Bits and Bytes No. 128: BRCA Gene Patents

  • Patentable Subject Matter During Prosecution: The PTO has asked for public comments on its interim examination instructions for evaluating patent subject matter eligibility. [PTO Request][Patently-O Discussion]
  • Breast Cancer Gene Patent Challenge:
    • The ACLU, PUBPAT, and others continue their fight against patents covering the breast cancer genes BRCA1 and BRCA2 held by Myriad and the University of Utah. The federal lawsuit argues (1) that the genes should not be patentable as “products of nature” and (2) that the patentee’s use of patent rights to limit scientific research on the genes violates constitutional First Amendment protections.
    • A key to ACLU’s argument is to look at what the patent prevents – i.e., making or using the isolated gene. The organization argues that “human genetic sequences and the scientific inquiry of looking at a gene or comparing two human genes constitute natural phenomena, laws of nature, and abstract ideas and thus are not patentable subject matter under 35 U.S.C. § 101.
    • The First Amendment argument has some merit because of the Supreme Court’s penchant for sharing principles between patent and copyright law. In copyright law, the idea-expression dichotomy is often used to ensure that First Amendment rights are protected. See Harper & Row v. Nation, 471 U.S. 539, 555-560 (1985). In patent law, the ACLU argues that “there can be little doubt that patenting of abstract ideas or thought or an entire body of knowledge would violate the First Amendment” protections of freedom of thought and speech. There are many interesting issues here – one in particular is a question of whether the bare patent could create a first-amendment violation, or does it also require aggressive enforcement.
    • Downside of eBay: Unfortunately, the cancer cells continue to ignore Myriad’s repeated warnings to stop making and using the gene. [joke]
    • Links: [ACLU Discussion][ACLU Summary Judgment Motion][Sarnoff’s Discussion][Holman’s Discussion]

91 thoughts on “Bits and Bytes No. 128: BRCA Gene Patents

  1. 89

    Tino you can just sit here by yourself if you’re not going to think critically and just troll us.

    K how’s that sound?

  2. 88

    Actually, he did invent something. The difficulty is that to avoid claiming too functionally, the claim have to recite the cylinder as follows:

    a 1″ long metal cylinder having a first spoke extending radially outward from a location 5 mm from a first end of the cylinder, a second spoke extending radially outward from a location 6 mm from the first end and circumferentially displaced along a first circumferential direction from the first spoke by 0.2 degrees of arc…etc. ad nauseum.

    I could write hundreds of similar claims to cover other such cylinders, all of which ultimately do the same thing, in effect achieving the same thing pointillism does in painting.

  3. 87

    “I still don’t know how to draft that music box limitation to avoid a trivial design around. Would you just tell the inventor he’s out of luck?”

    No, I’d tell him to invent something next time. And when he does, I’d suggest he get back to me. On the whole, he’s in luck, now he’s ready to invent.

  4. 85

    “Let’s say that someone came along with valid patents on DC’s style of blogging, written as method claims and Beauregard claims. And let’s say that Dennis had to pay a license to the patentee and so he started charging us to read and post here.”

    Well, ya see, I never actually suggested any such thing.

    Mal, I actually sympathise with many of your views. The problem is that you take the most extreme cases as a the basis for trashing the entire notion that patentable innovation might exist in the sphere of software or, might I venture, “information engineering”.

  5. 83

    “I’m afraid the distinction still eludes me. I know DNA is a molecule, but a disk is also made of matter. So the difference must be more than just that.”

    And thus ends our attempt to educate the troll.

  6. 82

    Hi 6,

    I’m glad to know we agree on a few things. I still don’t know how to draft that music box limitation to avoid a trivial design around. Would you just tell the inventor he’s out of luck?

    Malcolm

    I’m afraid the distinction still eludes me. I know DNA is a molecule, but a disk is also made of matter. So the difference must be more than just that.

    I also know that DNA-based computers (albeit still primitive) exist, so whatever the distinction is, it can’t be just that DNA is for making protein and disks aren’t.

    It sounds like the distinction may be between finite and infinite embodiments? I’m not sure that given a particular protein you actually can specify every possible structuree that would code for it. For one thing, the start codon could be anywhere.

    Even ignoring this issue, I think you could only draw every possible structure we know of. Do we know with certainty that the codes we know are exhaustive, i.e. there is nothing left to discover?

    In principle, one could write a very structural sounding claim for a disk with software to encode movie recommendations, but the claim would be so easy to design around that it would be useless.

    Sorry to be so troublesome.

  7. 81

    “The revolution is in the ways and manners of its use and value.”

    Let’s say that someone came along with valid patents on DC’s style of blogging, written as method claims and Beauregard claims. And let’s say that Dennis had to pay a license to the patentee and so he started charging us to read and post here.

    Am I still living in the wrong century if I suggest that only a moran would want to encourage that sort of reality?

  8. 80

    “”This means a phase change in the way that information is perceived and valued.”

    “Baloney. Information was always perceived and valued. It’s marketed differently now because it so incredibly easy for anyone to crank out massive amounts of it.”

    In the WAY, Malcy, not in the fact of being. Information has always had economic usefulness and value. The revolution is in the ways and manners of its use and value.

  9. 79

    “This means a phase change in the way that information is perceived and valued.”

    Baloney. Information was always perceived and valued. It’s marketed differently now because it so incredibly easy for anyone to crank out massive amounts of it.

    So, yes, IP rights do need to be re-defined. Just not in the way that you seem to be suggesting.

  10. 78

    The Information Revolution – maybe you’ve heard of it. The point in history where it becomes possible to encode all manner of information electronically and to provide Random Access to it to virtually anyone virtually anywhere on the planet…
    That information comes in complete spectrum, from mind-numbing ephemera to creative works of varying quality (the value – economic or otherwise – is of which is always in the mind of the consumer) to functionally useful facts, theories, models and algorithms which have a concrete economic value in the world of commerce.
    This means a phase change in the way that information is perceived and valued. If you can’t see that this creates at least an arguable need for a corresponding phase change in the way that IP rights are defined and administered in relation to “pure information” then you’re living in the wrong century.

  11. 77

    “My position is that Beauregard claims should be regarded as just as patentable as DNA claims because they have so much in common.”

    Yes, except they are fundamentally different for the reasons I pointed out upthread and which you are apparently too ignorant to grasp. You do understand that DNA is a molecule? And given a protein sequence I can draw every possible DNA ***structure*** encoding that protein sequence in 3 dimensions at the atomic level?

    Can you do that with a Beauregard claim to a computer readable medium encoding software for recommending movies?

    No, you can’t. Consider yourself educated.

  12. 76

    “So it doesn’t seem like the “information” carried by the cylinder could be structural by itself. For one thing, the information depends on the decoder so it’s indefinite to begin with.”

    I’ll disagree with you that it is “indefinite”, although I can see why you’d say that. The reason I disagree is because no court will take that stance.

    That said, it is simply broad. And that is ok so far as 112 goes.

    Other than that quibble, you appear to be taking the long way around to arrive at the proper result. However you appear to be on the path to enlightenment.

    “So it doesn’t seem like the “information” carried by the cylinder could be structural by itself. ”

    Preach it brother!

    “But the arrangement of spikes is clearly structural. The trouble is the arrangement depends on the information (tune) you are trying to encode, and on the structure of whatever decodes it (the comb). ”

    Ding ding ding! We have a winar!

    “I guess if being “structural” is important, you could recite the actual locations and lengths of each spike for a given music box.”

    Tell the man what he’s won Johnny! Why, it’s a new car!

    “Is it important to know how many types there are?”

    I was just pointing out to you that you should know more than 12 if you are technically literate. You can break your genus down into several species, and those species down into species, and those species into species… etc. on down to the level you’ll see claimed in some AU’s.

  13. 75

    NAL that is because I’m currently hiring an english teacher to make sure that it is perfection. I happened to talk to her the other day, but it will be awhile before she gets to it, busy with a move. She might not even do it, I offered her 10$ for what is approx 30 min to an hour of work, but she isn’t exactly hurting for cash.

    Plus, I keep forgetting to bring my paper to the scanner.

  14. 74

    Good morning 6,

    Sorry I didn’t get back to you. The question about information is a hard one. I’ll try not to be so abstract. Let’s consider the claim element:

    “a music box cylinder configured to cause a music box to play Happy Birthday”

    One embodiment might have little spikes coming out of it, with the spikes placed to engage tines on a comb. If the proper comb is used, and the spikes move past it just right, you should get “Happy Birthday.” But if the tines on the comb are all the same, you’d get no tune at all, just the underlying rhythm of Happy Birthday. So it looks like to the extent the spikes encode information, the information depends on what’s “playing” them back.

    So it doesn’t seem like the “information” carried by the cylinder could be structural by itself. For one thing, the information depends on the decoder so it’s indefinite to begin with.

    But the arrangement of spikes is clearly structural. The trouble is the arrangement depends on the information (tune) you are trying to encode, and on the structure of whatever decodes it (the comb).

    I guess if being “structural” is important, you could recite the actual locations and lengths of each spike for a given music box. But it would be so easy to design around by just changing the comb. Can you think of how else to claim it without being too “functional”?

    As for solid state memories, I don’t know how many types there are. I guess it depends on how different two memories have to be before they become different “types.” Is it important to know how many types there are?

  15. 73

    6,

    you never did get back to me with your proper diagraming of the 112 paragraph 1 rule
    “…we can piece this proper diagram together. I’m most of the way done. ” Posted by: 6 | Aug 23, 2009 at 04:17 PM

    from the thread at

    link to patentlyo.com

  16. 72

    “and solid state memory.”

    Do you know how many thousands of types of “solid state memory”‘s there are? Millions? Billions? Thousands more invented every day?

    You think in broad abstract terms. And that goes to the very heart of the issue with Beauregard claims. People aren’t thinking as they do for the rest of the inventive world. They allow bs functional wording to throw them for a loop instead of taking a breath and treating it like any other functional language.

    You never did get back to me about whether or not “information” was a structural limitation or not in your view.

  17. 71

    Allen: I am not suggesting that DNA claims such as that at issue here should be unpatentable under 101. My position is that Beauregard claims should be regarded as just as patentable as DNA claims because they have so much in common. In fact, as noted above, DNA molecules have already been used to encode information for computational purposes. Here is another SA article on the subject from 1999

    link to scientificamerican.com

    In cases like the above, DNA is carrying a nucleotide sequence that is used for computation. But the identical sequence would inevitably code for some protein. Yet, the structure is unchanged. Only the purpose has changed. It would be odd to have a regime in which a molecule that carries info used for mere computation is unpatentable, whereas the identical molecule, when used, as nature intended, to make protein, suddenly becomes patentable.

    The notion of “structural information” is unclear to me but I suppose you are right from an information theory point of view. Information theory tells us that the amount of information in a thing is log base 2 of the number of alternatives. That’s why a binary digit (0 or 1) contains 1 bit of information, since log base 2 of 2 alternatives is 1. Each position in a DNA molecule would have 2 bits (log base 2 of four alternatives). I suppose you could figure out the information content in your antibody molecule in much the same way, although this raises issues that are beyond the scope of this discussion. In any event, as you suggest, information content is not relevant to 101 analysis.

    I did not realize that chlorophyl turns light into electricity. I thought it had to do with making plant food somehow.

  18. 69

    Allen, great contribution. Hopefully Tino will appreciate it. Just a niggle on “Europe”. It isn’t “strange” that Europe forbids patents on business methods, as such, and computer programs, as such. That prohibition is statutory, dates back to 1973, and survived the thorough inter-Governmental re-write of the Convention that happened in 2000. It is not a puzzle why these prohibitions survived. Just look at what happens when they are not there.

    And by the way, there is a heavy flow of valid business method and software patents issuing from the EPO. As Applicants and their representatives learn how to draft around the “as such” (construe statutory exceptions narrowly) get-out words in the Convention, the flow gets ever stronger. But the statutory bars still do shut out pure non-technical business method stuff. Time will tell, whether that ongoing statutory bar hurts or helps European innovators to compete with those of the USA.

  19. 68

    “the number of distinct media that can encode instructions for a computer is infinite, (actually I can only think of a half dozen or so)”

    Name them.

  20. 67

    DNA claims do not attempt to claim the information “encoded” in it as opposed to Beauregard claims. I have never seen a claim to a DNA sequence which begins: The information comprised within the structure of a DNA molecule having SEQ ID NO:1. Why? If I have a novel chemical which is useful, the information it “contains” is irrelevant for patentability purposes.

    Also, note that all bio-molecules are encoded with “information” in the structure. For example antibodies are “encoded” with structural information on efficiently binding antigens (change one amino acid and the binding constant changes), insulin is encoded with structural information on activating the insulin receptor, antibiotics are encoded with structural information on how to disrupt bacterial metabolism, chlorophyll is encoded with structural information on how to convert light into electricity. cDNA is encoded with structural information for being translating a protein. The list goes on.

    Just pointing out that “information” is encoded in a biomolecule is a red herring. Information is everywhere and in everything examined critically by a human, whether subject to a patent or not. Whether biomolecules such as genes should not be patentable subject matter because they contain information is frankly a legislative issue. Congress drafted the statute so as not to exclude anything except the abstract and ephemeral. DNA is neither. Besides, Congress has been fine with patenting DNA and could have changed the law decades ago. If someone has a gripe about patenting genes, then go to the Hill, not the court.

    Strangely, Europe has more lax standards for gene patents than the US but refuses to grant “computer” and “business method” patents. The US is the exact opposite. It has expanded the scope of patentable subject matter to promote innovation by computer scientists and businessmen, but restricted the scope of subject matter in the physical sciences apparently. Do we really want more dis-incentives to innovation for chemists and biologists. The salaries alone (Computer scientist/Businessman vs. Chemists/Biologists) are doing a pretty good job of keeping American students from choosing a career in science.

  21. 66

    Please forgive my ignorance but you just noted at 2:49 that whether or not a limitation is deemed structural or not has nothing to do with whether or not that limitation reads on a finite number of embodiments.

    But now, it appears that because the number of distinct media that can encode instructions for a computer is infinite, (actually I can only think of a half dozen or so) it follows that Beauregard are somehow cannot have structural limitations.

    It is just a bit difficult to reconcile these two contradictory ideas.

  22. 65

    Tino, sorry, but you’ve pretty much demonstrated you aren’t interested in understanding. So, for the third time, there is one very simple genetic code and the only “thing” that has instructions for building a particular polypeptide is DNA (or RNA). This basic scientific fact, known for many decades, has been acknowledged by the courts, as I noted upthread.

    In contrast, the number of “things” that can encode instructions that a computer can read and the number of different ways that those instructions can be written is infinite. For that reason, applicants in the software area pursue only composition claims that are little more than “functions on a stick.”

    For years the PTO and the courts have tended to examine claims to the former “things” much more rigorously than claims to the latter things, especially with regard to written description. In part, this is why the Federal Circuit has been asked to revisit its written description requirement en banc. You can rest assured that the decision will have broad impact. But whatever you do, don’t try to plan ahead and adapt to the inevitable. Just stick your head in the sand and scream as loud as you can. That’s what seems to work best these days.

  23. 64

    “Malcolm, settled law is hardly what 1201 tuesdays serves up.”

    Really? Not according to the blog owner’s own comments regarding that claim. Geez, just admit it for once. Would it hurt so bad?

  24. 63

    “That took five seconds. Need more handholding? Try taking your head out of the sand for a couple days.”

    Malcolm,

    settled law is hardly what 1201 tuesdays serves up.

    But if you knew law, you would know that.

    Care to give any real examples?

    And what do you have against Allapat?

  25. 62

    Thanks. I’ll try.

    Why does the claim at issue, which is essentially:

    “a thing that has instructions for building a particular polypeptide.”

    have a structural limitation whereas a typical Beauregard claim

    II: “a thing that has instructions for carrying out a procedure.”

    doesn’t?

  26. 61

    Tino: “There was some suggestion that having a “near-infinite number of embodiments” was important. So is a limitation deemed structural if and only if it reads on a finite number of embodiments?”

    Of course not. Do you have a more intelligent and thoughtful question to ask? Go ahead, surprise me.

  27. 60

    “the problem is in the haphazard and consistently weak application by the PTO of the settled law”

    NAL: “…settled law,…” – examples please.

    link to 1201tuesday.com

    That took five seconds. Need more handholding? Try taking your head out of the sand for a couple days.

  28. 59

    Thanks for reminding. My Alzheimers is difficult to deal with at times.

    I think I pointed out that the claim at issue isn’t any more structural than most Beauregard claims (see 4:22).

    The claim is essentially

    I: “a thing that has instructions for building a particular polypeptide.”

    It is hard to understand the distinction between this and

    II: “a thing that has instructions for carrying out a procedure.”

    There was some suggestion that having a “near-infinite number of embodiments” was important. So is a limitation deemed structural if and only if it reads on a finite number of embodiments?

  29. 58

    “I know you want to pull the trigger Malcolm and I know that you know I will have the answer. I know that you know everyone knows.”

    Keep diddling yourself, Noise.

  30. 56

    “MD, the problem is in the haphazard and consistently weak application by the PTO of the settled law, particularly with respect to computer and business methods.”

    “…settled law,…” – examples please.

    “Therefore, both disk and DNA have two properties in common: (1) they both carry information, and (2) they both are made of chemicals in combination. It’s not so clear why they should be treated differently.”

    ROTFLMAO. I agree. Let’s treat them the same. For starters, let’s require that discs encoding software be claimed structurally, instead of functionally. You okay with that? I didn’t think so.

    You see, unlike the simple, direct and immediately cognizable structural relationship between nucleic acids and the proteins they encode, the functional language used to describe software in a Beauregard claim can be satisfied by a near-infinite number of structural embodiments (e.g., the arrangement of markings on the surface of the disc) corresponding to a near-infinite number of coding possibilities (each of which is a manifestation of someone’s idea of how the described function could be achieved).

    I hope this helps you understand the difference. It’s fairly straightforward.

    Posted by: Malcolm Mooney | Aug 31, 2009 at 03:21 PM

    Edging closer – it has been a few months since Malcolm was seen with skirt and track shoes.

    I’ll get the quote ready…

    Posted by: Noise above Law | Aug 31, 2009 at 03:55 PM

    I know you want to pull the trigger Malcolm and I know that you know I will have the answer. I know that you know everyone knows.

    When does the track meet start.

  31. 55

    Tino: “Maybe so, but if one buys that idea, why should it matter whether the substance upon which these instructions are encoded is a disk or a large molecule?”

    I already addressed this misleading canard of yours upthread on Aug 31, 2009 at 03:21 PM. Please don’t waste everybody’s time with your continuing display of Alzheimers and/or inability to read.

  32. 54

    “It’s just that instructions should not become patentable merely by “encoding” them onto a substance”

    Maybe so, but if one buys that idea, why should it matter whether the substance upon which these instructions are encoded is a disk or a large molecule?

  33. 53

    MD, the problem is in the haphazard and consistently weak application by the PTO of the settled law, particularly with respect to computer and business methods. The courts will get it right, eventually, but it would greatly speed things up if PTO first got its knives out and started chopping the snakes’ heads off.

    Odd that this will happen under Kappos? Slim to none.

  34. 52

    So, Malcolm, does this not all boil down to a failure of duty of the courts, to hand down to the USPTO i) a practical working method of sorting the non-obvious wheat from the obvious chaff and ii) a robust line on 35 USC 112 that shuts out over-broad claims? With such caselaw established, Applicants would pretty much give up trying to bamboozle to PTO into issuing over-broad CII claims, the backlog would start to go down, and respect for the patent system, including its application to computer-implemented innovation, would slowly return.

    So, where’s the problem?

  35. 51

    Tino “But the claimed subject matter in a Beauregard claim is not the information itself, but a manufacture with info encoded. That’s why it fits squarely in 101.”

    We get your “argument” Tino. It’s just that instructions should not become patentable merely by “encoding” them onto a substance. I know some people care whether such patents are prevented under 101, 102, or 103. It really doesn’t make any difference.

    It’s easy to see that the “disk” in a Beauregard claim is a trivial aspect of the alleged “invention.” Why do you think there was so much whining about the patentability of “signals”? The bottom line is that software is treated differently because software applicants are loud whining crybabies who want everything to be patentable because the cost of developing software and filing applications is minimal compared to the gold that can be extorted out of the deep-pocketed company of one’s choosing. The game for these people is to crank out the crap, lawyer up, and roll the dice. To the extent there are any additional rules put in place that slow down or hinder the game playing, these players will behave as if there Constitutional freedums are being taken away. Meanwhile, they’ve succeeded in ruining the PTO for everyone.

  36. 50

    B&F: “I don’t understand why any of this is not obvious under 103.”

    A lot of isn’t. See, e.g., In re Kubin.

    You’re welcome.

  37. 49

    Burgers, it is always a puzzle to law people, what is patentable and what not, what is obvious and what not. But consensus has emerged, between professionals, over more than 100 years. Despite what 6 would say, there is a great deal of international agreement about how to assess what is “obvious” in the context of a claim of a patent. It’s exactly because 99% is common that patent lawyers seem so pathetic, when they argue about the remaining 1%. But it is actually a sign of health in the patent system, as practised all over the world because it does promote the progress of useful arts, that patent attorneys are obsessed with only 1% of the big picture. Where would we all be, without our patents system? Mostly dead at much younger ages than those we regularly attain,for want of one life-saving drug or another. Mind you, people in Europe have a higher life expectancy than those in the USA (couldn’t resist that).

  38. 48

    Burgers and Fries,
    is it obvious to pick a specific ball from a collection of 30,000+ balls, even if all balls have different sizes and colours? Is it obvious to find a ball with which you can play a particular game if you do not know what size and colour would be required, even if you know that with some balls you can play soccer and with other balls you can play tennis. It really would seem undue experimentation required.

  39. 47

    I don’t understand why any of this is not obvious under 103. The relationships between the genes and various human conditions and attributes exist in nature, and the discovery of one of these relationships is a discovery, not an invention. Once someone showed that it is useful to isolate and analyze a gene, why would it not be obvious to isolate and analyze any of the others? They’re all useful for the same reason – what they can tell us about an individual human. We don’t add isolated DNA to our fuel, we don’t insert it into a human to cause something to happen. All we do is analyze it to glean information about the human it was copied from.

  40. 46

    It depends on how they are claimed Max. Your comment doesn’t make much sense that I can see, I think you need to rephrase that.

  41. 45

    Article 52 is the EPC’s “101”. It lists things that (as such) are not patentable. One of them is:

    “(d) presentations of information”

    which deals with claims like:

    …the improvement comprising (new and inventive) instructions…..

    …which brings me to my point. 6, I’m intrigued how you are going to use 102 to sweep away such claims (even when limited to a carrier carrying such instructions physically encoded on the carrier) without also throwing out with the dirty bathwater thousands of precious commercially useful claims to valuable baby computer-implemented inventions that cleverly solve real objective technical problems.

  42. 44

    “Encoding info is what you need to do to it before you can communicate info to someone else.”

    So then a definition might be?

    Perhaps something like this?

    link to yourdictionary.com

    Ok, I was just asking, I take no issue with most B claims over 101.

  43. 43

    That’s easy. I am encoding info right now in these letters. When you talk, you encode info as sound. Managers at ball games encode info by touching their nose and wiggling their belt. For long distances, smoke signals encode info. Encoding info is what you need to do to it before you can communicate info to someone else.

  44. 41

    “A chemical compound is statutory subject matter whether or not it codes for a protein”

    Same is true for a “manufacture” (which is what a disk w/ info would be).

    “most DNA does not code for a protein and thus carries no information”
    Same is true for a disk. There are large swaths that don’t code for info.

    “bytes (and thus pure information) are not be patentable”

    But the claimed subject matter in a Beauregard claim is not the information itself, but a manufacture with info encoded. That’s why it fits squarely in 101.

    In principle, there is nothing sacred about a binary instruction set (()’s and 1’s). You could use base 4 and map 0 to A, 1 to G, 2, to T, and 3 to C. Once you do that, there is nothing to stop you from defining a codon like “ATG” to mean “read data”, etc other than building an interpreter to do the translation. The only reason DNA encodes for protein at all is that the cell has components that “interpret” codons this way. So nothing really stops DNA from carrying any machine readable instructions, other than a suitable interpreter.

  45. 40

    “Would it help if the improvement were “the improvement comprising instructions for causing the computer to repetitively perform, at frequent intervals during each cure”?

    The corresponding method claim was blessed by the S.Ct.”

    I don’t know would it? Can a structure be distinguished from prior art by “instructions”? Or, can a structure only be distinguished from the prior art in terms of structure?

    I’ll let you decide.

    As for me, I’ll continue to reject this sort of nonsense any chance I get. And 102 will be my sword while ignoring limitations which aren’t structural limitations and treating functional limitations as I treat any other functional limitation.

    The USSC only usually answers questions of patentability which are before it. If nobody raises the issue, then the court will never address it. So far as I understand it, nobody questioned this patent on the grounds of 102/103, only 101.

    “http://digital-law-online.info/cases/209PQ1.htm”

  46. 39

    6

    Would it help if the improvement were “the improvement comprising instructions for causing the computer to repetitively perform, at frequent intervals during each cure”?

    The corresponding method claim was blessed by the S.Ct.

  47. 38

    I think it’s cclear that gene patents like the ones discussed here are merely products found in nature and should not be patentable under 101.

    However, I also agree that the ACLU’s argument is BS.

  48. 37

    “the improvement comprising causing the computer to repetitively perform, at frequent intervals during each cure, integrations to calculate from the series of temperature determinations the Arrhenius equation for reaction time during the cure, where v is the total required cure time, and to repetitively compare at frequent intervals during the cure each said calculation of the total required cure time calculated with the Arrhenius equation and said elapsed time, and to open the press automatically when said comparison indicates the rubber is cured”

    The improvement to your structure comprises a method step. “causing”.

    Thanks. That makes it a lot easier to point out the nonsense.

  49. 36

    A chemical compound is statutory subject matter whether or not it codes for a protein. DNA is a chemical, and chemicals have been patentable subject matter since the beginning of the patent system.

    Besides, most DNA does not code for a protein and thus carries no information (at least that we can discern) completely wrecking the “DNA is information” argument. Protein-coding DNA (the minority of the genome) has all the same chemical features of non-coding DNA but with the added bonus of being able to be translated into protein. The difference does not change the fundamental physical nature of DNA.

    The best proof of this is that until we have a method for dissolving a hard disk and extracting the bytes from it, bytes (and thus pure information) are not be patentable.

    In contrast, DNA can be isolated from the physical world and has physical properties– melting point, structure, charge, ionization constants, etc. while a byte has no physical structure, nor can it be measured or otherwise identified in nature. Thus, despite the fact that all bytes carry information, they are non-physical and thus non-patentable. The fact that DNA may have a non-physical property such as carrying genetic information, does not change the fact that it is real and can be physically isolated by man.

  50. 35

    Sorry but I guess I’m not seeing the difference yet.

    “can be satisfied by a near-infinite number of structural embodiments”

    Isn’t this als true in DNA. For one thing, the start codon can be any distance in from the end of the molecule. The molecule itself is flexible, so it can assume an infinte number of shapes and still do the job. Then there is codon degeneration, which further expands the number of codes available for encoding the very same polypeptide.

    So if the only argument is that there are more ways to write computer code than there are structures for encoding a particular protein, then it’s hard to understand exactly how many more there would have to be before one has to start treating Beauregard claims differently.

  51. 34

    Edging closer – it has been a few months since Malcolm was seen with skirt and track shoes.

    I’ll get the quote ready…

  52. 33

    “Therefore, both disk and DNA have two properties in common: (1) they both carry information, and (2) they both are made of chemicals in combination. It’s not so clear why they should be treated differently.”

    ROTFLMAO. I agree. Let’s treat them the same. For starters, let’s require that discs encoding software be claimed structurally, instead of functionally. You okay with that? I didn’t think so.

    You see, unlike the simple, direct and immediately cognizable structural relationship between nucleic acids and the proteins they encode, the functional language used to describe software in a Beauregard claim can be satisfied by a near-infinite number of structural embodiments (e.g., the arrangement of markings on the surface of the disc) corresponding to a near-infinite number of coding possibilities (each of which is a manifestation of someone’s idea of how the described function could be achieved).

    I hope this helps you understand the difference. It’s fairly straightforward.

  53. 32

    “What would be interesting is to see any Beauregard claim in Jepson format”

    That’s easy. I just took the one from the Diehr patent in Diamond v Diehr and rewrote as requested:

    1. A computer-readable medium having instructions for operating a rubber-molding press for precision molded compounds, the instructions causing a computer to retrieve a database for the press including natural logarithm conversion data (1n), the activation energy constant (C) unique to each batch of said compound being molded, and a constant (x) dependent upon the geometry of the particular mold of the press, to initiate an interval timer in said computer upon the closure of the press for monitoring the elapsed time of said closure, to constantly determine the temperature (Z) of the mold at a location closely adjacent to the mold cavity in the press during molding, and to constantly provide the computer with the temperature (Z),

    the improvement comprising causing the computer to repetitively perform, at frequent intervals during each cure, integrations to calculate from the series of temperature determinations the Arrhenius equation for reaction time during the cure, where v is the total required cure time, and to repetitively compare at frequent intervals during the cure each said calculation of the total required cure time calculated with the Arrhenius equation and said elapsed time, and to open the press automatically when said comparison indicates the rubber is cured.

  54. 31

    “The analogy to Beauregard is totally misplaced. DNA in essence is a chemical compound, and should follow the requirements for patentability of chemical compounds. ”

    A disk is a “manufacture” that, incidentally, is made of chemicals as well, and carries instructions.

    The claim recites “[a]n isolated DNA coding for a BRCA1 polypeptide.” Thus, its ability to carry instructions to make BRCA1 appears to be essential for patentabiliy.

    Therefore, both disk and DNA have two properties in common: (1) they both carry information, and (2) they both are made of chemicals in combination. It’s not so clear why they should be treated differently.

  55. 30

    #1) note to Allen – agreed. “isolated” sequences have been affected by the “hand of man” and are *NOT* found in nature.

    #2) so *this* is what the ACLU spends their money on? The ACLU has never done anything to try to cure cancer. Apparently, now they appear to be trying to hamper the efforts of those who are. Remind me to never contribute money.

  56. 29

    “The task force, led by Deputy Commissioner for Patent Operations Peggy Focarino and POPA President Robert Budens…”

    Sounds like an internal PTO circle jerk. Nothing will come of this.

  57. 28

    “… task force comprised of…”

    Written by illiterates. No wonder there are problems, when you can’t get the basic language usage issues right, what can you get right?

  58. 27

    As a Ph.D. biologist and patent attorney, I am appalled that this issue is even being considered. The “product of nature” argument ignores simple biology. The patent is directed to complementary DNA (cDNA) not genomic DNA (gDNA). Genomic DNA is found in nature within the chromosome and has intervening non-coding gene sequences termed introns. A scientist who discovers the gene has to remove these non-coding sequences to create a cDNA, which can be efficiently translated into protein. This procedure is performed by using a viral reverse transcriptase to convert RNA into DNA where it is subsequently amplified into cDNA and cloned into an in vitro cell system. cDNAs by definition are artificial since human chemical manipulation is required for it to exist. Thus, it is not even debatable as to whether it is the product of human ingenuity and thus is statutory subject matter. On the other hand, is it obvious to remove the introns from genomic DNA to create a cDNA? Well now, that’s debatable.

  59. 26

    “”Joint Union and Management Task Force Begins Work of Addressing the Patent Examiner Count System”

    Dennis, I think this topic merits a separate article.

  60. 25

    “Joint Union and Management Task Force Begins Work of Addressing the Patent Examiner Count System

    On Tuesday, August 25, a task force comprised of four members from the Patent Office Professional Association (POPA) and four from Patents Management met to begin work on re-engineering the patent examiner count system. The day-long session was kicked off by USPTO Director David Kappos who emphasized the importance of their work, stating, “Creating an examiner count system which gives examiners the time they need to do their job properly and which incentivizes compact prosecution, including the use of interviews, is currently job number one for the agency.” Director Kappos committed his support and involvement to the work of the task force and will be holding regular check point meetings with them.

    The task force, led by Deputy Commissioner for Patent Operations Peggy Focarino and POPA President Robert Budens, has been given a deadline of October 1 to recommend a solution which moves the Agency significantly forward towards a new examiner count system which is properly aligned to achieve both efficient and high-quality examination. As work progresses, regular communications will be provided by the task force to keep all employees apprised of the team’s ongoing work and accomplishments.”

    This will be interesting.

  61. 24

    Forgive me, Bread, for not making myself clear. My problem is NOT with the length of the patent term. Quite evidently, 20 years isn’t enough. My problem is with letting the owner of a claim to the molecule per se have 20 years (or more) of absolute protection for that molecule, regardless what use is made of it. Why should Exxon Mobil be enjoined by Pfizer, when it puts a Pfizer molecule in its engine fuel (for example)? Did Pfizer invent the fuel additive? No.

  62. 22

    Well said, Bartmans:

    “DNA in essence is a chemical compound, and should follow the requirements for patentability of chemical compounds.”

    The isolated compound is new, and not found in nature. A claim to it appropriates all uses of the new compound. With “reach through” claims under attack in Europe and in the USA, I see a growing recognition that the scope of protection enjoyed by an Applicant ought to be proportionate to the contribution the named inventor has delivered to the field. I look forward to the day when the legislator realises that absolute 20 year (or more) protection of a new chemical compound, any new chemical compound, per se, gives the Applicant a 20 year (or more) monopoly that is out of proportion to the inventor’s actual contribution to the field.

  63. 21

    “It would be interesting to see claim 1 in Jepson format.”

    What would be interesting is to see any Beauregard claim in Jepson format.

  64. 20

    The analogy to Beauregard is totally misplaced. DNA in essence is a chemical compound, and should follow the requirements for patentability of chemical compounds. The fact that it also is able to carry information should – in principle – have no bearing on the patentability of DNA.

  65. 19

    1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having
    the amino acid sequence set forth in SEQ ID NO:2.

    It’s hard to tell the difference between a claim to “isolated DNA” and a typical Beauregard claim. Both are instructions [code] encoded on a machine readable medium [machine is the cell, medium is the DNA molecule, which is turned into RNA by certain constituents of the cell [ribosomes?] for doing something [making a polypeptide]. The main difference is one cannot usually find software code in nature. It would be interesting to see claim 1 in Jepson format.

  66. 18

    Mark, the “experimental use” defense is extraordinarily narrow. It is limited to strictly philosophical inquiry. Taking the copyright analogy once more, it would mean that you could photocopy a case from the Federal Reporter (the headnotes are copyrighted by West) for strictly philosophical musing, but not for writing a brief for a client nor even teaching a law school class, since law schools charge tuition. I think the cramping of First Amendment rights is clear.

  67. 17

    Correct me if I’m wrong but aren’t you allowed to infringe a gene patent as long as you do it strictly for R&D purposes with no commercial intent? Doesn’t that undermine the “freedom of speech” argument?

  68. 16

    “6,

    Discovering a few genes that *may* be linked to causing one *particular* type of cancer is about as close to world peace as a U2 concert. You must have an electrical or mechanical background.

    I thought it said that they discovered proteins? Those are different from genes are they? They also said they just squirted a little bit in the tumorous rats and the tumors went away. Now if I have a big huge tumor then I don’t think I’d mind if they squirt just a little bit in me. Especially if the tumor is really ugly, or will kill me.

    Or are they just putting us on?

  69. 15

    Dennis:

    Genetic information isn’t patented. Anyone can take a sequence disclosed in a patent and, for example, interrogate a database for related sequences. And, in view of the narrowness of most gene patents, that anyone can then use the information to obtain another, related gene.

    So there is no “patent” on genetic information. The use of genetic information is another matter, for another time. But as asserted the First Amendment argument has no merit.

  70. 14

    “It’s a political stunt, and the legal merits are practically non-existent. That’s sad because there are patents associated with this technology that could be invalidated without a great deal of effort.”

    Right. Because the list of patents that have been invalidated by a proclamation from Malcolm Mooney that they’re “facially invalid” stretches from here to the moon. And back.

  71. 13

    Another colossal waste of judicial resources by the two-faced and hypocritical ACLU. This suit is absolutely meritless and deserving of sanctions under FRCP 11; that’s the only way the ACLU is going to learn when (and when not) to push such nonsense.

  72. 12

    6,

    Discovering a few genes that *may* be linked to causing one *particular* type of cancer is about as close to world peace as a U2 concert. You must have an electrical or mechanical background.

  73. 11

    Wait, never mind – I get it: “Clam 1: A method for denying insurance coverage comprising discovering the BRCA gene in the customer.” “Claim 2: The method of claim one further comprising blacklisting said customer from cancer insurance coverage from any other carrier.” Sorry, I was confused in the earlier post.

  74. 9

    IMO I hope the whole thing is anticipated and I hope it really does cure cancer. Then we’ll get to see if this cure for cancer never gets made ala Kev’s argument that cures that can’t be patented will never come to the people.

  75. 8

    “http://cosmos.bcst.yahoo.com/up/player/popup/?rn=3906861&cl=15276653&ch=4226722&src=news”

    OMG CURES IN MAH CANCER!

  76. 7

    “The First Amendment argument has some merit because of the Supreme Court’s penchant for sharing principles between patent and copyright law.”

    Despite this penchant, I don’t think that the First Amendment argument has merit.

  77. 6

    If I go into the woods with my chainsaw, chop up a tree into 1.01 ft long sections and I pick one up…then will it pass 101 when I claim it?

    You have to stick it in your fireplace and ignite it first.

  78. 5

    The only question in re this case is this:

    If I go into the woods with my chainsaw, chop up a tree into 1.01 ft long sections and I pick one up and decide that it is an invention then will it pass 101 when I claim it?

    Yes or no?

  79. 4

    Paul, two points. First, the labels of “expression” and “idea” in copyright law are post hoc labels, denoting permissible and impermissible levels of abstraction. Instead of figuring out whether something is an idea (and hence unprotected), the causation largely runs the other way. We first figure out if something is too broad for proper copyright protection, and if so then label it an idea.

    Second, patent law largely has the analogous doctrine that “abstract” ideas are unprotected. How do we figure out if an idea is excessively “abstract” (i.e. too broad)? Again, this is an empty label and the causation largely runs the other way. A court first figures out whether it thinks the claim is too broad to be protected, and if so then labels the idea as “abstract” and unpatentable.

  80. 3

    It’s a political stunt, and the legal merits are practically non-existent. That’s sad because there are patents associated with this technology that could be invalidated without a great deal of effort. They’d probably get less attention from the press (and blogs) though if they went that route.

  81. 2

    Furthermore, since “patenting of abstract ideas or thought or an entire body of knowledge” has never ever been patentable under any patent statute or any case law, this bizzare “First Amendment” argument violates the Constutional Law 101 principle every law student is taught that such cases do not get decided on a Constitutional basis.
    [This is not a comment on the validity of the subject patent, or even on so-called gene patenting, under a PROPER legal analysis by the legal system rather than hyperbole media publicity.]

  82. 1

    I do not see how the the “idea-expression” dichotomy of copyright law can have any relevence to patent law, even by analogy. Patent law, unlike copyright law, DOES protect certain ideas. Patent law, unlike copyright law, does not inhibit expression, much less prevent free speech, about anything [other than rare cases of communicating specific and knowing infringement instructions, only to actual infringers committing specific ACTS of infringement, to deliberately induce their patent infringement.]

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