US Government Argues in Court that Isolated Genes are Unpatentable

AMP v. Myriad (Fed. Cir. 2010)

In March, 2010, District Court Judge Robert Sweet held Myriad's gene patent claims invalid for failing to satisfy the subject matter eligibility requirements of 35 U.S.C. 101.  The ruling was directed toward claims that cover particular isolated DNA molecules (genes) and processes of detecting and screening for those genes, but was written broadly enough to essentially invalidate all patents covering genes that were isolated from an organism. 

Last month, I heard a rumor that Obama administration science and legal advisors outside of the USPTO supported Judge Sweet's ruling.  At the time I disregarded that suggestion as unlikely. I was wrong. [Andy Pollack at the NYTimes has the scoop]

The US Department of Justice (DOJ) has now filed an amicus brief supporting the lower court decision — arguing that isolated genes are unpatentable because they improperly claim a product of naturer [Link to Brief]:

The district court correctly held . . . that genomic DNA that has merely been isolated from the human body, without further alteration or manipulation, is not patent-eligible. Unlike the genetically engineered microorganism in Chakrabarty, the unique chain of chemical base pairs that induces a human cell to express a BRCA protein is not a “human-made invention.” Nor is the fact that particular natural mutations in that unique chain increase a woman’s chance of contracting breast or ovarian cancer. Indeed, the relationship between a naturally occurring nucleotide sequence and the molecule it expresses in a human cell — that is, the relationship between genotype and phenotype — is simply a law of nature. The chemical structure of native human genes is a product of nature, and it is no less a product of nature when that structure is “isolated” from its natural environment than are cotton fibers that have been separated from cotton seeds or coal that has been extracted from the earth.

. . . .

Thus, the patent laws embrace gene replacement therapies, engineered biologic drugs, methods of modifying the properties of plants or generating biofuels, and similar advanced applications of biotechnology. Crossing the threshold of section 101, however, requires something more than identifying and isolating what has always existed in nature, no matter how difficult or useful that discovery may be.

. . . .

A product of nature is unpatentable because it is not the inventive work of humankind. That essential rule cannot be circumvented by drafting claims for the same natural product removed from its natural environment and proclaiming the result “pure.”

Several other amici have filed briefs:

309 thoughts on “US Government Argues in Court that Isolated Genes are Unpatentable

  1. The functional part of the claim is what is there besides the “SEQ ID 33 is a 429 nucleotide sequence”. What you are saying is functionally we don’t care. We care about how the molecule is used to for example determine a marker or replicate the molecule. So, the other atoms that could hang off the molecule we don’t care about becasue functionally we get the same result.

    In EE we say that there are a number of ways of implementing the function say for example with a circuit or software so we don’t specify the function.

    Get it? Same thing.

  2. Yes, MM, but read Benson. Shift registers that aren’t eligible because they are capturing a law of nature.

    Funny how you have advocated and loved Benson and now that the same logic invades your turf you are now up in arms.

  3. An isolated oxygen atom is a chemically distinct species from a molecule of oxygen O2.

    Similarly an isolated genetic sequence does not exist in nature and is a distinct chemical entity with different properties from the sequence in vivo. In particular it is removed from its nucleic acid chain and will have new terminator groups (since the free chemical bonds at the end of the chain will not remain as such but will form a stable chemical group e.g. -OH which does not exist in nature

    All this argument is legally very interesting, but not technically very literate.

  4. 1. An isolated nucleic acid, wherein said nucleic acid consists of SEQ ID NO:33.

    SEQ ID 33 is a 429 nucleotide sequence, including modifications of every thymidine residue. As far as you know, there is no genome on earth that includes the sequence. Specification teaches that you can make the sequence using a well-known DNA synthesizing machine.

    Eligible under 101?

    Let’s see the analysis.

    Still waiting. Very simple, straightforward, real-world hypo. Maybe you want to take a shot, Lionel?

  5. no matter how the switches are arranged, the STRUCTURE of the switches are the same.

    Ya know, I tried that back when I was a novice student with my EE teacher a long time ago.

    Didn’t work then either.

    legitimate, engineering-related justification

    Surely, Willton, you know of the difference in structure when switches (moer than one) are created (heck, even just used) in series or in parellel, right? Ya might havta take off your policy blinders to recognize the plain truth.

    IANAE, is that a Nazgul on your shoulder?

  6. It escapes you?

    The reason is that people want to sue software companies as direct infringers. Because they want more money. Which, as you know, is a very good reason to twist the law beyond all recognition.

    Well, yeah, that I understand. Sorry, I was hoping for a legitimate, engineering-related justification, not the cynical “we want to make money” justification. I guess I was asking for too much.

  7. Good question, and an example that I thought up of before. The answer is yes. Machine 1 (i.e., OFF position) has a much different characteristic than Machine 2 (i.e., ON). If I claimed:

    An electric circuit, comprising
    a bulb,
    a power supply connected to the bulb, wherein
    the bulb is lit using electricity from the power supply.

    This claim would be infringed by Machine 2 but not Machine 1. Since Machine 2 infringes but not Machine 1, Machine 2 would not be anticipated by Machine 1 and vice versa.

    Nonsense. Machine 1 is capable of being Machine 2 by merely flipping a switch. There is nothing structurally different about Machine 1 compared to Machine 2. Your claim above would be anticipated by either Machine 1 or Machine 2, as they are the same machine arranged in different manners.

    Your position is basically saying that a machine in one position is unique compared to the same machine in a second position, even though the structure of the machine has not changed when moving from the first position to the second position. I’m sorry, but that makes absolutely no sense. A pair of scissors in an open position does not suddenly become a new and patentably different machine when the scissors are subsequently closed. The same principle should apply to electrical engineering.

  8. No, what escapes me is the reason why we are creating a fiction that a switch in the ON position is considered a new and different machine than a switch in the OFF position.

    It escapes you?

    The reason is that people want to sue software companies as direct infringers. Because they want more money. Which, as you know, is a very good reason to twist the law beyond all recognition.

    It’s absolutely laughable to think that a disclosure of a switch in the ON position would not be an anticipation of a switch in the OFF position. The mere disclosure of a switch teaches the “genus” of both positions. Sure, the switch is different now that you’ve switched it, but it’s not “a different switch”. It’s a switch. It’s designed to be placed in different configurations while still being the same switch.

    All this argument over switches. And yet, nobody seems to want to claim the positions of all the switches on the computer-readable medium. Claim a string of ones and zeros, show its utility, and I’ll be happy to agree that it’s a valid selection patent over the prior art memory device with all those switches.

  9. Now Willton, take the function of a multiple switch arrangement and re-arrange those that are on and off – You have more than a single function at hand. Now increase towards the Billion combination mark.

    It does not matter whether we have more than one function. What matters is the structure of the switches. The fact of the matter is that no matter how the switches are arranged, the STRUCTURE of the switches are the same.

    Perhaps you should stick to your policy arguments, as the facts of the art escape you.

    No, what escapes me is the reason why we are creating a fiction that a switch in the ON position is considered a new and different machine than a switch in the OFF position. If a practitioner wants to claim the arrangement of the switches in a computer, then logically the practitioner should be claiming the arrangement, not the apparatus.

    The fact that a practitioner can claim the arrangement as an apparatus is just an unfortunate circumstance regarding the state of the law.

  10. “The problem, though, is that jurists often analogize cutting a branch from a tree to finding an oncogene. And then they [accurately and logically conclude] that isolated DNA is a product of nature.”

    Fixed it for you. ;-)

    By the way, I am not arguing against the patentability of methods of isolating genes, modified isolated genes, treatments based upon the isolated genes, or gene therapies, etc.

    If the only difference between A and B is that B is isolated and A is part of a system or compound, then B as such should not be patentable if A is found in nature.

    And I should also say I am for very limited 101 rejections. In this case, I believe this is a plain 101 issue and I am surprised that patents to existing genes in isolated forms have been granted.

  11. “Lionel, I agree that such a claim should be patentable, but under the logic set forth in the DOJ brief, I don’t see how it would be. Inventor didn’t invent natural compound X — it exists in nature. Inventor didn’t invent X’s medicinal effect — he simply observed this law of nature. How exactly is Inventor doing more than seeking a monopoly on a natural phenomenon?”

    If the compound as such is found in nature, then the compound as such should not be patentable. However, if the compound or the lifeform/object containing it has not been used to treat people, why wouldn’t it be patentable under the logic of this case? The treatment does not exist until you invent it, regardless of whether the effect does.

  12. “Let’s say we have a light bulb connected to a switch and a power supply. If I turn the switch from the ‘OFF’ position to the ‘ON’ position, have I created a new and/or different machine?”

    Good question, and an example that I thought up of before. The answer is yes. Machine 1 (i.e., OFF position) has a much different characteristic than Machine 2 (i.e., ON). If I claimed:

    An electric circuit, comprising
    a bulb,
    a power supply connected to the bulb, wherein
    the bulb is lit using electricity from the power supply.

    This claim would be infringed by Machine 2 but not Machine 1. Since Machine 2 infringes but not Machine 1, Machine 2 would not be anticipated by Machine 1 and vice versa. Bearing in mind, that we aren’t considering obviousness.

    Obviousness is easy when you have a circuit with only two configurations. However, obviousness becomes a lot harder when you have millions of transistors connectable in an untold number of ways.

  13. “Your claim is anticipated by prior art computers or it’s simply abstract and not eligible for patenting. You can’t just claim a desired function and stick a computer on it and expect to get a patent.”

    You seem to have a problem distinguishing the first paragraph of 35 USC 112 from the second paragraph of 35 USC 112. Common problem among examiners.

    Regardless, computers having new functionality have been patentable for several decades now. Your hypothetical examiner would get drummed out of this USPTO rather quickly for failing to properly apply the law.

  14. You come to me like a moth to the flame
    It’s love you need but I don’t play that game
    ‘Cos you could be my greatest fan
    But I’m nobody’s friend

  15. C’mon Malcolm,

    Bring on those dozen corrections. Where are they? Chop chop, bring em baby. Bring em, unless ya want the world to see what a chump you are (oops too late).

    Me thinks you’ve run your mouth too much once again. Never fear, it’s windmill day.

    Get out there and vote peoples (unless ya wanna be like Malcolm and just sit there and be otch).

    I done told ya all before – it be like building blocks and abstractions. Molecules use the building blocks of atoms and computers use the building blocks O circuits and switches. Ya can make new molecules by picking and choosing which ones to put together and ya make a new machine by choosing which circuits and switches are configured. The abstraction of a general purpose computer is merely the playground of building blocks. Some of ya all need to reset your thinkin.

    Your buildin blocks inside a single chip gives ya so much more power and options than all the possible molecules that biology gives ya. There be the binary beauty of simple symmetry. Malcolm be jealous of this different world and its power of creation. Color be born from the simple binaries of black and white, of 1′s and 0′s. O such sweet nuance.

  16. Now Willton, take the function of a multiple switch arrangement and re-arrange those that are on and off – You have more than a single function at hand. Now increase towards the Billion combination mark.

    Perhaps you should stick to your policy arguments, as the facts of the art escape you.

    Your try at being obtuse fails
    Thank you for the compliment. Keep that 6 as your tutor.

  17. What are the two functions of that one switch? Your try here at being clever fails.

    Your try at being obtuse fails.

  18. What are the two functions of that one switch? Your try here at being clever fails.

    The two functions of the one switch do not change the fact that the switch in an OFF position is not structurally different from the same switch in an ON position. Turning a switch on does not magically turn the switch into a new machine.

  19. Similarly, your computer with a hard drive that includes your operating system plus all the programs you normally run would be considered a very different computer if the hard drive was replaced with the identical make/model hard drive but no software was loaded thereon. I would say that even a 5 year old would be able to tell the difference between the two computers.

    If you think they aren’t a different computer, why would anybody pay anything different for one computer over the other computer. Identical computers should be worth identical amounts – am I not correct?

    Passing Through, given what you have written above, let me ask you something:

    Let’s say we have a light bulb connected to a switch and a power supply. If I turn the switch from the “OFF” position to the “ON” position, have I created a new and/or different machine?

  20. Similarly, your computer with a hard drive that includes your operating system plus all the programs you normally run would be considered a very different computer if the hard drive was replaced with the identical make/model hard drive but no software was loaded thereon. I would say that even a 5 year old would be able to tell the difference between the two computers.

    Passing, that’s a nice summary of the challenge I ran awhile back in the Great Hall. 6 failed miserably. Several anti-software types failed miserably, IANAE wisely did not even try the challenge and Malcolm, well, he was nowhere to be found (sorta like, right after Bilski).

    Thanks for confirming once again your inability to articulate a coherent defense of Beauregard claims, ping.

    Wow, Malcolm, still taking reading lessons from 6 I see. No other reason for ya to mix up the volition aspect of Homey don’t give answers with the “inability” that ya run your mouth with. No surprise really, ya seem to think that kinda stench.

    Ya see Sunshine, I aint chasin ya like NAL did, criminy, she chased you for what 2 1/2 years and you always ran away. She even chased your sockpuppets into the ground. I don’t need to chase ya, cause I know you aint got the answers.

    If you can articulate a question that doesn’t incorporate a mistake that I’ve already corrected you on a dozen times, ping-a-ling I’m more than happy to answer. Got that? More than happy to answer.

    On this note Iza gonna take you up – document these so-called dozen mistakes you’ve done corrected me on Sunshine. Heck, let’s roll through a half dozen of ‘em.

    Pardon me if I don’t hold my breath waitin for ya there Chuckles. You don’t got Jack.

    One of the many important differences between you and me, ping-a-ling

    Yeah I bet – like your “integrity.” Thanks but no thanks Mr. Opposite day – Mr. dead president, Your type O “integrity” is somethin I am quite pleased that we have many such important differences.

  21. Passing: A block of iron can be configured to be an automobile engine. However, a block of iron does not identically disclose an automobile engine or would it infringe an automobile engine.

    What does this have to do with the lack of novel structural limitations in a typical Beauregard claim or the presence of structural limitations in a typical isolated nucleotide claim?

    Your ability to ramble on and kick up dust and change the subject reminds me of a certain poster who infamously imploded in these very threads.

    If you think they aren’t a different computer, why would anybody pay anything different for one computer over the other computer. Identical computers should be worth identical amounts – am I not correct?

    LOL.

    Claim 1: A computer, wherein said computer is capable of doing something new and desirable.

    Examiner: Your claim is anticipated by prior art computers or it’s simply abstract and not eligible for patenting. You can’t just claim a desired function and stick a computer on it and expect to get a patent.

    Applicant: But my claim says that it’s capable of doing something new and desirable. It’s in the claim. And one skilled in the art will know how to make it do something new and desirable.

    Examiner: Nope. Not buying it.

    Applicant: Well, if it wasn’t new and desirable, how do you explain this receipt where someone paid me more for my computer than for this other guy’s computer? Huh? How do you explain that, huh?

    Examiner: Maybe it was autographed by someone vastly more important than you.

  22. “Of course not. The machine is designed to have its switches flipped from time to time. It’s a known and intended (and reversible, usually) use of the very same machine.”
    That fact that something can be configured to do something doesn’t mean it has been. A block of iron can be configured to be an automobile engine. However, a block of iron does not identically disclose an automobile engine or would it infringe an automobile engine.
    The number of transistors on certain chips are approaching 1 billion. Considering that number of various ways that these switches can be configured, you have to imagine that most patented electrical circuits could be infringed by these chips assuming that the switches were so configured so as to create the patented electrical circuit.
    Would you say that your “general purpose computer,” that doesn’t include any software which reconfigures the computer, is infringing these patented circuits? If not, why not?
    What happens when a piece of software changes the configuration of these circuits such that the computer has been reconfigured and, in fact, the computer does have a configuration that matches a particularly claimed circuit? Is that “general purpose computer” then infringing the patented circuit? If not, why not?
    You answers to those questions would be appreciated. If you would like and you do not care to explain your answers, a simple (i) yes, yes; (ii) no, no; (iii) yes, no; or (iv) no, yes would suffice.

  23. “Nobody skilled or unskilled in the art considers any computer to be a ‘different computer’ in any way when different software is installed on it.”
    A computer with widget A connected to thingamajig B with a Phillips-head screw is different than the an otherwise identical computer but with widget A connected to thingamajig B with a flat-head screw. There may not be much difference, but there is a difference.

    Similarly, your computer with a hard drive that includes your operating system plus all the programs you normally run would be considered a very different computer if the hard drive was replaced with the identical make/model hard drive but no software was loaded thereon. I would say that even a 5 year old would be able to tell the difference between the two computers.

    If you think they aren’t a different computer, why would anybody pay anything different for one computer over the other computer. Identical computers should be worth identical amounts – am I not correct?

    “though much of the time a different operating system requires a different “structure” of the computer-readable medium for the software to actually work.”
    Not really, you can use the same DVD, hard drive, or USB drive to load up Linux, Windows or Leopard. Of course, it would be nice if you clarified what you meant by “a different ‘structure.’”

    “Could you possibly have claimed software that works on a different computer than was known to exist at the time?”
    Can you say Doctrine of Equivalents? Also claim a “manifold connected to a plurality of chambers” and the number of different manifolds that are covered by the claimed “manifold” is infinite and includes manifolds not even dreamed of. So what?

  24. >>This might be old news to you but every math >>equation that there has ever been “already existed”.

    Every information processing method already exists? Where are they?

  25. “The relationship between the genotype and the phenotype already existed and was discovered.”

    This might be old news to you but every math equation that there has ever been “already existed”.

  26. NWPA: Can we all just agree that you repeat the same arguments over and over again, IANAE.

    Pot, meet kettle. He called you black.

  27. ping Keep waiting Sunshine.

    Thanks for confirming once again your inability to articulate a coherent defense of Beauregard claims, ping.

    By the way, happy to defend the “Isolated DNA comprising SEQ ID X” as statutory under 101 until the cows come home. I’m sure I speak for a majority of the Federal Circuit as well.

    If you can articulate a question that doesn’t incorporate a mistake that I’ve already corrected you on a dozen times, ping-a-ling I’m more than happy to answer. Got that? More than happy to answer.

    One of the many important differences between you and me, ping-a-ling. Same applies to Night Wiper.

    Benson’s logic is that the method and hardware was nothing more than a way of capturing the natural law of how to convert from different bases of a number

    Now apply the logic to the following:

    1. An isolated nucleic acid, wherein said nucleic acid consists of SEQ ID NO:33.

    SEQ ID 33 is a 429 nucleotide sequence, including modifications of every thymidine residue. As far as you know, there is no genome on earth that includes the sequence. Specification teaches that you can make the sequence using a well-known DNA synthesizing machine.

    Eligible under 101?

    Let’s see the analysis.

  28. Benson’s logic is that the method and hardware was nothing more than a way of capturing the natural law of how to convert from different bases of a number.

    And what natural law is captured by an isolated gene that is useless for synthesizing protein in vivo? A particular gene, that in any event would code for only a particular protein and doesn’t generally pre-empt the use of other genes to code for other proteins?

  29. >>Why don’t you elaborate on that a little?

    Benson’s logic is that the method and hardware was nothing more than a way of capturing the natural law of how to convert from different bases of a number.

  30. Do you become a different person if you get a sun tan? Of course not. The ability to tan in response to the appropriate stimulus was always an inherent feature of the person you’ve always been.

    I beg your pardon, IANAE. You were right – it is sadly rare around here to get a satisfactory explanation of why one is wrong.

  31. The logic against these molecules is the same type of logic applied in Benson.

    Why don’t you elaborate on that a little? I don’t quite see the similarity. Benson claimed a hard-wired mathematical calculation, and Myriad claims a molecule. Also, Myriad clearly doesn’t preclude the use of the gene in nature to code for proteins, because if it did and it could get an injunction, it would have essentially cured breast cancer.

    With the stronger argument that the genotype to phenotype is a law of nature.

    Who cares about the phenotype? There are no claims to producing the phenotype. Isolated genes can’t produce any phenotype anyway.

    At most, the correlation between the isolated gene and the wild gene that produces the phenotype is a statement of utility. What is claimed is the molecule itself. Do you have a problem with molecules being statutory?

  32. You see what happens when you get intellectually dishonest people writing opinions for the supreme court.

    You, MM, should completely re-evaluate your miserable life.

  33. Can we all just agree that you repeat the same arguments over and over again, IANAE.

    The logic against these molecules is the same type of logic applied in Benson. With the stronger argument that the genotype to phenotype is a law of nature.

  34. Does it become a different machine if the switches are flipped to different positions, or is it the same machine being put to a different use?

    Of course not. The machine is designed to have its switches flipped from time to time. It’s a known and intended (and reversible, usually) use of the very same machine.

    Do you become a different person if you get a sun tan? Of course not. The ability to tan in response to the appropriate stimulus was always an inherent feature of the person you’ve always been.

    why don’t you explain to us how the computer readable medium recording the software is just an “abstract idea, law of nature, or natural phenomenon.”

    It’s an abstract idea because it’s the recipe and not the process. The real invention is a computer doing whatever useful thing the program does. Until you run the program, you don’t have a statutory process, you only have an unspecified medium with some writing on it that doesn’t affect the medium. We’ve had this discussion before.

    I think that’s what you really need to establish post Bilski to knock out Beauregard claims categorically under 101. Do you agree?

    If I agree with that statement, can we all agree that “molecule whose exact structure is specified” is statutory under 101 as being none of those three things?

  35. IANAE,

    Presume you have a circuit board with 1000s of analog elements connected with switches in between each element. Does it become a different machine if the switches are flipped to different positions, or is it the same machine being put to a different use?

    I think the answer is rather semantically determined, and based on whether you define the “machine” as the configured circuit, or as the reconfigurable collection of circuitry.

    That is basically what a computer is, and I’m pretty sure you know that. The software causes switches to be flipped, flip flops to be flopped, etc. to obtain a circuit, and outputs of that circuit to be stored and fed into another circuit, etc. That’s why many people say that a computer programmed with software is a different machine than a computer alone.

    But we know it’s really just semantics. Instead of getting caught up in those particular semantics, why don’t you explain to us how the computer readable medium recording the software is just an “abstract idea, law of nature, or natural phenomenon.” I think that’s what you really need to establish post Bilski to knock out Beauregard claims categorically under 101. Do you agree?

  36. This could have massive unintended consequences. By the reasoning used here, a natural compound that had never before been purified and identified, which turned out to be useful in treating cancer, would not be patentable as a composition of matter. The method of using it, maybe, but not the compound itself. That strikes me as perverse.

  37. Keep waiting Sunshine.

    and distinguish it structurally

    I done tell ya – that aint the legal requirement for Beauregard. Look again at the edges of the Printed Matter Doctrine. Oh wait – NAL tried to get ya to see that and ya chose not to.

    Understandable, as if ya did, ya would lose one of your favorite be otchin subjects.

    Iza don’t waste my time tryin to esplain things to those that won’t even try to understand the basics. That’s why I have the rule: Homey don’t do answers.

    Or perhaps since ya seem to be claimin that you do have the answer, Iza be waiting to see ya get off your duff and actually do somethin about in a court of law, instead of spending so much windmill time here.

    Seems like ya much prefer waiten and be othcin then actually doing somethin about it. Care to esplain that?

  38. Stick to explaining to us the functional aspects of the claims in suit and why it is not a law of nature.

    Oh, you only want to have patents on things that don’t use the laws of nature? Good news for business method patents that only use the laws of Congress, but bad news for computers, I’m afraid.

    The functional aspects of DNA are in how the DNA physically interacts with other things around it. In complete accordance with the laws of nature. Just like a ball bearing or a coffee cup (without writing on it) or anything else that one might attempt to patent.

    The DNA is claimed in terms of its exact and entire physical structure. It’s claimed as a series of quaternary bits. Go on, let’s see you draft a Beauregard claim reciting every one and zero on the medium.

  39. >>Just explain to us, ping, how Beauregard >>claims work exactly to distinguish >>one “readable” medium from another.

    If I can’t see it, then it ain’t there. ‘cept if it be a molecule.

    Isn’t Beauregard claims a bit off point here?

    Stick to explaining to us the functional aspects of the claims in suit and why it is not a law of nature.

  40. ping, anytime you want to explain to us all how it is possible to claim a composition and distinguish it structurally from the prior art without any recitation of a non-novel structure, you are welcome to do so.

    Until then, you and your sidekick Night Wiper got nothing but your name-calling and some truly awful, internally contradictory and self-affirming cases to back you up.

    Just explain to us, ping, how Beauregard claims work exactly to distinguish one “readable” medium from another.

    Been waiting a long time for you to step up.

  41. Anon: As you are the one that claims the “new machine” is but a lie, it is up to you to prove such a statement.

    It’s pretty obviously a lie, and a transparent one concocted to reach the desired result in the case. Curiously, that was the one day in the history of the judiciary that a panel of judges understood computer-related inventions.

    Nobody skilled or unskilled in the art considers any computer to be a “different computer” in any way when different software is installed on it. The idea that putting a disk in the drive makes the computer structurally different is more inventive than any Beauregard claim. You might be able to justify “different computer” in the case of a different operating system, though much of the time a different operating system requires a different “structure” of the computer-readable medium for the software to actually work.

    If someone later invents a new OS (as has been known to happen), would a computer-readable software for that new OS infringe your Beauregard claim? Could you possibly have claimed software that works on a different computer than was known to exist at the time? If so, all I have to do to invalidate your patent is design an OS that interprets a prior art string of bits as your program.

    Max: What I meant was that the debate about which tool to use has the potential to sharpen everybody’s focus.

    Unless, as I noted earlier, one’s interlocutor is a tool, or less preferably a spanner.

  42. MD What I meant was that the debate about which tool to use has the potential to sharpen everybody’s focus.

    The last thing the ACLU wants to do is sharpen anybody’s focus about patent law.

  43. Lionel, I agree that such a claim should be patentable, but under the logic set forth in the DOJ brief, I don’t see how it would be. Inventor didn’t invent natural compound X — it exists in nature. Inventor didn’t invent X’s medicinal effect — he simply observed this law of nature. How exactly is Inventor doing more than seeking a monopoly on a natural phenomenon?

  44. The funny thing NWPA is when his art unit is affected and business method patents and Beauregard claims survive.

    He just gonna blow.

  45. First Bilski smacks you in the face and now you must endure the mob coming after you. How’s it feel? How would it feel to have me and the others on this board intentionally obfuscate the arguments and conflate 101 and 102 and 103.

    Funny ain’t it.

  46. >>That is not my position.

    I think we have what amounts to functional claiming and claims that are to a law of nature. Wow, funny to hear you cry when the zealots come after you.

  47. it is your position that the relationship between the genotype and phenotype has nothing to do with the granting of the patent?

    That is not my position.

  48. IANAE, I did not intend to say that it doesn’t matter which tool. I agree with you, that it does matter. What I meant was that the debate about which tool to use has the potential to sharpen everybody’s focus.

  49. I’d complain less

    LOL

    Well that’ll be the day
    When you say goodbye
    That’ll be the day
    When you make me cry
    You say you’re gonna leave
    You know it’s a lie

  50. Sunshine Malcolm, so it is your position that the relationship between the genotype and phenotype has nothing to do with the granting of the patent?

  51. “Waaaaah!!!!! You violated my requiring structural features!”

    I’d complain less if all applicants were coddled like the softie woftie applicants. At least then there’d be some consistency in the PTO’s misapplication of the law.

  52. First off, Anon, don’t mess with my main man. Let me be the one that puts him in his place (it’s a lot higher than ya think).

    Second – Sunshine Malcolm, coming from the biggest crybaby on these boards (stop them Dennis, they’re picking on me), your “Waaaaah!!!!! You violated my Constitution!” is downright ironic – course, I don’t think ya recognize why, but think about this:

    The difference is that the PTO is actually quite strict (as they should be) about requiring applicants to recite the structural features

    Waaaaah!!!!! You violated my requiring structural features!

  53. Anon As you are the one that claims the “new machine” is but a lie, it is up to you to prove such a statement.

    The world of “anon”:

    Claim 1: “A new machine that does something that no machine ever did before.”

    Anon: “Go ahead, PTO. Prove me wrong or give me my patent.”

    PTO: “It’s an abstraction under 101.”

    Anon: “Waaaaah!!!!! You violated my Constitution!”

  54. Passing Through A claim to an “isolated gene” doesn’t have to recite the additional “stuff” with which it interacts, but through which utility is provided. Similarly, the disk (i.e., computer readable storage medium) interacts with a computer system (actually it is considered part of the computer system and it interacts with the other components). In so doing, the disk provides new functionality to a computer.

    The difference is that the PTO is actually quite strict (as they should be) about requiring applicants to recite the structural features of their molecules which provide the required utility and which distinguish those molecules from the prior art.

    Beauregard claims do not do this. They are composition claims which recite an old structure with an allegedly new function, without reciting any novel structural features that would give rise to the allegedly new function. As I’ve noted before, it’s basically a joke at the expense of the entire patent sytem. Worse than product-by-process claims even (at least as they were understood by Newman).

  55. NWPA Maybe they should assume the natural law of the relationship between the genotype and the phenotype were already known

    We’ve had this discussion before, too, Night Wiper. If the claims recited “A DNA with function X”, without an structural limitations, you’d have an argument.

    But that’s not the case. So instead we just have to wonder (not really) whether you are stoopit or lying.

  56. IANAE,

    I cannot control what you do not understand, what you choose not to understand, what you do not believe and what you choose not to believe.

    And unlike you, I have a real job to do, and will not spend my day patrolling blog message boards and spewing false rhetoric to suit a particular agenda.

    As you are the one that claims the “new machine” is but a lie, it is up to you to prove such a statement.

    In the meantime, the real world, the technical world and the courts will continue, thankfully without the need of your blessing or understanding.

  57. “Even more bonus points for why it should matter that the computer is a whole new computer, when all you’re claiming is a disk sold separately from the computer.”
    It matters with regard to the “utility” portion of 35 USC 101. A claim to an “isolated gene” doesn’t have to recite the additional “stuff” with which it interacts, but through which utility is provided. Similarly, the disk (i.e., computer readable storage medium) interacts with a computer system (actually it is considered part of the computer system and it interacts with the other components). In so doing, the disk provides new functionality to a computer. The “new functionality” satisfies the “new and useful” portion of 35 USC 101, and is consider a “new and useful improvement” of a machine. However, like with the “isolated gene,” you don’t need to claim the additional “stuff” which with the disk interacts. Along the same lines, I can claim a particular type of fluid used in shock absorbers. This fluid likely does not have any utility sitting alone without interacting with anything else, but a claim to the fluid alone still satisfies 35 USC 101.
    You state that “[t]here is apparently a perfectly logical reason that I refuse to believe, why a computer becomes a completely different computer when programmed.” Of course, you create a strawman be requiring a COMPLETELY different computer to be created. There is no requirement for a COMPLETELY different computer – just a different computer. Under 35 USC 102 (by which we judge whether something is new), even the slightest of differences is enough to establish that something isn’t new. Once I’ve found that slightest of differences and I can also establish that this slightest of differences produces some verifiable utility, then 35 USC 101 is locked up.
    Of course, all of this is a moot point. The law stands on my side. You can continue to throw out whatever pet theories of yours you want, but until you can convince the Federal Circuit otherwise, the best you can do is anonymously discuss your pet theories on this blog.

  58. Just recently I saw a show on the history Channel. It was about a Black family that in their particular gene structure they had a sequence that helped in the delviery of a Breast treatment. what happened is unbelievable.
    As bad as the syphilis story. and that was a sequence. Maybe not seperated by someone. But it was seperate and different none the less. And no one paid either group. Don’t call me ignorant!

  59. MM: funny how all of a sudden you understand the difference between 101 and 102 and 103. Odd.

    Maybe they should assume the natural law of the relationship between the genotype and the phenotype were already known and not consider it for 102 and 103 arugments. Gee does that sound familiar to you?

  60. Vision guy: I would guess that it has happened to some DNA strands in the past by natural acts.

    Worst. Inherency. Argument. Ever.

  61. Vision guy Thre is no other art area where claims allowed when the entire new and non obvious features are in the preamble.

    Not a fan of the claim drafting in the Myriad patents, but I’d like you to prove your statement. Seems like a load of b.s. to me. People have been successfully amending their preambles in response to Examiner rejections forever, in all art units.

    Sorry, I just don’t see it.

    Maybe try reading “isolated” as an adjective rather than as a process step. I am quite certain that the claims are not limited to isolated molecules that have been “snipped” (as you say) from other larger molecules.

  62. IANAE, the problem you’ll have discussing Beauregard claims with Night Wiper is that he believes that the recited functions are structures. At least, that is the alternate reality where he takes the discussion every time and then he sticks his fingers in his ears.

    The Government: Crossing the threshold of section 101, however, requires something more than identifying and isolating what has always existed in nature, no matter how difficult or useful that discovery may be

    No, it doesn’t. 102 and 103, however, require properly claiming the composition by reference to its structure so that it no longer reads on the composition that ‘existed in nature’ (or in the prior art, for that matter). Claiming the composition as “isolated” or on the basis of its relative purity is one way of doing that.

    A product of nature is unpatentable because it is not the inventive work of humankind. That essential rule cannot be circumvented by drafting claims for the same natural product removed from its natural environment and proclaiming the result “pure.”

    Ridiculous and wrong.

  63. One nuance that hasn’t seen a lotta discussion here, and that my pal Hal really points out with some force, is that Lord Kappos aint the one who wrote the government brief, but some dude over at Justice be the one speaking up for the Gov. here.

    What’s up with that?

  64. The structure of all these isolated DNA claims basically have the same form:

    An isolated DNA, comprising: something that exists in nature.

    The only possible part of that claim that is new and non obvious is the “isolated” portion, and that is in the preamble. Thre is no other art area where claims allowed when the entire new and non obvious features are in the preamble.

    What about moving “isolated” from the preamble to the body of the claim, as in:

    A DNA from a first DNA strand, the DNA comprising: a second DNA strand isolated from the first DNA strand.

    The first DNA strand exists in nature and the second DNA strand exists in nature as a smaller part of the larger first DNA strand.

    In general, isolating DNA (e.g. sniping the strand in two places) is not new and non obvious and I would guess that it has happened to some DNA strands in the past by natural acts.

    Since all the things in the claim exist in nature, how do these claims get past 101 merely because a human directs the snipping of the strand. Sorry, I just don’t see it.

  65. “Even more bonus points to you if you can figure out why you sound like a rustbrain.”

    Is it because I think software is a method of using a common computer, and should be claimed as such to be statutory?

    Is it because I don’t think “on a computer” makes a claim any better for its presence or worse for its absence?

    If you think being a Beauregard fan makes you sound all modern and avant-garde, don’t let me stand in your way.

  66. All the clarification ya need is in Alappat IANAE.

    Of course, we can re-visit the grand hall where 6 and others failed my great experiment. Any time ya wanna race your “same” machine without software versus my “same” machine with software Iza ready for ya. I done ripped up the “House” line of thought before and Iza could do it again.

    I recall that you were smart enough to not try your hand that day, seeing all the bodies left asunder that did try it and that ya would be plainly routed in your Middle-Earth prancing here.

    It be really basic “in the art” as software is really just hardware in another format.

    They say discretion is the better part of valor, my friend. My advise: use some here.

    As for Malcolm, Iza guess that he just didn’t realize all the windmills available in his own backyard.

  67. >>Even more bonus points

    Even more bonus points to you if you can figure out why you sound like a rustbrain.

  68. “Fixed for you IANAE.”

    Thanks for that clarification. There is apparently a perfectly logical reason that I refuse to believe, why a computer becomes a completely different computer when programmed. Maybe you could explain that reason again, bearing in mind that it retains all of its old “general purpose” functionality, and also bearing in mind that a computer has to be programmed before it can even read a computer-readable medium.

    Bonus points for explaining to me why I might refuse to purchase an ordinary computer on the basis that it has software on it and therefore is not the general purpose computer I thought it was.

    Even more bonus points for why it should matter that the computer is a whole new computer, when all you’re claiming is a disk sold separately from the computer.

  69. There’s no logical reason that I will believe in for a programmed computer to be anything other than the very same machine put to a different use.

    Fixed for you IANAE. It is a good thing that what constitutes a Lie in the courts is not what you perversely believe a lie to be, your selective reasoning and purposeful ignorance notwithstanding.

  70. Patents should not reward “sweat of the brow”.

    The problem, though, is that jurists often analogize cutting a branch from a tree to finding an oncogene. And then they come up with the idea that isolated DNA is a product of nature.

  71. Noonan: “But, Don, it is structural, which is what the court missed by focusing on how they are the same rather than how they are different. Comes from having science illiterates making these decisions. Arrogance and ignorance don’t make a pretty combination, in any field of endeavor.”

    Nice to see somebody else making an unequivocal and critical statement on this board for once.

    Of course, I’m now going to reverse roles:

    Kevin, you provide some basis for the claim of ignorance, but not for the claim of arrogance.

    More info please…

  72. Different subject that bears mentioning because while the securing of a patent may be nice, only the holder of the patent is able to exploit it. This is only too clear in the matter of Stanford v. Roche, for which the Supreme Court today granted Stanford’s cert petition.

    See SCOTUSblog for details.

  73. “The critical distinction in the patent sense is that software creates a new machine.”

    The big problem with that tenuous fiction is that a computer running an OS (and therefore capable of reading your medium) is no longer a general purpose computer. It’s a whole new programmed machine that you’re not describing or claiming. A true general purpose computer that hasn’t already been turned into some other machine can’t run any store-bought software.

    There’s no logical reason for a programmed computer to be anything other than the very same machine put to a different use. They say a lie can run round the world before the truth can get its boots on. Alappat got a good head start, but logic will eventually catch it up.

  74. Bert,

    Same machine,

    No. Read Allapat. The critical distinction in the patent sense is that software creates a new machine. This is established law.

  75. Can you describe that component? In terms other than…

    The “in terms other than” is not required – a distinction false to the circumstances.

  76. Ned,

    You say, “Can one re-patent an old machine because one discovers a new use for it?”.

    Isn’t that what software patents do?

    New inputs, new outputs. Same machine, new patent.

    Profit!

  77. “Beauregard claims are to a component of a machine.”

    Can you describe that component? In terms other than “a known (or later-invented) memory device with stuff written on it”? If you can, that’s what you should actually be claiming.

    “I say that 101 is not what should be used that the government again is mixing 101 with 102 and 103.”

    If we agree, why do you insist on fighting about it?

  78. Beauregard claims are to a component of a machine.

    I stated my position above. I didn’t see any response to that position. Sure they are more statutory and if you read my posts you will see that I say that 101 is not what should be used that the government again is mixing 101 with 102 and 103.

  79. “You do everything you possibly can to conflate and muddle arguments regarding information processing inventions”

    No I don’t. I’ve been saying for some time now that information processing inventions should be statutory, as long as you claim the actual processing of the information. Giving someone else instructions for processing information (Beauregard) is no more statutory than giving someone else instructions for taking a pill.

    Now, if you’re done with your name-calling, would you like to have a little discussion about why synthetic genes are more statutory than natural genes?

  80. IANAE>>the issue honestly and fairly.

    You do everything you possibly can to conflate and muddle arguments regarding information processing inventions and now you want everyone to play nice. Typical low life.

  81. What are the three 101 exceptions? Oh, right – laws of nature, natural phenomena, and abstract ideas.

    There’s no way a gene is a “law of nature”, and a wild gene is no more abstract than a brand new gene created in a lab. So what’s the argument that a gene is a “phenomenon”?

    A gene is a molecule. Everybody knows that. Everybody also knows that all molecules are patentable subject matter. The question never arises when people try to patent fuel additives, pharmaceutical compositions, or fancy polymers. When the molecule is found in nature, we talk about anticipation, not subject matter. The only difference, subject matter-wise, is that we have stronger feelings about genes.

    If the argument is that the named inventor did not make the invention, then state it that way. It amounts to the same anyway, if nobody invented the gene, but at least we can discuss the issue honestly and fairly. If the argument is that the gene is old or that isolating it is routine, make it a 102 or a 103 rejection.

    Max, you say that it shouldn’t matter what tool we use to arrive at the same result. I disagree. If you let some random spanner carry this debate, it changes the very principles of the law and changes how we handle all the debates to come.

  82. >>Patent rights, like copyrights, are not given >>to reward “sweat of the brow.”

    And, the hardest thing is to recognize and appreciate hindsight.

  83. Lionel said:
    “Why do so many people make this mistake. Of course isolated DNA exists in nature – it’s simply not isolated.”

    Man, that’s circular! If it is not isolated, then it isn’t “isolated DNA.”

  84. Lionel said:
    “High octane gasoline does not exist in any form prior to refining.”

    I don’t think you are right. It is part of the overall crude oil composition and it is merely extracted or isolated (i.e., by distillation). It’s always THERE in crude oil as part of the composition.

    Maybe I don’t understand the nuance of “isolated” in the DNA context, but you could argue that high octane gasoline was also there in nature.

  85. “the isolated nucleic acid molecules of these claims no more exist in nature than your electro/mechanical inventions.”

    Why do so many people make this mistake. Of course isolated DNA exists in nature – it’s simply not isolated.

    If I cut branch off a tree, have I invented a new plant?

  86. “I think this lower court decision is a product of people who have never set foot in a lab.”

    Patent rights, like copyrights, are not given to reward “sweat of the brow.”

  87. Andrew Dhuey wrote,

    “A hypo for the the DOJ authors of this brief:

    Inventor discovers natural compound X has medicinal properties curative of disease Y when administered to a human. Inventor claims method of curing disease Y through administration of X. Note that the method does nothing significant to alter X — it is merely “isolated” and collected.

    Not patentable, right? X is just a product of nature and its curative effect is just a law of nature. Inventor didn’t create anything — just observed a natural phenomenon that has existed for millennia.”

    If the use as a medicine was unknown, “method of curing disease Y through administration of X” is of course patentable. If the use was known, say by local medical practitioners and based upon administration of the source plant in question, then a simple claim like that should not be patentable. However, claims to compounds with that substance and particularly effective doses or treatment methods should still be patentable.

  88. “This does not make sense to me.

    How is ISOLATED DNA a product of nature? Does ISOLATED DNA exist in nature?

    Under this logic, ISOLATED DNA is a product of nature just as much as high-octane gasoline is a product of nature as it was extracted from crude oil.”

    You’re being ironic, right? The difference is obvious. Isolated DNA exists in non-isolated form. High octane gasoline does not exist in any form prior to refining.

    There was no real creation of the isolated strand, just recreation in an isolated form.

    Certainly, you are entitled to a partent if you invent a new process or apparatus for isolating DNA.

  89. Maybe the way to think of this is as a method of determining a natural law, which is surely patente eligible.

  90. What thing is clear the term “altered” is very much functional claim language.

    Seems to me the right analysis is to break this down just like the government did. Does finding a relationship between the genotype and the phenotype constitute an invention?

    If not then the other inventive elements must be how to get the isolated replicon of the DNA and how to test the genotype. These are likely obvious, so again we have the government wanting to conflate 101 and 103 issues.

    Pretty simple really. There is no doubt that isolated DNA is different.

    Funny thing is that the argument that discovering a relationship between a genotype and a phenotype is an invention is FAR weaker than the argument that an information processing algorithm is an invention. The information processing algorithm didn’t exist prior to being invented. The relationship between the genotype and the phenotype already existed and was discovered.

    I will place my bets early that the SCOTUS is going to say that at least the part of discoverying the relationship between a genotype and phenotype is not an invention. And the rest is just packaging.

    Now methods of using this information may be an invention. What of a method of treatment where you figure out what the genotype is and treat accordingly?

    Oh well, the rustbrains will likely flood this blog.

  91. 6,

    The compatriot of yours that rides a donk ey has gone awol – perhaps he is gearing up for all the windmills in his own backyard.

  92. Four Horsemen of the Patentpocalypse.

    lulz 6.

    And I guess it effortlessly passes any “utility” requirement because, as you say, it is an “antibiotic”

    reminds me of the omni-utility statement: throw it on the grass, if the grass grows, it’s a fertilizer, if the grass dies, it’s a herbicide.

    Maxie,

    Ya still haven’t accounted for teleportation (and the removal of introns) in your analogy.

  93. Agreed, Mr Noonan, analogies only get you so far. Assuming your purified antibiotic is a “new” “composition” of matter, which does not occur in nature, I guess that 35 USC 103 might be decisive to its patentability. And I guess it effortlessly passes any “utility” requirement because, as you say, it is an “antibiotic”, right, known to be efficaceous against disease indication X, or whatever, and said in your app to be useful as such, right?

    But a photograph of a length of road, or a recitation of naturally-occurring string of amino acid bases, is not a new composition of matter, is it?

    Aharonian now has Neifeld’s take on “isolated”. Interesting word, that. When I took a photo of the fragment of road surface, I “isolated” that fragment from the rest of the road.

    Since we have now touched upon the “ignorance and arrogance” of others, and since I happened to notice an “it’s” upthread, I should perhaps mention the arrogance of English patent lawyers whenever they gleefully detect an abuse of the apostrophe by English market traders. The little signs written in chalk, on individual hampers of fresh fruit and veg’, often recite something like “Superfresh Cherry’s, 5 EUR a pound”. We call that the Greengrocers’ Apostrophe. Maybe you have the same phenomenon in the USA?

  94. “As can be seen plainly here by the four, well three of the four horsemen.”

    I will thank you to use our full titles sir: Four Horsemen of the Patentpocalypse.

  95. “But if I discover how to detect phlogiston and purify it, why can’t I patent it?”

    Because good game Kev. Because GG.

    “Comes from having science illiterates making these decisions. Arrogance and ignorance don’t make a pretty combination, in any field of endeavor.”

    I’m not science illiterate and even after your presentation (which was a good one btw and I’m pretty sure brought me up pretty well to speed) I still have to say I would probably gg these kinds of claims too.

    I know, I know, it’s totally unfair. But that’s just how the ball bounces sometimes.

    Oh and Kev, ain’t no need to bad mouth ur courts. They’re the only reason you got away with this scam in the first place. Chacrapardy was crp back in the day, and it led to crp. You can only get out of a system that which you put in.

  96. “And our bodies, are still are our bodies. And our DNA belongs to each of us.”

    Yes, and claims to isolated DNA do not “read on” your body. Owners of their DNA have roamed the Earth for quite a while not knowing how to learn their propensity for breast cancer.

  97. Arrogance and ignorance don’t make a pretty combination, in any field of endeavor.

    As can be seen plainly here by the four, well three of the four horsemen.

  98. But, Don, it is structural, which is what the court missed by focusing on how they are the same rather than how they are different. Comes from having science illiterates making these decisions. Arrogance and ignorance don’t make a pretty combination, in any field of endeavor.

  99. Max:

    Analogies go so far and then break down. Why don’t you tell me why a new antibiotic that isn’t changed except for it’s purification should not be patent eligible?

  100. “view of the prevailing belief that combustion involved something called phlogiston.”

    Silly Kev, it still does, we just can’t detect it.

  101. What does Mr Noonan mean by “uses”, I wonder.

    A pebble, isolated from the London to Edinburgh road, surely has a multitude of “uses” that the road in toto does not. You could put it in somebody’s walking boot, for example, if you wanted something to give the wearer a limp. So, if you file a patent application on the pebble, isolated from the road, and if you mention the limp use in your specification, is that enough to endow your pebble invention with patentable utility, and to demonstrate that it is not obvious?

  102. A Cow may be able to think some. But, he is not Human. And last time I checked we were not only different from other species. but, we work, we also pay taxes, we vote, and we also are… free. And our bodies, are still are our bodies. And our DNA belongs to each of us.

  103. lol Kevin – nice to see ya have a sense of humor. Oh, how some others could learn from you.

    But tell me how “ultimately” it is Congress, when they haven’t moved on the Courts pronouncements of the keep out zones…

  104. Dear Ned:

    Judge Sweet was wrong. The isolated DNA has many uses the DNA in the chromosome does not. The info is the same, but that’s like saying the bovine insulin keeps the cow from getting diabetes. Doesn’t do humans much good until you isolate it.

  105. Just reading the AIPLA brief, it said the utility was directly related to the structural differences.

    How so?

    The brief did not elaborate.

    Going back to Max’s example of a photo of a highway, if I discover the location of a vein of gold, oil or the like, can I photograph its location and then claim exclusive rights to its extraction by use of a ulility patent? Clearly the location is quite valuable, but it that the sole criteria for patentable subject matter?

    The claims in Bilski and Benson for that matter both passed that test.

    The problem I see here is that a patent on the gene is effectively a patent on something old, and unless the utility of the isolated DNA is directly related to the structural differences, the isolated DNA patent is a patent on the gene itself.

  106. to simply say “DNA isn’t patentable because we say it isn’t” – the problem is that’s something Congress, not the courts, are empowered to do.

    Not quite there Noonster. Tell me again who set up the great other keep out zones on patent eligibility…

    Per chance, was it the courts…

    Looks like it will be one more keep-out (or more likely, just shoehorned into the existing three).

    So sorry.

  107. Kevin, so, why then can’t the second disoverer of an use for an old compound repatent the compound?

    Back to bark: the purefied bark has a utility that wild bark does not have. Purefied bark is really a new article of manufacture, not a new compound. That is the reason, in my view, it is patentable. It is equivalent to steel: iron that has different properties that do not exist in nature.

    But, the utility of the isolated DNA is identical to that of the wild DNA, at least according to Sweet. Malcolm said the stucture was different. If so, that structure should not exist in the wild. This moves the ball closer to the goal of patentability, no doubt.

    But, now we get to the rub. If the utility is in the information common to both wild and isolated and is not related to the structural differences, the claim to the isolated DNA is equivalent to a claim to the wild DNA.

    Circling back, the utility of purefied bark is due to its purefication. The utility of steel is due to its manufacture. But the utility of isolated DNA? Is it really due to the structural differences in the isolated DNA?

    That is the question.

  108. Dear Ned:

    You can chew a lot of bark of a tree containing medicinal compound X, or you can take a pill. Why would we prefer the first to the second manner of producing a useful drug?

    The problem with the “you didn’t invent it” argument is that if the prerequisite is the type of invention required in the electromechanical arts, we might as well declare most chemistry to be outside the patent system. Doesn’t make a lot of policy sense – in fact, it would be a better (but not a good) outcome to simply say “DNA isn’t patentable because we say it isn’t” – the problem is that’s something Congress, not the courts, are empowered to do.

  109. Moocow, but you subtly shift the argument. The utility discovered is the medicinal use. A patent for that use is entirely justified.

    But does the discover of the utility justify claiming the pre-existing compound?

    Can one re-patent an old machine because one discovers a new use for it?

    When in history has one ever been able to re-patent something old just because one has discovered an new use for it?

    Now the purefication patents are argued to justify patenting isolated DNA. But, aren’t they justified precisely because the purefied form has utility that does not exist otherwise?

    But, the holding here by Sweet is that there is no change in utility between wild and isolated. It is the same.

    So, what IS the argument for patentability. I see the struggle for one, but I have yet to see a good one.

    Off to read the other briefs.

  110. moocow – I agree that the particular isolated nucleic acid molecules of these claims don’t exist in nature.

    However, don’t their counterpart isolated mRNAs exist on a regular basis.

    Accordingly, isn’t an isolated DNA segment of its counterpart mRNAs an obvious variant?

  111. Seemingly ignored in this discussion thus far has been the fact that an aggregation of base units can exhibit properties that a single base unit does not.

    Obvious example: pure gold “metal” exhibits malleability and ductility, a single atom of gold does not.

    Even where all macroscopic properties are present in, say, a naturally-occurring compound, a particular combination of properties is unique to a particular substance, and it is that particular combination that gives the substance its specific and substantial utility.

    It is a “the whole is greater than the sum of the parts” argument. If the isolated units act as individual units and do not cooperate, not 101-eligible; if they do cooperate, 101-eligible.

    Of course, gold would have been anticipated by elemental gold, pure to the extent that it exhibited substantially the same macroscopic properties as pure gold metal.

    Combinatorial uses such as alloying? A hybrid answer to a hybrid question–depends on the type of alloy, and on whether it depends on the atomic properties, or if grains of independent metals are formed…

    Anyway, just a thought…anybody know of any discussions of this concept in case law?

  112. Gennie:
    the isolated nucleic acid molecules of these claims no more exist in nature than your electro/mechanical inventions. There is nothing “to get away with” here when you think about things like immunosuppressant molecules found in scorpion venom, or anticancer drugs from tree bark, and other molecules found at great effort and expense in nature and now presented for the first time in any useful form for uses that are impossible with the natural thing. Can you give me a reason why such things should be excluded from the patent system?

  113. Further on the above US 5,693,473 Claim 1, everything after the word “comprising:” in the preamble is not new (as I understand it) and existed in nature.

    So the only thing “new” is the word “isolated” and that is in the preamble.

    Would you allow the claim:

    1. An isolated DNA comprising: something that exists in nature but was hereto for not recognized and described by any human and now is described in this patent application.

    I work in the electro/mechanical area and there is no way we could get away with something like that. The examiners in the isolated DNA area have lost the upperhand and the leadership at the USPTO needs to help them get hand back.

  114. One of the claims at issue, US 5,693,473 Claim 1, is directed to “An isolated DNA comprising an altered BRCA1 DNA having at least one of the alterations set forth in Tables 12A, 14, 18 or 19 with the proviso that the alteration is not a deletion of four nucleotides corresponding to base numbers 4184-4187 in SEQ. ID. NO:1.”

    Notice how many times the claim uses “altered” (altered, alterations, alteration). I haven’t read the spec, but I would guess that altered is not transformation. Also, the table content themselves are not infact in the claim, just the words “Tables 12A, 14, 18 or 19″ are in the claim.

    Sounds like they are trying to hide something.

    If someone sought to patent a hammer with three tongs, curved tongs, etc. instead of two straight tongs for the claw, how many patent practitioners would structure the claim as:

    A hammer, comprising:
    a shaft; and
    a head attached to the shaft, the head having a weighted end and an altered claw end having at least one of the alterations set forth in Table I.

    How does a hammer claw “have” an alteration? It would be an addiiton to something. How does a DNA “have” an alteration? The “alteration” existed prior to the isolation and nature is the one who formed the alteration.

    A problem here (and likely in isolated DNA in general) is that the isolated DNA examiner do not compel the patent practitioner via 112(1) or 112(2) to more particularly specify the structure of the claimed machine, manufacture, or composition of matter.

    The term alteration gives a more structure sounding claim, yet nothing infact is altered or modified. The “alteration” existed prior to the isolation.

    The isolated DNA examiner should not have let the patent practitioner get away with using “altered” in the claim.

  115. Unless ya two have something going on outside this thread, Cy, you’re off your game a little bit.

    Hah! How long have you been saving that up, ping?

  116. You keep using that word.

    As far as I can tell, that was the first and only post by “Colin Mallory.”

    Unless ya two have something going on outside this thread, Cy, you’re off your game a little bit.

  117. DOJ supports Obama’s desire to overturn longstanding USPTO policy but opposes Obama’s desire to overturn DOD’s DADT. Talk about hypocrisy.

    You keep using that word. I do not think it means what you think it means.

  118. The Two Bobs,

    You are the second Bob that has used that type of analogy – the US government has already used the Element-in-natural-form gambit in their brief in at least at page 23-24.

    lithium, tungsten, americium…

    The nuance there is that only americium – the only one that got a patent – is the only one actually made by man AS a building block itself. The others were already there, albeit not in pure forms.

  119. Maxie,

    I do find your “isolation-as-travel” analogy interesting. Cepts, how do you eliminate parts of that journey like the introns of the molecule? It’s not like in your journey analogy, you’ve just not taken a picture of them – they are not there.

    Sounds like you’ve invented a new form of travel Maxie. Iza haven’t seen anywhere where teleportation been reduced to practice, so your patent application teaching such should be golden.

  120. ping asserts that what makes it “interesting” is that it is a “fragment” of a molecule. Well, ping, every yard length on that naturally existing, long road that leads from London to Edinburgh is, I suppose, in some way “interesting” to you (and to the foot musculature, the vehicle suspension systems and the pneumatic tyres that “encode” to it). But if I should merely take a photograph that “isolates” that yard from the rest of the thousand miles, why should I then have made myself eligible for a patent for the act of “isolating” that yard? Beats me.

  121. Any one that has ever worked in a biology lab will surely know that it does not require much inventive enginuity to isolate a gene. Where the inventive inguinity lies is which gene to pick that actually does something useful. For that, you have to either luckily or through an incredible amount of work deduced the importance of that 1 gene out of the tens of thousands (and many more non conding sequences). And the utility requirement already prevents one from simply claiming non useful genes. So I think this lower court decision is a product of people who have never set foot in a lab.

  122. I have discovered a new element, which I have taken the liberty to name Patenteon, in honor of the patent system. (I was all set to name it “Patentbarium” in honor of the patent bar, but a colleague mentioned something called “Barium”. Also, a friend at Intel warned me against calling it Patentium.) I can PROVE that this element does not exist in its pure, elemental form in nature, where it can only be found as an oxide. But I have learned that Patenteon can be reduced to its never-to-be-found-in-nature pure, elemental form through the same sort of process by which aluminum oxide is reduced to pure aluminum. I am planning on filing a patent application on the pure element, and expect it to be approved on a first action. Is there any substantive reason why the PTO would grant a patent on a gene but not on my newly discovered element, in its pure, elemental form?

  123. “… prompted the United States to reevaluate the relationship …”

    Speak for yourselves; ’cause you sure aren’t speaking for me.

  124. Amusing thread, so far. The debate about whether a molecule is patentable per se, or only when tied to a specified specific utility, is as old as patent law. The shifting tides of opinion, how best to balance between helping the public, and helping the inventor, have washed over Europe for most of the last Century. It’s a real 50:50 question.

    So, I welcome the debate now, in the Myriad case. It will add to our wisdom, even though it concerns only a fragment of a molecule.

  125. A hypo for the the DOJ authors of this brief:

    Inventor discovers natural compound X has medicinal properties curative of disease Y when administered to a human. Inventor claims method of curing disease Y through administration of X. Note that the method does nothing significant to alter X — it is merely “isolated” and collected.

    Not patentable, right? X is just a product of nature and its curative effect is just a law of nature. Inventor didn’t create anything — just observed a natural phenomenon that has existed for millennia.

    If this is not patentable, what sense does that make on a policy level? Why would Congress want to distinguish between the above claimed therapy from those involving synthetic compounds?

  126. Even if you can’t patent the extract or isolated gene/matter/composition, you still could patent the process of isolating/extracting as well as the method of use of that extracted/isolated gene/matter/composition.

    Sure ya can – only problem here is that both the methods of extraction/isolation and the methods of use are old and no longer available for patenting.

    Sorry Charlie.

  127. Guest:

    What you are saying goes counter to decades-old precedent which holds that a NEW product (as distinguished from an OLD product as in In re Schreiber or Spada) can be unobvious based on an unobvious use or property.

    If something (in this case ISOLATED DNA) does not exist in nature, and assuming that the ISOLATED DNA has new and unobvious properties over ISOLATED RNA, how is that obvious over isolated RNA?

    Again, referring to high octane, which “exists” in crude oil, how is it obvious when you will destroy your engine if you filled your tank with crude oil?

    How is a plant extract unpatentable if you ingested the plant itself, you might die from other toxins?

  128. “Aren’t many drugs EXTRACTED or ISOLATED from natural things such as plants, requiring human intervention, to be suitable as a drug?

    Are these unpatentable (patent ineligible) just as high octane gasoline I mentioned previously under Obama’s logic since they “exist” in nature?”

    Even if you can’t patent the extract or isolated gene/matter/composition, you still could patent the process of isolating/extracting as well as the method of use of that extracted/isolated gene/matter/composition.

    Also, seems to me that it is obvious to extract/isolate most things. The tough thing (that should be patentable) is how to do with it and what to do with it.

  129. RE: How is ISOLATED DNA a product of nature? Does ISOLATED DNA exist in nature?

    Isolated DNAs on the whole don’t exist (I believe there may be a few exceptions to this general rule).

    However, isolated mRNAs exist on a regular basis.

    Accordingly, isn’t an isolated DNA segment of its counterpart mRNAs an obvious variant?

  130. Aren’t many drugs EXTRACTED or ISOLATED from natural things such as plants, requiring human intervention, to be suitable as a drug?

    Are these unpatentable (patent ineligible) just as high octane gasoline I mentioned previously under Obama’s logic since they “exist” in nature?

  131. Dear John:

    I would suggest that in the 18th century purified oxygen should have been patent-eligible, in view of the prevailing belief that combustion involved something called phlogiston.

  132. The brief tries to be all things to all people and (besides being a complete misreading of Funk Bros.) does nothing to the gene patent debate. First, in trying to placate biotech and pharma, the brief contends that cDNA is patent-eligible, thereby saving >90% of all the “gene patents” that the ACLU and PubPat are trying to eliminate. Second, by making the “product of nature” argument the brief puts at risk most of medicinal chemistry and any other useful “product of nature” (even outside the biotech field – is something isolated from petroleum a “product of nature?’ How about ultrapure silicon?).

    The brief’s position does not address the real issues, like avoiding patent thickets for personalized medicine (since the oligos used in chips are patent-elibigle as being synthetic, for example) or the problem of methods for detecting mutations (which do not require isolating genomic DNA).

    With any luck the Federal Circuit will reverse on the procedural issues and sanity will return to the administration.

  133. Give. Me. A. Break.

    But since Obama’s doing his best to destroy economic recovery, I shouldn’t have been surprised by this.

  134. It was said in another thread, the courts, including the Supreme Court, follow the government’s recommendation more than 90 percent of the time.

    Now, if the Feds want to reject the government position, the case will end up in the Supreme Court where, again, the goverment position wins more than 90% of the time. The Feds know this.

    Prediction: the Feds will follow the governments position.

    Circling back: on the issues of patentable subject matter in particular, I think it is the duty of the patent office to follow court decisions as best as possible, not to assume that subject matter is patentable without prior court precedent. It is the patent office obligation to bring new issues to the courts as soon as possible.

    They did not do that here. And certainly they did not do that in the case of In re Beauregard.

  135. anon and EG,

    I think the gov is looking at building blocks of nature.

    In an abstract view, they seem to be saying that merely stripping out some building blocks to get to other building blocks is not really doing anything – especially when the stripped down version behaves just like the building block in nature.

    This is actually a mix of two very different arguments, along a slender commonality – the building blocks are in nature, and the action of both the isolated building blocks and the non-isolated, but similar natural product behave in the same manner.

    Personally, I think this type of error (conflation of the two legal streams) causes more confusion in an admittedly complex art, but Iza wanna see how my pal Malcolm feels about this.

  136. This sums up the government’s about face:

    “We acknowledge that this conclusion is contrary to the longstanding practice of the Patent and Trademark Office, as well as the practice of the National Institutes of Health and other government agencies that have in the past sought and obtained patents for isolated genomic DNA. The district court’s judgment in this case, however, prompted the United States to reevaluate the relationship between such patents and the settled principle under Supreme Court precedent that the patent laws do not extend to products of nature. For the reasons below, the United States has concluded that isolated but otherwise unaltered genomic DNA is not patent-eligible subject matter under 35 U.S.C. § 101.”

    If the Federal Circuit adopts this position, many issued-patents will be effectively invalidity.

  137. This does not make sense to me.

    How is ISOLATED DNA a product of nature? Does ISOLATED DNA exist in nature?

    Under this logic, ISOLATED DNA is a product of nature just as much as high-octane gasoline is a product of nature as it was extracted from crude oil.

  138. The DOJ’s brief appears to characterize the US PTO’s position on this issue by reference to 2001 revised examination guidelines and an 1889 Commissioner’s decision. MPEP 2144.04 VII (“purifying and old product”) reflects the reality of how the Office handles these claims. A case-by-case fact driven analysis. Isn’t that the type of approach that the Supreme Court will cotton to?

  139. “The chemical structure of native human genes is a product of nature, and it is no less a product of nature when that structure is “isolated” from its natural environment than are cotton fibers that have been separated from cotton seeds or coal that has been extracted from the earth.”

    This statement is utter sophistry and rhetorical nonsense. “Isolated” nucleotides, as claimed by Myriad, don’t exist in nature.

  140. The DOJ’s brief is interesting. I wonder what percentage of biotech inventions are merely isolated from the human. As someone that work in biotech patent law, I wonder what they would consider sufficient manipulation? Putting a different promoter in front of the gene?

  141. I’m looking forward to Malcolm Mooney’s take on this.

    Fascinating in patent law (world-wide) is how often different jurisdictions agree on whether a particular claim is good or bad, but then resort to a different tool to despatch the bad claim. Tools available are available in any standard 101, 102, 103 or 112 toolbox.

    How about a claim to a specified portion of a naturally occurring DNA molecule, per se, and unsupported by any disclosure of any specified and specific utility? Such subject matter strikes me as a claim that, one way or another, ought not to survive. Up to each jurisdiction though, to choose the tool it likes best.

  142. Wow. This is messed up. DOJ supports Obama’s desire to overturn longstanding USPTO policy but opposes Obama’s desire to overturn DOD’s DADT. Talk about hypocrisy.

  143. I’m a mechanical guy, so Judge Sweet’s decision initially seems sensible to me. If his holding is wrong, please explain without too much bio terminology that I won’t understand why this is different from the discovery of elemental oxygen which I also presume would not have entitled one to article claims?

    trying to understand

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