start you out:

    dis·sem·ble [dih-sem-buhl]
    verb (used with object)
    1. to give a false or misleading appearance to; conceal the truth or real nature of

  96. “What is that structure, MF? Um, er, um, ….”

    BWWWWAAAAHHHHHHAAAAAAAAHHHHHHHHHAAAAAAAAAHHHHHHHHHAAAAAAA!!!!!!!!!!!!

    Yeah, what is the difference in structure?

  97. “isolated” needs to be construed.

    LOL – it’s a term of structure, man, dontcha know?

    What is that structure, MF? Um, er, um, ….

    Hey, if in fact Myriad’s claimed item is different in kind and not effectively a claim on something in the warehouse of man, I be happy for that patent holder.

    You, on the other hand, continue to flop around with your vacuous hold on patent law, pretending to know everything, except anything you would actually need to know (sort of like with what “effectively” means – Leopold, did you find the archive location for your nice definition yet? What? Haven’t had time?)

    LOL

  98. Of course, the manner in which the claimed nucleic acid composition was originally made or discovered is not the issue.

    LOL – Prometheus thought so too.

    Oh wait – you want a patent on the underlying thing? Is that thing different in kind? No? So sorry for you.

  99. Anon Coward : My question is whether or not these isolated DNA fragments differ in chemical composition and/or properties from the ‘isolated DNA’ claimed by Myriad.

    Great question. In order to answer that question, the term “isolated” needs to be construed. For instance, would one skilled in the art reading Myriad’s specification understand an “isolated nucleic acid” composition to include human serum comprising nucleic acid fragments in which the specified nucleic acid sequence is a micro-component among millions of contaminants? If so, then the properties of the claimed composition and the composition described by Mandel are quite similar.

    I think it’s understood by most artisans (and the PTO) that the term “isolated” is put into these claims precisely to distinguish the invention from living cells and serum compositions such as that described by Mandel.

    what structure or properties are possessed by ‘isolated DNA’ that distinguishes from circulating or cell-free DNA?

    Again, depends on the definition of “isolated”. See above.

    From personal experience, I can tell you that while human serum may be interesting to study, it has very little utility as, say, a tool (a “probe”, in the trade) for determining the presence of specific sequences. In contrast, there’s no dispute that highly purified DNA molecules with specified sequences (which certainly are within the scope of Myriad’s claims) are extremely useful for that purpose. That’s the reason the PTO granted Myriad’s claims in the first place. If you need further explanation as to why human serum lacks substantial utility for the purposes contemplated by Myriad’s invention (and similar inventions), let me know.

  100. Are you proposing different eligiblity analyses

    Why? What made you suggest that?

    And I love how you are attempting to turn a question long asked of you around. That question had to do with YOU showing how – if you were allowed to have a patent on a product of nature – would you show infringement of “your” item versus someone having something out of the warenouse belonging to all men.

    You never did answer that simple questions, and now you seek to have others help you out.

    Sorry – that ball is still in your court.

  101. Maybe MM you would agree with some of what I am saying about information in that it appears to be devalued in their analysis.

    Maybe information processing should be characterized as producing a manufacture.

  102. I am beginning to think IANAE that you really are a very dim bulb and not trying to troll the board.

    (Duh, no kidding is my response to what you wrote.)

  103. Moocow: Medicinal chemists produce novel, patentable compounds every day, using only the routine tools of synthetic chemistry.

    Indeed. Of course, the manner in which the claimed nucleic acid composition was originally made or discovered is not the issue.

    The argument being made by the ACLU is that “medical professionals who regularly use routine, conventional genetic testing methods” will necessarily infringe Myriad’s claims when they practice the prior art, e.g., when they sequence all or part of a person’s genome, even if they aren’t actively looking or interested in Myriad’s claimed sequence. As we’ve been discussing, if the premise of this argument is accurate then it appears there would be a solid inherent anticipation argument. Yet another reason to put the “101 is a threshold issue” nonsense to bed.

  104. The petitioner’s brief, pp. 10 and 11 makes reference to ‘circulating DNA’ aka ‘cell-free DNA’ found in the form of DNA fragments in blood plasma. This was described by Mandel and Metais in 1948. In particular both maternal and fetal DNA is to be found in the blood plasma of pregnant women, and can be used for non-invasive genetic testing. Apparently the entire genome is represented in fragments in blood plasma. I am not a biologist, but I found quite a number of interesting pages on the Web.

    My question is whether or not these isolated DNA fragments differ in chemical composition and/or properties from the ‘isolated DNA’ claimed by Myriad. The CAFC majority judgement relied on the difference in chemical structure (Lourie) and/or properties (Moore) between ‘isolated DNA’ fragments and ‘natural’ DNA in chromatin. But the fact that the isolated chemical might differ from the natural compound found in chromatin does not prove that the ‘isolated DNA’, as a composition, is a new product of man’s ingenuity which Nature is unable to produce.

    I understand that the Supreme Court (Cochrane v. Badische Anilin & Soda Fabrik) that an industrial product (artificial alizarine) chemically indistinguishable from a product of nature was not patent-eligible. So what structure or properties are possessed by ‘isolated DNA’ that distinguishes from circulating or cell-free DNA?

  105. isolation and purification are not necessarily the same things, are they

    Really? Are you proposing different eligiblity analyses depending on whether a composition is “isolated” from its “natural” state versus whether it’s “purified” from its “natural” state?

    Here’s an idea: rather than play word games with us, Humpty, how about you simply answer the question I asked you. Explain what you wrote. How does one determine whether a claimed invention is “effectively” a “product of nature”? Assume the composition is novel when you provide your answer. Thanks.

  106. how can 101 be a pure question of law when it turns on fact-intensive inquiries such as as “marked differences,” or “preemption?”

    Any question before the courts depends on the facts of the particular case or controversy. The text of the claim is a fact.

    A question can be a pure question of law if the facts are not reasonably in dispute. For example, if both parties agree on how isolated DNA differs from chromosomal DNA, but they disagree on whether the differences are legally sufficient.

    That’s how summary judgment happens. The parties agree on the facts, and what’s left is a question for a judge. No presumptions, just a legal yes/no.

  107. Well, to be a little tongue-in-cheek: what we’re actually getting from the claimed DNA is recombinant protein, not information. But I fully agree with you – how can 101 be a pure question of law when it turns on fact-intensive inquiries such as as “marked differences,” or “preemption?”
    About the method: what was used was actually not a method for isolating the claimed gene. Isolating the claimed gene is scientifically quite pointless. The BRCA1 gene was cloned, not ‘isolated.’ Meaning, random pieces of chromosomal DNA were first artificially replicated millionfold in bacteria; those that contained BRCA-coding DNA were then further cut up into random shorter overlapping fragments, and these overlapping short fragments were sequenced, and finally the “full” BRCA sequence was assembled in a computer. So nobody made an isolated BRCA gene, and the so-called inventive contribution in this case actually has nothing to do with isolation.
    Now I grant you, Myriad didn’t invent the process of cloning genes either. But what does the method for making a chemical (assuming it’s enabled) have to do with the validity of the claim to that chemical? Medicinal chemists produce novel, patentable compounds every day, using only the routine tools of synthetic chemistry.

  108. The other problem is that you have the method/underlying “thing’ issue.

    If that underlying “thing” belongs to the warehouse of men, then stop – the judicial exception applies.

  109. The problem with what you are saying is it is argued that the method of isolating the nucleic acid sequence was well-known. Again, seems factual to me so how can 101 be purely legal question.

    So, I understand what you are saying, but consider that what we are actually getting is information from the DNA.

  110. NWPA,
    no, I don’t think information processing is relevant to the Myriad case. What is claimed is a tangible nucleic acid molecule. In the form claimed, it’s useful mainly to make recombinant protein in cell culture, or for use as molecular biology tools in the form of primers and probes. The claimed molecules – especially the longer ones – are not particularly useful for diagnostic purposes.
    I want to reemphasize something MM said above: it’s a claim construction issue; it’s certainly possible to examine, study, or use a natural gene without excising it from the chromosome. So those who argue that these claims “preempt” any use or study of the natural gene must be applying a claim construction that’s so broad that it would almost certainly render the claims invalid for other reasons. It’s fair to assume that the PTO, when it examined and granted these claims, gave them a broadest reasonable claim construction that is nonetheless narrower than what the petitioners now argue in the Supreme Court.
    Oddly enough, for all the hysteria over the purported evils that flow from such patents and the pure malevolence of those who own them, no time is being spent on construing these claims and reading them on the activities that are supposedly preempted. Instead, the briefs are replete with inane statements like “these patents have contributed to the death of children,” or “these patents prevent anyone from ‘looking at’ the natural gene.” It’s painful to watch.

  111. I understand all that anon. My point is that if instead of information instead a chemical was being produced, then I don’t think we’d be in court.

    Somehow, information is not being seen as a manufacture, but as abstract and not valuable. But, I think information is a manufacture. You see what I am getting at? It is the devaluation of information, which is ironic as information takes the stage front and center in almost every aspect of our economy.

    Just think about how many people work in our information processing society that the SCOTUS apparently would classify the output of their jobs as abstract.

  112. I just don’t even see an issue here

    The issue is (in at least one way of putting it) that certain information – and thus processing of that information – belongs to the “warehouse of men,” and cannot be constrained or encumbered in patent rights.

    Mere discovery is not enough.

    “Putting to good use” is allowed, as long as you realize that the invention is in the act of putting – or how it is being put – a method – method claims are allowed**. Claiming the item itself, the underlying item – or anything that is effectively that item – is not allowed per the judicial exceptions.

    **as long as the method too is not effectively precluded by one of the judicial exceptions. One argument presented here is that the act of isolation does not do enough, as that act is required to access the information, and thus is not “enough” (see Prometheus).

  113. Seems to me that there is a common thread with this case and CLS Bank case. That is that in both cases information is being processed. Here, the amino acid sequence is being used to determine an outcome of the organism. The produce is information. It seems to me that information is being treated like it is 1920 and not almost 2020. We live in an information age where processing that information is the very foundation of our society in every way imaginable (manufacturing, distribution, health care, government). Even the census could not be performed with information processing machines.

    I just don’t even see an issue here. Something new is being discovered and put to good use. The invention is in determining the outcome of the organism based on a sequence of nucleic acids. Sounds like an invention to me.

    The policy question MM raises–franklhy disgusts me–the PTO should figure out how to serve modern research and not try to pare the patent system down to suit its needs. Maybe the solution is to wipe the PTO and start again. Just wipe the entire PTO off the map and start completely new with the new agency’s mission to serve the modern information processing inventions.

  114. That’s not a strawman at all. As I noted, the construction of the term “isolation” is a key issue in this case

    Nice. but isolation and purification are not necessarily the same things, are they?

    Do I really need to break out the definition of strawman and map it too your posts as I have done with dissembling to show that (once again) you accuse others of what you do? I can, you know. The definition of strawman has already been so mapped to your posts, this site has archived that.

  115. Dr. Noonan, you are correct in that he Court granted cert on only the first question, albeit Prof. Crouch’s post is showing all of the questions presented in the petition for certiorari.

  116. I continue to remain baffled…looms larger than “subject matter eligibility” in my mind

    First there is denial.

    why limit the analysis to novel, non-obvious nucleic acid compositions

    If you keep on repeating that mantra that these are novel and not just effectively products of nature, you will never solve your “continu[ing] to remain baffled.”

    You have to open your eyes to see.

    regardless of their purity

    Nice attempt at a strawman. Because no one has actually argued that no amount of purifying would be able to overcoem the judicial exception. In fact, purifying may make the item in question different in kind, or in the beloved words of your “9-0 Baby dance a jig Prometheus case, it might “do enough.”

    But then again, I have already explained this to you.

    Weren’t you listening? Or were you still sitting there with your eyes closed, remaining baffled?

  117. I continue to remain baffled by a few recurring aspects of this case:

    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 is a claim construction issue. It’s certainly possible to “examine” human DNA (or any other DNA) which encodes a protein or other functional molecule (e.g., a tRNA) without “isolating” the DNA in the normal sense of that term. It may not be cost-effective or efficient to do so but … isn’t the presentation to competitors of the opportunity to overcome those sorts of hurdles a major “benefit” of the patent system? Just playin’ devil’s advocates here …

    I don’t think it’s disputable that if patents are allowed on novel non-obvious nucleic acid compositions merely because the DNA sequence of those compositions can be “correlated” with some trait (disease, risk of disease, armpit odor, whatever) the PTO will quickly become inundated with j–k and the thicket will become obnoxious to say the least. To me, that’s the real policy issue. It’s very unfortunate that the Supremes have to make the call based on the storytelling of these particular parties, but here we are. The utility, inherent anticipation and enablement issues with these compositions as claimed (i.e., to the extent they cover sequence space much broader than that known to possess any substantial utility) looms larger than “subject matter eligibility” in my mind.

    1. Are human genes patentable?

    It’s not clear to me why the focus is on “human genes” and not “isolated nucleic acids with sequences identical to sequences newly discovered or later discovered in human chromosomes.” From the policy perspective above, that’s the real issue. Whether the nucleic acid composition in question comprises a sequence that is identified as a “gene” seems completely irrelevant to the analysis.

    Along the same lines, I don’t see why the focus is on “human” nucleic acids. What about isolated nucleic acid compositions with sequences identical to those newly found or later found in bacteria or viruses that are lethal or dangerous to our children? Do we want those compositions to be monopolized? What about isolated nucleic acid compositions with sequences identical to those newly found or later found in animals we keep as pets or use as livestock? Do we want those compositions to be monopolized?

    And why limit the analysis to novel, non-obvious nucleic acid compositions that resemble those found in humans or any other animal? Shouldn’t the same eligibility restrictions proposed by the ACLU apply to any novel, non-obvious chemicals, regardless of their purity and regardless of their activities, that are newly found or later found floating around “in nature”, e.g., in microscopic quantities in the bladder of a three headed frog found in a pool Fukushima Daiichi Nuclear Power Station?

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