Guest Post by Dr. Jeffrey Lefstin on What’s Really at Stake in Myriad

Guest Post by Jeffrey Lefstin, Ph.D., Professor of Law at the University of California Hastings College of the Law.  In his previous life Dr. Lefstin was a molecular biologist, studying mammalian gene regulatory mechanisms and DNA-protein interactions.  Below, he provides his thoughts on the true stakes in Association for Molecular Pathology v. Myriad Genetics.

Playing with Fire: What's Really at Stake in Myriad

In a previous post I noted that the Supreme Court’s Mayo v. Prometheus decision, while acknowledging that “all inventions can be reduced to underlying principles of nature which, once known, make their implementation obvious,” appears to have revived the analytical framework of Funk BrothersFunk denied patentability to a mixture of nitrogen-fixing bacteria because, even if the patentee’s discovery about the bacteria was “ingenious,” it was a phenomenon of nature and not patentable. Once that discovery was made, the state of the art made production of the claimed mixture obvious;  the patentee therefore had not claimed a patentable application of the law of nature. In Mayo the Court likewise demanded that a claim embody an inventive application of a natural law, denying patentability to a process claim where the steps beyond the natural law consisted of nothing more than “well-understood, routine, conventional activity.”

Mayo’s grounding in Funk means that the Mayo analysis governs the patent-eligibility of a claim to a composition of matter, such as the isolated and purified DNA molecules at issue in Myriad.  But the stakes in Myriad are actually far higher. For twenty years after Funk, the lower courts employed the “something else beyond a law of nature” analysis to invalidate a variety of claims that we would probably regard as innocuous today. If the Court reaffirms the analysis of Funk, Parker v. Flook, and Mayo in Myriad, this line of authority presents a disturbing vision for the future.

The line began with Davison Chemical Corp. v. Joliet Chemicals, Inc., 179 F.2d 793 (7th Cir. 1950).  Davison Chemical dealt with a process for producing silica gel. While the process of making silica gel was long known in the art, the patentee had discovered that the temperature of the wash step determined the density of the gel.  He therefore claimed an improved process wherein the temperature of the wash step was adjusted to control the density of the final product. But the Seventh Circuit regarded the relationship between wash temperature and gel density as “a newly discovered scientific fact.”  Under Funk Brothers, it was necessary that the patentee’s application of that fact be inventive. According to the court, once the relationship between temperature and density was discovered, it required “nothing more than the ordinary skill of the scientist” to determine that maintaining the temperature of the wash step would control the density of the silica gel.

The Court of Customs and Patent Appeals followed Davison Chemical in In re Arnold, 185 F.2d 686 (CCPA 1950), involving a claim to a process of electrostatic welding. In Arnold, the applicant had discovered that molecules near the surface of a material responded more readily than interior molecules to alternating electrostatic fields. By selecting a particular frequency, the applicant could selectively weld the surface of the material, or selectively weld a plasticizer applied to the surface.  But according to the CCPA, the differential response of surface molecules was a “phenomenon of nature” discovered by the applicant. The claimed process merely selected a particular frequency based on that discovery, and therefore lacked “invention.”  (While the Federal Circuit has never cited Arnold, the case, being precedent of the CCPA, is technically binding on the court.)

National Lead Co. v. Western Lead Products Co., 324 F.2d 359 (9th Cir. 1963), was similar to Davison Chemical. In a process for making a lead / lead oxide suspension (useful for storage batteries), the patentee had supposedly discovered that two different crystalline forms of lead oxide were present; by controlling the temperature of the reaction, the patentee could control the proportion of these two forms and thereby the uniformity of the final product. But following Davison Chemical, the patentee’s discovery of the relationship between temperature and product uniformity was not patentable.  The question was whether the claimed method would have been obvious to an artisan – an artisan assumed to already know the relationship between temperature and product uniformity.  Since the patentee used only conventional methods to regulate temperature of the reaction, the method was unpatentable.

The pinnacle – or perhaps the nadir – of the Davison line was the Third’s Circuit’s decision in Armour Pharmaceutical Co. v. Richardson-Merrel, Inc., 396 F.2d 70 (3d Cir. 1968). The patentee made the surprising discovery that trypsin – a proteolytic enzyme with anti-inflammatory properties – could be absorbed by the small intestine, and thereafter transported into the bloodstream. Whereas the prior art relied on administering trypsin to patients via injection, the patentee determined that oral administration would be possible if the trypsin was given a coating permitting it to resist digestion in the stomach and reach the small intestine. But the Third Circuit concluded that a claim to the enteric-coated trypsin formulation was not patentable under Funk.  Once “nature’s secret” was discovered – the ability of the small intestine to absorb trypsin – any artisan would have employed known coatings to enable the trypsin to reach the small intestine. And even if the patentee’s discovery was the anti-inflammatory effect of trypsin administered to the small intestine, not merely the ability of the small intestine to absorb trypsin, the application of that newly discovered principle still lacked inventiveness under Funk.

Despite being framed as “lack of invention,” these are not obviousness cases.  In each case the information that might render the invention obvious was the patentee’s own discovery.  That is the point of Mayo: despite Diehr’s admonition to the contrary, the Court appears to have resurrected Funk’s rule that a claim must embody a non-obvious application of a law of nature or natural phenomenon to be patent-eligible. And the district courts have already begun applying that analysis to question the patent-eligibility of claims.[1] The Davison line suggests that a wide variety of claims to improvements or optimizations of known processes and compositions are vulnerable under the Mayo analysis.  Unless we can distinguish the “natural laws” in these cases from the “natural law” in Mayo, a reaffirmance of Funk and Mayo in Myriad could presage a dramatic contraction in the scope of patent-eligible subject matter in the future.



[1] See, e.g., Aria Diagnostics, Inc. v. Sequenom, Inc., 2012 WL 2599340, at *11-12 (N.D. Cal. July 5, 2012); Tessenderlo Kerley, Inc. v. Or-Cal, Inc., 2012 WL 2054994 at *5-6 (N.D. Cal. June 5, 2012).

 

83 thoughts on “Guest Post by Dr. Jeffrey Lefstin on What’s Really at Stake in Myriad

  1. He needs to do more than *click* it.

    He needs to read it.

    He needs to understand it.

    He needs to accept it.

    He needs to integrate it into his posts.

    Are you listening MM?

  2. He needs to do more than *click* it.

    He needs to read it.

    He needs to understand it.

    He needs to accept it.

    He needs to integrate it into his posts.

  3. anon: “Has anyone seen my pal Leopold? I wanted to borrow his echo chamber for Malcolm and Ned.”

    Leo hasn’t been around here since he was humiliated In the challenge to apply Integration Analysis to Ultramercials claims using the USPTO Official Guidance.

    Now he knows why MM is so afraid.

  4. MM:” *click* Get help, 101E.”

    101 Integration Expert: I already did from this informative link on Integration posted by you. It “clicks” real nice.

    Go ahead and try it.

    link to uspto.gov

  5. almost as if nobody told them they’re supposed to do as the Federal Circuit says

    (sigh)

    More @_$$ without the smart.

    It’s about what Congress has writ, and the “implicit” spin that the Court wants to maintain.

    You know, like what the actual comment about “dead letters” was addressed to in Prometheus.

    Tell me IANAE, are you still eating those paint chips?

  6. the addicted Supreme Court will not pull their greedy fingers from the patent pie.

    It’s almost as if nobody told them they’re supposed to do as the Federal Circuit says. Who do they think they are, the Supreme Court?

  7. claiming the use of a computer to calculate the math was a known means, and thus ‘trivial?’

    Nope – you just described Diehr.

  8. Not sure you are using the word “indefinite” correctly in regards to product of nature, which would in fact be something physical.

    Perhaps a better example of “indefinite” would be the concept of “abstract,” which, like p0rn0graphy, is only known post facto when seen by the SC.

    Regardless, the addicted Supreme Court will not pull their greedy fingers from the patent pie. See Prometheus.

  9. The whole concept of “product of nature” for a 101 analysis should be tossed out as too indefinite. Instead, the only inquiries under 101 should be: (1) is the invention useful; and (2) can you perform the totality of a claimed method in your head. If the answer to (1) is yes and to (2) is no then you are good to go under 101.

  10. Prior art…
    Breadth…

    See Prometheus and the destruction of the government argument sounding in anything else but 101.

    Point of novelty…

    See any number of posts debunking that canard.

    Functional language…

    Squint as I may, I don’t actually see a case on point ascribing to the agenda being advanced.

    Has anyone seen my pal Leopold? I wanted to borrow his echo chamber for Malcolm and Ned.

  11. Comparing Funk to Benson, could it be said that claiming the use of a computer to calculate the math was a known means, and thus “trivial?”

  12. •Frankfurter explained,

    “Unless I misconceive the record, Bond makes no claim that Funk Brothers used the same combination of strains that he had found mutually compatible. He appears to claim that since he was the originator of the idea that there might be mutually compatible strains and had practically demonstrated that some such strains exist, everyone else is forbidden to use a combination of strains whether they are or are not identical with the combinations that Bond selected and packaged together. It was this claim that, as I understand it, the District Court 134*134 found not to be patentable, but which, if valid, had been infringed.”

  13. Agreed. The product claims are indistinguishable from the chains in Perkins Glue that defined the product in terms of what it does. Under Perkins Glue, the claims are indefinite.

    Had the claims recited instead a specific product, I think the result in Funk Bros. would have been different.

    But, due to its breadth , the claim might also fail 101 as claiming a principle in the abstract.

    The subsequent cases clearly did not fully understand that the problem in Funk Bros. was functional claiming.

    Further, I also think Funk does say that “invention” requires a practical application. It really did not hold that the Law of Nature itself was prior art to the discoverer.

  14. Yes, scientist. They actually held a claim that included a shift register unpatentable as capturing a natural law. In Benson, anything that has a mathematical formula was equated with a natural law and thus unpatentable. Since then, R. Stern and his ilk have been so humiliated over this holding that they have now shifted their position to trying to use “abstract” to claim that claims are too broad.

    Their arguments are policy driven. The only way to square their arguments with reality is to realize they will say and do anything to get the end result they want.

  15. “Any data receiving, processing, or outputting step that can be done with a computer can be done without one”.

    If so, the idea has been LIMITED to applications in digital computers, hence patentable. The original argument against its patentability as I understood is that the idea has been patented for ALL its possible applications…is that not so?

  16. That is true IANAE. But, just consider that we have seen this type of progression before in the automation of manufacturing with machines. The machines and the methods were nothing more than improved (for the machines) ways to perform physical actions that were done by humans before the machines.

    Similarly, the information processing is now seeing methods that are adapted for machines and not people.

    What is a tragedy is that the antis are so willing to distort and lie about the reality of the technology. That is a tragedy of our time. It is the zeitgeist, though. The whole world is filled with liars and thieves. Everyone just wants theirs before and then run away and live in a hole in New Zealand.

  17. But Benson algorithm would work only on a computer, not on a paper. Someone just could not think of Benson algorithm, it has to be applied in a computer.

    You can’t convert binary to BCD on paper? Since when?

    Any data receiving, processing, or outputting step that can be done with a computer can be done without one. You could manually simulate a Turing machine with a pencil and an eraser. Ask NWPA what huge implications that has, he’s always going on about it. The computer only does it faster.

  18. It is outrageous that the antis are trying to bring in this if it could be done in the head business.

    Mechanical methods could be done by our human body and yet they are not removed from 101. See Deener.

    The fact is that to remove information processing algorithms from 101 you have to go back to patent law to about 1850 and form opinions about information processing from before 1920.

    Plus, they don’t even understand the Church Turing Thesis and the implications it has for what they hold. Nor do they understand the term abstract in an engineering sense. Nor do they understand the difference (or lack thereof) between hardware, firmware, and software.

    The worst part about it is they don’t want to understand. They are intellectually dishonest scoundrels at best. Lemley and R. Stern intellectually misrepresent technology for their ends.

  19. Benson was flat out wrong, but it has a least been cabined (as has Flook) – see Diehr and Bilski.

  20. “Benson knew he couldn’t directly patent his algorithm, so he opted instead simply claim everything that such a claim would have covered anyway.”

    But Benson algorithm would work only on a computer, not on a paper. Someone just could not think of Benson algorithm, it has to be applied in a computer.

    Is it not configuring the computer as opposed to an algorithm written on a paper? And how is this abstract. Try using a computer that is not programmed!

  21. And the surpremes don’t much like people making an end run around their pronouncements, which, I take it, is actually just their take on 101′s explicit language.

    Not even close 6.

    Do you want to try again?

  22. Because its the lawl for 1 thing. But it is the lawl because allowing him to do so is giving him the exact same thing (or in some instances practically the same) as giving him the patent on the JE. And the surpremes don’t much like people making an end run around their pronouncements, which, I take it, is actually just their take on 101′s explicit language.

  23. *click* Get help, 101E.

    Already done, thank you. Some nice gentleman was the very first to provide a hyperlink to the official USPTO understanding of the Prometheus case and how to apply that understanding.

    Notably (and had that poster bothered to read prior to posting), that posting secured the philosophical victory of “integration” and (equally) noticeable was a total absence of any [oldstep+newthought] c_rrp theory.

    Have we not given you enough credit for your (self-defeating) contribution yet Malcolm?

  24. “Oh, of course. The “concluding” analysis. But is the “concluding” analysis the “ultimate” analysis? The analysis that really, really matters?”

    The concluding analysis reached by the Supreme Court is what matters. And since you have been forced to concede that the Court in Prometheus took the claims as a whole, and did not ignore any steps in the concluding analysis, I would say your mental steps dissection theory has been soundly defeated. Or as you would say, “9-0 Baby!”

  25. 6, why can’t an inventor get a patent on all practical applications of a JE, if indeed, no one else has ever invented or discovered the “applications”, nor would it have been obvious to do so?

  26. “Simplify. Simplify. I will again note that these tests that are being proposed bring in so much 102/103/112 analysis that we have in effect collapsed the entire statute into 101.”

    I’ll be honest with you NWPA, I agree quite a bit with what you’re saying here. But on the other hand, the existing system is quite simple at heart. It is just the attempts to render the existing system dead letter law that constantly makes these impossibly difficult questions pop up.

    Just as a few examples, Benson knew he couldn’t directly patent his algorithm, so he opted instead simply claim everything that such a claim would have covered anyway.

    Likewise with Flook except he got even more clever and decided that he should limit the scope by way of inserting a field of use.

    In Prom they discovered the correlation at issue, but, knowing they couldn’t simply patent the correlation, they just went ahead and patented all practical uses of the correlation and called it a day.

    Here we have Myriad that discovered the BRCA loci first, but, knowing that they couldn’t patent that, decided to go ahead and file on every practical application thereof.

    I mean, it is a fairly repeatable pattern we see cropping up. IMO it is simply a matter of drafters not paying attention to what they’re doing :/

  27. All of this is just too complicated. When you have to spend weeks understanding all the arguments–guess what—it is too complicated. If you can’t figure out if something is 101 in 2 minutes, then the test is too complicated.

    If it takes more than 2 minutes, then you are bringing in too much into the analysis that should be considered later. This is just nuts to be having arguments like this. Reminds me of the test for whether or not someone is entitled to a jury trial or not.

    Simplify. Simplify. I will again note that these tests that are being proposed bring in so much 102/103/112 analysis that we have in effect collapsed the entire statute into 101.

  28. Thanks for reading the decision and thanks for the “integration” thought, anon. I want to say something meaningful in reply, but words fail me.

  29. In fact Diehrs claim as a whole is composed of individual elements/steps that are old and conventional. I have never said otherwise.

    Where your theory goes bankrupt is in when you propose to ignore steps/elements in the concluding analysis

    Oh, of course. The “concluding” analysis. But is the “concluding” analysis the “ultimate” analysis? The analysis that really, really matters?

    Stay tuned, folks. I know you can’t wait to find out how this story ends.

  30. 101 Integration Expert: “we have a workable “Integration Analysis” as modeled in Diehr … and applied by the USPTO in their Official Guidance.”

    MM: “Right. The “official guidance” that says to look at whether a claim recites a mental step (=abstraction) and then look at whether the other steps are “old and conventional.” That’s precisely what you told us for years that Diehr prohibited..”

    101 Integration Expert: First of all there is no sentence within the four corners of the USPTO’ s Official Guidance on “Integration Analysis” that says, ” look at whether a claim recites a mental step..” You just lied.

    Second, even if the Guidance does include looking at steps/elements, that’s what you do when you analyze! In fact Diehrs claim as a whole is composed of individual elements/steps that are old and conventional. I have never said otherwise.

    Where your theory goes bankrupt is in when you propose to ignore steps/elements in the concluding analysis.

    The Court in Prometheus NEVER said to do this.

    The USPTO Guidance on Integration does not instruct that you do this.

    Diehr absolutely prohibited you from doing this.

    It’s called dissection, and is not allowed ever. Even during extra solution activity analysis the Court and the PTO instructs you to “view the claims as a whole beyond the sum of their parts taken separately.”

    MM in your obsessive drive to strip away and ignore certain mental steps in claims you have been exposed for being nothing more than a dissembling dissectionist.

  31. the description of the present patent application makes it sufficiently clear how the distinguishing features (i) and (ii) of the method of claim 1 should be implemented and how they interact with the remaining steps of the claimed method in order to provide a common technical result,

    sounds like integration to me.

  32. You know what Ned’s hero – the drafter of the 1952 act had to say about this, right?

    No, I am not talking about Rich – the other drafter (Frederico).

  33. “- and nobody complained about that patent either”

    Because nobody was a di ck about using the patent. Myriad on the other hand was.

    It’s not clear whether anyone was a di ck when it came to the insulin patent but it is clear that if there was any “orthodox” case law remotely resembling the “product of nature” tests being bandied about here, it was completely ignored by the PTO and by any would-be competitors wishing to produce what would seem to be an incredibly valuable composition that was, if anything, more similar “in kind” to the composition in “nature’s warehouse” than the nearest “natural” composition is to Myriad’s claim.

    But these are just facts. Let’s not let them get in the way of a really cr-ppy handwavey “test.”

  34. The Court never said that insignificant pre-solution activity or any “extra” solution activity was “the” test for 101 or even the starting point in claims analysis.

    In fact, nobody ever said that. Nice strawman, though!

    some ethically bankrupt people have tried to use extra solution activity as a dissection test for all claims

    Please name these “ethically bankrupt people” and show us all exactly where each of these people have proposed to “use extra solution activity as a dissection test for all claims” (whatever the quoted language is supposed to mean).

    we have a workable “Integration Analysis” as modeled in Diehr … and applied by the USPTO in their Official Guidance

    Right. The “official guidance” that says to look at whether a claim recites a mental step (=abstraction) and then look at whether the other steps are “old and conventional.” That’s precisely what you told us for years that Diehr prohbited, back when you posted under your other pseudoynm (“Actual Inventor”) and who knows how many other s–p-ppets.

    Let’s see the names of these “ethically bankrupt” people, 101E, and the evidence that they are doing what the claim. Go ahead. You brought it up, man. Finish the thought.

  35. MD, I was only looking for you to type in what you thought the breadth of the claim should be in prose. In other words, you are saying the current claim is too broad. OK. What do you think he deserves?

    And, yes, MD that is fine if you don’t read through the claims, although they aren’t hard to understand.

  36. “- and nobody complained about that patent either”

    Because nobody was a di ck about using the patent. Myriad on the other hand was.

    There’s always one bad apple that just has to ruin everything for everyone else.

    Myriad’s attitude is why you guys can’t have nice things.

  37. IBP: “In Mayo, the court articulates an idea, but never articulates a meaningful test with any level of particularity to go along with it. Effectively, on page 10, they have given their assent to the concept of “insignificant pre-solution activity”.

    The Court never said that insignificant pre-solution activity or any “extra” solution activity was “the” test for 101 or even the starting point in claims analysis.

    When reading the Courts entire line of 101 cases it is apparent that a new and useful process claim in general has a clear presumption of “Integration” and the presumption remains valid, and requires no further analysis under 101 unless the claims as a whole recite;

    1. A bare Court created judicial exception, (derived implicitly from the Congressional Statute of 101) or

    2. The first element of the claim is a bare Court created judicial exception (derived implicitly from the Congressional Statute of 101) followed by additional steps or claims that apply the judicial exception. In the case of the latter, analysis for extra-solution activity, (pre or post ) occurs to determine if the claims are integrated or instead pre-empt the judicial exception.

    And that is the ONLY instances when claims are subject to extra solution activity analysis.

    It is true that some ethically bankrupt people have tried to use extra solution activity as a dissection test for all claims or certain claims they have a bias against. Going as far as trying to dissect claims from the outset into eligible steps and ineligible steps in a intellectually dishonest means end analysis to prevent patents on software, business methods, and any other art they wish to prevent from advancing. People who employ such a tactic are in clear violation of the law and in conflict with the Courts precedents

    We do not even need a bright line test at all when we have a workable “Integration Analysis” as modeled in Diehr, referenced in Prometheus, and applied by the USPTO in their Official Guidance. Mr. Kelly, the Government Attorney at the Alice oral arguments even stated on the record that the essence of claim analysis is taking the claim as an “inseparable whole”.
    That my friend is the concept and practice of integration. And it is the honest and fair way to promote the progress of the useful arts for all Americans and their dreams.

  38. Likewise, in the Tessenderlo case, Judge Alsup declined to hold a Summary Judgment hearing prior to a claim construction hearing. There are process claims and composition claims at issue but they are not “determine and infer claims” of the sort at issue in Prometheus. There is no mention at all of Funk Brothers in Judge Alsup’s order.

    link to law.justia.com

    Rather, in his brief discussion of the 101 issue, Judge Alsup immediately and expressly cites Mayo for the exact proposition I discussed above, the proposition which shows that the Supreme Court in Prometheus was decidedly NOT endorsing any runaway analysis:

    The Supreme Court has recognized that “all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas.”

    Judge Alsup then proceeds to very effectively frame the proper question:

    [T]he natural law’s application must not be “well-understood, routine, conventional activity previously engaged in by researchers in the field.” Here, purportedly patentable subject matter is the application of finely divided particulate materials of a certain size and with certain reflectivity properties in a particular quantity for certain horticultural crops. The natural law is that those particulates will increase CO2 assimilation. As discussed, more discovery is needed to determine whether the application of those particulate materials in the manner described was routine and conventional.

    Judge Alsup is a smart guy. You can bet that he knows that if those “particulate materials” are “routine and conventional” then the claim falls under 102/103 and the 101 analysis is not only moot but is best ignored. Perhaps it will be Alsup who takes the reins in putting the “threshold issue” nonsense to rest.

  39. Professor Leftsin cites a couple district court cases in a footnote as examples of the Supreme Court’s holding in Mayo being applied to claims. I’m not sure why that should surprise anybody. Supreme Court case comes out. It’s going to be cited.

    And the examples provided seem to be the sorts of claims where analysis under Mayo v. Prometheus is appropriate, i.e., process claims that appear to recite conventional steps followed by an ineligible step of looking at something “new”. Here’s the claim in Aria Diagnostics:

    1. A method for detecting a paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample from a pregnant female, which method comprises:

    amplifying a paternally inherited nucleic acid from the serum or plasma sample and

    detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample.

    The district court did right thing in its opinion (concerning a preliminary injunction, only; the injunction was denied for a variety of reasons, including ineligibility under 101). First, it construed the claims, in light of the claims themselves, the specification and the prosecution history. Then, the court noted the fact that the discovery upon which the claim is based is the discovery of the natural phenomenon that fetal DNA exists in maternal serum and plasma. Then the court noted that the patentee has admitted that the amplification and detection steps are conventional.

    This case has nothing to do with Myriad’s composition claim. The questions will be resolved upon further briefing, assuming that is necessary after claim construction and a better understanding of the relationship of the claims to the prior art.

    My off-the-cuff analysis in this case would be that if it is true that prior to the inventor’s discovery maternal serum was never taken from pregnant women and subjected to paternal-specific (e.g., Y-chromosome specific) primers, then there can be no 101 issue. The troublesome final “detecting” step recited in the claim is “rescued” by the preceding non-conventional and eligible method of obtaining maternal serum and contacting it with paternal-specific probes in an amplification reaction. It goes without saying (or should go without saying, anyway) that a novel, non-obvious and otherwise eligible (e.g., transforming) methods can not be rendered ineligible merely by tacking on a mental step (whether that mental step is old or new). That is because such a claim does not prevent any otherwise lawful actor from practicing a “judicial exception”.

  40. Can you imagine NWPA, that I can’t be bothered, to read through all the claims and ponder which is OK? I spend time here only to the extent I find useful. Mostly that time is spent reading what you and others write.

    But sometimes I give the others a nudge or a prompt, just for fun.

    So will you excuse me then, not going exhaustively through all the claims?

  41. link to epo.org

    MM, the Link above is to a short new (19 Feb 2013) EPO Decision on DNA analysis, at first refused as a mental step (math, statistical analysis) but now found technical/eligible by the Board of Appeal and remitted to the Examiners to do obviousness.

    I found it on the K’s Law blog which I commend to readers here. Thinking about the notion of what is “abstract”, I think you will find the Decision a fun read.

  42. [continue from 11:27 am]

    For completeness sake, I’ll note that the dissent in Funk Brothers (Burton and Jackson) is completely off-the-wall:

    An inventor should not be denied a patent upon an otherwise patentable discovery merely because the nature of the discovery defies description in conventional terms. Terms ordinarily unsuitable to describe and distinguish products that are capable of description and distinction by their appearance may be the most appropriate in which to describe and distinguish other products that are not reasonably possible of identification by their appearance, but which are easily identified by their effects when being sought for or described by those skilled in the art.

    Does that nonsense sound familiar? It should. It’s basically Newman’s argument in dissent in Abbott v. Sandoz (Fed Cir 2009), the case in which product-by-process claims were held to be limited, for infringement purposes, to the recited method steps. Readers will recall that the pummelling Newman received in that decision was given the thumbs up by the Supreme Court (in the form of a denial of cert, without comment).

  43. Effectively, on page 10, they have given their assent to the concept of “insignificant pre-solution activity”.

    Yes, they certainly did. And you also know what “insignificant pre-solution activity” means when the only other step in a process claim is an ineligible step.

    Why is that not a “workable understanding”, IBP? Any claim in the form [oldstep]+[newthought] is ineligible under 101. That’s Prometheus v. Mayo.

    It’s easy to understand. Are there trickier cases on the margins? Sure. There always will be. But Mayo is pretty clear about what’s not eligibile and there’s nothing “unworkable” about the analysis, at least applied to process claims (and that’s what the case was about, after all).

    I suspect the reason many people find 101 “difficult” is because the claims they are concerned about are, in fact, extremely troublesome for reasons that include not only 101 but also other patent statutes.

  44. Which flag would that be then? I think the balance of which I speak is inherent in any functioning patent system.

    I think a claim to the isolated gene, per se, is broader than the contribution to the art made by the claim’s owner. I think the proper tool to control breadth of claim is the utility tool.

  45. I’m not sure what this means–does it mean that the analysis undertaken wasn’t an obviousness analysis, or does it mean that the various courts didn’t consider themselves to have been undertaking obviousness analyses?

    I’m pretty sure he means the latter. At least, the latter characterization is an accurate one.

  46. In Mayo, the court articulates an idea, but never articulates a meaningful test with any level of particularity to go along with it.

    Effectively, on page 10, they have given their assent to the concept of “insignificant pre-solution activity”.

    I especially love the “informing the relevant audience” language.

    I repeat: there is currently NO workable understanding of either 101 or 103 in US jurisprudence. What a mess.

  47. [continued from 6:30 pm comment]

    As one can learn from Justice Frankfurter’s relatively reasonable concurrence in Funk Brothers, the Court of Appeals appeared to have construed the patentee’s claim to be limited to the specific species and for that reason the Court found the patentee’s claims to be eligible. The Supreme Court, on the other hand, recognized Funk’s claims as encompassing the broad concept.

    [Allowing claims such as those at issue to be patentable] would require, for instance, in the field of alloys, that if one discovered a particular mixture of metals which, when alloyed, had some particular desirable properties, he could patent not merely this particular mixture, but the idea of alloying metals for this purpose, and thus exclude everyone else from contriving some other combination of metals which, when alloyed, had the same desirable properties. In patenting an alloy, I assume that both the qualities of the product and its specific composition would need to be specified. The strains that Bond put together in the product which he patented can be specified only by the properties of the mixture. The District Court, while praising Bond’s achievement, found want of patentability. The Circuit Court of Appeals reversed the judgment of the District Court by use of an undistributed middle — that the claims cover a “composite culture” — in the syllogism whereby they found patentability.

    It only confuses the issue, however, to introduce such terms as “the work of nature” and the “laws of nature.” ….In finding Bond’s patent invalid, I have tried to avoid a formulation which, while it would in fact justify bond’s patent, would lay the basis for denying patentability to a large area within existing patent legislation.

    Functional claiming at the point of novelty. Justice Frankfurter recognized that it’s a bad thing for composition claims because it effectively allows one to patent the underlying concept (the “desired” composition), rather than the specific compositions which actually have patentable utility. Frankfurter also recognized that it’s better to deal with this issue using 112 rather than creating an unworkable incomprehensible “natural law” rule for ineligibility of compositions of matter.

  48. According to the majority in Funk Brothers, here’s a representative claim (claim 4; see footnote 1):

    “An inoculant for leguminous plants comprising a plurality of selected mutually noninhibitive strains of different species of bacteria of the genus Rhizobium, said strains being unaffected by each other in respect to their ability to fix nitrogen in the leguminous plant for which they are specific.”

    I assume every here can see the real problem with this claim immediately: functional claiming at the point of novelty. It’s a 112 issue, really, and claims like this are routinely dealt with by 112, at all levels of examination and at trial. Again, Myriad’s claims may be readily distinguished as the compositions are defined structurally, not by their function. Tell me the structure of your composition and I can tell you immediately whether it infringes Myriad’s claim (at least, I can tell you immediately after Myriad’s claim is properly construed).

    The patentee in Funk Brothers “discovered” that certain species of Rhizobium could be identitied as non-mutually inhibiting and thus capable of being mixed. He provided some specific examples of compositions comprising such species in a mixture, but unfortunately did not recite those species specifically. Rather the patentee chose to claim the universe of all species, known and unknown (and completely unpredictable), that possessed the desirable function set forth in the claim.

  49. “Despite being framed as “lack of invention,” these are not obviousness cases.”

    I’m not sure what this means–does it mean that the analysis undertaken wasn’t an obviousness analysis, or does it mean that the various courts didn’t consider themselves to have been undertaking obviousness analyses?

    To me, the various courts definitely undertook to perform obviousness analyses–even if IMO incorrectly–and these were therefore “obviousness cases”.

    Maybe Lefstin meant to say that “these were not cases of obviousness”.

  50. NWPA How do you anti’s distinguish Funk from a claim to a mixture of metals in a certain percentage that are mixed around under heat?

    I don’t know about you but I am “anti-Funk,” at least insofar as the case sets forth an unworkable and incomprehensible test for eligibility of composition claims.

    That’s why the case has been mostly ignored for the past 60 years, except to cite some banal statements within regarding the ineligibility of laws of nature. Prosecutors in chem/bio have been obtaining claims to mixtures of all kinds of chemicals based on “new discoveries” during that time and I bet you can count the number of composition claims challenged under Funk Brothers on two hands, at all levels. It’s a g-rbage Supreme Court case, even worse than Diehr in its clumsiness and lack of foresight.

  51. anon: The guest professor states (and is unchallenged): “Mayo’s grounding in Funk

    Mayo isn’t “grounded in Funk” and I challenged the Professor’s claim. So has Professor Collins, implicitly at least. Professor Leftsin has chosen not to reply to the counter-arguments.

    Danced that 9-0 Baby Prometheus jig way too soon

    No, I didn’t. Mayo was correctly decided, it addressed a real problem in claiming ineligible subject matter that arose from (1) poor language in Diehr and (2) the Federal Circuit’s abandonment of the mental steps doctrine, and Mayo is never going to be overturned.

    its biting you in the @_s$

    Hardly. Mayo is the gift that keeps on giving. I was happy to see Myriad’s process claims bite the dust under Mayo. As for Myriad’s composition claims, I have no love for them and they are almost certainly invalid whether they are eligible or not. If anyone is “bitten in ***” by the Supreme Court’s holding, it will have little or nothing at all do with the holding and reasoning in Mayo and everything to do with a combination of (1) a failure to construe the claims properly and understand their relationship to the prior art; and/or (2) a failure to recognize the differences between process claims and compositions of matter claims and how such claims relate to “judicially excepted subject matter”.

    I’ll note again that with respect to (1), it’s entirely possible that a focused series of questions to the attorneys will forced everyone on the Court to see that when it comes to structurally defined composition claims such as those at issue in Myriad, that 101 should never be the “threshhold issue”. Rather, the “threshold issue” is 102, either in view of the prior man-made art or described (including inherently described) “natural” compositions (102 doesn’t care who made the prior art).

  52. Wolfman: I hope Dr. Lestin is wrong and that Mayo and Myriad don’t portend an era in which nothing is deemed patentable

    I don’t think you need to worry about that. Among other omissions, Professor Leftsin has ignored the fact that the Court in Prometheus specifically tells you that if you discover a fact/”correlation”/law of nature or any other ineligible abstraction, you can’t obtain a patent on it merely by appending old conventional steps: “simp­ly appending conventional steps, specified at a high level of generality, to laws of nature, natural phenomena, and abstract ideas cannot make those laws, phenomena, and ideas patentable.” There’s nothing new or controversial there. And the Supreme Court in Mayo cited Funk only for its most banal propositions. Nowhere do they suggest that Funk sets forth an important or even comprehensible test for determining whether a composition claim is eligible subject matter. And that’s a good thing because Funk does not set forth a comprehensible test for eligibility.

    The Court in Mayo does give an example of an English claim in Nielsen, wherein “unconventional” steps in the claim led to a new “machine embodying the principle”, which was therefore deemed eligible. I would argue that this is also why Diehr’s claim was also deemed eligible: rightly or wronly, the process was viewed as requiring the use of a new, non-obvious machine, albeit one that embodied an old principle (the Arrhenius equation) rather than a newly discovered one.

    The bottom line is that the Supreme Court was very, very much aware of the issue you are concerned about when they wrote the Mayo opinion. They were plainly far more aware of what they were writing, in fact, than the previous Court was when they wrote Funk and Diehr.

    What we should be worrying about, in my opinion, is a broad holding that sets forth a “product of nature” test that can be applied to render other (non-human gene) novel, non-obvious compositions of matter and articles of manufacture ineligible because they are not sufficiently “different in kind” from something later-identified “natural” object. The Supremes granted a very narrow question for cert so hopefully they won’t “go there.”

  53. That was a fine statement of promoting innovation. I am willing to use that for the purposes of this thread. Now, how does what you just said apply to this case?

    Why didn’t you just stand up and wrap a flag around yourself?

  54. No longer care? Not sure about that. I think this case is all about the balance of rights (and therefore profits) between i) the owner of the claim and ii) all the other scientists who are working on something within the scope of that claim.

    I want to use the patent system to promote the progress of useful arts. I like the idea of the useful arts making progress. I like the idea of all those other scientists getting enough research money to work within the scope of claims directed to “human genes”. Each time they make a useful advance in the art they should patent their invention, with claims having a scope that is commensurate with their contribution to the progressing arts. In that way, the general welfare is nurtured and asdvanced. But it is hindered if the issued claims are broader than that.

  55. The Banting, Best, and Collip patent was thought to be extremely important at the time to restrict the manufacture of extracted cow or pig insulin only to reputable manufacturers, and to keep out businesses that sold snake oil elixirs. And you’re right, that patent would pretty clearly be invalid under the well-meaning logic of the ACLU (and also the DOJ).
    I don’t think they care. Francis Collins’ patent on the isolated cystic fibrosis receptor DNA, btw, would be a goner too – and nobody complained about that patent either. That’s one curious thing about this whole litigation. The ACLU and its supporters have worked themselves into such a lather that they no longer care about scores of well-meaning businesses, researchers, and university tech transfer offices that would become collateral victims of their reckless scorched-earth theory.

  56. How do you anti’s distinguish Funk from a claim to a mixture of metals in a certain percentage that are mixed around under heat?

  57. link to nobelprize.org

    Why is Insulin patent in 1923 any different than DNA patent in 2013? Never read any controversy about Insulin “discovery” being awarded a patent?

    “Banting, Macleod, and the rest of the team patented their insulin extract but gave away all their rights to the University of Toronto, which would later use the income from insulin to fund new research.”

  58. I hope Dr. Lestin is wrong and that Mayo and Myriad don’t portend an era in which nothing is deemed patentable because ostensibly it’s merely an application of a natural law. Modern science is predicated on the notion that things will behave the same way every time time they’re exposed to the same conditions. Pass an electric charge through a sealed tube filled with neon, and every time you’ll get red light. Mix two molecules at the right temperature in the right solvent at the right concentrations, and you’ll always get certain products (or in some cases no reaction at all). In other words, everything that conceivable could be discovered and applied by man is merely a natural law. That shouldn’t be a reason to deny patentability. Or to quote Judge Rich, only God creates from nothing, the rest of us have to work with what’s already there.

    By the criterion that Dr. Lestin says SCOTUS is now espousing, the light bulb and the telegraph shouldn’t have received patents. I doubt that that would lead to the end of new developments altogether – man by nature is too creative for that to be the case (or if you’re a cynic, too bent on destroying himself for the military to ever stop needing to invent new things). But making “non-obvious application of a natural law” the test is for patent eligibility is a surefire way to reduce investment in new technologies by ensuring that many hitherto patentable invention will be unprotectable.

  59. Unless we can distinguish the “natural laws” in these cases from the “natural law” in Mayo, a reaffirmance of Funk and Mayo in Myriad could presage a dramatic contraction in the scope of patent-eligible subject matter in the future.

  60. Someone refresh my memory, the item in Funk that was disallowed was a “product,” and the reason it was disallowed was because it merely covered a product of nature?

    Is that the shorthand version?

  61. Some addititional serious QQ_ing by Malcom, but with the delightfully ironic intro of “most mundane and non-controversial propositions imaginable“.

    The very same that gird my posts on products of nature judicial exception under 101 that for some reason Malcolm never seems capable of understanding.

    Or is it that Malcolm is just being caught in his typical spin and blatant 1_ies?

    The guest professor states (and is unchallenged): “Mayo’s grounding in Funk means that the Mayo analysis governs the patent-eligibility of a claim to a composition of matter” emphasis added

    The very thing Malcolm has been s_creaming “just cannot be” in any number of ways, even though several (including myself) have diligently pointed out this very notion.

    Danced that 9-0 Baby Prometheus jig way too soon Malcolm, and its biting you in the @_s$.

    Just like I said it would.

    Your frantic dancing is most amusing.

  62. So a majority of Republicans voted against VAWA, and there’s a real chance the Roberts court will overturn 60s-era civil rights voting laws? Good god, the Republicans have become the party of straight-up bigotry. It’s just indefensible in this day and age.

  63. MM: see Professor Collins excellent article

    The article is essentially defective by the fact that it ignores the Supreme Courts use of “integration” in reference to Diehr. In addition the article fails to acknowledge the USPTO view of Prometheus to stand for “Integration” when determining subject matter eligibility for at least Laws of Nature.

    To discredit, debunk, or simply disagree with “Integration Analysis” is one thing, but to propose an academic theory, without even addressing the issue is to advance an intellectually bankrupt analysis. Or as they say in Texas, that check won’t cash.

  64. “just as the Prometheus court disaffirmed the concept (allegedly sanctioned by Diehr) of permitting ineligible subject matter to be “shunted” through the 101 gate by tossing on an old eligible step in a process claim.”

    Prometheus told you that a LoN that is “integrated” into the process as a whole is patent eligible subject matter.

    Prometheus did not tell you to dissect claims by ignoring an old step ( of any type) in the concluding analysis.

    Please see:

    “In Diehr, the overall process was patent eligible because of the way the additional steps of the process “integrated” the equation into the process as a whole. 450 U. S., at 187. These additional steps transformed the process into an inventive application of the formula. ” [MAYO COLLABORATIVE SERVICES v. PROMETHEUS LABORATORIES, INC 566 U. S. (2012) 3 Syllabus] (Emphasis Added)

    MM: You can lie, spin, and post on this blog 24/7 to the contrary but there is no way around what the Court so stated above.

    All roads on are “integrated” at 101.

  65. a reaffirmance of Funk and Mayo in Myriad

    Just so we’re clear on this, Mayo is certainly going to be re-affirmed, regardless of the holding in Myriad. It’s the reasoning in Funk Brothers (i.e., the application of obviousness principles to a claim in the guise of a 101 analysis) that needs to be disaffirmed by the Supreme Court, just as the Prometheus court disaffirmed the concept (allegedly sanctioned by Diehr) of permitting ineligible subject matter to be “shunted” through the 101 gate by tossing on an old eligible step in a process claim.

  66. [continued from previous]

    I do agree with the conclusion that it is foolish to apply Mayo’s reasoning to a claim to a structurally defined composition of matter without first determining tehe precise scope of the claim and without first understanding the relationship of that composition to the prior art (which includes human cells and, inherently, the prior art manipulation of those cells) … but I’m not sure that (again, non-controversial) conclusion is even implied by your analysis.

    As I pointed out in your first post on this topic, Mayo had very little to do with Funk Brothers and everything to do with much more fundamental concepts about patent eligibility that pre-date Funk Brothers. Specifically, the claim in Mayo attempted to claim a new correlation (indisputably ineligible subject matter) by appending a step of thinking about that correlation (also indisputably ineligible subject matter) to an old prior art step of obtaining data to be correlated. As noted by the Supreme Court, such a claim is, for all practical purposes, a claim to the “new” correlation itself. Indeed, Prometheus’ own experts testified that Mayo clinicians who who merely thought about previously obtained data in light of the Promethetus’ newly discovered “fact” were guilty of infringement.

    The result in Mayo (a process claim) therefore has nothing to do with any particulars of Funk Brothers (concerning a composition claim) and everything to do with reaffirming some much more longstanding and fundamental principles regarding what is patentable (principles that were threatened by the combination of some poorly chosen language in Diehr and the CCPA’s ill-conceived reversal of the mental steps doctrine in Musgrave — see Professor Collins excellent article in the Houston Law Journal: link to houstonlawreview.org). Mayo, in fact, is the furthest thing from “Funk Brothers-redux”, mainly because Funk Brothers is little more than an obviousness case dressed in 101 clothing, and it’s a poorly reasoned obviousness case at that (composition claims of indistinguishable merit have been found eligible and non-obvious by the Federal Circuit on innumerable occasions).

  67. P.L.: That is the point of Mayo: despite Diehr’s admonition to the contrary, the Court appears to have resurrected Funk’s rule that a claim must embody a non-obvious application of a law of nature or natural phenomenon to be patent-eligible.

    Huh? Diehr’s “admonition to the contrary”? “Resurrecting Funk’s rule”? What? Are you suggesting, Profession L., that Diehr overruled Funk? It seems that way. But there is nothing in Diehr that would suggest that the Supreme Court in Diehr thought they were overruling Funk. Notably, there is no attempt in Diehr to discuss the facts in Funk (for good reason). Rather, just as in Mayo, the Court in Diehr cites Funk for the most mundane and non-controversial propositions imaginable (“Excluded from such patent protection are laws of nature, natural phenomena, and abstract ideas.” “Einstein could not patent his celebrated law that E=mc^2; nor could Newton have patented the law of gravity. Such discoveries are ‘manifestations of . . . nature, free to all men and reserved exclusively to none.’” “If there is to be invention from [a discovery of a natural phenomenon], it must come from the application of the law of nature to a new and useful end”).”

    I also have to disagree with the previous commenter (Stephen Turner) regarding the “great line of reasoning” in your post. I don’t see much “reasoning” at all. A do see a bunch of cites to some ancient CCPA and irrelevant circuit opinons which tried to apply the t-rtured reasoning of Funk Brothers (itself a very poorly reasoned case, notwithstanding the banal, non-controversial language regarding eligiblity quoted above).

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