Supreme Court denies cert. in Sequenom v. Ariosa Diagnostics

By Gene Quinn
June 27, 2016

scotus-supreme-court-front-BWEarlier today the United States Supreme Court denied certiorari to Sequenom, Inc., which will let stand a decision of the United States Court of Appeals for the Federal Circuit that ruled a truly revolutionary medical test to be patent ineligible.

The discovery at the heart of the innovation in question resulted in a test for detecting fetal genetic conditions in early pregnancy that avoided dangerous, invasive techniques that are potentially harmful to both the mother and the fetus. The Federal Circuit concluded that the discovery  was “a significant contribution to the medical field,” but that did not matter insofar are patent eligibility is concerned.

The invention, which became embodied in U.S. Patent No. 6,258,540, claimed certain methods of using cffDNA. The patent teaches technicians to take a maternal blood sample, keep the non-cellular portion (which was “previously discarded as medical waste”), amplify the genetic material that only they had discovered was present, and identify paternally inherited sequences as a means of distinguishing fetal and maternal DNA. The claimed method does not preempt other demonstrated uses of cffDNA.

Judge Linn, who wrote a separate concurring opinion, explained that given the unnecessarily sweeping language of the Supreme Court’s decision in Mayo he was constrained to agree that the patent claims at issue were ineligible. Judge Linn explained that the Supreme Court lumped all post-solution conventional activity together as if it necessarily had to be qualitatively the same. Judge Linn wrote:

The Supreme Court’s blanket dismissal of conventional post-solution steps leaves no room to distinguish Mayo from this case, even though here no one was amplifying and detecting paternally-inherited cffDNA using the plasma or serum of pregnant mothers. Indeed, the maternal plasma used to be “routinely discarded,” because, as Dr. Evans testified, “nobody thought that fetal cell-free DNA would be present.”

Judge Linn concluded “Sequenom’s invention is truly meritorious.”

In March 2016, Sequenom filed a Petition for Writ of Certiorari in the Supreme Court of the United States, challenging the decision of the United States Court of Appeals for the Federal Circuit in Ariosa Diagnostics, Inc. v. Sequenom, Inc. “We think that there is a compelling case for the Supreme Court to step in,” said Sequenom’s counsel Thomas Goldstein, the founder of the widely popular SCOTUS Blog, said at the time the Petition was filed. “The issue turns entirely on how to read the Court’s cases. The stakes could not be higher for the life sciences. And this is undoubtedly a breakthrough invention that illustrates the harm from the Federal Circuit’s ruling.”

The single question presented by Sequenom in the petition for certiorari denied by he Supreme Court was as follows:

Whether a novel method is patent-eligible where: (1) a researcher is the first to discover a natural phenomenon; (2) that unique knowledge motivates him to apply a new combination of known techniques to that discovery; and (3) he thereby achieves a previously impossible result without preempting other uses of the discovery?

If the Supreme Court were to have taken the case they would have been required to reconsider the overwhelming breadth and scope of their prior ruling in Mayo Collaborative Servs. v. Prometheus Labs. Obviously, the Supreme Court is not ready to reconsider Mayo. 

For innovative companies in the life sciences space the only possible short-term relief will come from Congress if they choose to amend 35 U.S.C. § 101 to undo the damage done in recent years by the Supreme Court. Efforts within the industry have been underway on multiple levels to rally support for a legislative fix that would overrule the Supreme Court’s recent forays into patent eligibility, but time is short for the 114th Congress and the Obama Administration would simply not be receptive anyway. Perhaps a new year, a new Congress and a new President that will have a more pro-patent view than does President Obama will result in a different outlook. For now, the industry will continue to suffer the consequences of the Supreme Court’s ignorance on the issue of patent eligibility.

 

The Author

Gene Quinn

Gene Quinn is a Patent Attorney and Editor and founder of IPWatchdog.com. Gene is also a principal lecturer in the PLI Patent Bar Review Course and an attorney with Widerman Malek. Gene’s specialty is in the area of strategic patent consulting, patent application drafting and patent prosecution. He consults with attorneys facing peculiar procedural issues at the Patent Office, advises investors and executives on patent law changes and pending litigation matters, and works with start-up businesses throughout the United States and around the world, primarily dealing with software and computer related innovations. is admitted to practice law in New Hampshire, is a Registered Patent Attorney and is also admitted to practice before the United States Court of Appeals for the Federal Circuit. CLICK HERE to send Gene a message.

Warning & Disclaimer: The pages, articles and comments on IPWatchdog.com do not constitute legal advice, nor do they create any attorney-client relationship. The articles published express the personal opinion and views of the author and should not be attributed to the author’s employer, clients or the sponsors of IPWatchdog.com. Read more.

Discuss this

There are currently 72 Comments comments.

  1. Paul Cole June 27, 2016 5:08 pm

    This is truly a disaster for my US colleagues, for the profession as a whole, and more importantly for the life sciences industry in the US and worldwide. It is also a disaster for doctors and the patients that they serve since the flow of new medicaments and tests will be jeopardized.

    It is a disappointment for the many amici who put so much effort in supporting the petition with briefs of high quality. For those who have not been through the experience, CAFC and Supreme Court briefs do not originate in 10 minutes work on the back of an envelope. The contribution of the European professors was outstanding.

    It reflects no credit on US jurisprudence. The CAFC panel opinion in Sequenom was plainly unsupportable and wrong for the reasons so clearly expressed in the many amicus briefs.

    Hopefully ways forward will emerge, but at present good ones are difficult to foresee.

  2. Gene Quinn June 27, 2016 5:55 pm

    Paul-

    I think you summarize the situation best when you say: “Hopefully ways forward will emerge, but at present good ones are difficult to foresee.”

    It is very difficult to see a way forward that does not either include an end to biotech related medical innovations or an amendment to 101.

    -Gene

  3. step back June 27, 2016 6:17 pm

    Disappointing yes, but not unexpected.

    The Mount Olympus Inquisition Committee has been on a witch hunt to put an end to trollish/abstract inventors and discoverers for a number of years now.

    These “natural phenomenon” and laws “of nature” absurdities are part of their drown-the- witch and see-if-she-still-lives tool box.

    That and the magic compass that determines which direction a claim is “directed to”.

    All part of their useful (for witch identification and burning) arts.

  4. EG June 27, 2016 7:11 pm

    Hey Gene,

    Very disappointing refusal by SCOTUS to hear this important case on patent-eligibility and clean up the mess they’ve created with the broken Mayo/Alice framework. If Congress won’t now fix this mess, may be the WTO will when the U.S. is hauled before them for violation of its TRIPS obligations.

  5. IPdude June 27, 2016 7:21 pm

    We had a good 101 decision today by the circuit court in Bascom vs. AT&T. Interesting concurring opinion in this one too. Looks like we are seeing some push back from circuit court judges.

  6. Night Writer June 27, 2016 7:27 pm

    @5 Yes from Chen. Bizarre that Chen has turned out to be strong for patents when he was so virulently against patents when he was at the PTO. Weird, but great.

  7. Night Writer June 27, 2016 7:32 pm

    I wouldn’t read too much on denying cert. This doesn’t mean they aren’t going to pick up the exact same issue next year with a new justice.

  8. Edward Heller June 27, 2016 8:41 pm

    Paul, the way I see it, the Supremes are being very serious about their requirement that the discovery of a phenomena of nature cannot be patented — either in the abstract, or by adding convectional techniques. I know we have discussed this before; and you thought that Morse only required some practical application to remove the discovery from the abstract to the practical regardless of whether that application was conventional or inventive. Well, that interpretation is no longer tenable.

    I had thought that the argument would have been the focus on the words of the statute itself that required only that a claim be to a “new” process, and the process claimed here was literally new – the search in the previously discarded maternal plasma for fetus DNA. But that concept is not sufficient. The justices actually requires some actual novelty in the methods other than to use the previously known methods in a search motivated by the discovery.

    In other words, they are reading into 101 the requirement for invention beyond simple newness and beyond simple discovery.

  9. Night Writer June 27, 2016 8:44 pm

    @8 except a denial of cert is not a holding.

  10. Paul Cole June 28, 2016 3:47 am

    One of the things we have to do is to find ways round the problem. For example, would a claim to serum or plasma taken at 7-14 weeks gestation have run into the same difficulties given that it would have been less preemptive and that amniocentesis was and still is carried out at 15-20 weeks gestation? That defined with more precision the steps needed to go from raw serum or plasma to an analysable sample? That better defined the tests to be carried out on the sample?

    The problem that we now face is to draft claims that cover the scope that we need to protect without unnecessary and woolly generalisation that discredits the claimed subject matter in the eyes of the judges. A difficult task, I think, but not impossible.

  11. Joe Page June 28, 2016 5:07 am

    Completely shocking that an effort to curb patent trolls has led to an absolutely gutted patent office. For over 25 year I’ve written patent applications and in this time you just know and feel what is ‘protectable invention’ and what is not. For the first time ever, I can’t explain to my clients where the line is. An outrageous disservice to all. Will be expensive in the long run.

  12. Moshe June 28, 2016 6:21 am

    Paul — the problem is the trend is to ignore many claim limitations and to ONLY look at the ‘gist’ of the claim (whatever THAT is).
    And if you include your more focused limitations in a dependent claim, the trend is to first invalidate the independent claim for ‘gist,’ and then to basically ignore all dependent claims, stating that they do not add anything ‘significant more’ — once claim 1 is invalidated for 101, all dependents are considered ‘drawn to’ the judicial exception. The next step is to cavalierly just brush off the dependents without any thought — all conventional, nothing ‘significantly more’ (whatever the hell THAT is).
    HOW DO YOU DRAFT AROUND THIS??

    Probably the thing to do in prosecution is to make sure all of your extra limitations are in an independent claim (so they can’t characterize your claim as ‘basically drawn to’ a rule of nature, etc). get that allowed, and then file a broader continuation, and repeat, one by one. Of course, in litigation in front of the liberal arts judges, all bets are off.

    BOTTOM LINE — I doubt that better claiming will solve this.

  13. A Rational Person June 28, 2016 6:50 am

    Paul@10,

    I’m afraid your strategy will not work if the USPTO does the logical thing at this point, based on the Supreme Courts scientifically and legally unsound decisions, and, publish one or more examples that effectively state that diagnostic methods are not patent eligible. I would not be surprised if the Ariosa appeal was the only thing stopping the USPTO from already issues such examples in its patent eligibility guidance.

  14. Anon June 28, 2016 9:11 am

    As mentioned elsewhere, there is but one solution to a Court that believes itself above the law and that will mash the nose of wax of 101 no matter what the scriveners down below do:

    Employ jurisdiction stripping to remove the non-original jurisdiction of patent appeals from the Supreme Court and place in a new (untainted) Article III court.

  15. Lost In Norway June 28, 2016 9:17 am

    This is so infuriating. They (the Supreme Court) were too chicken to revisit a decision that was misguided at best. At what point are they going to admit that they screwed up?

    What is more patent eligible than combining known techniques to arrive at something new? Isn’t 101 supposed to be an easy hurdle to get over? I just don’t understand why the courts have decided that “patent ineligible material” is the new black.

  16. John White June 28, 2016 10:05 am

    By S.Ct. edict, with complete disregard for the Constitution and implementing statute, software (computer implemented methods) and, now, diagnostics (discovery) are off the table for patent eligibility. The only fix is legislative and, while doing it, a solid legislative history expressly ridding us of these precedent.

  17. Night Writer June 28, 2016 11:49 am

    @14: I think taking off the table computer implemented methods is a bit strong, but it is odd the way the SCOTUS throughout our history always seems to want to lessen the patent laws. Maybe it is because as a group they are ignorant of science, technology, business, and the real world. I think the main reason this happens is that they are ignorant of hindsight reasoning. They always diminish any advance as if they could easily have done it had they cared to think about it.

    Imagine, though, if Clinton is elected and she appoints another Sotomayor, Breyer or Ginsburg. Breyer is one that is particularly bad regarding hindsight reasoning. He sits there and contemplates how his great mind could have easily done all these advances had he merely contemplated them.

  18. step back June 28, 2016 12:04 pm

    @15: There isn’t a one of them that is not ignorant and incompetent when it comes to matters of science, technology, neurobiology and admissibility of evidence and expert testimony.

    That is why the amici curie (“friends”) can slip utter nonsense into their “minds” and they will buy it hook, line, paper and pencil.

    (No Virginia, doing it with pencil and paper is not the same as doing it entirely in your mind. For example, try writing a book like Tale of Two Cities entirely in your “mind”. How does it go again? It was the best of times, it was the worst of times … definitely the worst of times thanks to a bunch of scientifically incompetent and gullible uber intelligentsia up there on the bench.)

  19. Edward Heller June 28, 2016 12:20 pm

    I am not an expert in this area so I am going to have to ask the question whether the discovery of the existence of fetal DNA in maternal plasma can be kept as a trade secret?

  20. Edward Heller June 28, 2016 12:21 pm

    If it can be kept as a trade secret, and the only way the public can obtain disclosure of the information is by offering exclusive rights in exchange for publication, then this would have been a better argument the Supreme Court.

  21. step back June 28, 2016 2:09 pm

    @20: Nothing would have persuaded the “naturally” anti-patent huff and puffs of the higher bench.

    Glad that you admit you are not an expert. Neither am I.
    But I did stay at this one famous motel chain way back.
    And also I happen to know a few physicians.

    Medical tests have to be scientifically verified.
    “Science” means that a whole bunch of independent challengers get to understand fully how the test works and then they run clinical trials (usually hundreds of them) to verify that indeed the tests do provide reliable results in a large percentage of the patient population. In other words, there is scientific proving that the invention works for its intended purpose. (Note that except for identical twins, each patient is a unique composition of Mother Nature. Mother has no “law” about how stray fetal DNA fragments might appear in each of them.)

  22. staff June 28, 2016 2:28 pm

    ‘The Federal Circuit concluded that the discovery was “a significant contribution to the medical field,” but that did not matter insofar are patent eligibility is concerned.’

    WE are aghast! Now would be a good time for the CAFC and all other courts and Congress to re read the Constitution while there is still an economy left to protect.

    “To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries”

    The principal questions then are:

    1. does the invention promote science?, and

    2. is it useful?

    Insofar as the courts and Congress deviate from these principal lines of investigation regarding patentability, they venture into territory which is not supported by law or reason. It’s time to reclaim our fundamental American heritage of the protection of property before further damage is done to the American economy and job creation.

    For our position and the changes we advocate to truly reform the patent system, or to join our effort, please visit us at https://aminventorsforjustice.wordpress.com/category/our-position/
    or, contact us at aifj@mail.com

  23. Edward Heller June 28, 2016 3:00 pm

    Staff, with all due respect, there is a difference between discovery and invention. Calling a discovery an invention is a real problem.

    Invention is the act of creation.

    Discovery is the finding of something that previously existed.

  24. Anon June 28, 2016 3:10 pm

    Granted that there is a difference, Mr. Heller, but shall we take another look at a section of law written by Congress on the topic?

    The section of law is one that you have a habit of “disappearing” when the section is brought up in discussions.

    This particular section is 35 USC 100(a) [you also tend to disappear when 35 USC 100(b) is discussed].

    So before you attempt to wipe “discovery” clean from the books (or once again exalt the Supreme Court for wiping out the words of Congress), can you point out why 35 USC 100(a) is not dispositive here?

  25. Edward Heller June 28, 2016 3:15 pm

    anon, you do raise an interesting point here that should, I think, be addressed. But, until it is addressed, there is the matter of 400 years of case law.

  26. step back June 28, 2016 3:25 pm

    @25 Ned, only 400 years?

    IIRC this fellow Noah had a unique design for an article of manufacture and method of use for same that he referred as “System for Preserving Living DNA Specimens in case of Climate Change Induced Floods”

  27. Edward Heller June 28, 2016 3:43 pm

    step, hey, since you bring it up, there is discovery, invention and revelations from the beyond. They are all different.

    Now, if both Noah and Susie had receive the same revelation, could Noah have patented the revelation so as to prevent Susie from building an Ark of a completely different design or perhaps of assembling her people/beasts on a high plateau?

  28. Anon June 28, 2016 4:51 pm

    Until…?

    How about we START with the statute?

    Is that not the most appropriate thing to do with statutory law?

  29. step back June 28, 2016 4:59 pm

    Anon @28:

    Statutes?
    Who needs statutes?
    We can create laws out of thin oblivion as did that other one who collaborated with Noah on the design of the DNA preserving system. We are SCOTUS. We know all and understand all. It is you who is not up to snuff because you cannot understand our “abstract ideas” and “natural phenomenon” revelations.

    Spend more time with others in a place of worship of the soothsayings of the SCOTUS ones and perhaps one day you will comprehend. 😉

  30. Anon June 28, 2016 8:34 pm

    step back,

    You will have to pardon me – I have this crazy notion for what is quaintly called the Rule of Law which includes the notion that NOT ONE of the three branches of our government is above the Constitution – and thus, the Supreme Court does NOT get to make up any law that it wants to (especially when it concerns statutory law and the authority to write such law as designated in the Constitution).

    Call me old-fashioned in that way.

  31. Edward Heller June 28, 2016 9:23 pm

    For the sake of argument, assuming that discoveries of new phenomena were patentable as such (perhaps with a change in the statutes). Could one claim the following:

    1. A phenomena of nature comprising: maternal DNA contains fetal DNA and may be identified by any process that detects paternal DNA?

  32. Anon June 28, 2016 11:59 pm

    Mr. Heller,

    Please desist from the obvious strawman of the Morse-like “by any process.”

    (unless of course, you are trying an odd ‘product-by-process’ claim, the insertion of the process steps into a composition claim just reeks of rhetorical manipulation)

  33. step back June 29, 2016 1:01 am

    Ned@31:

    This is where you fall from grace together with the 9 demigods (currently only 8) of Mount Olympus.

    Nature?

    Everything is Nature.
    You are Nature.
    I am Nature.
    The Internet and this website are “Nature”.

    “Nature” is a BS word used by those who are ignorant of science, of history and instead believe in some sort of ever present spiritual world where some things “were meant to be” (to naturally occur) because the spirits will it, and other things are not meant to be except that the “unnatural” hand of man brings them into being (perhaps with the aid of “conventional” means such as geriatric computers and lab analysis instruments).

    That belief system is all foul smelling spillage from the cow farm. If “Nature” as you refer to it or her were truly left to do her “natural” doings then you, I, and the molecular biologists at Sequenom would not have been here in the first place because most of us would have succumbed to some “natural” virus or bacteria or parasite or beast of prey or famine at a young age and would have never made it to a stage where we are wise enough to contemplate our navels. There would be no unnatural “schools” and teachers, no unnatural institutions of government and law. The would just be the harsh unrelenting and senseless beat of the jungle. Eat and be eaten.

    Nature? “Natural” phenomena?
    Really?

    (Have you ever even touched a test tube? Turned on a Bunsen burner? Actually done some real world lab work? So you can understand what is naturally involved in all this natural phenomenon talk?)

  34. A Rational Person June 29, 2016 8:48 am

    Ned@31,

    “For the sake of argument, assuming that discoveries of new phenomena were patentable as such (perhaps with a change in the statutes). Could one claim the following:”

    35 USC 101 already states: “Whoever invents or DISCOVERS ANY NEW and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.” (Emphasis added)

    Why does the statute need to be changed to cover discoveries for new phenomenon, except for the fact the Supreme Court has improperly rewritten the statute?

  35. N June 29, 2016 9:17 am

    DNA and Protein’s “natural” functions have little to do with being markers for a disease. The idea of a marker is an entirely creature-made concept.

    Darkened clouds do not naturally exist to be a marker for an impending storm. A creature interprets the presence of darkened clouds as a marker for a potential storm (and then takes action accordingly – and creatures which do not make this correlation may die as a result).

    The whole concept of a ‘marker’ has little to do with nature and natural functions. We anthropomorphize nature. It is as if nature’s reason for being is for and about people. Nature does not care – it does not make dark clouds to warn people – dark clouds will naturally be present whether creatures are around to observe it or not.

    Determining that a natural product is correlated somehow with another natural condition is not necessarily straight-forward, especially when working at the sub-cellular level in all of its complexeties, tremendous number of possible interactions, and variations (not to mention the basic challenge of access and view).

    The value of identifying such markers for humans can be tremendous, affecting many individual’s entire lives.

    The final embodiment of this discovery is (perhaps unfortunately?) distilled down to a practical embodiment which is typically a straight-forward assay (for a scientist) which to an unskilled person can appear simplistic (dark clouds = potential storm, what’s the big deal? this is natural?).

    And then of course everyone wants anything which benefits health for free – a desire which is quite understandable and worthy of striving for, but this issue goes far beyond markers and patents. It seems people have died for failure to have access to patented diagnostics which is clearly not right, however people also suffer and die for not having proper access to health care either (of course this is not good either). But this does not mean health care should just be made free – clearly this would be unsustainable. Just as such an approach is too simplistic, so too is killing diagnostic patents. Not to mention all of the collateral damage this approach has resulted in…

  36. Edward Heller June 29, 2016 10:08 am

    step, regarding chemistry, I have a degree in physics and have worked in a chemical lab.

    This from Flook,

    “The rule that the discovery of a law of nature cannot be patented rests, not on the notion that natural phenomena are not processes, but rather on the more fundamental understanding that they are not the kind of “discoveries” that the statute was enacted to protect.[15]

    15. ….`mere’ recognition of a theretofore existing phenomenon or relationship carries with it no rights to exclude others from its enjoyment. . . . Patentable subject matter must be new (novel); not merely heretofore unknown. ”

    This from Myriad,

    “We have “long held that this provision contains an important implicit exception[:] Laws of nature, natural phenomena, and abstract ideas are not patentable.” … This would be at odds with the very point of patents, which exist to promote creation. ”

    But here step is the link to an argument that my persuade the Supreme Court:

    … As we have recognized before, patent protection strikes a delicate balance between creating “incentives that lead to creation, invention, and discovery” and “imped[ing] the flow of information that might permit, indeed spur, invention.”

    Myriad at 2116.

    Even though the fact that maternal plasma contains fetal DNA is not new, but discovered, there is no incentive to research this kind of information or to disclose it without protection. This is the only argument that would have made sense to the Supreme Court.

  37. Edward Heller June 29, 2016 10:17 am

    A rational, my apologies for the lack of clarity of my question. I was asking if one could patent the discovery of a phenomena of nature – as such – perhaps as a new category, how would the claim be structured?

    Turning back to the case at hand, assuredly you would agree that the amplification process claimed is conventional. It was conceded to be so. Therefore there was no discovery of a “new process.” There was a discovery, instead, of a phenomena of nature. Such phenomena of nature is not a process, but a fact. It is information.

  38. A Rational Person June 29, 2016 10:58 am

    Ned@36,

    “A rational, my apologies for the lack of clarity of my question. I was asking if one could patent the discovery of a phenomena of nature – as such – perhaps as a new category, how would the claim be structured?”

    I repeat:

    35 USC 101 already states: “Whoever invents or DISCOVERS ANY NEW and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.” (Emphasis added)

    Why does the statute need to be changed to cover discoveries for new phenomenon, except for the fact the Supreme Court has improperly rewritten the statute?

    The ONLY question should be how to structure the claim.

  39. Edward Heller June 29, 2016 11:11 am

    But the problem a rational, laws of nature and phenomena of nature are not processes. They are facts. They disclose relationships or the existence of something.

    If we want to make such patentable subject matter, we are going to have to pass legislation to do so. The Supreme Court has already decided Mayo and the declined certiorari here. There is nothing left but a legislative remedy.

  40. Edward Heller June 29, 2016 12:01 pm

    N, you make a strong case that the research into the causes of diseases is important and should be promoted. This argument is best made to congress, not to repeal 101, but to add to it the protection of discoveries of natural phenomena useful in the prevention or cure of diseases.

  41. A Rational Person June 29, 2016 1:14 pm

    Ned@39

    “But the problem a rational, laws of nature and phenomena of nature are not processes. They are facts. They disclose relationships or the existence of something.”

    First, processes are not the only type of discovery protected explicitly by the words of 35 USC 101. Discoveries of compositions of matter are explicitly protected by the words of 35 USC 101.

    Second, every patented process every patented in some way applies a “law of nature” or a “phenomena of nature”. The members of the Supreme Court are too arrogant and willfully ignorant to recognize this fact.

    “If we want to make such patentable subject matter, we are going to have to pass legislation to do so. The Supreme Court has already decided Mayo and the declined certiorari here. There is nothing left but a legislative remedy.”

    The better way to phrase this is that if we want to stop the Supreme Court from ignoring basic legal principles of interpreting a statute with respect to 35 USC 101 and unlawfully usurping the power of the legislature to legislate, we will unfortunately need to pass further legislation to try to force the Supreme Court to follow the law that was passed in 1952.

    My own suggestion for a legislative remedy would be something along the lines of the following:

    1. Make the rewrite the word “Any” in 35 USC 101 in all caps as “ANY”.
    2. Add the following sentence to 35 USC 101. There are no judicial exceptions with respect to this section of Title 35 and past, present or future judicial decisions with respect to this section of Title 35 as including a judicial exception are null and void.

    Would such an amendment to 35 USC 101 be extraordinary? Yes, but the Supreme Court’s behavior with respect to 35 USC 101 has also been extraordinary. The Supreme Court has totally rewritten 35 USC 101, for no reason based in logic or fact, to create judicial exceptions that effectively contradict the meaning of 35 USC 101. The Supreme Court justices deserved to be scolded by the legislature for how they have handled the interpretation of 35 USC 101.

  42. step back June 29, 2016 2:15 pm

    Ned @36:
    Dear Sir, it appears you absolutely don’t get it despite having a degree in physics and once handling a test tube.

    There is nothing “natural” about the population of females that the Sequenom clinicians ran their proof-of-concept clinical trials on. Had the situation been truly “natural”, the majority of them would have been stinky, unbathed, malnurished, disease ridden (no teeth) and God knows what compositions of matter would have been there in their blood stream for possible detection by assumed-to-be “conventional” methods.

    As “N” tries to explain @35 is that our Supreme leaders (of the SCOTUS) are ill equipped to understand the “fundamentals” of science. What they understand are the fundamentals of some unnamed religious cult they belong to (perhaps we can call that cult the organic/nature’s-way cult). It appears that you belong to that cult as well.

  43. Edward Heller June 29, 2016 4:13 pm

    “Discoveries of compositions of matter are explicitly protected by the words of 35 USC 101.”

    Let us be more precise: Discoveries of NEW and useful compositions of matter of patentable under 35 USC 101.

  44. Edward Heller June 29, 2016 4:14 pm

    Should read “are patentable” under 101.

  45. A Rational Person June 29, 2016 4:43 pm

    Ned@43,

    “Let us be more precise: Discoveries of NEW and useful compositions of matter of patentable under 35 USC 101.”

    Okay, let’s look at some definitions of “new” the could be used with the terms “discovery” and “discoveries”:

    From the first definition that comes back when you Google search: “definition of new”:

    https://www.google.com/#q=definition+of+new

    1. not existing before; made, introduced, or discovered recently or now for the first time.

    http://www.dictionary.com/browse/new

    3. having but lately or but now come into knowledge:
    a new chemical element.

    http://www.thefreedictionary.com/new

    3. Just found, discovered, or learned: new information.

    So i”discoveries of new processes” and “new compositions of matter” with respect to 35 USC 101 would be reasonably interpreted by most literate people, other than the members of the Supreme Court who can’t be bothered to try actually reading the statute and consulting a dictionary to learn the definitions of the words with which they appear to have trouble understanding, as referring to a process that was “just discovered” or a composition of matter that was “just discovered”, even if such a process or composition of matter has previously existed.

  46. N June 29, 2016 5:05 pm

    @39 Edward, consider that the ‘laws of nature’ are not being claimed.

    The claim is to a specific assay (method) carried out in a particular context it would never have otherwise been carried out in. The ‘law of nature’ has been reduced to a practical application.

    While the so-called ‘law of nature’ has been in existence for as long as human kind has existed, thanks to the ingenuity and efforts of the inventors, for the first time ever a physical test, never previously carried out in its claimed context, has been newly brought into existence.

    And the utility of this new method is readily apparent to all, and in fact is so valued that everyone thinks it should immediately be freely available to all.

    @40 I think the frustration is that the protection mechanism already exists and has been carrying us forward until as of late. There is no need to reinvent the wheel (so to speak).

    While there may be particular conflicts which can arise between the patentee and individuals in the context of diagnostics this does not mean we throw the baby out with the bath water. There must be more constructive means for addressing these conflicts which can leave the (patent) incentive in place.

    And lastly, while there may be fundamental ‘laws of nature’ and ‘natural phenomena’ it is pure ego to think that we know what they all are and that we can just manipulate them at our whim. Our understanding of natural phenomena is something that evolves under the basic principles of the scientific method. The earth was flat and then it was not (of course the earth did not change, only our understanding). The process of extracting this knowledge and understanding is arduous and is developed by giants standing upon the shoulders of giants. Surely having painstakingly extracted a tidbit of information regarding a natural phenomenon and appreciating its significance insofar as it can be correlated to a disease condition and bringing a new and useful test into existence to help humankind where such a test might never have been known (or known too late to save many people) is an invention worthy of patenting?

  47. Anon June 29, 2016 7:15 pm

    Mr. Heller @ 43.

    It is one thing to ask another to be more precise – but when you yourself refuse to do so, well….

    This fantasy of yours with the “new” in 101 meaning something that you have concocted – AFTER I have provided the statutory reference is simply beyond the pale.

    Your “selectivity” when it comes to legal discussions is quite appalling.

  48. step back June 29, 2016 7:38 pm

    Anon @47:

    An isolated molecule (like the one in Myriad) is NEW. An isolated DNA fragment (as opposed to it being mixed in with many other blood components) is NEW.

    However Heller and friends (the ones on Mount Olympus) imagine themselves skipping happily through Mother Nature’s bountiful jungle, stumbling upon a banana tree, spotting the fruit and “isolating” it by means of simply plucking it off the tree, peeling it and eating it.

    See again top of page 20 of this amicus brief for understanding of how SCOTUS came to talk of plucking leaves and lathing baseball bats:

    http://www.americanbar.org/content/dam/aba/publications/supreme_court_preview/briefs-v2/12-398_pet_amcu_g-lp.authcheckdam.pdf

  49. Edward Heller June 29, 2016 8:56 pm

    Rational @43, nice. But what did it mean in 1793 when Jefferson dropped “discover” and added both “new” and “composition”. That is the question. Did Jefferson intend to allow the patenting of newly discovered compositions regardless that they were products of nature? If it can be proven that he did, then the Supreme Court might be interested.

    (The canons of statutory construction require the terms in a statute to have the meaning they had at the time of enactment.)

    However, since the Supreme Court has consistently held to the contrary for long time now one would think that they would have addressed this issue of statutory construction long ago.

  50. Edward Heller June 29, 2016 8:59 pm

    N, what was being claimed was the use of a conventional process to identify the presence of fetal DNA in maternal plasma. The process was conventional, not new. Only the information that the maternal plasma contained fetal DNA was new. Neither the Supreme Court nor the Federal Circuit was confused on this issue.

  51. Anon June 29, 2016 9:38 pm

    Mr. Heller,

    The time of enactment was 1952 with the taking of the single pre-1952 paragraph and creating separate sections of law, as well as adding the definitions of 35 USC 100 (which, it has not escaped me, that you have NOT YET recognized for what they are).

    Once again, we see you attempt to pretend that the Act of 1952 just did not happen.

    To put it as simply and directly as possible: You are wrong.

    1952 happened.

    It is about time that you deal with this in an inte11ectually honest manner.

  52. N June 29, 2016 10:44 pm

    @50 Edward, yes, I understand that was the case in Prometheus. I had Myriad more in mind. Prometheus is admittedly a borderline situation (in my opinion). Same method used in same context and just interpreting the information differently. I can see the argument more clearly there vs Myriad. However in my experience the Prometheus scenario is a relatively uncommon one.

    re: ‘conventional method’ consider it was not just about the method itself but also that the conventional method was used in a conventional context.

    Anyway I feel somewhat out of my depths here, so I will leave it at this. Thanks.

  53. A Rational Person June 29, 2016 11:14 pm

    Ned@49,

    As Anon has pointed out @51, the time of enactment of the 35 USC 101 was 1952, not 1793. I am also aware of no version of Title 35 that gives notice to anyone attempting to intrepret the statute that one or more terms have their “1793 meaning” and not their “1952 meaning.”

    Has the the Supreme improperly interpreted he sections of the 1952 statute using decisions from pre-1952 cases that should have been rendered moot by the 1952 statute? Oh, absolutely the Supreme Court has done this with no discussion as to why they believe the pre-1952 cases are still good law, despite the intervening 1952 statute.

    But that does not make what the Supreme Court has done right. In fact, the Supreme Court justices have brought dishonor on the U.S. judicial system by unlawfully legislating from the bench in this way and rewriting the law passed by the legislature and signed by the President.

    Currently, with respect to 35 USC 101, the Supreme Court believes it is above the law.

  54. Edward Heller June 30, 2016 6:05 am

    A rational, Congress has not changed the words of “101” since 1793, albeit, reenacting the statute in the various forms of the Statutes and codes from time to time. Congress intended no change.

  55. Anon June 30, 2016 8:24 am

    Mr. Heller,

    You are not – and cannot be – correct.

    To continue to ply your type of “eyes closed” mantra of no change is beyond preposterous.

    You refuse to listen to reason.
    You refuse to listen to what first-hand learned commentators have said.
    You refuse to even listen to what Congress has said.

    ALL that you want to do is repeat a line of known-to-be-wrong mantra without regard to what anyone has to say.

    You are advocating in the blind, with a known disregard for points presented.

    Ask yourself if that is ethical advocacy.

  56. Edward Heller June 30, 2016 10:20 am

    anon, as you well know, the legislative history was discussed at the other site showing that some in Congress tried to change 101 to reverse Funk Bros. Congress had none of it, but preserved the language that had prevailed since 1793.

  57. step back June 30, 2016 10:27 am

    Heller, you haven’t responded to my point @33 re the difference between what is truly fully “natural” versus what is the result of massive support by the unnatural forces of civilization (by the manipulation of environment by civilized mankind)

  58. Anon June 30, 2016 12:03 pm

    Mr. Heller,

    And as you well know the language alone is not the story – you still need to recognize the entire change to that pre-1952 single paragraph, the new definitions (which show that you desired “version” of the congressional exchange is NOT how you would portray it) and the bottom line that you simply cannot ignore what happened in 1952 with your attempt to adhere to your fabricated story from 1783.

  59. Edward Heller June 30, 2016 12:33 pm

    Mr. Step back, since you wish to engage in personal insults and rude behavior, our discussion is at an end.

  60. step back June 30, 2016 12:57 pm

    @57 is about the issue. Not about you.

  61. Edward Heller June 30, 2016 4:59 pm

    Anon, the legislative history included a discussion of Section 100. No change in the law was intended.

  62. Anon June 30, 2016 6:39 pm

    You simply are not correct Mr. Heller, nor have you even attempted to discuss 35 USC 100(a) or (b).

    Your reply is non-responsive.

  63. step back July 1, 2016 3:45 am

    Check out page 86 of this site:
    http://ipmall.info/hosted_resources/lipa/patents/patentact/rich.pdf

  64. Anon July 1, 2016 7:24 am

    Thank you step back, but as I am sure that any long time reader of the exchanges between Mr. Heller and I would realize, this tome (from 1960 – my error in attribution to the year 1962) has been supplied to Mr. Heller on countless occasions.

    Never mind the fact that this is from one of the two principle architects of the Act of 1952, and is thus a key insight into that Act of Congress**, that this captures the facts and history of the day, that this lesson surely has been sough to be denied (and hence, we are in the midst of re-learning it), we STILL to this day have people dead set against learning it.

    And why is that?

    The only logical answer available is that because that lesson reaches an end that is just not in line with the philosophical desires to deny eligibility to such things as “software” and “business methods.”

    ** emphasis is added that this carries the weight of Congress because certain individuals have also engaged in a smear campaign in attempts to vilify the author in an attempt to discredit or “spin” what Congress had done. Truly a darker shade of manipulation, and worth noting that deniers of history and facts are just a more subtle shade of the deception aimed at achieving a very specific ends.

  65. Edward Heller July 1, 2016 9:16 am

    In the opening paragraph, Rich says, “Also outside that group is one of the greatest inventions of our times, the diaper service.” The group he refers to are the four classes “process, machine, manufacture, or composition of matter.”

    I find it interesting therefore that it was the same person that eventually held that the patent statues did not have an exclusion for business methods. He seemed, in 1960, to clearly understand that business methods were not excluded, but rather were not within the four classes – they were nonstatutory. That is how business methods were then understood, and that understanding had been the law for very long time by 1960.

  66. Edward Heller July 1, 2016 9:27 am

    Also the Rich article is primarily the directed to the issue of whether an improvement is required for patentability. He talked about the topic in a vague sense without actually even attempting to understand why Congress found it necessary to include in the statute in 1790 the idea that patents could extend to improved Arts, engines, manufactures etc.

    Well it goes back to Lord Coke when he held a patent to an old combination to be invalid. He basically said this is like the button to the coat – effectively saying that one cannot re-patent the button-coat combination simply by improving the button. So the English law began to think that the rule that Lord Coke had announced was rule that one could not patent improvements. But it was better understood that what Lord Coke was really addressing were old combinations.

    The original patent statues addressed the old combination problem by stating it that one could not patent more than one had invented. One could not, they thought, re-patent the machine by improving a component, – the button to the coat. But it became obvious that improvements to some components could actually improve the entire machine, and therefore the law specifically had to be stated that patents could be issued to improved machines, manufactures, compositions, etc.

  67. Anon July 1, 2016 11:07 am

    Mr. Heller,

    Your attempts to twist what was said to fit your version of reality is – quite frankly – preposterous.

    You keep on circling back to attempts to enshrine pre-1952 law as if the Act of 1952 never happened.

    It DID happen.

    That Act removes the chain of authority that you want to depend on to eliminate the authority of the Act of 1952. Such circularity and bootstrapping is appalling.

  68. step back July 1, 2016 3:17 pm

    Also the AIA of 2103 did happen.

    Congress did not remove mention of business methods (i.e. CBM’s) from the law.
    Congress did not delete or re-word section 101. It stands as is.

  69. Kenny July 27, 2016 1:44 pm

    It is simply horrendous for the biotech industry. How many patents in biotech and medicine are based on natural phenomena? Most of them. Why is a physical embodiment based on knowledge of a natural phenomena, such as a plane based on the knowledge of gravity, not patentable?

    The late Justice Scalia once admitted on stage that “Patent cases are the hardest”. Simply put, no sitting justice, and probably anyone in the past, has endeavored themselves in the pursuit of science. Hence the lack of understanding.

    When will this improve? Either Congress of the Supreme Court itself will sort this out, somehow. The clear consequence is both the biotech and medical industry will suffer for a long time.

  70. Kalimero July 28, 2016 3:49 pm

    Note of appreciation to Mr. Edward Heller:

    I read the comments, at times, hoping for additional insight into a 101-related court ruling that I feel does not comport with my understanding of the current 101 eligibility landscape. An ongoing effort directed to formulating a more 101-robust drafting and prosecution strategy. In that regard I would really like to Thank Mr. Edward Heller for actually providing some practical insight into the matter, rather than venting out frustrations and endless statement of complaints about judges and rulings which forms the bulk of feedback and serves no practical value whatsoever.

  71. Edward Heller July 28, 2016 6:46 pm

    Kalimero, thanks.

    US patent law has not fundamentally changed since the founding, building on the English law in its state in the 1790’s. So, we can trace our patent law back to cases as early as the 1600. All of it is really pertinent.

    As good sources, I recommend Bracha, Oren. Owning ideas: A history of Anglo-American intellectual property. Diss. Harvard Law School Cambridge, Massachusetts, 2005 and, of course, Curtis, who has often been cited by the Supreme Court. I have and often refer to the 1867 version, which is also available on Google Books.

    Also, there is no substitute for reading the important US Patent Law cases. Pennock v. Dialogue is first among these, as well as Le Roy v. Tatham, O’Reilly v. Morse, Corning v. Burden and a host of others. These cases are still followed by the Supreme Court.

  72. Anon August 6, 2016 8:50 am

    Mr. Heller,

    Part and parcel of the problem is the Supreme Court wanting to follow cases that come prior to 1952 and what Congress did in 1952 pertaining to the removal of authority from the judicial branch for using common law to define “invention.”

    You repeatedly ignore this critical facet of controlling law.