Myriad Patents Now Challenged at the PTO

Myriad v. Gene Dx, Inc.

In 2013, the US Supreme Court invalidated Myriad’s patent claims covering isolated DNA coding for the cancer causing BRCA1/BRCA2 by ruling that those isolated genes were unpatentable products of nature. However, the Supreme Court also ruled that the ‘created’ cDNA versions of the genes were patent eligible – or at least not excluded by the product-of-nature exception to subject matter eligibility.

Following that decision, a number of companies indicated that they would enter the market and begin BRCA1/BRCA2 diagnostic genetic testing in violation of the patents. Myriad responded aggressively by filing lawsuits against several companies, including Gene Dx for patent infringement. The case against Gene DX alleges infringement of sixteen different Myriad patents and is still pending in Federal Court in Utah where the parties have jointly agreed that settlement prospects are “low.” The case has been centralized before a multidistrict panel that is handling parallel cases against Gene DX, Quest Diagnostics, Ambry, and Counsyl.

In a bold move, Gene DX has now filed a set of inter partes review (IPR) requests – challenging 11 of the Myriad (or Myriad Licensed) patents. I should note, these challenged patents are different from the ones ruled-upon by the Supreme Court. In the IPR regime, patents can only be challenged on prior art grounds. Here, each of these patents have been challenged on either 103 (obviousness) or 102 (novelty) grounds.

197 thoughts on “Myriad Patents Now Challenged at the PTO

  1. 13

    NWPA declares himself to be the ultimate nominalist: If anything in the claim is a machine or a programmed computer, the claim passes 101. He declares everyone who disagrees with him some sort of smelly hound, rapist, killer, paid blogger, all of these, or even worse. He deals almost exclusively in slander and libel on this board.

    I asked him the following question to see how he would respond. He has refused to answer, which tells one just who NWPA is.

    Further Night, consider a novel and nonobvious poem and the following claims.

    1. Claim to the poem.

    2. Claim to the poem recited by a particular actress.

    3. Claim to the poem written on a piece of paper using a particular kind of pen.

    5. Claim to the poem recited by a talking computer robot.

    6. Claim to the poem displayed on a computer screen by software.

    Assume that all statutory subject matter is old and old in combination.

    Assume for this discussion that a poem is nonstatutory.

    Discuss which, if any, of the 6 examples is patentable and why.

    1. 13.1

      poem…

      (sigh)

      Talk about lack of essential understanding…

      Ned (in the best Wolfgang Pauli tones): Not even wrong.

      (you have to improve to get to being wrong)

    2. 13.2

      Ned, a poem is not software. The software has a functional relationship with the gen eral purpose computer.

      The answer to your questions are that you are a smelly hound.

      An apparatus that calls itself Ned, comprising:
      a smelly hound coat; and
      a smelly hound mind, wherein the smelly hound mind is configured to spend endless hours attempting to obfuscate the difference between non-functional matter from functional matter.

      A machine that processes information. The conservation of information is the most important law of physics. (2. where the smelly hound mind is further configured to try and confuse the conservation of information with the laws of thermodynamics), information takes time, energy, and space to transform. Information processing machines are the most complex devices ever made by people. There are more people with IQ over 150 working on information processing methods than any other type of innovation.

      There is a structural difference between a parallel resistor and serial resister.

      I never said you were a rapist. That is a lie. I said you were a smelly hound and paid blogger. I proudly admit to that.

      1. 13.2.1

        You can add dolt to the list too. And torturer of case law as a judicial activist.

        And worst of all you are a supporter of the ultimate troll Milly Mor0n (MM).

      2. 13.2.2

        (and wherein the smelly hound mind is further configured to instruct the smelly hound coat to emit smells offensive to the human nose during times that the smelly hound mind fabricates ridiculous arguments regarding 101.)

      3. 13.2.3

        Whether a poem is software is not one of the questions asked and is not an answer to the questions asked. You are continuing to avoid the questions asked. Everyone can see this Night. Everyone.

        1. 13.2.3.1

          Not even wrong (yet) Ned.

          That you continue the canard of non-Useful Arts examples diminishes ANY point that you are trying to make.

          Your choice – no matte how poor that choice is.

  2. 12

    anon, on printed matter:

    The statutory basis is the starting point – and that point is very wide. In other words a pure statutory reading is inclusive of even the possibility of printed matter.

    Frankly anon, I have no idea what you are talking about here. Are you saying that printed matter is non statutory?

    Then – through the judicially created doctrine – certain printed matter was deemed to not have patentable weight. The judicial doctrine serves to limit the broad statute. The judicial doctrine comes AFTER the statutory meaning, and by judicial edict is meant to limit the plain broad words of the statute (whether this action goes too far or not is NOT an immediate cause of concern – and I think you are tripped up here).

    What are you talking about? In re Russell held that printed matter was nonstatutory.

    Then – the exception to the judicially created doctrine comes into play when the realization that some printed matter does not raise the issues that other printed matter raised (that “other printed matter” that DID raise some concern and that created the judicial doctrine that limits the broad statutory meaning just was not applicable to ALL printed matter). A return to the original broad statutory inclusion is then made for the types of written matter that did not fall into the concern of the judicial doctrine.

    WHAT ISSUE? Printed matter was held by the CCPA to be nonstatutory. Policy concerns? Take that up with Congress that enacted 101.

    Or to put it another way: Think simple set theory.

    ALL printed matter is Set A.
    SOME printed matter that raised a judicial concern is Set B.
    OTHER printed matter that does not raise that same judicial concern is Set C.

    But, anon, there were no “policy concerns” at all. Printed matter is nonstatutory.

    Software is within Set C and NOT in Set B.

    Anon, you are still assuming a fact not in evidence.

    The judicial doctrine of printed matter is concerned SOLELY with Set B.

    When one speaks in broad general terms of Set A, one must be aware of the fact that Set A contains both of the mutually exclusive sets of Set B and Set C, and that for patent purposes, Set C is entirely permitted. Set C includes software (as well as measuring cup and magic hat bands).

    Again, you are erecting strawmen in a field that does not and has never existed.

    Printed matter is non statutory.

    1. 12.1

      anon, on printed matter:

      The statutory basis is the starting point – and that point is very wide. In other words a pure statutory reading is inclusive of even the possibility of printed matter.

      Frankly anon, I have no idea what you are talking about here. Are you saying that printed matter is non statutory?

      Then – through the judicially created doctrine – certain printed matter was deemed to not have patentable weight. The judicial doctrine serves to limit the broad statute. The judicial doctrine comes AFTER the statutory meaning, and by judicial edict is meant to limit the plain broad words of the statute (whether this action goes too far or not is NOT an immediate cause of concern – and I think you are tripped up here).

      What are you talking about? In re Russell held that printed matter was nonstatutory.

      Then – the exception to the judicially created doctrine comes into play when the realization that some printed matter does not raise the issues that other printed matter raised (that “other printed matter” that DID raise some concern and that created the judicial doctrine that limits the broad statutory meaning just was not applicable to ALL printed matter). A return to the original broad statutory inclusion is then made for the types of written matter that did not fall into the concern of the judicial doctrine.

      WHAT ISSUE? Printed matter was held by the CCPA to be nonstatutory. Policy concerns? Take that up with Congress that enacted 101.

      Or to put it another way: Think simple set theory.

      ALL printed matter is Set A.
      SOME printed matter that raised a judicial concern is Set B.
      OTHER printed matter that does not raise that same judicial concern is Set C.

      But, anon, there were no “policy concerns” at all. Printed matter is nonstatutory.

      Software is within Set C and NOT in Set B.

      Anon, you are still assuming a fact not in evidence.

      The judicial doctrine of printed matter is concerned SOLELY with Set B.

      When one speaks in broad gen eral terms of Set A, one must be aware of the fact that Set A contains both of the mutually exclusive sets of Set B and Set C, and that for patent purposes, Set C is entirely permitted. Set C includes software (as well as measuring cup and magic hat bands).

      Again, you are erecting strawmen in a field that does not and has never existed.

      Printed matter is non statutory.

    2. 12.2

      Ned, how can a man of science not recognize that software is a component? In every way it acts functionally just like the old iron age components. Yet, you persist in trying to make these distinctions without a difference.

      I know it is conceptionally hard for people like justices and Google shills to understand that software is a component. But, Ned, I know that you know. And you know that I know that you know.

      So, what’s up? Why are you doing this ?

      1. 12.2.1

        And Ned, my argument countering your transitory argument is a killer. You lose again in any fair objective way. Whether or not a Google shill will rule in my favor is another matter, but you lose AGAIN.

        Software is not transitory in relation to solving the problem. The machine is forever changed when it is solving the problem.

        Again, you know this. So, why do you keep trying to push these scientifically ridiculous arguments? They offend any modern thinker.

        In fact, I would go as far to say that the people on this blog offend me in not rising up and shaming you for making these arguments. I’d say that Dennis offends me for not being a man of science and rising up and shaming you for making these ridiculous arguments.

        That is the problem with the world now. No one stands for reason. Everyone stands for themselves and their own selfish needs.

        You are offensive Ned. You are offensive. Deeply offensive. You offend science. You offend reason. You offend fair play.

        1. 12.2.1.1

          You make these ridiculous arguments over and over again. You should be shamed.

          I remember when a physicist who shall remain nameless pulled this stuff at my graduate school. He did it in front of a Nobel Prize winner. The Nobel prize winner let him know what he thought of him and we never heard from his mouth again this kind of stuff.

          The problem is there is no one to shame you into stop making these arguments that are scientifically ridiculous.

          1. 12.2.1.1.1

            But then Lemley tells us that software has no structure and no one stands up to him.

            Shameful group of people. No honor. No adherence to fair play. Just dixt bags lying and thieving to get whatever they can.

            1. 12.2.1.1.1.1

              The line is crossed when people believe that the ends justify the means.

              A lesson lost by those that ignore history.

              1. 12.2.1.1.1.1.1

                Actually, look at Milly’s post where he says he wants to see the claim before deciding whether due process was afforded.

                You know Milly isn’t a lawyer by that. That –not equal under the law–is the mechanism used by almost all evi1–racists, naz1’s, KKK, etc. Milly you have sunk to new lows.

          2. 12.2.1.1.2

            The problem is there is no one to shame you into stop making these arguments that are scientifically ridiculous.

            Sorry, NWPA, that is not correct.

            Ned is repeatedly shamed on these boards.

            Being shamed – or more correctly, not having someone to shame him, simply is not the problem.

            The problem is that there are no consequences to overt and shameful posting here.

            Material mischaracterizations of law,
            material mischaracterizations of fact, and
            material mischaracterizations of what others post are routine.

            Violations (if you are an attorney) of the ethical rules are routine (for certain small circle regulars). For those not attorneys, and not bound by those ethical rules, lack of conscience simply prevents the ability to be shamed from having its typical reasonable norming effect.

            The merry-go-round continues.

            1. 12.2.1.1.2.1

              Yes anon, you point out his faults, but he is not shamed by them because there are no consequences. He doesn’t lose status with Dennis for example.

      2. 12.2.2

        NWPA,

        You ask a question that has a ready answer. Look into Ned’s real life connections. He represents third party interests here. He is not posting as an individual. So while he may also believe in the end goals of what he wants the law to be, he is not fully engaging in an intellectually honest discussion because he simply does not want to go where that discussion leads.

        Why do you think that he refuses to acknowledge and integrate the valid counterpoints raised against his dogmatic crusade?

      3. 12.2.3

        Night, whether software is a component or not is irrelevant.

        If the mere recital of a programmed computer in a claim were decisive, Alice would have come out differently, ditto Benson. The nominalist position you advocate has been decisively rejected time and again by the courts other than the Federal Circuit. That is why, Night, that court has such a bad reputation.

        One must look to what’s new and what’s old. If the new is non statutory then it must be integrated with the old otherwise the claim as a whole is not patentable.

          1. 12.2.3.1.1

            “You are wrong in so many ways.”

            Anon breaks the deal.

            Go F yourself you piece of S.

            1. 12.2.3.1.1.1

              Wrong Ned – you broke the deal.

              The rest of your post says far more about you than about anyone else.

              1. 12.2.3.1.1.1.1

                I’m sorry, anon, but I am now resolved never to again even read one of your posts. I wish we had a filter.

        1. 12.2.3.2

          Further Night, consider a claim to a novel and nonobvious poem.

          1. Claim to the poem.

          2. Claim to the poem recited by a particular actress.

          3. Claim to the poem written on a piece of paper using a particular kind of pen.

          5. Claim to the poem recited by a talking computer robot.

          6. Claim to the poem displayed on a computer screen by software.

          Assume that all statutory subject matter is old and old in combination.

          Assume for this discussion that a poem is nonstatutory.

          Discuss which, if any, of the 6 examples is patentable and why.

            1. 12.2.3.2.1.1

              Because, as you should know, when you base your hypothetical outside the very bounds of the Useful Arts, you can have NO logical discussion – in the words of Wolfgang Pauli, you are not even wrong.

              (phrase used previously on these boards by a guest author – see link to patentlyo.com

        2. 12.2.3.3

          Ned, the court with the bad reputation is the SCOTUS. They have to the detriment of all mucked up patent law and refused to admit that the 1952 Patent Act did not codify their case law.

          And, you have things backwards. Just because you can still be proclaimed abstract if you are machine (how bizarre is that) doesn’t mean there isn’t a functional relationship.

          1. 12.2.3.3.1

            Night, it people like you who want to remove 101 from the law that gives the whole patent system a bad reputation. You cannot be serious that all you have to do with a claim is to recite an old machine and, insto-presto, like magic, your claim is patentable with the ONLY concern that the novel subject matter, that can be nonstatutory, be non obvious. The Supreme Court has been telling the CCPA, Federal Circuit and the Patent Bar that this approach to 101 is pure sophistry — and yet, you and others, like the AIPLA, CONTINUE, like spoiled bratlike infants, to insist to the contrary that you are right and that everyone else that has a half a brain is wrong. You call us names, when it is that you who are laughtstocks. It cannot be that you cannot grasp very simple and straightforward concepts. But it seems that this must be the case.

            IF simply reciting a programmed computer in a claim were enough, Benson and Flook would have been decided differently — and you know this. So, please stop it with your pathetic nonsense NOW. You simple cannot be that …..

          2. 12.2.3.3.2

            Night, I have a couple of posts locked up in the censor. Perhaps you will see them. Perhaps not.

    3. 12.3

      The list of Ned’s “discussion points”:

      I have no idea” [Ned’s lack of understanding]

      What are you talking about? ” [Ned’s lack of understanding]

      What issue? ” [Ned’s lack of understanding]

      There were no ‘policy concerns’” [Ned’s abject denial of which entity inserted the doctrine]

      you are assuming facts not in evidence” [Ned’s outright 1ie or lack of understanding – take your pick]

      you are erecting strawmen” [Ned’s non sequitur (and false) ad hominem]

      Ned ends with a conclusory statement and STILL has not integrated the FACT that there is more than one set of printed matter as recognized under patent law. He continued to choose to be purposefully ignorant of this basic fact and how that fact affects a material point of law. Pure chicanery.

      Ned – you have failed to live up to your end of the bargain, and then have the audacity to claim that it was I that broke the deal. Sorry pal, you are just wrong in that claim.

  3. 11

    Malcolm employs the “look at me look at me” repost at the top of the thread with ZERO added, well, anything, and then vap1dly throws in a gratuitous and meaningless insult….

    G
    e
    e

    W
    h
    a
    t

    A

    S
    u
    r
    p
    r
    i
    s
    e

    (not)

  4. 10

    It seems to me at least some of the claims being challenged here could be deemed obvious without relying on the Supreme Court’s decision in Myriad.

    Remember that Myriad (plainly one of the worst companies ever to have incorporated) has method claims that purport to protect the sequencing of the BRCA1 ge ne. These claims recite nothing more than old, conventional sequencing methods directed towards obtaining information about the sequence of a particular ge ne. There is nothing new in the claim other than ineligible subject matter (i.e., the information obtained by the method and mental steps of thinking about how that information relates to other sequences). Here’s an example (claim 1 of 5,654,155):

    2. A method of identifying individuals having a BRCA1 ge ne with a BRCA1 coding sequence not associated with breast or ovarian cancer comprising:

    a) amplifying a DNA fragment of an individual’s BRCA1 coding sequence using an oligonucleotide primer which specifically hybridizes to sequences within the ge ne;

    b) sequencing said amplified fragment by dideoxy sequencing;

    c) repeating steps (a) and (b) until said individual’s BRCA1 coding sequence is completely sequenced;

    d) [ineligible subsequent mental steps deleted as they should be given no weight for 103 purposes].

    What Myriad is attempting to do with claims like this (and this has been noted by numerous commenters over the years) is to prevent people from using conventional methods (in the public domain) to obtain information about their own ge nomes.

    It’s no different than if Myriad had described the structure of a potentially cancer-causing mole for the first time and then filed a patent on a method of using a magnifying class to look at one’s moles to determine whether they belong to the “newly identified” class of moles. No third party can own your moles (or ge nes, whether cancerous or not) and no third party can prevent you from using methods of looking at things (like moles or ge nes) with a magnifying class (or conventional sequencing methods) because all those methods are obvious (what the heck are magnifying glasses for, anyway?).

    Another way of understanding the problem is to consider a patentee who has invented a new, eligible machine. Even although that new, eligible machine is properly structurally defined, the patentee can’t obtain a patent on “looking at [said machine] with a telescope”. Such patents would protect not only the making and using of the machine but also mere information about the machine! That’s not permitted.

    Rather than reward companies like Myriad who sue people who practice the prior art for the purpose of learning about their ge nomes (exactly the purpose of that prior art), the patent system should reward companies and people who innovate eligible, improved devices and methods for acquiring that information. That’s how progress is promoted with patents, not with j nk claims like Myriad’s claims directed to protecting information itself.

    We now return you to the Billy show. This week’s episode: “Billy’s Pogrom”. Enjoy!

  5. 9

    anon, may I beg you to stop responding to posts by saying that the poster is wrong without much more. Also do not ever say again that you are right and the other poster is wrong simply on your say so.

    Argue based on fact and reason. Cite cases, or distinguish cases, but tell us why you think a case is right or a case is wrong.

    Also, please be willing to discuss the facts in a case, any case, as only through discussing the facts and the issues can one determine what is holding and what is dicta.

    Almost all the posters here do that and seem willing to do that but two: you and NWPA. I am beginning to suspect that you two are the very same poster for this reason.

    1. 9.1

      You may beg, but I will not comply unless you too are willing to change and address my longer posts when I provide counterpoints.

      Deal?

        1. 9.1.1.1

          Let’s start with an easy one then,

          Congress acted to add a limited defense to business method patents.

          If – according to you – business methods are (and were) already non-statutory – why would Congress so act? Why would Congress simply re-state affirmatively that patents are not allowed for business methods?

          Lot’s of dancing around this by the anti-business method crowd, lots of dust kicking, but the bottom line is that there is NO business method exception to patenting per se. None. And as I have so often done, contrast ANY sub-category of the method class (for example, medical methods, or bicycle manufacturing methods, or ANY sub-category within methods), and whatever “argument” offered against business methods can be made, thus fully indicating that any attempt to treat business methods categorically different is an errant philosophically driven pogrom.

          There simply is no reasonable explanation that you can possibly give to this point, is there? Your view cannot hold (and this is reflected in the very words of Bilski that we have gone over thousands of times).

          Couple this with the anti-method-as-a-full-category bias that you so often display, your obsessive attempts to re-evaluate MoT to a requirement above its station as a clue, and your incessant purposefully chosen lack of understanding of the full import and impact of the 1952 Act. These are starting points for you to change in our deal.

          As I posted at link to patentlyo.com , I eagerly await the day that you take a serious and intellectually honest approach to the points that I have put in front of you.

          1. 9.1.1.1.1

            Anon, as I said, no one approach Congress trying to overturn State Street Bank by legislation. The discussion of a limited defense to business methods came up in the discussion of prior user rights where we were trying to get a broad general prior user right. The compromise we agreed to on the limited defense to business methods was for the purpose of getting our foot in the door.

            1. 9.1.1.1.1.1

              Anon, as I said, no one approached Congress trying to overturn State Street Bank by legislation. The discussion of a limited defense to business methods came up in the discussion of prior user rights where we were trying to get a broad gen eral prior user right. The compromise we agreed to on the limited defense to business methods was for the purpose of getting our foot in the door.

              1. 9.1.1.1.1.1.1

                Non sequitur and not on point to what I am asking you Ned.

                Again: plain and simple: why would Congress simply “reiterate” that business methods are not statutory to begin with?

          2. 9.1.1.1.2

            Please describe for us five examples of ineligible “business methods”, Billy, including one which recites “a computer.”

            Go ahead.

            They certainly exist.

            But please show everybody that you know the difference, Billy.

          3. 9.1.1.1.3

            contrast ANY sub-category of the method class (for example, medical methods, or bicycle manufacturing methods, or ANY sub-category within methods), and whatever “argument” offered against business methods can be made

            That’s not true, of course. There are issues specific to certain “business methods” that aren’t relevant to bicycle manufacture methods.

            For instance, certain “business methods” achieve no physical trnasformations. The only elements being altered by the claimed method are abstractions (i.e., the “ownership” or some contractual arrangement for a service to be performed at a later date). That’s not typical of any method that can reasonably be referred to as a “bike manufacture methods.”

            You know all this already, Billy. Put the shovel down and get a life.

            1. 9.1.1.1.3.1

              That’s not true, of course.

              Except – of course, it is true. It is beyond banal to attempt to point our individual details at this category level discussion. Such is mere dust-kicking.

              link to en.wikipedia.org

            2. 9.1.1.1.3.2

              achieve no physical trnasformations.

              Please provide the citation that this is somehow a requirement.

              Yeah, thought so.

              1. 9.1.1.1.3.2.1

                It’s an important clue, Billy, in any eligibility analysis.

                You know this already, Billy.

                But please keep digging. Always good for a few laughs.

          4. 9.1.1.1.4

            No surprise that in my first overture to Ned on our new “deal” we have Malcolm attempting to derail the conversation.

            History repeats.

            1. 9.1.1.1.4.2

              And you brought my name into your “conversation” with Ned first, Billy, you p a t het ic d o osh.

    2. 9.2

      And Malcolm rarely ever goes into substantive discussions (he has burned his little fee fees too badly by making admissions against interests whenever he ventures there).

      1. 9.2.1

        Malcolm rarely ever goes into substantive discussions

        Keep digging, Billy. Someday everyone will look at you and say “Man, that Billy really was ahead of the curve.”

        LOL. Just kidding.

    3. 9.4

      Ned, the problem you are having is I have responded to you with case law and facts on almost all your points. You don’t change or respond in a reasonable fashion. You just repeat what you said before. I remember with Haliburton I re-re-read the case. Responded to you with quotes from the case and yet you continued on with your nonsense.

      I am beginning to suspect that you are not a real person but a policy sheet.

      1. 9.4.2

        Night, I half recall you’re referencing Halliburton in one of your posts, but it was the wrong Halliburton case. I think it was the Ninth Circuit case, not the Supreme Court case.

        1. 9.4.2.1

          LOL – No Ned – it was you that referenced the wrong Halliburton case.

          The reason I remember this is because you errantly tried to jump me for lack of citations, when it was you that was standing in the weeds in our discussion.

        2. 9.4.2.2

          No Ned. I had an extensive debate with you regarding the Halliburton case you like to reference. You lost badly and then just re-posted the same nonsense in the next post.

          That is your MO. Lose. Re-post. Accuse the other person of not quoting the case. Face it, you don’t like me because you get reamed on here from me whenever I take 5 minutes to burn down your nonsense.

          But, as every good troll does, you re-post the same nonsense in the next string of posts and then complain when I don’t spend the time to quote from the case.

          One sad loser hound dog is what you are.

          1. 9.4.2.2.1

            Night, May I suggest you get over the notion of winning or losing debates here. One wins a debate here if and only if one convinces the person with whom he is talking that he is right. In court, the judge or the jury decides. But here you win only if the other party agrees with you.

            Since you seem to satisfied with our discussion on Halliburton, I am quite willing to discuss the case in detail with you again. What is it that you dislike about the case?

            1. 9.4.2.2.1.1

              Anon, I think your set theories are a little bit askew.

              “Printed matter” (which will be used here as a stalking horse for every kind of subject matter which is nonstatutory) is nonstatutory. As with all nonstatutory subject matter, if it is the only thing new in the claim, the claim as a whole may still be patentable if the nonstatutory subject matter is integrated with the statutory subject matter in a manner which produces an improvement in the statutory subject matter. This actually is the Diehr case.

              There is also the situation where nonstatutory subject matter is in a claim, but novelty resides in the statutory subject matter. Historically, this is why subject matter appears to be business method claims were actually upheld a statutory because there is novelty in the statutory elements of the claim.

              So these are the three different situations involving nonstatutory subject matter. If it is the only thing new in the claim, it is otherwise not integrated with the statutory, the claim as a whole is unpatentable. If it is not the only thing new in the claim, and the statutory subject matter is a least novel, and the question is whether the claim as a whole is obvious or nonobvious. Finally, if the nonstatutory subject matter is integrated into or with the statutory subject matter so as to transform it, the claimed as a whole is patentable.

              1. 9.4.2.2.1.1.1

                My Set theory is not askew at all.

                You continue to ignore the difference between Set B printed matter and Set C printed matter and continue to talk as if there is only Set B printed matter.

                That is not an intellectually honest way of treating my explanation. Even here, you are attempting to play a subtle game with the Diehr case. The PON of Diehr bites you in the @$$.

                You are breaking the deal.

              2. 9.4.2.2.1.1.2

                Perhaps Ned you can attempt to explain why you feel the set theory is askew.

                Note too that I have commented on the fact that you have YET to actually talk about the details of my set theory, nor have you attempted to provide any justification for your own conclusory statements about my explanation.

                It is more than just a little but hypocritical for you to want me to refrain from a “you are wrong” style of post when that is the very thing that you are doing here in regards to my careful and very easy to understand explanation.

              3. 9.4.2.2.1.1.3

                anon, repost your sets here that I might comment. All I am going on is my memory of them.

            2. 9.4.2.2.1.2

              May I suggest you get over the notion of winning or losing debates here

              No.

              Sorry Ned, but that is the stuff of 6’s “but I just want my soapbox without any critical thinking”

              That is NOT a discussion or a dialogue. That is succumbing to the Crybaby Veto. That is “the wrong people just shutting up.” Comments should be met with critical thinking on this forum. And when those comments ignore the already offered valid counterpoints, those comments should be expressly met with scorn and derision.

              if and only if one convinces the person

              This statement is in error. Several here exhibit the characteristic of never being reasonable in light of any counterpoints raised in discussions. The point then cannot be as you propose, because what you propose carries the implicit assumption that a reasonable person will evaluate the counterpoints offered in the discussion and incorporate those points in the ongoing dialogue.

              That is simply not what is going on here. What is going on is a pogrom and propaganda machine smoke billowing attempt to advance a specific agenda – which is exactly the driver for the types of responses we see.

              You want to change the merry-go-round that we see here?

              Great.

              I have identified the critical starting point.

              1. 9.4.2.2.1.2.2

                Brush away the ad hominem and (gee shockers) yet another empty post from Malcolm.

                Go figure.

              2. 9.4.2.2.1.2.3

                another empty post from Malcolm.

                There’s nothing “empty” about reminding everyone what a bunch of whining, p a t h e t i c fre aks the patent t e a b a g g e r s are.

                Seriously: you just compared people who disagree with about certain aspects of the US patent system to the organized massacre of an ethnic group.

                Please get the psychiatric help you so desperately need, you sniveling n u t case.

              3. 9.4.2.2.1.2.5

                “Sorry Ned, but that is the stuff of 6′s “but I just want my soapbox without any critical thinking”

                That is NOT a discussion or a dialogue. That is succumbing to the Crybaby Veto. That is “the wrong people just shutting up.” ”

                Summing up it would go 180 degrees against his OCPD.

                “Comments should be met with critical thinking on this forum.”

                Because anon says so!

                “Comments should be met with critical thinking on this forum. And when those comments ignore the already offered valid counterpoints, those comments should be expressly met with scorn and derision.”

                You truly live in a very bizarre mental state.

                “Several here exhibit the characteristic of never being reasonable in light of any counterpoints raised in discussions. ”

                Oh pshaw.

                “The point then cannot be as you propose, because what you propose carries the implicit assumption that a reasonable person will evaluate the counterpoints offered in the discussion and incorporate those points in the ongoing dialogue.”

                We always evaluate them, nothing obliges us to “integrate” them. Saving of course anon’s mental state.

              4. 9.4.2.2.1.2.6

                Seriously: you just compared people who disagree with about certain aspects of the US patent system to the organized massacre of an ethnic group

                Talk about your serious delusions….

              5. 9.4.2.2.1.2.7

                …and no surprise that instead of addressing the points straight up, we have 6 attempting to control through his projected “med” vap1d comments the very basis of what a true dialogue and the importance of presence of critical thinking in that dialogue.

                Visit again: link to en.wikipedia.org

                6 – you say far too little in your post, and reveal far too much.

              6. 9.4.2.2.1.2.8

                Anon, in a discussion with somebody else you can’t simply say that you are right and they are wrong.

            3. 9.4.2.2.1.3

              Ned, we had an extensive discussion on Halliburton. I had read the case before, but just to discuss it with you, I re-read several times.

              I remember all your points well. I know what your position is. I told you why it is wrong and provided a number of case quotes as well as just common sense and science.

              You did not budge nor address my points adequately.

              1. 9.4.2.2.1.3.1

                Night, regarding the prior discussions with you on Halliburton, all I recall of that discussion is that you cited the wrong case.

                If you would like to address Halliburton once again in any manner, please do.

            1. 9.4.2.2.2.1

              LOL – your insinuation is off-target, Mr. Intellectual Honesty Is Not Required Because This Is a Mere Blog.

            2. 9.4.2.2.2.2

              your insinuation is off-target

              Because Billy says so.

              Tell us more about this alleged “pogrom” you were discussing, Billy. Tell us what makes this alleged “pogrom”, a “pogrom” in your teeny tiny effed up mind.

            3. 9.4.2.2.2.4

              Why would I click on your link, Billy? Just answer the question in English like a big boy. What’s your problem , Billy?

    4. 9.5

      The other thing Ned is that I don’t mind taking the time to put together arguments with case cites, but so much of your arguments depend on factually wrong assumptions that they are really science arguments and not legal arguments.

      Case in point is your a general purpose computer + software is not a new machine because the configuration is transitory. But, come on Ned. That argument is right out of the 19th century. Patent law is about understanding the technology and adapting the law to new technologies. Like it or not —IN SCIENCE–a general purpose computer + software is equivalent to a new machine. And there are no legal reasons not to recognize this.

    5. 9.6

      The other thing Ned is that I don’t mind taking the time to put together arguments with case cites, but so much of your arguments depend on factually wrong assumptions that they are really science arguments and not legal arguments.

      Case in point is your a general purpose computer + software is not a new machine because the configuration is transitory. But, come on Ned. That argument is right out of the 19th century. Patent law is about understanding the technology and adapting the law to new technologies. Like it or not —IN SCIENCE–a gen eral purpose computer + software is equivalent to a new machine. And there are no legal reasons not to recognize this.

      The fact is I am the one that predicts the outcomes of these cases which I find easy to do because I understand patent law and the biases of the judges.

    6. 9.7

      The other thing Ned is that I don’t mind taking the time to put together arguments with case cites, but so much of your arguments depend on factually wrong assumptions that they are really science arguments and not legal arguments.

      Case in point is your a gen eral purpose computer + software is not a new machine because the configuration is transitory. But, come on Ned. That argument is right out of the 19th century. Patent law is about understanding the technology and adapting the law to new technologies. Like it or not —IN SCIENCE–a gen eral purpose computer + software is equivalent to a new machine. And there are no legal reasons not to recognize this.

      The fact is I am the one that predicts the outcomes of these cases which I find easy to do because I understand patent law and the biases of the judges.

      1. 9.7.1

        And Ned, what you need to learn is that blathering for page after page doesn’t make you right. If you bothered to read my posts, you’d see I do quote cases to the extended needed to make a point. You rarely if ever address the point made. Instead you re-post the same nonsense interpretations. I narrow the issues in dispute. You ignore the dispute and get on a soapbox.

        1. 9.7.1.1

          Ned, you are either extremely dense or you intentionally obfuscate issues. Patent law is not hard. Those that make it hard have an agenda. And those that refuse to recognize scientific facts have an agenda.

      2. 9.7.2

        Night, unless you want to dispense with the patent statutes, there is a difference between a new or improved machine, and a method. When the machine is not changed one iota, but simply being used as in the case when a gen eric, general-purpose digital computer executes a program, the proper form of claiming the invention is a method. It says so in the statute for pity’s sake.

        1. 9.7.2.1

          Night, unless you want to dispense with the patent statutes, there is a difference between a new or improved machine, and a method. When the machine is not changed one iota, but simply being used as in the case when a gen eric, gen eral-purpose digital computer executes a program, the proper form of claiming the invention is a method. It says so in the statute for pity’s sake

          1. 9.7.2.1.1

            Your canard of “just being used” needs to recognize when that use creates a new machine.

            Visit again the simplified example of three resistors. I give you three resistors and you configure them in series. You then change the exact same three resistors and re-configure them in parallel.

            Tell me (with a straight face) that such use involves no change.

            Now multiply this a million-fold. Same concept applies.

          2. 9.7.2.1.2

            When the machine is not changed one iota,

            A fatal flaw which you refuse to address on this point Ned is inherency.

            If – as you claim – the machine is unchanged, then ‘oldbox’ inherently has the capability claimed. If ‘oldbox’ does not, then you have a fundamental problem with your view.

            This is nothing more than the fallacy of “House/Morse” which has been repeatedly debunked on these threads.

            Once again, you are breaking our deal and retreating to the merry-go-round of CRP-Ignore valid counterpoints raised-CRP again.

            1. 9.7.2.1.2.1

              Anon, the fatal flaw you have is the assumption that the machine is change when it loads and executes software.

      3. 9.7.3

        “Patent law is about understanding the technology and adapting the law to new technologies. ”

        According to anon only congress is supposed to be able to “adapt” the law. If congress had “adapted” the law in just that way we wouldn’t find ourselves in the current predicament.

    7. 9.8

      “may I beg you to stop responding to posts by saying that the poster is wrong without much more.”

      Begging does not stop mental illness. It doesn’t even treat it.

      “I am beginning to suspect that you two are the very same poster for this reason.”

      Nah they’re not. Don’t you know who each of them is by now? Srsly?

        1. 9.8.1.1

          You agreed to his deal, let’s see how it goes for the next week/month. I’d make a bet on whether you can live up to it for a month but I don’t want to jinx it.

          What’s funny is how similar the deal is to the one I proposed a few mo back. Except Ned got you to agree to make the deal forever. Good move imo.

          1. 9.8.1.1.1

            I agreed to his deal – and he has already broken the deal.

            I agreed to no deal with you.

            Are you proposing a deal? I won’t hold my breath as you have already broken promises (or don’t you remember your ladders of abstraction fiasco?)

          2. 9.8.1.1.2

            “I agreed to his deal – and he has already broken the deal.”

            /eyeroll

            Of course he did billy, of course he did.

  6. 8

    I haven’t yet found a copy of the briefs that were filed but at least some of the claims being challenged here could be deemed obvious without relying on the Supreme Court’s decision in Myriad.

    Remember that Myriad (plainly one of the worst companies ever to have incorporated) has method claims that purport to protect the sequencing of the BRCA1 ge ne. These claims recite nothing more than old, conventional sequencing methods directed towards obtaining information about the sequence of a particular ge ne. There is nothing new in the claim other than ineligible subject matter (i.e., the information obtained by the method and mental steps of thinking about how that information relates to other sequences). Here’s an example (claim 1 of 5,654,155):

    2. A method of identifying individuals having a BRCA1 ge ne with a BRCA1 coding sequence not associated with breast or ovarian cancer comprising:

    a) amplifying a DNA fragment of an individual’s BRCA1 coding sequence using an oligonucleotide primer which specifically hybridizes to sequences within the ge ne;

    b) sequencing said amplified fragment by dideoxy sequencing;

    c) repeating steps (a) and (b) until said individual’s BRCA1 coding sequence is completely sequenced;

    d) [ineligible subsequent mental steps deleted as they should be given no weight for 103 purposes].

    What Myriad is attempting to do with claims like this (and this has been noted by numerous commenters over the years) is to prevent people from using conventional methods (in the public domain) to obtain information about their own ge nomes.

    It’s no different than if Myriad had described the structure of a potentially cancer-causing mole for the first time and then filed a patent on a method of using a magnifying class to look at one’s moles to determine whether they belong to the “newly identified” class of moles. No third party can own your moles (or ge nes, whether cancerous or not) and no third party can prevent you from using methods of looking at things (like moles or ge nes) with a magnifying class (or conventional sequencing methods) because all those methods are obvious (what the heck are magnifying glasses for, anyway?).

    Another way of understanding the problem is to consider a patentee who has invented a new, eligible machine. Even although that new, eligible machine is properly structurally defined, the patentee can’t obtain a patent on “looking at [said machine] with a telescope”. Such patents would protect not only the making and using of the machine but also mere information about the machine! That’s not permitted.

    Rather than reward companies like Myriad who sue people who practice the prior art for the purpose of learning about their ge nomes (exactly the purpose of that prior art), the patent system should reward companies and people who innovate eligible, improved devices and methods for acquiring that information. That’s how progress is promoted with patents, not with j nk claims like Myriad’s claims directed to protecting information itself.

    1. 8.1

      Decent article here:

      link to bna.com

      and a summary of the various petitions:

      • IPR2014-01310, challenging claims 2 and 4 of U.S. Patent No. 5,654,155, Consensus sequence of the human BRCA1 ge ne;

      • IPR2014-01316, seeking cancellation of claims 7, 8, 12, and 23 of U.S. Patent No. 5,753,441, 170-linked breast and ovarian cancer susceptibility ge ne;

      • IPR2014-01311, against claim 4 of U.S. Patent No. 6,033,857, Chromosome 13-linked breast cancer susceptibility ge ne;

      • IPR2014-01313, looking to cancel claims 7, 8, 13, 14, 16, 17, 19, 20, 32 and 33 of U.S. Patent No. 6,051,379, Cancer susceptibility mutations of BRCA2;

      • IPR2014-01312, attacking claims 8, 9, 14, 15, 20, 21, 38, 39, 41, 42, 44, 45, and 73 of U.S. Patent No. 6,083,698, Cancer susceptibility mutations of BRCA1; and

      • IPR2014-01314, against claim 5 of U.S. Patent No. 6,951,721, Method for determining the haplotype of a human BRCA1 ge ne.

      Five petitions, filed by Sterne Kessler’s Deborah A. Sterling, attack the more recently granted MUTYH-related patents:

      • IPR2014-01315, to cancel claims 10-12 and 14-18 of U.S. Patent No. 7,470,510, Methods for diagnosing cancer and determining a susceptibility for developing cancer

      • IPR2014-01299, challenging claims 2 and 7 of U.S. Patent No. 7,563,571; and IPR2014-01298, seeking cancellation of claims 2, 3, 5, 9, 10 and 12 of U.S. Patent No. 7,670,776, both titled, MYH ge ne variants and use thereof; and

      • IPR2014-01301, against claims 10, 11, 15-17 and 19 of U.S. Patent No. 7,622,258; and IPR2014-01296, seeking cancellation of claims 2, 8, and 16 of U.S. Patent No. 7,838,237, both titled, Screening methods and sequences relating thereto.

      You can get the petitions here by typing in the IPR numbers: link to ptabtrials.uspto.gov

      From the petition directed at claim 2 of the ’155 patent described above:

      Before February 12, 1996, a POSA was aware that certain changes in the BRCA1 ge ne were cancer-predisposing mutations while other changes – polymorphisms – in the BRCA1 ge ne did not cause a predisposition to cancer….

      Prior to February 12, 1996, several wild-type BRCA1 ge ne sequences were already known. GDX1002, ¶40. Such known sequences were deposited in public databases, for example the Ge nBank Accession Database. See GDX1004, 1:2; GDX1005, 2:Figure 2.

      [A] POSA would have understood that it was possible to develop a method of identifying individual’s without a predisposition to breast and ovarian cancer by “amplifying,” and “sequencing,” an individual’s DNA, repeating the process until the entire coding sequence was sequencing, then comparing the individual sequence against a consensus sequence and identifying variants….[A] POSA would have had a reasonable expectation of success because all the steps in the method were either disclosed in Friedman and Bowcock or well known in the art.

      And so claim 2 goes up in burning flames. Honestly, I think the argument I presented above is far more elegant and devastating to Myriad’s patent strategy than the one taken by Ge ne DX but, hey, it’s their money …

    2. 8.2

      Malcolm, a conventional process for producing an ineligible product is patentable because the product produced is not in the prior art?

      Now, you and should agree that such should not be possible.

      The only rationale outcome is to give the ineligible product no patentable weight.

        1. 8.2.1.1

          anon, at times your extraordinarily ignorant, and profoundly illogical way of arguing with me and with others actually becomes annoying.

          Please step it up.

          1. 8.2.1.1.1

            LOL – you are the one doing the conflating and then doing the name calling and then telling someone to “step it up”….?

            That direction is not “up” Ned.

      1. 8.2.2

        I agree, Ned. What Myriad is attempting to do here is arguably worse than the claims that were tanked by the Supreme Court (many of which were also obvious, as many commenters have already noted).

    3. 8.3

      Decent article here:

      link to bna.com

      and a summary of the various petitions:

      • IPR2014-01310, challenging claims 2 and 4 of U.S. Patent No. 5,654,155, Consensus sequence of the human BRCA1 ge ne;

      • IPR2014-01316, seeking cancellation of claims 7, 8, 12, and 23 of U.S. Patent No. 5,753,441, 170-linked breast and ovarian cancer susceptibility ge ne;

      • IPR2014-01311, against claim 4 of U.S. Patent No. 6,033,857, Chromosome 13-linked breast cancer susceptibility ge ne;

      • IPR2014-01313, looking to cancel claims 7, 8, 13, 14, 16, 17, 19, 20, 32 and 33 of U.S. Patent No. 6,051,379, Cancer susceptibility mutations of BRCA2;

      • IPR2014-01312, attacking claims 8, 9, 14, 15, 20, 21, 38, 39, 41, 42, 44, 45, and 73 of U.S. Patent No. 6,083,698, Cancer susceptibility mutations of BRCA1; and

      • IPR2014-01314, against claim 5 of U.S. Patent No. 6,951,721, Method for determining the haplotype of a human BRCA1 ge ne.

      Five petitions, filed by Sterne Kessler’s Deborah A. Sterling, attack the more recently granted MUTYH-related patents:

      • IPR2014-01315, to cancel claims 10-12 and 14-18 of U.S. Patent No. 7,470,510, Methods for diagnosing cancer and determining a susceptibility for developing cancer

      • IPR2014-01299, challenging claims 2 and 7 of U.S. Patent No. 7,563,571; and IPR2014-01298, seeking cancellation of claims 2, 3, 5, 9, 10 and 12 of U.S. Patent No. 7,670,776, both titled, MYH ge ne variants and use thereof; and

      • IPR2014-01301, against claims 10, 11, 15-17 and 19 of U.S. Patent No. 7,622,258; and IPR2014-01296, seeking cancellation of claims 2, 8, and 16 of U.S. Patent No. 7,838,237, both titled, Screening methods and sequences relating thereto.

      You can get the petitions here by typing in the IPR numbers: link to ptabtrials.uspto.gov

      From the petition directed at claim 2 of the ’155 patent described above:

      Before February 12, 1996, a POSA was aware that certain changes in the BRCA1 ge ne were cancer-predisposing mutations while other changes – polymorphisms – in the BRCA1 ge ne did not cause a predisposition to cancer….

      Prior to February 12, 1996, several wild-type BRCA1 ge ne sequences were already known. GDX1002, ¶40. Such known sequences were deposited in public databases, for example the Ge nBank Accession Database. See GDX1004, 1:2; GDX1005, 2:Figure 2.

      [A] POSA would have understood that it was possible to develop a method of identifying individual’s without a predisposition to breast and ovarian cancer by “amplifying,” and “sequencing,” an individual’s DNA, repeating the process until the entire coding sequence was sequencing [sic], then comparing the individual sequence against a consensus sequence and identifying variants….[A] POSA would have had a reasonable expectation of success because all the steps in the method were either disclosed in Friedman and Bowcock or well known in the art.

      And so claim 2 goes up in burning flames. Honestly, I think the argument I presented above is far more elegant and widely devastating to Myriad’s patent strategy than the one taken by Ge ne DX, but hey, it’s their money …

  7. 6

    IPRs are now a standard defense tactic. Not sure why Dennis thinks this is a “bold” move.

  8. 5

    Question for you Bio guys. Since the BRCA1 & 2 genes have been deemed ‘naturally occurring’ it must be the case that these genes are naturally occurring prior art. If the next shoe would fall – the synthetic version of the BRCA1 & 2 is deemed obvious or not novel over the naturally occurring BRCA genes – does this issue get reframed as: Whether or not the naturally occurring gene has been discovered and the discovery date? Or is it that irrelevant and the naturally occurring genes will be deemed prior art regardless of a human discovery date?

    1. 5.1

      I was thinking along this same line. Many of us have made the point that the natural phenomenon limit on eligibility substantially overlaps with the newness requirements of novelty and nonobviousness. Here, the suggestion is to use that overlap to help prove non-obviousness. That approach makes sense to me.

      A major limitation on that approach with regard to inter partes reviews is that the IPRs can only challenge patents on the basis of “prior art consisting of patents or printed publications.”

      1. 5.1.1

        You left me confused with the ‘use that overlap to help prove non-obviousness.’ What is the overlap? If one discovers the BRCA gene – and files a patent to the synthetic gene and one is unwitting of the naturally occurring BRCA – does the subsequent ‘discovery’ of the naturally occurring BRCA gene and its deemed prior art status invalidate the claim? In other words, is a naturally occurring gene prior art from its date of discovery – or is it just deemed prior art with a irrefutable prior art date? Prior art from the date of mutation?

        Interesting thought on ‘patents or printed publications’. Applying KSR type reasoning, however, it is easy to see how the board could take notice of the naturally occurring BRCA gene – and force the patent owner into the impossible position of rebutting that ‘administrative notice’ or common sense as KSR would have it.

        1. 5.1.1.1

          iwasthere, you aptly point out why newly discovered, but nonstatutory subject matter is not prior art and cannot be prior art — because it is not prior art.

          Regarding the example, if one creates a new composition artificially, I am sure the courts will declare the subject matter statutory for the reason that it is man made regardless that it is later discovered in nature.

          But if one is trying to patent newly discovered compositions not otherwise known or in public use, there is a problem under 101, not under 102.

          1. 5.1.1.1.1

            that it is man made regardless that it is later discovered in nature.

            Wrong – See Chakrabarty.

            Do you still think the universe is static, Ned?

            1. 5.1.1.1.1.1

              Let’s see your analysis of Myriad’s claims, Billy.

              Go ahead. Show everyone that you’re as smart as you like to pretend that you are.

              Otherwise just shut the e f f up.

              1. 5.1.1.1.1.1.1

                Y.A.W.N.

                Let’s pretend that I did not already explicate the issue here prior to the Myriad Supreme Court decision – the very same discussion you treated in your usual short script manner prior to the case, and then had a vom1tfest of well over 30,000 mewling words of QQ immediately after the case.

                Then look at your own advice of “just shut the e f f up.”

                Have a nice day.

              2. 5.1.1.1.1.1.2

                short script manner prior to the case

                LOL.

                Excuse me, Billy but … seriously? You seem to be suggesting that “prior to the case” I did not discuss at exhaustive length the many strange conundrums raised by tanking man-made compositions under 101 under a theory that the claimed compositions are similar to “naturally occuring” compositions.

                If so, that would be major falsehood on your part, Billy. Let me know if you need a little memory refreshment.

              3. 5.1.1.1.1.1.3

                your many odd obsessions spoke to the OPPOSITE position that you are now admitting to

                All I’m “now admitting”, Billy (and I’ve never deviated from this since the Court’s opinion was issued) is that the Supreme Court held in Myriad that man-made non-naturally occuring isolated polynucleotides with contiguous primary sequences that are identical to some contiguous primary sequence found “in nature” are ineligible for patenting.

                I’m not a fan of the Opinion and I was hoping it wouldn’t turn out the way it did (for reasons I explained at length and which will eventually come home to roost and force the Supreme Court to put substantial limits on its “Myriad doctrine”) but the holding is what it is.

                I have no idea why you believe any of this reflects poorly on me. I do have an idea why you’d be desperate to find any example of an instance where you correctly predicted the result of an important eligibility case, even one where you have no clue about the technology and you’re “analysis” is even less coherent than the Supreme Court’s.

              4. 5.1.1.1.1.1.4

                Your thirty thousand plus words of mewling QQ (and recent protests of “not understanding” the decision, coupled with your odd refusal to admit that I nailed that case all the way up and all the way down tell a different (spin) story Malcolm.

        2. 5.1.1.2

          does the subsequent ‘discovery’ of the naturally occurring … gene and its deemed prior art status invalidate the claim?

          Under Myriad, a claim drawn to an unmodified isolated nucleic acid with a sequence identical to a “naturally occurring” nucleic acid (e.g., a sequence buried in some organism’s ge nome) is ineligible for patenting. The Supreme Court gave us no reason to believe that the date of discovery of the “naturally occuring” nucleic acid changes the outcome. The bigger question now, in my opinion, is: what constitutes a “natural occurrence” of a nucleic acid sequence as opposed to a “non-natural occurrence”? For example, if the occurrence of a particular sequence was unintended by humans but can be traced to some human act (e.g., pollution by mutagens), is it “natural” for the purposes of tanking a claim under 101?

          1. 5.1.1.2.1

            The Supreme Court gave us no reason to believe that the date of discovery of the “naturally occuring” nucleic acid changes the outcome.

            Funny that – that’s the same thing I tried to tell you and you thought it was some other language.

        3. 5.1.1.3

          does the subsequent ‘discovery’ of the naturally occurring … ge ne … invalidate the claim?

          Under Myriad, a claim drawn to an unmodified isolated nucleic acid with a sequence identical to a “naturally occurring” nucleic acid (e.g., a sequence buried in some organism’s ge nome) is ineligible for patenting. The Supreme Court gave us no reason to believe that the date of discovery of the “naturally occuring” nucleic acid changes the outcome. The bigger question now, in my opinion, is: what constitutes a “natural occurrence” of a nucleic acid sequence as opposed to a “non-natural occurrence”? For example, if the occurrence of a particular sequence was unintended by humans but can be traced to some human act (e.g., pollution by mutagens), is it “natural” for the purposes of tanking a claim under 101?

          1. 5.1.1.3.1

            MM, see my post at 5.1.1.1

            I think the problem is claiming as one’s invention a newly discovered product of nature not prior art because it was not known or in public use.

            If one creates a new composition, the patent will be valid even if it is later discovered that the composition is naturally occurring.

            1. 5.1.1.3.1.2

              Ned: If one creates a new composition, the patent will be valid even if it is later discovered that the composition is naturally occurring.

              “Valid”, maybe … but definitely not eligible, at least if the product is an isolated polynucleotide. That’s the Myriad holding.

              I don’t see any suggestion by the Supreme Court that it matters for 101 purposes whether your claimed polynucleotide was “discovered” (e.g., by newly sequencing a part of an organism’s genome) or “created” synthetically (e.g., by a sequencing machine, with a specific new utility in mind). All that matters if whether the contiguous sequence of nucleotides that you recite in your composition claim is found “in nature” somewhere. If the answer is yes, your composition claim is ineligible.

              1. 5.1.1.3.1.2.1

                Hmmm, what exactly does valid but not eligible mean?

                GA would have a comment on the use of the quotes there…

              2. 5.1.1.3.1.2.2

                what exactly does valid but not eligible mean

                In this context it means that a claimed polynucleotide composition with a particular sequence did not exist, as a matter of fact, at the time the application was filed. Therefore the claims can’t logically be deemed anticipated or obvious in view of an identical sequence that later occurred “naturally.” It’s an eligibility issue, not a patentability issue.

                That’s all it means. At least, that’s all that I meant. You can pretend it means something else if you want to, Billy. Gob knows you’re an expert at doing that.

              3. 5.1.1.3.1.2.3

                It’s an eligibility issue, not a patentability issue.

                LOL – you should go back into the archives and check out the message that you refused to listen to (from me) prior to the Supreme Court telling you exactly this very thing.

              4. 5.1.1.3.1.2.4

                the message that you refused to listen to (from me)

                Billy, I am 100% certain that I never once argued that a later-occuring “natural” mutant sequence created a patentability issue for an earlier filed claim reciting an identical sequence.

                You’re doing that thing again when you make up stories that please your fantastically narcissistic views about yourself and then you rely on those fantasies to insult other people.

                If you want to impress everybody, let’s see you analyze some of Myriad’s claims under your beloved “actual law”. Make some predictions and provide your explanations in plain English. Good luck, Billy.

      2. 5.1.2

        Dennis, but if one can give no patentable weight to nonstatutory subject matter, the problem about 101 in IPRs is resolved.

        1. 5.1.2.1

          Funk Bros. (in addition to Hotel Security and its line of cases) are all on point regarding giving nonstatutory subject matter no patentable weight.

          If Myriad objects, this issue can be taken back up to the Supreme Court where the result is highly predictable.

            1. 5.1.2.2.1.1

              patentable weight – exactly in the context of this discussion.

              This is not a hard question.

      3. 5.1.3

        The limitation of prior art to actual publications is significant for these administrative routes, but in court “prior art” can indeed extend to nature itself. Since that’s where this underlying issue of cDNA will surely end up eventually anyway, I agree that the combination/overlap of grounds is the right approach.

        link to ssrn.com

        1. 5.1.3.1

          BME, ““prior art” can indeed extend to nature itself.”

          I STRONGLY DISAGREE to the extent that this statement suggests that anything that not is prior art by statute (102) is prior art for 103 purposes.

          The “exclusion” of nonstatutory subject matter for patentablilty purposes is entirely different.

          1. 5.1.3.1.1

            I STRONGLY DISAGREE to the extent that this statement suggests that anything that not is prior art by statute (102) is prior art for 103 purposes.

            I agree, Ned. It makes no sense to talk of previously unknown “naturally occuring” compositions as “prior art” for any purpose.

            It does make sense, as we discussed above, to give zero patentable weight to the recitation of such compositions in a claim where the claim seeks to protect information about the otherwise ineligible compositions. On the other hand, certain “principled” people might object to ignoring any claim element when undertaking an analysis under 103, given the language of the statute. That just gets us right back into 101, which works equally well for tanking claims with the defects we’re discussing.

            1. 5.1.3.1.1.2

              “I agree, Ned. It makes no sense to talk of previously unknown “naturally occuring” compositions as “prior art” for any purpose.”

              I might agree, but only with a strong 101 in place. Otherwise, we’ll need to put all the natural world in 102 or somewhere else.

        2. 5.1.3.2

          Furthermore, BME, if nonstatutory subject matter can be given no patentable weight, a claim can be invalidated in an IPR or CBM by showing the statutory subject matter is old over printed publications and the like.

      4. 5.1.4

        §101. Inventions patentable

        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.

        (July 19, 1952, ch. 950, 66 Stat. 797.)

        What is there to DISCOVER besides products of nature and natural laws?

        1. 5.1.4.1

          Les – we’ve discussed this before, the word – in the legal context – is not the same as you are attempting to use it here.

            1. 5.1.4.1.1.1

              Your question is not asking what you think that you are asking because you are conflating contexts of the word “discover.”

              1. 5.1.4.1.1.1.2

                The expert?

                Um, you do realize that you can always be the expert at asking a conflated question, but that won’t get you very far.

              2. 5.1.4.1.1.1.3

                Does –arrogance– have a special legal context meaning that I shouldn’t conflate with the plan-meaning too, or am I good to go on that one?

        2. 5.1.4.2

          Les, admittedly the statute reads problematically with respect to products of nature.

          Note, however, that when Thomas Jefferson rewrote the patent laws in 1793, he added compositions to the statute, he added new to the statute, and he removed discovery.

          Thus the statute read something along the lines of the following: he who invents a “new” composition is entitled to a patent therefor.

          When in 1836 the statute was amended again, “discovery” was put back in, and it created the ambiguity you now note. There is inherent tension between “discovery” and “new.” Do not agree? How can one discover something that is new? One discovers something that is old.

          1. 5.1.4.2.1

            Doesn’t that depend on to whom “new” is directed, Ned?

            Take up again (with some trepidation as the risk of muddying the water), our past discussions on the ability to obtain patent rights on those things that were previously trade secrets. Quite arguably (i.e., the famous Senate soliloquy) the AIA now allows patents for such things that are “new to you” – with the “you” being the public, as opposed to the inventor.

            Circling back and answering your question as to how does one discover something that is new, one viewpoint answer is that you can ONLY discover something that is new, as the act of discover is part and parcel of the words “dis” and “cover” so far as what you are uncovering is new to you.

            Of course, the lovely phrase absent (as of yet) from the discussion is “warehouse of nature” and this reminds me of a question that i have oft put to you – that you have never bothered to answer: is the universe static?

            The answer, of course, is no, the universe is not static. And the immediate offshoot of that question comes to light directly in the distinction between section 101 and the different sections of law that are more directly tied to aspects of prior art.

            Again – the notion of what exactly “prior” means can be seen to be reflected in the words (and record) of Congress – again, I reference to the AIA soliloquy and the notion that “new to you” (as I use above) counts as “new” in the patent context.

            1. 5.1.4.2.1.1

              anon, there are two kinds of new, absolute and not previously known, albeit, existing.

              A particular apple variety, a product of nature, is not new even if not previously known. So, the discovery of that apple variety is not patentable even if previously unknown.

              A trade secret process created by man is new. The second inventor also creates something new. In the battle of the new, the statute provides a definition of prior art to determine who gets the patent.

              I think Pennock v Dialogue is consistent with this view.

              1. 5.1.4.2.1.1.1

                is not new even if not previously known.

                Um, no, not according to one of the (at least two) definitions of “new.”

                And that’s kind of the point, isn’t?

                And while we are at it with Pennock, we can also fold into the discussion the notion of inchoate, right?

              2. 5.1.4.2.1.1.2

                New, anon, has to be absolutely new to the entire world.

                The statutes since 1790 independently (until the AIA) prohibited patenting someone else’s invention.

                Regarding “inchoate,” what did you have in mind?

              3. 5.1.4.2.1.1.3

                Um,… no.

                Even before the AIA, independent invention existed (hence, someone inventing – but concealing – can lose out to someone else inventing.

              4. 5.1.4.2.1.1.5

                Les, “New can be “newly discovered.”

                But there is the problem, Les. Consider the 1793 statute. Discover was dropped from 1790 when composition and new were added. I think the point was that just because one discovers a preexisting composition that subject matter is not patentable.

                The word discovery is always used in the context of something old and pre-existing. I think Congress fully intended to exclude patents involving old and pre-existing subject matter except to the extent they are applied to produce something new.

              5. 5.1.4.2.1.1.6

                Why are you considering just one version of the statute in isolation?

                Are you stuck in yesteryear?

              6. 5.1.4.2.1.1.7

                The word is back in now Ned. Doesn’t that support my point? Congress clearly wants discoveries to be eligible subject matter.

              7. 5.1.4.2.1.1.8

                Les, I think this goes to the manner of making an invention. If one discovers a new product of law of nature, one can still obtain a patent on an application of it.

                See the second sentence of 103.

          2. 5.1.4.2.2

            Ned – I don’t see any ambiguity. What I see is that the Judicially created exceptions, especially the ones related to products of nature and natural laws, are clearly baseless and wrong.

            Discoveries are patentable. The only things to discover are products of nature and natural laws. Therefore products of nature and natural laws are clearly patent eligible.

            If the cure for ALS is laying on the floor of the rain forest, I want they guy that finds it to be able to patent his discovery, because I want him to be motivated to find it.

            1. 5.1.4.2.2.1

              Well, Les, I kind of agree. Congress really screwed up Jefferson’s plan if they allowed one to discover and patent old products of nature despite the limitation in 101 that only new compositions are statutory.

              1. 5.1.4.2.2.1.1

                How can Congress “screw up” Jefferson’s plan, when from the start Jefferson (alone) had no right to make such a plan?

        3. 5.1.4.3

          I agree Les. Myraid is IMHO is wrongly decided. The result of which will be large confidential databases of naturally occurring discovered genes owned by the big guys. WRT the discussion, I would lay odds that the board is going to take administrative notice of the naturally occurring BRCA gene – and deem it prior art for the purpose of 102/103 invalidity of the ‘identical’ synthetic BRCA. The board is authorized to make policy through case law.

    2. 5.2

      I haven’t yet found a copy of the briefs that were filed but at least some of the claims being challenged here could be deemed obvious without relying on the Supreme Court’s decision in Myriad.

      Remember that Myriad (plainly one of the worst companies ever to have incorporated) has method claims that purport to protect the sequencing of the BRCA1 gene. These claims recite nothing more than old, conventional sequencing methods directed towards obtaining information about the sequence of a particular gene. There is nothing new in the claim other than ineligible subject matter (i.e., the information obtained by the method and mental steps of thinking about how that information relates to other sequences). Here’s an example (claim 1 of 5,654,155):

      2. A method of identifying individuals having a BRCA1 gene with a BRCA1 coding sequence not associated with breast or ovarian cancer comprising:

      a) amplifying a DNA fragment of an individual’s BRCA1 coding sequence using an oligonucleotide primer which specifically hybridizes to sequences within the gene;

      b) sequencing said amplified fragment by dideoxy sequencing;

      c) repeating steps (a) and (b) until said individual’s BRCA1 coding sequence is completely sequenced;

      d) [ineligible mental steps deleted].

      What Myriad is attempting to do with claims like this (and this has been noted by numerous commenters over the years) is to prevent people from using conventional methods (in the public domain) to obtain information about their own genomes.

      It’s no different than if Myriad had described the structure of a potentially cancer-causing mole for the first time and then filed a patent on a method of using a magnifying class to look at one’s moles to determine whether they belong to the “newly identified” class of moles. No third party can own your moles (or genes, whether cancerous or not) and no third party can prevent you from using methods of looking at naturally-occuring things (like moles or genes) with a magnifying class (or conventional sequencing methods) because all those methods are obvious.

      Rather than reward companies like Myriad who sue people who practice the prior art for the purpose of learning about their genomes (exactly the purpose of that prior art), the patent system should reward companies and people who innovate eligible, improved devices and methods for acquiring that information. That’s how progress is promoted.

  9. 4

    Of course that is one strategy of the patent trolls. You keep everything pending so that if your patent is invalidated, you just go back to the well and get another one on the same disclosure.

    What is going on here, though? Unfortunately, I’d say that the IPR really should have all the invalidity challenges if it has any. The problem is that people will game the system.

    The more complex they make the system the more opportunity to game it and the more expensive it gets. So, it favors the sophisticated people with money.

  10. 3

    each of these patents have been challenged on either 103 (obviousness) or 102 (novelty) grounds

    And you’re going to make us look up the claims and the arguments on our own? Dang.

    Or are these the same excellent and straightforward arguments people have been making for years?

    1. 3.1

      Well, there is no reason to post any claims. You do it, MM, at least several times on each thread.

  11. 2

    You didn’t indicate if any of the challenged patents are being asserted by Myriad against Gene DX. If so, prima facie this seems like a smart move on Gene DX’s part (although I admit I haven’t studied the matter in detail): with the broadest reasonable interpretation standard for claim construction at the PTO, and the understanding that so far, IPR proceedings have been akin to a “patent death squad”, the odds of getting some claims invalidated at the PTO are higher than in court.

  12. 1

    Re calculating the low odds of invalidating all of the attacked claims of that many patents, see:
    “Probabilities of Losing As To At Least One Patent In Multi-Patent Litigation,” Journal of the Patent and Trademark Office Society (JPTOS), October 1986, Vol. 68, No. 10, pp. 498-502.

    1. 1.1

      Interesting, but what are the odds that they will invalidate some and not infringe the others I wonder? How those types of situations tend to turn out would be interesting to know.

      1. 1.1.1

        IPRs are not cheap and few companies go around trying to start them against claims that they are not being accused of, and ususually already being sued for, infringing.

    2. 1.2

      Would be interesting to get an update from a 1986 report. 1986 is like a million dog years ago.

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