Federal Circuit: Isolated Human DNA Molecules are Patentable

ASSOCIATION FOR MOLECULAR PATHOLOGY V. MYRIAD GENETICS (Fed. Cir. 2011)

In a much anticipated decision, the Court of Appeals for the Federal Circuit has rejected the Southern District of New York’s court’s holding that could have rendered invalid all patents claiming isolated forms of naturally occurring DNA molecules. However, the decision is somewhat nuanced and will be appealed.

Judge Lourie drafted the opinion of the court that was joined in-part by the entire panel. Judge Moore drafted a concurring opinion that agrees with the conclusion that the isolated DNA is patentable but disagrees with Judge Lourie’s methodology for determining when an isolated compound is sufficiently “man made” to no longer be considered a natural phenomenon or product of nature. Judge Bryson concurred in part, but dissented on the issue of whether an isolated human DNA molecule should not be patentable. Judge Bryson writes:

We are therefore required to decide whether the process of isolating genetic material from a human DNA molecule makes the isolated genetic material a patentable invention. The court concludes that it does; I conclude that it does not.

Focusing here briefly on the majority opinion, the court made four specific holdings:

  • Affirmed: The District Court properly had jurisdiction over the case;
  • Reversed: The district court erred in holding that Myriad’s claims directed to isolated DNA were invalid;
  • Affirmed: The district court properly held that Myriad’s claims directed to comparing or analyzing gene sequences were invalid; and
  • Reversed: The district court erred in holding that Myriad’s claims directed to screening potential cancer therapeutics via changes in cell growth rates were invalid.

The result here is that Myriad’s BRCA Gene patents are somewhat damaged, but remain strong. The plaintiffs are likely to either request an en banc rehearing or immediately file a petition for a writ of certiorari with the Supreme Court. Myriad is likely to request a rehearing on the issue of subject matter jurisdiction.

[More to Come]

Documents: Read the 105 page decision here.

202 thoughts on “Federal Circuit: Isolated Human DNA Molecules are Patentable

  1. Malcolm, if the claimed test covers both a physical test and an unpatentable mental steps comparison of two sequences, and the test is the point of novelty, is the claim invalid under 101? What if the specification discloses both tests, and declares them equivalent?

    Personally, I think the claims are valid under 101 because, under Phillips, the courts would limit the claims to the physical test.

    But shouldn’t such claims be invalid under 112, p.2, because they literally read on non statutory mental steps? See, Prater II. Prater II was, however, a case coming from the PTO using BRI.

  2. You have a very limited set of tools, Mooney.

    Maybe if you got your head out of your bvtt, you could see what was going on around you.

    Meanwhile, you’re being left behind.

  3. This makes no sense whatsoever, since I have never expressed a favorable opinion about the patent-eligibility of Beauregard claims.

  4. Lourie at page 47:

    “With respect, no one could contemplate that snapping a leaf from a tree would be worthy of a patent, whereas isolating genes to provide useful diagnostic tools and medicines is surely what the patent laws are intended to encourage and protect. Snapping a leaf from a tree is a physical separation, not one creating a new chemical entity.”

    There is so much that is inadequate about this statement. First of all, a leaf is chemically bonded to the branch, and removing it from the branch represents a chemical separation, just as in the isolation of genes. Lourie’s empty statement that it is a physical separation is devoid of meaningful content.

    Second, he uses a potential utility of the isolated gene to imbue it with patent-eligibility, but does not do the same for the leaf. There are many instances in which “…isolating [leaves]…provide[s] useful…medicines…”

    Is this “surely what the patent laws are intended to encourage and protect”? Isolating a gene and isolating a leaf are technical activities that are both well within the capability of the PHOSITA.

    Like I said, I think that the holding is correct, but that the decision does not articulate cogent reasoning–which is par for the course at the CAFC.

    I would rather have cogent reasoning and an unfortunate outcome, which could be reviewed, than bad reasoning or no reasoning at all and a correct outcome.

  5. I wrote it in response to Malcolm’s observation that one cannot patent the correlation between the existent of a disease and the existence of a protein/encoding gene, which is abstract. I think one can, that is if one recites the physical steps for a test that determines the presence of the gene.

    C’mon, Ned. If you are claiming the physical steps, and the non-mental steps are novel, you are not “claiming the correlation”. This sort of sloppiness on your part is what drives people nuts.

  6. I really do not understand why one cannot just claim “testing for BRCA1 and BRCA2″ where the specification discloses a physical test using a probe, for example.

    I explained one potential problem in my comment, immediately above.

  7. BTW, by correct result, I mean that isolated DNA is patent eligible. Your presumption that it should not be is simply wrong. Patents were put in place to incentivize research by providing a mechanism for harvesting the fruits of one’s labor. But you would remove that incentive for genetic research. Wrong result. Wrong assumption.

  8. Was the discovery public knowledge before they filed their patent on the isolated DNA? if so, for how long was it public knowledge prtior to the filing?

    It’s a simple obviousness analysis. You don’t get to end run 102 definitions of what constitutes prior art by conflating 101 with 103, and calling the invention de minimus in view of the discovery. Stop conflating 101 and 103, and you’ll find that the statutes provide the guidance for reaching the correct result.

  9. Hans,

    Please re-read 35 USC 101 for what is “patent-eligible.”

    Step away from the crowd conflating “patent-eligible” and “patent-able” – as noted by Dennis on the new thread, these are different, even fundamentally different, questions.

  10. Ned, some of Myriad’s diagnostic method claims do indeed involve the utilization of mutation-specific hybridization probes. I have no problem with those claims. The way the test is done in practice is that human genomic DNA is extracted from a cell and purified. The purified genomic DNA is then amplified with selected primers that permit amplification of the coding sequences of the BRCA1 (or BRCA2) gene (and some amount of non-coding sequences), but NOT amplification of any other part of the genome. The amplicons are then sequenced using known sequencing techniques. The sequence reads are then compared to a reference sequence to determine the presence of variation. Any variations identified are evaluated to determine if they increase risk of cancer (some variations do, some do not). That’s it. The only thing that is patent-eligible here are the amplification primers, but those can be worked around.

  11. Hans, I’ll leave it to the experts in the field to craft a technically competent claim. I wrote it in response to Malcolm’s observation that one cannot patent the correlation between the existent of a disease and the existence of a protein/encoding gene, which is abstract. I think one can, that is if one recites the physical steps for a test that determines the presence of the gene. Malcolm’s last point is that the point of novelty in the test cannot be a mental correlation.

    On this last point, I really do not understand why one cannot just claim “testing for BRCA1 and BRCA2″ where the specification discloses a physical test using a probe, for example.

    The question would not be whether the claim was statutory, but rather whether a test that involved digitally comparing two sequences in a computer, or by hand for that matter, would be an infringement. That would of course depend upon claim construction.

  12. But wait, you’re really just arguing for a change in the law by pretending it’s already the law and closing your eyes and holding your breath, right?

    Yes.

  13. You heard it here first, folks: Keith Ellison and Michelle Bachmann “are both ideologues who have precisely the same basic motivations.”

    LOL.

  14. Malcolm–

    I just love the way you plant the impression in a reader’s mind that I thought a certain way.

    Of course, whether I believe it or not, I never stated that I believed that my reasoning was significantly different from Lourie’s and Moore’s.

    Your strategy is a time-honored one, and is not always easy to address successfully.

    There are a couple of strategies that work, however. One is to completely ignore the statement and respond with an in-kind statement using the same logic, only with greater force, allowing for the precedence effect to erase the signal caused by the first comment.

    Another is to expose the tactic for what it is, and hope that readers are smart enough to understand. Because I hold most of the patently-o readers in high esteem, this is the route I have chosen.

    Malcolm, do you remember that thread where you asked about the motivation of Republicans, and I said that it was exactly the same as that of the Democrats, and that 2 people could do 2 different things for the very same reason?

    Well, that logic works the other way around, too–for instance, Sen. Michelle Bachmann (R) (ugh) of Minnesota voted NO on the debt ceiling bill, as did Rep. Keith Ellison (D) (ugh).

    2 people, politically opposed to each other in every conceivable way, both voted NO.

    That is the conventional wisdom–the reality is that they are not so different as they would like everyone to believe. They are both ideologues who have precisely the same basic motivations.

    Me, I am ashamed for the USA that either of them holds public office.

    Anyway, I think that Lourie and Moore reached the correct decision, although they failed to cogently articulate their reasoning.

    A perfect decision for further review.

  15. I believe that those terminations are inherent in the composition claims, and therefore constitute explicit claim limitations. It is for that reason that I believe there to be patent-eligible S-M in those claims

    If you think your reasoning is significantly different from Lourie’s and Moore’s, you are very confused.

  16. You need somebody else to point out your error, and when they do, you run away.

    Keep sxcking on that lollipop, IBP. Whatever makes you happy.

  17. Strawman!

    That is not the comparison given–it was to a leaf attached (chemically bonded) to a tree, not to a diamond in the ground.

    Wrong. Your own words, IBP: “He should have stopped while he was ahead, because he contradicts his own reasoning: “…the diamond is the same lattice of carbon molecules, just with the earth removed…” It can just as easily be said that “the BRCA gene is the same lattice of nucleotide molecules, just with the remainder of the DNA molecule removed”, or something chemically correct to the same effect.”

    That’s the quote what I was referring to.

    I would urge you to simply stop digging.

  18. Of course, I have no idea whether or not the terminations actually DO enable the asserted utility!

    See Malcolm, the difference between you and I is that I KNOW when I don’t know what I’m talking about, and I own it.

    You need somebody else to point out your error, and when they do, you run away.

  19. If you’re going to define uniqueness by the availability of a utility that is unavailable to the natural form (which is what both Lourie and Moore do), then for a claim to be commensurate with the scope of the invention, the claim should explicitly be limited to those features of the invention that enable the asserted utility.

    In this case, that would mean including as limitations the termination at the 3′ and 5′ ends of the sequence in question as a hydroxyl and a phosphate group, respectively.

    I believe that those terminations are inherent in the composition claims, and therefore constitute explicit claim limitations. It is for that reason that I believe there to be patent-eligible S-M in those claims.

  20. Ned, I know it’s not your field, but BRCA1 and BRCA2 are different genes, not variants of a “BRCA gene.” Also, what do you mean by “isolating” the gene? This sounds like you are suggesting that you actually create a BRCA1 (or BRCA2) cDNA from a person’s genomic DNA, then sequence the cDNA for the existence of mutations/variants. This would never, and I mean NEVER, happen in reality.

  21. Strawman!

    That is not the comparison given–it was to a leaf attached (chemically bonded) to a tree, not to a diamond in the ground.

    Nice try.

    I see you haven’t responded to the policy-decision post, likely because you cannot do so and save face.

    I’ll do it for you. Lourie’s reasoning is inconsistent and contradictory. Moore’s reasoning WRT smaller molecules follows the same reasoning as does Lourie’s, which one could say was based on the judicial policy of stare decisis–but when it comes to larger molecules, she relies on policy entirely. Not only that, she doesn’t define the dividing line between large and small–it’s like pornography, she knows it when she sees it, although she can’t tell you what it is.

  22. “and the claims should have been so limited.”

    Could be Ned, but that isn’t at issue right now. The applicant’s arbitrarily defined their invention as they saw fit. What is currently before the court is whether their way of defining the invention is patentable or not.

    Something which is not before the court, which you are now bringing up, is whether they could have claimed something different that would be patentable.

  23. 1. A method comprising:

    isolating the BRCA gene from a sample cell of a patient; and

    testing for the presence in the isolated gene of a type 1 or a type 2 variant.

    What’s wrong with this claim?

    From a 101 perspective, nothing is obviously wrong.

    However, if “isolating the non-variant BRCA gene” is in the prior art, then you may have big problems, even if the “variant” sequences are newly discovered. The reason being that the claim you wrote captures the practice of the prior art in certain instances, e.g., the claim reads on the steps of isolating the normal BRCA gene and sequencing it.

    Note that in the claim you wrote, you can’t avoid this potentional anticipation problem by referencing the fact that the recited variant sequences weren’t known. The reason that strategy doesn’t (or shouldn’t) work is because allowing the mere recitation of new “facts” to distinguish the claim from the prior art effectively precludes people who are practicing the prior art from merely thinking about those facts.

    A better claim would recite a step of of testing for the variants that used a probe that specifically recognized the variants. An alternative improvement would be to limit the first step in the claim to the step of “isolating the BRCA gene from a cell, wherein said BRCA gene is a type 1 or type 2 variant.”

    Just for the record, I’ll note that none of the issues I’ve identified here are “new”. They weren’t “new” when Breyer highlighted them in LabCorp either. Careful prosecutors of diagnostic claims have recognized the issues for many years.

  24. Macolm, To take it from the abstract to the real, I think the claim could include the isolation of the BRCA gene as a step to determine whether the gene has a -1 or -2 variant.

    For example

    1. A method comprising:

    isolating the BRCA gene from a sample cell of a patient; and

    testing for the presence in the isolated gene of a type 1 or a type 2 variant.

    What’s wrong with this claim?

  25. The reasoning in my 12:13 comment is 100% accurate. If any aspect of my reasoning is incorrect, please let me know where you disagree. For example, you could explain how you would respond to an Examiner’s rejection of the claim on the grounds I set forth.

    Thanks.

  26. I’m big enough to tell you that

    1) diamond versus diamond in the ground

    2) isolated DNA molecule versus same sequence of nucleic acids in a chromosome

    are two very different comparisons.

    You know who else is big enough to tell you that? Myriad’s experts and their lawyers. And at least two judges (and surely quite a few more) on the Federal Circuit are big enough to agree (and why not? it’s correct and reasonable).

  27. Ned–

    When you said that “By allowing patents on DNA, or genes, where one first discovers the association between that DNA and something desirable or undesirable, the patent office is systematically allowing claims that are not commensurate in scope with the invention.”, you were on the right track.

    The resulting claims MUST be circumscribed by the asserted utility, if it is the utility that is responsible for their S-M eligibility under 101. Furthermore, that circumscribing must be achieved through claim limitations, not limitations in the spec.

    I so wish I could continue this discussion, but I–unlike Malcolm–have paid work to do.

  28. I admit when I don’t know what I’m talking about.

    If you don’t know what you’re talking about, maybe just don’t talk about it.

  29. Did you even read the decision?

    Yes. If there’s any “policy” “driving” her decision, it’s stare decisis and application of well-settled patent law. Hardly a radical policy.

  30. “Did you even read the decision? You have entirely misunderstood what it is that she said.”

    I get that same feeling that he hasn’t read the decision when reading what MM has posted on here on this topic. He may be correct that the “holding” will not be overturned on appeal, but if it isn’t then there sure as f will be better reasoning behind it because the current reasoning leads one inexoriably to the opposite conclusion than that which was reached.

  31. Hey mal, why don’t you take it in the spirit in which it was offered?

    Oh that’s right…I forgot who I’m talking to.

  32. What I think patentable, 6, is the isolation of the two genes from a patient as part of a diagnostic method.

    I think Moore and Bryson would agree that this was the real invention here, and the claims should have been so limited.

    Which does suggest, does it not, that any test that results in a negative determination is not an infringement.

  33. The difference being, I admit when I don’t know what I’m talking about. Instead of recognizing that and helping out, you find humor where there is none.

    I really didn’t expect anything that lame from you–although, from your previous post, I should have recognized that you’re in fine form today.

  34. Come on Mooney, cut me slack on this one…you know what I’m saying.

    Are you big enough to put it into chemically correct terms?

  35. It’s not ridiculous at all.

    Did you even read the decision? You have entirely misunderstood what it is that she said.

    The part to which you refer–the part where she said that “If I were deciding this case on a blank canvas, I might conclude that an isolated DNA sequence that includes most or all of a gene is not patentable subject matter.”–is put into context by her statement later in the paragraph concerning the preservation of settled expectations and extensive property rights.

    The remainder of the design on the canvas is not the design of the law, but the design of policy.

    Her decision was predicated on her desire to preserve “…the settled expectations of the inventing community…”, and upon the policy statement that “The settled expectations of the biotechnology industry…deserve deference.”

  36. It can just as easily be said that “the BRCA gene is the same lattice of nucleotide molecules, just with the remainder of the DNA molecule removed”, or something chemically correct to the same effect.

    LOLOLOLOLOLOLOL!!!!!!!

  37. My own view is that the composition claims do contain patent-eligible S-M, but that the method claims do not contain patent-eligible S-M as written.

    The majority agreed with you and their decision was grounded in easily understood case law. That’s why I and many, many others were able to confidently predict the result and the rationale for the result. That’s also why I can assure you that their holding won’t be overturned.

    Lourie’s was a policy-driven decision, as was Moore’s.

    Ridiculous. Moore expressed her view that if she didn’t have to follow the law, she might find that all isolated human genes are unpatentable. How can that possibly be characterized as a “policy-driven decision”?

  38. However the issue is framed, one should not be able to patent the protein, the gene, or the isolated gene. That is my opinion.

    I expect the 102 and 103 issues will be addressed soon enough, taking into account all the relevant facts.

    I think that claims that properly limit the scope of the claims to the invention, the correlation between the presence of the BCRA 1 and 2 and the susceptibility to a to breast cancer, should be patentable.

    Well, you’ve described the discovery perfectly, Ned. Unfortunately “correlations” and other facts are not patentable subject matter and they never will be.

  39. I’m with Shilling on this one again. All the discussion about diagnostic methods is unnecessary if one adopts MY version of the utility test. So much easier, so much better.

    Even the CEO of Fedex has now said that UNCERTAINTY is his #1 business concern. The uncertainty surrounding US patents is totally unacceptable, and worse, unnecessary.

    As far as this decision goes, Lourie judges the composition claims patent-eligible based on a structural difference that is exclusively attributable to human intervention, and as a unique entity based upon a utility not exhibited by the naturally-occurring form.

    Lourie’s was a policy-driven decision, as was Moore’s.

    One of my favorite lines of Lourie’s was on page 46 where he refers to “carbon molecules”. Remember, THIS is the guy deciding a DNA patent case.

    He should have stopped while he was ahead, because he contradicts his own reasoning: “…the diamond is the same lattice of carbon molecules, just with the earth removed…”

    It can just as easily be said that “the BRCA gene is the same lattice of nucleotide molecules, just with the remainder of the DNA molecule removed”, or something chemically correct to the same effect.

    He contradicts his own reasoning again when he states that breaking the leaf off a tree is not the same thing. It’s just breaking bonds, isn’t it? Is it not “cleaved from its combination with other parts of the tree”? Is it not “chemically different” than an intact, complete tree?

    And he does it a third time, in his statements on page 47 regarding the physiologic use or benefit of diagnostic tools and medicines, which directly contradicts his statement on page 44 that physiological use or benefit NOT be used to determine patent eligibility.

    Finally, on page 52, he tries to distinguish Myriad’s method claims from those upheld in Prometheus. This is bvllcrap, they are exactly the same. The only difference is that Prometheus was wrongly decided.

    Nice job, Lourie. Nice policy-making.

    Same goes for Moore. Her policy-based decision wasn’t even veiled at all, she put it right out there.

    I particularly chafed when I read her bit about the “legitimate expectations of inventors”.

    Essentially, this is her logic: we screwed up in deciding that genes were patentable, but everybody has relied in good faith on that screw-up, so we’re going to stick with it going forward.

    What a cr*p decision, they just wrote all sorts of junk, knowing full-well that it would be appealed, or that it would be re-heard en banc.

    My own view is that the composition claims do contain patent-eligible S-M, but that the method claims do not contain patent-eligible S-M as written.

  40. “By allowing patents on DNA, or genes, where one first discovers the association between that DNA and something desirable or undesirable, the patent office is systematically allowing claims that are not commensurate in scope with the invention.”

    Well remember Ned, the applicant gets to subjectively determine that lol.

    Which is of course one of the problems with the patent system from my point of view, but which old hands at the system espouse as being the only way.

    “This said, I think that claims that properly limit the scope of the claims to the invention, the correlation between the presence of the BCRA 1 and 2 and the susceptibility to a to breast cancer, should be patentable.”

    So then in other words, we shouldn’t allow claims to chemical manufactures but we should allow claims to abstractions like a correlation?

    Lulz, gl with that position.

  41. Idk, I loled. It was your attempt to enforce e-authority beside his attempt to make a mockery of your attempt that was funny.

  42. Take your pick. I could care less.

    Lulz – meanwhile real attorneys very much care to apply legit reasoning.

  43. Hard, TINLA, Malcolm, 6, NWPA, I know the problem should be analyzed under 102/103 and 112. But bear with me for a second. The only discovery here is that patients with certain types of breast cancer have high amounts of a certain protein, i.e., that a then unknown gene was increasing the susceptibility to certain forms of cancer. Once the protein was identified, it was not invention to identify the gene that encodes the protein. Further, it is not invention to “isolate” that identified gene. The methodology for identifying a gene from a known protein was well known and within the skill of the art. The methodology for isolating a gene was within the skill of the art. Because the correlation between the protein/gene and the disease was the only discovery, the only thing patentable here should of them a test for the susceptibility to the disease by identifying whether a patient had the gene.

    However the issue is framed, one should not be able to patent the protein, the gene, or the isolated gene. That is my opinion.

    Now I would agree that isolated DNA is a manufacture of man, and presumptively within section 101. But since the answer to this question does not result in the correct answer, the question must be wrong.

    By allowing patents on DNA, or genes, where one first discovers the association between that DNA and something desirable or undesirable, the patent office is systematically allowing claims that are not commensurate in scope with the invention.

    This said, I think that claims that properly limit the scope of the claims to the invention, the correlation between the presence of the BCRA 1 and 2 and the susceptibility to a to breast cancer, should be patentable.

  44. Hard, I know the problem should be analyzed under 102/103 and 112. But bear with me for a second. The only discovery here is that patients with certain types of breast cancer have high amounts of a certain protein, i.e., that a then unknown gene was increasing the susceptibility to certain forms of cancer. Once the protein was identified, it was not invention to identify the gene that encodes the protein. Further, it is not invention to “isolate” that identified gene. The methodology for identifying a gene from approaching was well known and within the skill of the art. The methodology for isolating a gene was within the skill of the art. Because the correlation between the protein/gene and the disease was the only discovery, the only thing patentable here should of them a test for the susceptibility to the disease by identifying whether a patient had the gene.

    However the issue is framed, one should not be able to patent the protein, the gene, or the isolated gene. That is my opinion.

    Now I would agree that isolated DNA is a manufacture of man, and presumptively within section 101. But since the answer to this question does not result in the correct answer, the question must be wrong.

    By allowing patents on DNA, or genes, where one first discovers the association between that DNA and something desirable or undesirable, the patent office is systematically allowing claims that are not commensurate in scope with the invention.

    This said, I think that claims that properly limit the scope of the claims to the invention, the correlation between the presence of the BCRA 1 and 2 and the susceptibility to a to breast cancer, should be patentable.

  45. Whatev you say little Ms. I Don’t Like To Read Mah Caselawl N Understand It.

    You can even read numerous articles on the subject, they’re ez to google. I’ll let you google your own, but I found three on my first go.

  46. Hardworking and Noting that Malcolm Will Not Give Straight Answer Because He Cannot Give A Straight Answer says:

    Please show me the Supreme Court phrasing of “take claims as a whole” that yields the selective result you arrive at.

  47. Your error is the thought process you engage in by incorrectly parsing claims and not taking them as a whole as captured in your selective phrasing “claim effectively.”

    Not an error. And it’s not “my” selective phrasing. It’s the Supreme Court’s phrasing.

  48. Malcolm,

    The given task was for you to rewrite the claim.

    Pay attention please.

  49. Hardworking and Noter that Some Things are So Crystal Clear That Malcolm Keeps Bumping into the Same Crystal Clear Supreme Court Mandates says:

    Malcolm,

    Anyone who has read this blog for more than a month or two would be “up to the task” of correcting you on this issue.

    Your error is the thought process you engage in by incorrectly parsing claims and not taking them as a whole as captured in your selective phrasing “claim effectively.” You have shown that you arrive at this by violating Supreme Court direction and not taking the claim as a whole in your 101 analysis.

    Your answer here will indeed by “crystal clear” – just not in the manner you think it to be.

  50. Ned,

    As you are a student of history, you are no doubt aware that 101 does not cover the statutory requirement of “new,” nor does it cover the distinction from that which is “within the skill of the ordinary artisan.”

    To conflate any such 102/103 items with a 101 analysis is simply improper.

    I believe that is all that TINLA IANYL is trying to impress upon you.

  51. It’s a correct legal argument. I explained myself clearly. If you disagree with any of the following, please state clearly why you disagree:

    “X correlates with Y” is certainly a fact or an abstraction. If your claim prevents an otherwise non-infringing actor from thinking that “X corrrelates with Y”, it is ineligible under 101 because the claim effectively covers a mental process (or is effectively a claim to an abstraction, or effectively claims a fact).

    Thank you. I’m sure you aren’t up to task but I thought I’d make that fact crystal clear for everyone.

  52. “Thus, Congress has passed protection for certain categories of inventions and discoveries.”

    No, that’s not how it has been interpreted. It’s thus, you can “protectlol” certain categories of things which in turn may either be invented or discovered.

    It’s past time to get back on your meds. You really do need them.

  53. Have MM take his best shot at the claim that was rejected under 101 so that the claim would be eligible under 101.

    LOL.

    “The moon is a sphere.”

    Rewrite it so it’s eligible under 101, NWPA.

  54. “Please refer to my comment above, particularly the part where I quoted 35 U.S.C. 101 to you as follows:”

    I’m aware of how it is worded little lady, are you aware of how it is interpreted by your courts? Yes, no, maybe so? Because it appears your answer is “no”. I just explained it to you above.

    “Thus, Congress has passed protection for certain categories of inventions and discoveries.”

    No, that’s not how it has been interpreted. It’s thus, you can “protectlol” certain categories of things which in turn may either be invented or discovered.

    “You attempted to bifurcate inventions as patentable and dicoveries as unpatentable.”

    It wasn’t me, it was your courts ya jackarse. Read ur caselawl on the subject.

    Holy f broje, stop embarrassing yourself. Go read your 101 caselawl.

    And btw, if “I” was wrong, so were your courts. Because that’s where I got my “wrongness” from.

  55. That’s rather the point trying to be force fed to you, isn’t it?

    *yawn*

    Here’s a lollipop. Go play with the other Diehrbots in your fantasy world where claim elements can never be analyzed, for any reason.

  56. Why? I, and I believe MM as well, are both perfectly content to leave it unpatentable. How about you do the work, figure out what subject matter you want to add, and take your best shot at making it patent eligible?

  57. “Would people be sequencing that part of the DNA molecule if not for the invention?”

    I’m pretty sure the answer is yes.

    They said they have people sequencing the whole thing now.

    Besides that, there are so many shades of re tarded in your post I’m not even going to bother with the rest of them.

  58. Under your incorrect logic a claim that read turning the oven off when it reaches 405 degrees would be inelgible under 101

    That would be *your* incorrect logic, NWPA.

    A claim that read “A method for controlling oven temp, comprising determining the temp of the oven, wherein a temp of 405.345233 degrees indicates that the oven should be turned off” would certainly implicate 101.

    Or it would be anticipated or obvious after we ignore the “wherein” clause (because of the 101 issues raised by the clause).

    Take your pick. I could care less.

  59. “And, Shall Shill, I usually am near the top of the recommmended list on the New York Times”

    Lulz, I’m not even one the “new your times list” tard. If you’re near the top of the list it is merely because the people reading it are nearly entirely ignorant.

  60. Read the statute: “Whoever… discovers any new and useful process …composition of matter….

    The hypo is that the discovery is of the protein. What did the inventor discover? What did he patent?

  61. If what you said were true, Malcolm, then wouldn’t the panel have also upheld the invalidity of claim 20 of the ‘282 patent?

    No.

  62. Malcolm, said: “If you want to patent a process that uses this discovery, at least one step in the process OTHER THAN the mental step needs to be novel and non-obvious (and eligible under 101, and also valid under 112).”

    If what you said were true, Malcolm, then wouldn’t the panel have also upheld the invalidity of claim 20 of the ‘282 patent?

    20. A method for screening potential cancer therapeutics which comprises: growing a trans-formed eukaryotic host cell containing an altered BRCA1 gene causing cancer in the presence of a compound suspected of being a cancer therapeu-tic, growing said transformed eukaryotic host cell in the absence of said compound, determining the rate of growth of said host cell in the presence of said compound and the rate of growth of said host cell in the absence of said compound and comparing the growth rate of said host cells, wherein a slower rate of growth of said host cell in the pres-ence of said compound is indicative of a cancer therapeutic.

    How do you explain that?

    But wait, you’re really just arguing for a change in the law by pretending it’s already the law and closing your eyes and holding your breath, right?

  63. 6 said: “[Congress] has yet to pass any protection for discoveries that I’m aware of.”

    Please refer to my comment above, particularly the part where I quoted 35 U.S.C. 101 to you as follows:

    Congress wrote 101 to grant patents to “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.”

    Thus, Congress has passed protection for certain categories of inventions and discoveries. You attempted to bifurcate inventions as patentable and dicoveries as unpatentable. You were wrong. Please simply recognize it and move on to something else.

  64. What difference does it make?

    Gee, let’s see – a correct legal argumnet, or a specious rant….

  65. Sequencing ANY part of the DNA molecule as of the filing date of the patent applications was not novel or non-obvious. There have been later-developed sequencing techniques, of course, but the point remains. And last time I checked, it doesn’t matter WHY someone infringes. They do or they don’t.

  66. “Myriad’s method claims were terrible.”

    You’re not alone in saying that the Myriad method claims were drafted poorly, Malcolm. My patent attorney brother has said the same thing. If Myriad truly focused on the isolated gene claims, it’s entirely possible that the method claims were somewhat an afterthought, and thus not given the attention they needed.

  67. It might be nice if this blog had the same feature as the New York Times where you can recommend comments that way you can filter out comments based on the number of people that like them.

    (And, Shall Shill, I usually am near the top of the recommmended list on the New York Times for my comments. 6 and MM are always at the bottom. But, since DC has been editing my comments, they have not been getting as many recommendations.)

  68. You know, Shall, the arguments that are played out here actually mirror pretty closely the arguments that are played out at the SCOTUS and the Federal Circuit.

    And, some of us have excellent records of predicting the outcomes of these cases. MM and 6 are the comic relief. We need them to constantly remind us that the barbarians (6) are at the gate and the mob (MM) is outside the great hall.

  69. Under your incorrect logic a claim that read turning the oven off when it reaches 405 degrees would be inelgible under 101 as it would prevent people from thinking about ovens.

  70. Have MM take his best shot at the claim that was rejected under 101 so that the claim would be eligible under 101.

  71. Hans:

    Would people be sequencing that part of the DNA molecule if not for the invention? A patent would not preclude someone from contemplating anything, it would preclude someone from practicing the invention, which is a diagnostic method.

    The reason we have such jumbled thinking throughout 101 is that people just do not seem to acknowledge that their brains process information. When we get an invention where part of it is processing information then suddenly all sorts of bizarre words and characterizations start appearing. Diagnostic patents do include information processing. Do some information gathering and figure out what it means.

    The fact that there is a step of figuring it out does not make it abstract or a mental step. It would be abstract if the step of figuring it did not enable a person of ordinary skill in the art to practice the invention. It would be a mental step if you couldn’t program a computer to do the step. Neither are true.

  72. When analysis of the prior art reveals that the only distinction between the prior art and the claim is ineligible subject matter,

    Of course, what you don’t say – and what Diehr does say, is that “the claim” must be taken as a whole.

    That’s rather the point trying to be force fed to you, isn’t it?

  73. Just to be clear, when I wrote “it can be purified from the cell and studied”, the “it” is the protein encoded and expressed by the gene.

  74. Diehr (the correct holding): the presence of ineligible subject matter in a claim does not by itself render the claim ineligible for patenting.

    Mooney: When analysis of the prior art reveals that the only distinction between the prior art and the claim is ineligible subject matter, there is a 101 issue. The issue can be resolved in either of two ways, both of which render the claim invalid.

    Take it to the bank.

  75. Serious beating??

    Do you mean, like the one you got with Bilski 14 !!!

    The one that made you cower in abject fear for two months before you dared show your face around here?

    The one that proved you wrong (yet again) on the ascendency of Diehr?

    You remember Diehr, right? Where the Supreme Court laid down the law and put a beating on you – Thou Shalt Not Dissect Claims!!!!!

    Mark this down and repeat it one million times:

    !!! Bilski 14 !!!

  76. Can one claim a known compound when one is the first to discover its utility?

    No. The flip side is that if I describe a billion different molecules and teach you how to make them, you can’t get a broad patent on *any* one of the molecules, even if you discover that one of them cures baldness overnight with no side effects.

    Can one claim the isolated gene if one discovers the protein (and the disease with which it is associated) that it encodes?

    If you are the first to sequence a protein with a substantial utility, it seems reasonable to allow you to claim any isolated DNA encoding that protein. This is due to the existence of the genetic code(s) (plural because there are organisms which use codes which vary slightly from the “canonical” version in high school textbooks). I believe this has been the PTO’s position for a long time. One could quibble enablement or written description around the edges, but I’ve never heard a serious argument from anyone as to why it isn’t a reasonable standard.

    Why should or does the result change if the gene or its diseased variant has already been recorded in a DB

    See the answer to your first question, above, and consider the fact that if the gene or its variant has been recorded in a database (and recognized as such), anyone skilled in the art can at that moment make it and use it (e.g., it can be inserted into a vector and overexpressed in a cell to determine its effect on the cell, or it can be purified from the cell and studied). Given these facts, the “isolated” gene *composition* claim is obvious, regardless of whether someone else discovers an incredible life-saving use for the isolated gene ten days after the sequence is published or 1,000 years afterwards. Elementary patent law.

  77. The Shilling:

    I assume all your comments can be deleted as you are never wont to say anything remotely on point.

    Secondly, since you seem to think the discussions of the other three are off topic or irrelevant, one would think, you, as the arbiter of taste and topics, would adopt instead of your current moniker, rather the fictitious name of the glorious Gaius Petronius, who one opined on matters of taste and propriety at Nero’s court to the great amusement of the dimwitted and debased monarch and to the appalled horror of the cowered assembly who trembled at the whim of Nero’s fancy.

  78. Tinla, does your hypo change at all if you consider that the discovery is of the protein associated with breast cancer. Once that was ID’d, the identification of the gene that encodes the protein was within the skill of the ordinary artisan.

  79. Malcolm, 6, NWPA et al.,

    Assume that the identification of the gene, and a claim to its corresponding isolated DNA, is obvious from the protein it encodes, and that the real discovery is of the protein that corresponds to certain types cancer.

    Can one claim the isolated gene if one discovers the protein (and the disease with which it is associated) that it encodes? The gene is not discovery, after all. The discovery is of the protein.

    At first blush, I think so, but see below. Why should or does the result change if the gene or its diseased variant has already been recorded in a DB, but not its correlation to any particular disease?

    Asked in another way: Can one claim a known compound when one is the first to discover its utility?

  80. 65% of the comments on this thread can be wiped out with NO IMPACT to anything of consequence.

    Not surprising (to anyone) those comments belong to a mere four people.

  81. NWPA, this is stunningly simple stuff. Myriad’s and Prometheus’s (and Metabolite’s) correlation claims fail 101 because they purport to exclude people from contemplating facts of the natural world. 2 + 2 = 4 no matter whether someone knows it or not. These claims would be valid if they included novel and non-obvious physical steps which, in combination with the mental step, actually achieved a useful result. There isn’t a rational person that thinks these claims are valid. Do you acknowledge that women faced a higher risk of breast and ovarian cancer as the result of mutations in BRCA1/2 prior to the patent applications being filed? Of course you do. The researchers who identified the link between these genes and risk of breast and ovarian cancer did the public a valuable service, but they would have done so even if there was no such thing as a patent.

  82. Presuming you wish to add no new subject matter in your re-writing of the claim then MM’s answer is “no” NWPA. If you desire to add new subject matter to the claim in your re-writing then it is absolutely possible to to draft a patentable claim including a diagnostic somewhere inside of the claim.

  83. You know exactly what the meaning of the question is.

    No, I don’t. That’s why I asked you to clarify. What’s the “meaning” of the question?

  84. If one has a protein and a known gene, BRCA, which codes for the protein but for small differences, wouldn’t one be “inclined” to sequence the BRCA gene of cancer victims to determine whether they have the variants that code for the protein?

    Seems like common sense to me?

    Yes, and such a method would be obvious. Likewise, a generically claimed method of identifying all genes related to all cancers and sequencing as many individuals as possible to identity cancer-linked variants would also be obvious (actually, anticipated at this very late date in our history).

    The identity of the vast majority of those variant sequences, of course, can not be predicted until you do the research. That’s where the money is.

  85. Not a plausible dodge. You know exactly what the meaning of the question is. You just don’t want to answer it as it makes you look ridiculous.

  86. So, are you saying that the diagnostic claim is eligible for patentability if written differently

    I don’t know exactly what you are referring to when you say “the diagnostic claim”, so I can’t answer your question. Does the phrase “if written differently” encompass the inclusion of additional novel, independently patent-eligible steps? If so, I believe that your question answers itself.

    I will also say this: a claimed method “for diagnosing disease X” is not per se ineligible under 101 merely because of its recited utility.

    Try to keep all these basic points in mind before you type your next comment. That will be really difficult, I know. But please try.

  87. anon, OK, let’s try KSR. If one has a protein and a known gene, BRCA, which codes for the protein but for small differences, wouldn’t one be “inclined” to sequence the BRCA gene of cancer victims to determine whether they have the variants that code for the protein?

    Seems like common sense to me?

  88. MM wrote: >>Many of us patent prosecutors in the chem/bio field have >>recognized and understood the 101 issues for years before >>Bilski and drafted claims accordingly.

    So, are you saying that the diagnostic claim is eligible for patentability if written differently?

  89. “:By the way, mental step is a term of art in patent law and I am sure that you are not using properly.

    I lulzed.

  90. Which is it?

    What difference does it make? “X correlates with Y” is certainly a fact or an abstraction. If your claim prevents an otherwise non-infringing actor from thinking that “X corrrelates with Y”, it is ineligible under 101 because the claim effectively covers a mental process (or is effectively a claim to an abstraction, or effectively claims a fact).

    This isn’t difficult to understand. There’s nothing radical or landscape-changing about the concept.

    Many of us patent prosecutors in the chem/bio field have recognized and understood the 101 issues for years before Bilski and drafted claims accordingly. Myriad’s method claims were terrible. Good riddance. They’ll never win on appeal but I suppose they’ll try anyway.

  91. MM wrote: >>It is a fact, an abstraction, or a mental step.

    A good belly laugh. So what exactly is your twisted bizarre logic? Which is it? Or it it all and do they all mean the same thing? Or, are you really saying you just don’t like it and I have a bag of magical terms that rid inventions from 101 eligibility?

    (We all know the last option is the correct answer, but please go ahead and answer it anyway. Probably will be good for another belly laugh.)

  92. Under 101, claims as a whole

    I am no longer interested in educating those who do not wish to learn. Suffice it to say your childish view of patent law has always been incorrect and is about to take a serious beating. Why is it going to take a serious beating? Because you’re asking for it.

  93. at least one step in the process OTHER THAN

    Must… resist… urge… to slap… Malcolm…

    Malcolm, repeat after me:

    Under 101, claims as a whole
    Under 101, claims as a whole
    Under 101, claims as a whole

  94. “The Constitution empowers Congress to grant patents on inventions and discoveries. ”

    Indeed, but it has yet to pass any protection for discoveries that I’m aware of. In the patent statutes it is expressely forbodin, according to your courts of lawl anyway. See Morse.

    “So arguing that a discovery is not an invention is relevant to its patentability in what way? ”

    First and foremost and most importantly, in the way that: judicial exception. RESPECT THEIR AUTHORITIE!

    Also in the way that you need to learn to interpretlol the statutes like the courts do. See, as a good reference of your failure to do so, Ariad. Remember Broje, the actual language takes a backseat to how it has traditionally been interpreted.

    In addition to that, you seem to not understand how the judicial interpretationlol goes. It goes such that you can either invent or discover the thing to be patented, but the thing which is to be patented may not necessarily the discovery itself. That is, your discovery, in this case some information relating tangentally to being able to then diagnose someone, that is, some information, is itself not necessarily patentable. Indeed, courts have noted since time immemorial that the discovery itself is not patentable as such would be absurd upon its face. To put this simply for you in a way you’ll likely absorb easily, it is axiomatic that one may not patent the discovery itself.

    “The discovery is the link between the gene and the disease, and the usefuil process of diagnosing or detecting the disease by results of a gene test ought to be a patentable process. Any other conclusion conflicts with the plain language of the statute.

    That is merely your subjective attempt to characterize the discovery. Watch as I provide a far superior subjective attempt to characterize the discovery by simply inserting the definition of diagnose:

    The discovery is the link between the gene and the disease, and the discovery is also the realization that one may recognize by signs or symptoms a disease by some results (or information).

  95. the useful process of diagnosing or detecting the disease by results of a gene test ought to be a patentable process. Any other conclusion conflicts with the plain language of the statute.

    The statute has been construed to exclude new and useful mental processes. When you discover a “fact” (e.g., a correlation between X and a disease), your claim can not effectively prevent others from thinking about the fact. If the claim has this effect, the claim runs afoul of 101.

    The discovery is the link between the gene and the disease

    That discovery is unpatentable. It is a fact, an abstraction, or a mental step. Call it what you will, it is not eligible for patenting. If you want to patent a process that uses this discovery, at least one step in the process OTHER THAN the mental step needs to be novel and non-obvious (and eligible under 101, and also valid under 112).

  96. Sort of like saying comprise. Wouldn’t that be a double negative. A fender, fender?
    And finally today I took matters into my own hands. I find out that a stall is being perpetuated. And then I also see this LVNV? FIVE YEARS, I let my husband pay the Bills! And I never looked at the list. Wow that also must be a double negative, Fraud on Fraud to keep the perpetuity going. Can’t Wait. And now they add another month? All in the GRAND SCHEME!

  97. EG : Put differently, the fact that Section 101 comes first numerically in the patent statutes does not mean it should be used as the initial screen.

    Agreed. 101 should be used whenever a 101 issue becomes apparent. For example, if an analysis under 102 and/or 103 reveals that the only distinction between the prior art and the claim is a mental step recited in the claim, then there is a 101 issue.

  98. The Constitution empowers Congress to grant patents on inventions and discoveries. Congress wrote 101 to grant patents to “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.” So arguing that a discovery is not an invention is relevant to its patentability in what way?

    The discovery is the link between the gene and the disease, and the usefuil process of diagnosing or detecting the disease by results of a gene test ought to be a patentable process. Any other conclusion conflicts with the plain language of the statute.

  99. NWPA I sure would like to provide an incentive for people to invent ways to diagnose my problems.

    Must … resist … bait …

  100. “The fact is that figuring out that a sequence on a DNA molecule means that someone has a disease and then applying this knowledge to diagnose someone is an invention. Again, we see this problem where information processing is being discounted as not important. ”

    That’s a weird and false factual finding and then an even worse conclusion. Diagnosing someone is not an invention. It is purely a medical action. And nobody said that info processing isn’t important. In fact, it is so important that you (and more importantly judges) cannot allow someone to have have a claim to all the uses of some specific info processing. It is the base from which invention flows.

    Don’t get all arse backwards NWPA.

    “There is no sound reason to exclude diagnostic patents. I sure would like to provide an incentive for people to invent ways to diagnose my problems.”

    Whereas judges see it as violatin’ on their judicial exceptions and the rest of us would simply prefer that doctors think of ways of diagnosing things without being able to tell all other doctors not to be able to do so.

    “And, I think a principled approach to patent law leaves one to conclude that there is no way to distinguish between a diagnostic invention and another invention (like fiber optic cable).”

    Hmmm, except that whole, “one is a method and one is a product” thing right?

    “What we have is a bizarre invention on the part of judges where the word absract has been morphed from its term of art in patent law to have no meaning other than I can construct some argument with this term “abstract” to exclude anything I feel like excluding. ”

    Not really, they just understand the word and you do not. Pity actually.

  101. Nice addition regarding my views on the Bryson/Dyk “camp,” Malcolm. I had hoped on Judge Dyk’s unasked for (and unneeded) view in his concurrence in Intervert Inc v Merial Ltd would have stayed there but it didn’t.

  102. What you say Ned (“Bryson’s opinion sounds in 112, 103) is why I think trying to resolve cases like this one starting with 101 is a bad idea. Once you run the claims through the paragraph 1 and 2 Section 112 gauntlet, any “abstractness” in the claimed subject matter usually becomes apparent, like Chief Judge Rader essentially said in Research Corp. Technologies v Microsoft. Put differently, the fact that Section 101 comes first numerically in the patent statutes does not mean it should be used as the initial screen. Section 112 is a much better initial screen.

  103. Ned,

    Your reasoning is completely based in hindsight – sure, any solution looks easy after the fact.

    You also do not address the “Flash of Genius” diminution of the ability to patent “any new and useful improvement thereof” as provided by law.

  104. Anon, correct me if I am wrong, but if I have a protein with a sequence, I know the sequence of  the gene.  Given that BRCA was a known sequence, discovering the protein all but identifed the BRCA gene as the culprit.  It was trivial to sequence the genes of known cancer victims to determine the variant.
     
    Do I have this wrong in any way?

  105. the finding of the BRCA variants was all but trivial

    This smacks of “Flash of Genius” line of thought – how could such a “trivial” advance merit a patent?

    Quick answer: because that last “trivial” step was the one that actually merits the utility. Merely seeing the whole genomic sequence is data, not understanding, not applying that data in a new and useful manner.

    Confusing the building blocks and the end product – while here this is notably close, is still a result of confusion.

  106. NWPA, “The fact is that figuring out that a sequence on a DNA molecule means that someone has a disease and then applying this knowledge to diagnose someone is an invention.”

    Huh?

    The facts as I thought reported was that the inventors ID’d the protein for breast cancer. BRCA was known at the time. Determining the varianst was within the skill of the ordinary artisan.

    What then entitled the discoverers of the protein to claim the (isolated) gene? This might be right from 102/103 law, but it really doesn’t just jump out at one as an ineluctable proposition of law.

  107. I think Bryson’s opinion sounds in 112, 103 — the scope of the claim must be commensurate with the scope of the discovery. His opinion is not largely based on science, but on policy.

    I think the problem does lie in 112, 103 with the compound claims. The discovery was of the protein associated with breast cancer. From my understanding of the discussion, I am not a biologist, the finding of the BRCA variants was all but trivial given that BRCA was known at the time.

  108. Then, you would agree that if one has a protein with a sequence, that identifying a gene or gene variant is obvious (within the skill of the aritisan), especially if the gene is already known, as BRCA was?

  109. Red Monkey,

    A good place to start is the concurrence at page 30:

    This case typifies an observation by the late Chief Judge Markey, our first Chief Judge, that “[o]nly God works from nothing. Men must work with old elements.” Fromson v. Advance Offset Plate, Inc., 755 F.2d 1549, 1556 n.3 (Fed. Cir. 1985) (quotation, citations omitted).

  110. If you care to think about some of the games that are being played by judges such as Moore, here are a couple.

    (1) The put in or take what is known game, or how much do we include as the invention.

    (2) The omniscient I know that all uses are excluded game.

    etc…If I decide to read this decision thoroughly I will post more on this. I might just punt this decision as in reality diagnostic claims are going to be decided by the Supreme Court. Still, we need to help Rader prepare arguments for the SCOTUS to adopt.

  111. The big picture is that pharma wants patents and some big name software companies do not. So, judges that are not interested in applying the law but pandering to big corporations hold that diagnostic type patent claims are not eligible for 101.

    The fact is that figuring out that a sequence on a DNA molecule means that someone has a disease and then applying this knowledge to diagnose someone is an invention. Again, we see this problem where information processing is being discounted as not important. How ironic as clearly the advances in information processing are the foundation of our modern society.

    There is no sound reason to exclude diagnostic patents. I sure would like to provide an incentive for people to invent ways to diagnose my problems. And, I think a principled approach to patent law leaves one to conclude that there is no way to distinguish between a diagnostic invention and another invention (like fiber optic cable).

    What we have is a bizarre invention on the part of judges where the word absract has been morphed from its term of art in patent law to have no meaning other than I can construct some argument with this term “abstract” to exclude anything I feel like excluding. Simply shameful thinking.

  112. Ned: How can the PTO continue to issue patents to compositions of matter described in public databases?

    The PTO routinely and diligently rejects claims to isolated nucleic acids under 102 and/or 103 when the identical sequences (or even similar sequences) have been previously disclosed.

    I also am a bit perplexed by the assertion that the claimed 15-n sequences are present in 4% of all human genes so that sequencing them for any purpose would infringe. Is this right?

    As discussed in previous threads, the answer would depend on how the claim is drafted and how the terms in the claim are defined.

    After reading Lourie’s opinion, I thought the matter very simple. But it is not, not at all.

    Actually, the 101 issues are very simple. The 102 and 103 issues are also fairly straightforward. The 112 issues are more complicated but that is because 112 case law is fairly muddled.

  113. should turn their attention to Beauregard claims now

    Wah wah wah.

    WAH WAH WAH.

    Wah wah wah.

  114. Bryson goes on a bit about how lithium never exists alone and must always be isolated by breaking an ionic bond, yet the majority regards it as an un-patentable product of nature. Is this really true? I thought Lithium existed by itself in interstellar space. We can pick it up by its spectral lines. I thought it was made in stars that start running low on hydrogen and have to start fusing hydrogen with helium to stay burning.

    Where is that Judge Markey line from? I’ve been looking for it for years.

  115. EG Judge Bryson is apparently in Judge Dyk’s camp on the isolated gene sequence issue. Their view mystifies and annoys me from the standpoint of ignoring the science, chemistry, molecular biology, and more significantly, the reality here.

    Their “view” is simply incorrect from a multitude of angles, as pointed out by many commenters (e.g., yours truly) and the majority in this case. There is simply no basis in the case law for removing a novel and properly (i.e., structurally) claimed molecule from patent eligibility.

    I don’t really care if the case goes en banc or to the Supreme Court. It’ll just be more smackdown for the ACLU’s ludicrous position. I hope the District Court judge learned something here. In fact, I hope everybody learned something here.

    Maybe the ACLU should turn their attention to Beauregard claims now. At least they wouldn’t have to turn any rock solid Supreme Court or Federal Circuit case law on its head. And by doing so they’d actually be accomplishing something constructive that would greatly benefit both participants and non-participants in the US patent system.

  116. Yet we know from Bryson’s dissent, the claims are overbroad.

    Only if the dissent carries the force of law. Since it does not, this means the claims are not overbroad.

    Shoots a little hole in an otherwise nice soliloquy.

    The undue breadth problem was one of indefinite scope

    Breadth and definiteness are two different concepts.

    Shoots a major hole in an otherwise nice soliloquy.

  117. Back in the day, the Supremes held overbroad claims invalid under 112, p. 2. Claims that were supported really had no problem under 112, p.1. The undue breadth problem was one of indefinite scope, claiming not only what one invented, but also a lot of other subject matter not invented.

    I know that one can use p.1 as a substitute for p.2 by demanding that the specification enable the full scope claimed, but if the claim is to the isolated DNA, and nothing more, there appears to be no p.1 problem. As well, since the claim appears to be definite, the appears to be no p.2 problem. Yet we know from Bryson’s dissent, the claims are overbroad. The disclovery was not of the isolated BRCA gene. That was “obvious” once the proteins encoded by the genes were discovered. The genes were within the skill in the art to identify. The process of isolation was known. It was just a matter of work.

    Per Bryson and Moore, the claims should be limited to the utility discovered. If they claim far beyond the that, as here, there is a problem and it should be addressed. But I am not sure if the proper way of addressing it is 101.

  118. I see the main purpose of the patent system as encouraging investment in new technology and encouraging the marketing of such. That is why our economy needs a patent system. I see no discussion of how the requested patent would serve that purpose. The patent doctrines should be applied to serve that purpose. A claim scope can be so broad as to discourage new development. A claim scope can be so narrow as to inhibit the deveopment and marketing of the invention. The doctrines should be construed to take those considerations into account. The 1852 U. S. Supreme Court Samuel Morse case shows an appropriate understanding of the balance required.

  119. It is a fragment. Be sure to alert the lawyers right away. This could be a strong rehearing argument, and wouldn’t want anyone to overlook it.

  120. “This also implies that there is magic when other atomic or molecular forces are altered. ”

    Um no it doesn’t. And I think he actually specifically addressed that there was no other magic akin to this sort of magic the majority wishes to conjure up.

  121. “Bryson wishes to dismiss an act of man that is required in order to arrive at the actual claimed entity. ”

    Would you wish to “dismiss” an act of man that just plucked a leaf from a tree when considering the patent eligibility of the leaf?

    I think you would.

  122. “Why can’t they just simply state “isolated human DNA molecules are patent eligible subject matter under 35 USC 101 but obvious under 35 USC 103. kthxbye”

    I lulzed.

  123. and “friends” continue to play the “he said/she said” game with themselves

    lulz – MaxDrei you have been invited to share in Malcolm’s tinfoil hat collection. Don’t forget the secret handshake.

  124. “I did hear Detkin say that IV’s sale agreements (with residual royalties for future licenses left poor IV with no control over what those naughty trolls did with the patents afterwards”

    I know right? This is what happens when a “legal” business model fails (oh, we’ll just license to everyone and they’ll <3 us for it! Oh wait…). The lawltards try to cut mental corners around their own original thinking so that they still will profit.

    Corruption is an insidious thing.

    “I also heard the part where somebody calculated that IV needed to suck another $35B out of the system in order to justify its existence”

    Lulz. Massive fail incoming.

    One can only hope that some good comes from all this nonsense and some sort of reform goes on.

    “I plan to get my retirement plan in order in the meantime, but the end is coming. People are beginning to catch on that the patent system as it is today is rigged to benefit just about everybody except the consumer. We’ve got 5 years until the field is so infested with parasites and incompetents that it’s going to be completely intolerable. 10 years until it collapses completely. My humble opinion, of course.”

    Yeah, that’s the good I was talking about. Of course, excising such a huge tumor from the US will of course be difficult. For that reason, I don’t think it will implode entirely.

    On another front there are alternative business practices and models which hopefully will enable innovation to proceed on course and perhaps at the same time speed it up.

    ” People are beginning to catch on that the patent system as it is today is rigged to benefit just about everybody except the consumer.”

    That, and to an extent the manufacturer.

    And what is so funny about the whole thing is that the patent system could be just fine if the courts would reign in the nonsense business method/software and if the gov. would make it so that only the inventor can hold the patent. There is nothing wrong with the foundation system of giving an inventor rights to “concrete” inventions of yesteryear. The problems arise when those rights start doing crazy things beyond the basics.

    In any event, be sure to spread the story around guys!

  125. Correct, MD.

    I recommend letting Looking Glass and “friends” continue to play the “he said/she said” game with themselves, as that seems to amuse them.

  126. Another tag fix attempt.

    I find that if you repeat the closing tag three times, that usually works.

  127. I think that one of the mistakes that is made in this discussion is that ‘a gene’ is seen as one long chemical compound with a fixed structure. In cases of genes, this view is not completely right. The difference lies in the fact that every human being has a gene for BRCA, but they do not all have the same sequence. This is where human variation comes in and where the importance of the BRCA gene lies: some variations are heavily linked with the occurrence of breast cancer and detection of these differences thus has a diagnostic value.
    Now in the human genome project the BRCA gene was found, sequenced and published in the database. However, this was only the BRCA gene of one person. After that, it was discovered that many variations in the BRCA gene were possible and thus the database information was extended with this information. Somewhere in between Myriad filed their patent applications on these variations and the diagnostics merits thereof. In some cases these inventions were denied patentability because of lack of novelty (if this variation was already known in the prior art), for other variations they have obtained granted patent claims.

    In the scientific world these variations (called SNPs or single nucleotide polymorphisms) are increasingly important, especially in the world of diagnostic testing.

  128. Spoiler Alert: This is a long post.

    Bryson: “Yet some of Myriad’s challenged composition claims effectively preempt any attempt to sequence the BRCA genes, including whole-genome sequencing.

    False.

    a claim to a composition does not limit anyone from identifying the composition (akin in this thread to merely repeating the knowledge of the composition’s structure, be it AGCGCTATCATATACG or whatever. The knowledge itself is not claimed, just as a claim to a new widget does not prevent anyone from discussing the knowledge of the new widget’s shape or inherent characteristics.

    Now, the isolation arguement, and whether isolating that particular sequence is a separate argument, a separate discussion.

    The Chakrabarty-Funk Bros. line of cases in distinguishing between naturally occurring substances and nonnaturally occurring manufactures, along the characteristic of “a product of human ingenuity ‘having a distinctive name, character [and] use’ ” is the frontier being explored.

    Bryson: The only material change made to those genes from their natural state is the change that is necessarily incidental to the extraction of the genes from the environment in which they are found in nature.

    Bryson wishes to dismiss an act of man that is required in order to arrive at the actual claimed entity. This is hardly “incidental.” Likewise, for a composition claim, the method of arriving at the composition need not be novel itself – that line of thinking runs the risk of conflation and befuddlement.

    Bryson: “Yet there is no magic to a chemical bond that requires us to recognize a new product when a chemical bond is created or broken, but not when other atomic or molecular forces are altered” – this simply is too broad a statement to merit any agreement. Chemistry does in fact matter.

    This also implies that there is magic when other atomic or molecular forces are altered. Why make such an artificial distinction? The example introduced first in a footnote – an element such as Lithium – is a strawman, as an element is not being extracted – but a molecule. Bryson thinks the two should be characterized the same. That is just not so, and hardly “arbitrary” as Bryson would have us believe. Bryson also neglects to notice that elements have actually been patented. Whether Lithium itself should have been able to be patented, then, may be a debatable (but separate) topic – but suffices to weaken the point of his argument.

    Likewise the example of dirt and diamonds is a strawman, as the diamond does not depend on the dirt like the excised strand depends on the larger molecule for its purpose within the larger collection. The difference in the relationship of the components of a dirty diamond and a full DNA molecule make this attempted analogy downright laughable.

    The argument then proceeds on page 9 of the dissent to discussing the language of the claims “with the protein being defined by the amino acid sequence encoded by the naturally occurring BRCA1 gene. From a molecular perspective, that claim covers a truly immense range of substances. But this is not a 101 point – this is a 112 point. To mix these points is not wise.

    Bryson continues: “That would remain true if there were minor differences between the plucked leaf and the fallen autumn leaf, unless those differences imparted “markedly different characteristics” to the plucked leaf.

    This is a much stronger argument. While I am sure that – to the leaf – being plucked does in fact impart a markedly different character – for example, the ability to continue developing from a bud to an autumn beauty, a claim to something extracted from nature should do more than simply cleave at nature’s cleaving point. However, the amicus briefs dicuss this transcription process and point out that this is just not the same as the claimed product. Bryson himself admits slyly to this with his comment of “Of course, it is an oversimplification to say that something that can be characterized as “isolated” or “extracted” from its natural setting always remains a natural product and is not patentable. Bryson wishes to hide in an oversimplification, admitting the weakness of doing so and thus the frontier we must explore further here, not stopping at the broad oversimplification. We must explore further other aspects of the argument – such as “use.” Whether the use must necessarily be entirely different or not is a debate point – not a given presumption.

    Bryson: “In the case of the BRCA genes, by contrast, nature has defined the genes as independent entities by virtue of their capacity for protein synthesis and, ultimately, trait inheritance.

    But the same logical argument can be taken to the extreme with the baseball bat in so far as the characteristics of the particular wood chosen for the baseball bat lie in the wood as nature provides. Where to draw the line at the activity of man is the touchpoint. If Bryson’s position were to be adopted, patenting would be out of reach for all of man’s mere mechanical changing of the workblocks found in nature. The quote to the late Chief Judge Markey, the first Chief Judge, that “[o]nly God works from nothing” is appropriate here. Must bats be made by first completely deconstructing the input material such that that material no longer has any of the inherent characteristics actually found in nature? If that were true, than any input material that provided at least the same elements would do. Anyone familiar with baseball knows this not to be true.

    The marble example in the footnote actually leads away from Bryson’s position, as is not the IP protectable result composed exactly of the same material as the starting slab? The fact that Bryson admits to the freeing of something to a level of protection that still shares every characteristic of the startng point material weakens his earlier argument.

    Continuing in the vein (sorry for the pun), of introducing argument sthat weakne his own position, Bryosn continues on page 12: “On the other hand, the purified natural substance is patentable if the “purification” results in a product with such distinct characteristics that it becomes “for every practical purpose a new thing commercially and therapeutically.” Clearly, the claimed item is different commercially and therapeutically. Bryson leaves this major argument without a rebuttal, almost as if he thinks by stating the position he has adopted it to support his belief. It actually holds the opposite.

  129. Very interesting decision. Lourie actually has one his better and more understandable opinions (compared to Ariad and Prometheus). I definitely agree with his analysis on the isolated gene sequence quesiton. And can sort of go along with his analysis on the method claims. And I can live with the view of the entire panel on the standing issue which is a significant “kick in the gut” for the ACLU’s PR-inflated and disingenuous “broad standing” view.

    Judge Moore’s concurring is also interesting in that she recognizes the reality of of overturning what the USPTO has done for 30 or so years in granting patents to isolated gene sequences. She’s definitely “growing-up” as a Federal Circuit judge and I applaud her for that

    I not happy that the panel held all but one of the method claims patent-ineligible using the M or T test (I don’t agree with their view, but I at least I understand where the current demarcation line is between patent-eligible and patent-ineligible for such method claims). Given ruling that Claim 29 of the ‘282 patent (“A method for screening potential cancer therapeutics which comprises: growing a transformed eukaryotic host cell containing an altered BRCA1 gene causing cancer in the presence of a compound suspected of being a cancer therapeutic, growing said transformed eukaryotic host cell in the absence of said compound, determining the rate of growth of said host cell in the presence of said compound and the rate of growth of said host cell in the absence of said compound and compar-ing the growth rate of said host cells, wherein a slower rate of growth of said host cell in the presence of said compound is indicative of a cancer therapeutic.”) is patent-eligible as being transformative in at least the “growing” step, Claim 29 (assuming there’s no en banc Federal Circuit or SCOTUS ruling that suggests otherwise) should give us patent attorneys/agents a pathway to how to write such claims to be compliant with 35 USC 101.

    Judge Bryson is apparently in Judge Dyk’s camp on the isolated gene sequence issue. Their view mystifies and annoys me from the standpoint of ignoring the science, chemistry, molecular biology, and more significantly, the reality here.

    Overall, this decision should be viewed favorably by the biotech world. Let’s hope there’s no en banc Federal Circuit (or even worse, SCOTUS ruling) that messes this decision up.

  130. Looks complete to me. Subject=”we”, Verb=”note”. It’s saved by the comma after “Although” and after “note”. But it’s weird because the “Although” lead-in leaves you hanging until you re-read it.

  131. that you neglected to actually read the words I cited.

    lulz – MaxDrei does the same. Glass is discussing comments here on the blog – the language here on the blog that one poster used and that another did not read correctly. There is no “implicit” reading – Glass pointed out “neglected to actually read the words I cited.” This is what it is.

  132. Why can’t they just simply state “isolated human DNA molecules are patent eligible subject matter under 35 USC 101 but obvious under 35 USC 103. kthxbye”

    You don’t need a magic microscope to see that Myriad’s claims are little piles of excrement.

  133. Reminder: NWPA is the same insightful fellow that used the word babboon in regards to Mooney so much that Dennis had to add it to the spam filter.

  134. Fortunately for those of us who make our living selling patents (from drafter on up to the trolls), neither the courts nor congress (especially not congress) has the will to do anything about it. Against the backdrop of everything else that is wrong on Capitol Hill, the country has bigger fish to fry.

  135. Not my field, but my impression is that MM thinks a claim fails 101 when it includes within its ambit a process that is no more than “abstract”, whereas Glass thinks a “transformation” is implicit in the language of the claim.

    Glass urges that “real” is implicit in the claim yet, as far as I can see, even if you were to write “real” into the claim explicit, the claim so amended would still read on to processes (as explained by MM) of merely “comparing” which by consensus now are no more than “abstract”.

    If the claim embraces an abstract idea then it fails 101 doesn’t it, even if it also covers also processes with transformations?

  136. and considering they used “comprising” language

    Still don’t get “comprising,” do ya 6?

  137. Actually I’m making the exact opposite point, but relying on similar facts.

    Actually, you are FAILING.

    Re-read TINLA IANYL.

    Re-read my posts.

    Nowhere in either is anyone saying “After that first sequencing event.” Your introduction of this, and then saying “is no longer required if someone wishes to “determine” the sequence” is a logical absurdity – of course you do not need to “determine” that which you just “determined” (and that first determining involves the point made by TINLA IANYL. If you are going to compare real gene sequences, you need to get real gene sequences.

    W

    T

    F

  138. Thanks for the link, 6. I caught the tail end of it, and meant to look it up.

    I did hear Detkin say that IV’s sale agreements (with residual royalties for future licenses) left poor IV with no control over what those naughty trolls did with the patents afterwards. As if giving up control wasn’t necessary to avoid being dragged into the suits as an essential party.

    I also heard the part where somebody calculated that IV needed to suck another $35B out of the system in order to justify its existence. I’ve seen some of the Lodsys allegations. If that’s as good as it gets, I’m not impressed.

    I plan to get my retirement plan in order in the meantime, but the end is coming. People are beginning to catch on that the patent system as it is today is rigged to benefit just about everybody except the consumer. We’ve got 5 years until the field is so infested with parasites and incompetents that it’s going to be completely intolerable. 10 years until it collapses completely. My humble opinion, of course.

  139. ” thought the human genome was sequenced. ”

    Only part of it iirc. Plus, remember when that sequencing took place. Was this patent before or after that? Kev said the other day that there were fewer genes in the human genome not yet patented than there were ones that were patented or disclosed in the human genome project. In other words, in another 10 years practically the whole genome will be discovered and disclosed/patented and once that happens then the whole issue goes away when those patents expire.

    “If this is the case, isolated BRCA is old”

    Pretty sure it is not old as of the filing date. That said, Kev though that it was old/obvious based on some publication he had, he posted in on the web. But, alas, that issue was not raised in the court case.

    “How can the PTO continue to issue patents to compositions of matter described in public databases?”

    I don’t think that all of the isolated genes are disclosed just yet.

    “Is this right?”

    I do believe so.

    But, that’s what happens when things that ought not be patentable are patented. Same thing is happening over in software and websites.

    Bottom line as I understand it is this Ned, back in the day not much work had been done on isolating genes. Now much more work has gone on, so much fewer genes are novel/non-obvious. But, there may still be a few that aren’t. Presumably there are otherwise Kev probably would have announced it.

  140. “Some claims are so broad that the sequencing of any gene in the genome for any purpose would infringe!!!!”

    Considering everyone has a BRAC1 & 2 gene and considering they used “comprising” language, I’m guessing so.

  141. Lourie holds that isolated DNA is patentable molecule not occurring in nature.

    Moore does not necessarily agree based on lack of new utility, but goes with settled expectations.

    Bryson’s dissent sounds in 112 — the claim wholly preempts the (two) BRCA gene based on a discovery of a single utility. If someone else discovers a different utility for the same gene or subsequence, the broad claims here preempts that use. For example, the mere sequencing of the genome itself (a different utility) would infringe. Some claims are so broad that the sequencing of any gene in the genome for any purpose would infringe!!!! Is that true? If true, this patent cannot be justified regardless of 101 issues.

    I thought the human genome was sequenced. If this is the case, isolated BRCA is old. The only discovery is of the new use. Do I have this wrong? I think Bryson mentioned this, that even at the time of the alleged discovery of the correlation BRCA to breast cancer, the particular genes had already been sequenced by others. But, even if that was not the case then, is it not the case now? Cannot one look up any human gene in a library? link to ornl.gov How can the PTO continue to issue patents to compositions of matter described in public databases?

    I also am a bit perplexed by the assertion that the claimed 15-n sequences are present in 4% of all human genes so that sequencing them for any purpose would infringe. Is this right?

    After reading Lourie’s opinion, I thought the matter very simple. But it is not, not at all.

    Perhaps we shouldn’t mix novelty and 112 issues with 101 issues. But Bryson does raise a lot of very good points.

    Help me here Malcolm, 6. I might have missed something, this is not my field.

  142. Easy, now. I have a patent pending on that magic microscope. This teaching gig is getting old.

  143. I like Moore’s concurrence.

    This part made me laugh:

    In place of these guidelines, the Solicitor General suggested that we should use a “magic microscope” as part of our section 101 analysis. If we could observe the claimed substance in nature using this microscope, the Solicitor General argues, it is not pat- entable. The magic microscope test applies equally to portions of a larger, naturally occurring molecule. For example, the optical field of view could be zoomed to see just a sequence of fifteen nucleotides within the chromo- some. As long as you could “see” the claimed molecule in nature using the magic microscope, it would fall into the “laws of nature” exception and be unpatentable subject matter.

    Certainly the magic microscope has curb appeal—its child-like simplicity an apparent virtue.

    Yes, in its “child-like simplicity” the “magic microscope” test reminds me very much of the test that was used by the CAFC in Prometheus v. Mayo to find the claims at issue eligible under 101.

  144. Nah, not necessarily. I just said it was better than most. The USSC will make up its own reasoning of course, as it always does. The CAFC En banc court will also likely make up it’s own patent protectionist reasoning to hold all claims patentable everywhere for eternity amen.

  145. Oops — last sentence should be “then your claims should not eligible under 101.”

    Slight difference there. ;)

  146. Awesome, although the CAFC still doesn’t seem to grasp that it botched Prometheus. Been waiting for this for a long time. I see Myriad issued a PR stating that it still has lots of method claims left. Sure, but none that cover the actual test. Make no mistake, this is a huge decision, and the correct one.

  147. Just to be clear, you think that a majority of Federal Circuit or Supreme Court justices are going to buy Bryson’s reasoning?

  148. I can’t patent diagnosing the disease by comparing a person’s DNA sequnce to the pathological sequence.

    False. You can patent a method of diagnosing the disease. The method, however, can not merely recite a step of “obtaining information about a sample sequence, wherein the presence of X indicates Y.”

    What didn’t exist before was knowing that the sequence causes the disease.

    YES! This is absolutely correct. And if your claimed method effectively turns people who are de facto non-infringers (e.g., people who sequence DNA using old, unpatentable technology) into infringers merely because they have acquired certain bits of patent ineligible knowledge, then your claims should be eligible under 101.

  149. Several reasons, most, if not all of which you and I have been over before MM.

    Although, Bryson’s reasoning is more compelling than most. I find Lourie’s (and perhaps Moore’s) fascination with intermolecular, specifically covalent, bonds to simply show off their lack of natural sciences edumacation and understanding.

    Along the lines of what I was discussing below, the USSC might uphold cDNA, but the rest is going out d door.

  150. You do realize that you FAIL because this is precisely the point that TINLA IANYL made above

    Actually I’m making the exact opposite point, but relying on similar facts.

    TINLA recognizes that a physical transformation is required sometimes when you want to look at a “real” DNA sequence. This is true, however, only when you are determining the sequence of DNA in a sample for the first time.

    After that first sequencing event, a physical transformation (e.g., the transformation of a patient’s tissue into another form) is no longer required if someone wishes to “determine” the sequence. For example, I can certainly “determine” or “obtain” the DNA sequence of interest to me merely by looking the information up, e.g., in a database of patient information.

    Of course, if “determining” or “obtaining” a sequence is expressly defined to require a de novo sequencing step, then TINLA’s point has more merit. Otherwise, TINLA’s point is simply inaccurate, for the very easy to understand reasons that I’ve just provided to you.

    You’re welcome.

  151. they are, at best, looking at a “representation” of the actual molecule and not at the molecule itself.

    You do realize that you FAIL because this is precisely the point that TINLA IANYL made above, and that you neglected to actually read the words I cited.

    That’s the extent of my comment. Read more (or less) as you will (anyway).

  152. On appeal the En Banc court or the USSC, or both … will hold the isolated DNA ineligible

    Nope. Neither of those things is going to happen. There is no way to reach that conclusion without necesarily declaring ineligible many other properly (i.e., structurally) claimed novel compositions of matter.

    Why on earth would the Federal Circuit or the Supreme Court do such a thing?

  153. W T F

    LOL.

    You do understand that DNA strands are really, really really skinny so everytime anyone “determines a DNA sequence” they are, at best, looking at a “representation” of the actual molecule and not at the molecule itself. Most DNA sequencing data, in fact, relies on the visualization of products of chemical reactions performed on the DNA of interest.

    The point (and I’m sure I’ll need to repeat this a thousand times for the peanut gallery) is that when the “invention” is a method of “comparing a test DNA sequence with an important DNA sequence, wherein the important DNA sequence is important because [insert novel, non-obvious reason here],” the claim is effectively claiming the information itself unless the method of determining the test sequence is novel and non-obvious and that method is recited in the claim.

    Such claims should be found invalid under 101 in light of Bilski and many many years of prior case law.

  154. I’ll make another observation. The better the examiner understands the invention the simpler the invention usually is. There is something about the nature of simple inventions that often minimizes their value, and that something is often 35 U.S.C 103.

  155. “Why does is the machine or machine process become re-patentable simply by changing the information?”

    Lulz, that’s a good qusetion to ask NWPA, he’s all over those kinds of claims.

  156. “A flag pops up yes or no. Is that an invention?”

    The flag? Sure, a flag is an invention.

    The “black box” is also an invention unless it is a metaphorical black box.

  157. Good question, here.

    Let us assume that the black box contained a database of all diseases, the analyzer performed the same steps on every sample of blood regardless of disease.

    Then someone discovers a new disease and its signature from a blood sample. They re-patent the old machine, and machine process with the new, updated information contained in the database.

    Is this right? Can the old machine be re-patented if it does exactly the same thing? Can the old process be re-patented if it is identical?

    I have a book but change the words. I have a database, but change its content. I have a record player but change the music.

    Why does is the machine or machine process become re-patentable simply by changing the information?

  158. I’ll make a prediction.

    On appeal the En Banc court or the USSC, or both, will hold that the same way on jurisdiction, will hold the isolated DNA ineligible, and will hold the first set of method claims ineligible and the last set of method claims eligible.

  159. One more observation: I’ve noticed that in patent prosecution practice that often the better the examiner understands the invention, the less likely the examiner is to find the invention worthy of a patent. There is something about human nature that minimizes the value of those things that we understand.

  160. And what you are saying is that it is not an invention. I think your view is very narrow and seems to assume an awful lot.

    What if there was a black box. You place a drop of blood in the box and it tells you whether or not you have a disease. A flag pops up yes or no. Is that an invention?

    I think these sequence claims are merely claims that are trying to include only the necessary elements of the black box. Are you excluding from eligibility an invention merely because of the form of the claim?

  161. observe actual
    compare real

    and

    Here’s gene sequence [typed letter representations - neither actual nor real]”

    W

    T

    F

    One big FAIL for Malcolm.

  162. So, if I can figure out what sequence causes a disease according to your thinking I can’t patent diagnosing the disease by comparing a person’s DNA sequnce to the pathological sequence. What didn’t exist before was knowing that the sequence causes the disease.

  163. WHAT IS WITH THE SETENCE FRAGMENT ON PAGE 43:

    “Although, we note, Judge Learned Hand held the claimed purified ‘Adrenalin’ to be patentable subject matter.”

    That’s a subordinate clause, not a complete sentence. Argh.

  164. semi: as far as I know, she has no background in patent law except being a clerk on the fed. cir. The whole point is that she did not practice patent law and puts herself out as an expert based on writing a mediocre book with the chief judge she came to know as a clerk.

  165. Sounds like Gramps is still bitter about the trick those ladies played on him at the Blue Motel back in ’73.

  166. We do not have the capability to observe actual gene sequences with our senses. The only ways we have to compare real gene sequences involve physical transformations.

    Here’s gene sequence one: AGCGCTATCATATACG

    Here’s gene sequence two: AGCGCTATCAAATACG

    Compare them.

    These sequences are no less “real” than the sequences that your DNA sequencing machine spits out. What possible difference could it make how the sequence information is obtained, as long as the method used to obtain the information is admittedly old in the art (and therefore unpatentable)?

    Recall that one of the alleged “discoveries” here is the sequence information itself, which is not eligible for patent protection. How can it be that such information magically becomes eligible for patent protection merely by inserting an old method step prior to the step of thinking about the information? Effectively, such a patent is a patent on the information itself, at least with respect to those thousands of individuals who have been practicing the recited sequencing step for years prior to the filing date.

    If this sounds familiar, that’s because it should sound familiar.

    What is even stranger is that they imply that somehow it would be patent eligible if the method included extracting and sequencing the DNA and then comparing. OK.

    The Federal Circuit is bound by their awful decision in Prometheus v. Mayo. Thankfully, the Supreme Court will soon be cleaning up that mess.

  167. “When I read the reasoning about abstraction from judges like Moore I feel like I am in a trial at the Planet of the Apes. There is simply no basis in patent law for the reasoning they are applying about an abstraction. ”

    Except for that whole entire cannon of it. But you’re right to feel like you’re in the POTA. Just as religious dogma had the apes believing themselves superior so it is religious patent dogma that is applied here.

    In any event, now to read this monster!

  168. Weak. I’m not a Judge Moore fan, but your comments don’t reflect well on you. Judge Moore has a substantial background in patent law. and whatever it is you don’t like about her opinion doesn’t seem to me to come from any lack of experience responding to office actions.

  169. Lulz, who didn’t see the patent protectionists patent protecting?

    To the USSC!

    Although, on the whole, not a bad result.

    “A young beautiful woman writes a mediocre book with the chief judge and uses it to jiggle her way onto the court. ”

    I have to say, well played.

  170. This doesn’t bode well for diagnostic claims.

    Maybe in an en banc Rader and Newman will set the #### straight. [Comment edited by the editors]

  171. TINLA: it is just bizarre reasoning. What do you expect with Moore as part of the panel. What is even stranger is that they imply that somehow it would be patent eligible if the method included extracting and sequencing the DNA and then comparing. OK.

    When I read the reasoning about abstraction from judges like Moore I feel like I am in a trial at the Planet of the Apes. There is simply no basis in patent law for the reasoning they are applying about an abstraction. The reasoning should be whether or not one skilled in the art would konw how to walk down the abstraction to enable them to carry out the invention. Instead we have a psychotic application of the word to mean that if it precludes all uses of a method then it is an abstraction. What? There is no sense to that. None.

    The method of capturing light by total internal refraction would be an abstraction according to these pschotic thinkers.

    See, this brings us to we need patent attorneys on the federal circuit. Patent attorneys. [] [Comment partially deleted by editors]

  172. “The court held that the claims covered “analyzing” or “comparing” DNA sequences by any method, and thus covered mental processes independent of any physical transformations.”

    What I find troublesome, is that the panel essentially agreed with the disctrict court that the claim read on comparing imaginary gene sequences. We do not have the capability to observe actual gene sequences with our senses. The only ways we have to compare real gene sequences involve physical transformations.

  173. Reversed: The district court erred in holding that Myriad’s claims directed to isolated DNA were invalid;

    Affirmed: The district court properly held that Myriad’s claims directed to comparing or analyzing gene sequences were invalid

    I’m loving it.

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