Integration vs Filtration: Federal Circuit Asked How to Determine Eligibility

University of Utah and Myriad Genetics are back at the Federal Circuit after losing a motion for preliminary injunction against the genetic testing company Ambry Genetics.  The case still focuses primarily on BRCA genetic testing, although the asserted claims are different from those in the Supreme Court decision.

For instance, Utah has asserted claim 7 of its Patent No. 5,753,441 listed below.

7. A method for screening germline of a human subject for an alteration of a BRCA1 gene which comprises

comparing germline sequence of a BRCA1 gene … from a tissue sample from said subject … with germline sequences of wild-type BRCA1 gene…

wherein a difference in the sequence of the BRCA1 gene … of the subject from wild-type indicates an alteration in the BRCA1 gene in said subject, [and]

wherein a germline nucleic acid sequence is compared by hybridizing a BRCA1 gene probe which specifically hybridizes to a BRCA1 allele to genomic DNA isolated from said sample and detecting the presence of a hybridization product wherein a presence of said product indicates the presence of said allele in the subject.

Because Claim 7 is a dependent claim, I have rewritten it to include the limitations of independent claim 1 and also eliminated some language written in the alternative.  I have also eliminated some redundancy.

The advance embodied by the University of Utah’s BRCA patents all center around the researchers’ discovery of the genetic sequence and location of the naturally occurring BRCA1 and BRCA2 genes and that the mutations correlate with a high risk of cancer.  That discovery itself is not patentable because it is a law of nature, or alternatively, an abstract idea or perhaps even a product of nature.  The question then is whether the claim includes the necessary “something more” – an “inventive concept” that transforms the invention into one that is patent eligible in a way that ensures that fundamental building blocks of science and technology are not monopolized through the patent.  A problem for Myriad on this front is that the tools of hybridized screening were already known and were not themselves inventive concepts at the time.  However, clearly the invention as a whole is practical, transformative, and inventive.

On October 6, 2014, the Federal Circuit heard oral arguments on the case with a panel consisting of Chief Judge Prost, Judge Dyk, and Judge Clevenger.  Oral arguments focused largely on the question of integration versus filtration.  Namely, when applying the second step of the Alice/Mayo analysis, is it proper to consider the invention as a whole integrated invention or must the court first filter-out the excluded subject matter and then ask whether an inventive concept can be found in the remains. It will be interesting to see how the court resolves this important and tricky question.

147 thoughts on “Integration vs Filtration: Federal Circuit Asked How to Determine Eligibility

  1. 12

    Hello Go,

    I know you have asked multiple times. The Supreme Court in Mayo clarified what consider ing the claims as a whole meant in Diehr, with the word, Integrated. Here is the ordinary, contemporary definition and use of the term, from dictionary.com

    integrated

    [in-ti-grey-tid]

    adjective

    1. combining or coordinating separate elements so as to provide a harmonious, interrelated whole.

    2. organized or structured so that constituent units function cooperatively.

    Copyright 2014 Dictionary.com LLC
    The Supreme Court made it expressly clear in Mayo that the claims in Diehr were found statutory because they were, “Integrated”. In reconciling Diehr with it’s precedents the Court established an “Integration Analysis”. Therefore, in all 101 cases the claims must be considered as an “Integrated Whole” in the concluding analysis, as was done in Mayo and Alice. In the concluding analysis, the concept, ( or other Court created exception ) “must” be “Integrated” to the point the concept itself is not preempted. If not the claims will fail 101, as was the case in Mayo and Alice. Business methods and software are not Court created exceptions and therefore should not be treated as such. Instead, such claims should be afforded a full and proper “Integration analysis” as was done in Mayo and Alice and allowed to rise and fall on their individual merits.
    Today, many members of the Judiciary are not following the Court’s Integration and instead following a dissection analysis under the guise of such terms as, filtration, gist, and distillation, or just as flagrant, totally ignoring “Integration” and inserting another test in the concluding analysis, such as machine or transformation. Judge Lourie is the latest and highest ranking member of the courts to do just that. If the Supreme Court wanted to reinterpret it’s precedent in Diehr as standing for any form of dissection it would have done so in Mayo, instead the Court introduced the term “Integrated” and proceeded with a framework that considers the claim as a whole, in its concluding analysis. Those members of the lower courts that ignore, and willfully violate the Supreme Court’s Integration, must be held accountable. They must have their feet held to the fire of the law!

  2. 11

    Regarding “claim as a whole,” from Graham v. John Deere, at 34

    Here, the patentee obtained his patent only by accepting the limitations imposed by the Examiner. The claims were carefully drafted to reflect these limitations and Cook Chemical is not now free to assert a broader view of Scoggin’s invention. The subject matter as a whole reduces, then, to the distinguishing features clearly incorporated into the claims.

    In other words, the novel subject matter unless the old subject matter is somehow integrated that it cannot be ignored.

    1. 11.1

      “In other words, the novel subject matter unless the old subject matter is somehow integrated that it cannot be ignored.”

      No disrespect intended but your post is unintelligible. Besides, whenever you start your comment about a Supreme Court case with, “In other words”, you know you are no longer discussing the Courts words and instead advancing your own agenda.

      1. 11.1.1

        The same agenda that has been “discussed”*** before.

        If you count the running away of valid counter points raised as “discussion.”

        1. 11.1.1.1

          I apologize if this has been addressed ad nauseum but I am confused about the following.

          What exactly, do people mean when they say “claim as a whole.” To me, that phrase means that in 101 or 103 analysis one cannot completely disregard an element of the claim.

          However, it appears to me that some think “claim as a whole” means something else. Something that works around the Alice decision, even.

          Do these people mean that “claim as a whole” mean that (old stuff) + (abstract idea) cannot be analyzed as such and that, by being combined in a claim with (old stuff), an abstract idea becomes patent eligible? I’m just sort of confused.

          Could someone provide an example of a claim that fails 101, or 103 without being considered “as a whole” but does not when it is considered as a whole? Again, sorry if this has been thoroughly addressed.

          1. 11.1.1.1.1

            Do these people mean that “claim as a whole” mean that (old stuff) + (abstract idea) cannot be analyzed as such and that, by being combined in a claim with (old stuff), an abstract idea becomes patent eligible? I’m just sort of confused.

            That is what they mean.

            And, yes, they do perfectly understand the ramifications of that but they pretend not to.

  3. 10

    To watch this unfold:

    I wonder which products can now be copied because of Alice.

    I also wonder if employment agreements are getting heavier towards non-disclosure.

      1. 10.1.1

        When Congress (not the Court) says so.

        By the way, the tally for the Court saying so is at 3 (and those three, no coincidence, are the exact same three that were flagged in the recently released President Clinton papers as being too judicially activist minded).

      2. 10.1.2

        I believe this passage from Chakrabarty applies to Business Method as well.

        We have emphasized in the recent past that “[o]ur individual appraisal of the wisdom or unwisdom of a particular [legislative] course . . . is to be put aside in the process of interpreting a statute.” TVA v. Hill, 437 U. S., at 194. Our task, rather, is the narrow one of determining what Congress meant by the words it used in the statue; once that is done our powers are exhausted. Congress is free to amend § 101 so as to exclude from patent protection organisms produced by genetic engineering. Cf. 42 U. S. C. § 2181 (a), exempting from patent protection inventions “useful solely in the utilization of special nuclear material or atomic energy in an atomic weapon.” Or it may choose to craft a statute specifically designed for such living things. But, until Congress takes such action, this Court must construe the language of § 101 as it is. The language of that section fairly embraces respondent’s invention. Diamond v. Chakrabarty, 447 U.S. 303, 318 (1980).

        I read Justice Stevens’s concurrence in Bilski and the gist of his argument boils down to “traditionally, business methods are not patentable”. It is ironic that “tradition” is applied to laws that are suppose to “promote the progress of science and useful art”, which necessarily encompass inventions not contemplated by Courts and Congress.

        1. 10.1.2.1

          A fully reasonable view Richard. And given the fact that Congress could have EASILY said “no business methods” and have repeatedly NOT DONE SO, the message should be clear.

          1. 10.1.2.1.1

            I should qualify the above cite with these:

            Ass’n for Molecular Pathology v. Myriad, 133 S. Ct. 2107, 2116 (2013) (“without this exception, there would be considerable danger that the grant of patents would ‘tie up’ the use of such tools and thereby ‘inhibit future innovation premised upon them…this would be at odds with the very point of patents, which exist to promote creation””); Richmond Screw Anchor Co. v. U.S., 275 U.S. 331, 346 (1928) (explaining that when interpreting statutes, the Supreme Court has a duty to reach a conclusion that will avoid serious doubt of their constitutionality); Robertson v. Seattle Audubon Soc., 503 U.S. 429, 441 (1992) (citing NLRB v. Jones & Laughlin Steel Corp., 301 U.S. 1, 30 (1937)) (stating that between a valid interpretation and an unconstitutional interpretation of a statute, the Supreme Court has a duty to adopt the valid interpretation).

      3. 10.1.3

        Whenever we thought of business methods, we think about the one-click patent, method to training a cat, swing it side ways and etc. But we should also remember Henry Ford’s method of mass assembly and distributive tasking, which made our industrial capacity much more efficient than Japan and Nazi Germany. Are we willing to exclude Henry Ford’s method just to exclude a million “one-click”, “swing it sideways” etc.?

  4. 9

    As a general proposition, I think it’s fair to say that the issues presented by claims that recite “products of nature” and/or the use of conventional methods for detecting otherwise ineligible compositions are quite different from the issues presented by claims to, e.g., the use of computers to “automate” otherwise ineligible information processing tasks.

    Myriad’s counsel focused quite a bit on the definition of “conventional” and asked an interesting question: is it proper to read the new subject matter out of a step and then define that step as “conventional”? The problem with that question is that, in the case of claim 7, the hybridization “step” is the only potentially eligible subject matter in the claim … and other than the recitation of ineligible subject matter (the BRCA1 gene probe) it is conventional. In addition, the BRCA1 gene is used in that conventional step for the decidedly obvious purpose of detecting its complement (a purpose that would not suffice as a substantial utility for a new nucleic acid — the presumed difference here is the ineligible information about cancer risk that allegedly flows from the result of the hybridization).

    I thought both attorneys did a pretty good job of presenting their cases. I was disapppointed when the counsel for Ambry pointed to the research method claim (inserting the gene into a cell to see what happens — another obvious no-brainer application of any new polynucleotide) as an example of a claim that might be eligible. That claim struck me as quintessentially ineligible given the ineligibility of the gene itself.

    1. 9.1

      The only argument that had any sway with me was a question from one of the judges – what kind of claim would incentivize the release of the clearly ineligible natural law information? That’s a good question.

      is it proper to read the new subject matter out of a step and then define that step as “conventional”?

      The answer has to be yes, otherwise you would have a situation where there was a different eligibility determination based upon whether someone phrased it by using a “wherein” clause or not, or whether someone wrote out the step versus simply truncating the already-known act. Eligibility does not depend upon the draftsman’s skill.

      1. 9.1.1

        Mayo, 132 S.Ct. at 1298 (“Anyone who wants to make use of these laws must first administer…so the combination amounts to nothing significantly more than an instruction to doctors to apply the applicable laws…”); see also id. at 1299-30 (defining conventional steps as steps that must be taken in order to apply the laws in question).

        In light of how the Supreme Court defined “well-understood, routine, conventional activity previously engaged in by those in the field”, i think the answer should be no, it would be improper to read the new subject matter out of a step and then define that step as conventional unless that step is necessary to apply the subject matter / judicial exception in question.

        1. 9.1.1.1

          it would be improper to read the new subject matter out of a step and then define that step as conventional unless that step is necessary to apply the subject matter / judicial exception in question

          Well, in that case reading the new (ineligible) subject matter out of a step is proper here because the step in which the ineligible subject matter appears is definitely necessary for the method to work. That step is the only non-mental act in the claim.

        2. 9.1.1.2

          unless that step is necessary to apply the subject matter / judicial exception in question.

          By that logic, if your claim is directed to “applying abstract idea X on a computer” then the limitations directed to doing it on a computer would be necessary and the claim would be ineligible. Simple Alice, Right?

          But if you simply change your claim to direct it to “applying abstract idea X generally”, then the limitations directed to doing it on a computer would not be necessary (as a computer is not the only way to do it) and the claim would be eligible.

          Eligibility does not depend on the draftsman’s skill.

          1. 9.1.1.2.1

            I don’t think thats what the Supreme Court meant by “necessary”. Its more in line with how we make inherency rejections where a feature is inherent when it is necessarily present under all circumstances.

            I think Judge Rader got the proper definition of “necessary”. Ultramercial, Inc. v. Hulu, LLC, 722 F.3d 1335, 1348 (Fed. Cir. 2013) (“whether implementing the abstract idea in the context of the claimed invention inherently requires the recited steps…steps were those that anyone wanting to use the natural law would necessarily use”).

            In order to watch Tv, you necessarily has to turn it on. In order to drink water, you necessarily need to find a water source. So the correct way to frame it for “applying abstract idea generally” is to ask whether this abstract idea necessarily requires a computer.

            For example, applying decryption algorithm to decipher Caesar’s cipher does not necessarily require a computer since Caesar does not have a computer when he was fighting the Gauls. However, to decipher Edward (aka the rat in Moscow) S’s decryption algorithm would necessarily require a computer.

    2. 9.2

      As a general proposition” – Prof Crouch disagreed with you the last time you trotted this out.

      It would have been nice to see that conversation evolve further.

  5. 8

    This just shows how crazy this Alice Corp “test” is.

    “Does the claim relate to an abstract idea?”

    Show me a claim that doesn’t.

    But to answer the question, the claim must be considered as a whole.

    Of course, The Supremes might disagree.

    1. 8.1

      This just shows how crazy this Alice Corp “test” is.

      “Does the claim relate to an abstract idea?”

      Show me a claim that doesn’t.

      That’s not the Alice Corp test.

    2. 8.2

      I’d say that Alice kills hand-waving in claims. There are two limitations in this claim that should end this discussion.

      wherein a difference in the sequence of the BRCA1 gene … of the subject from wild-type indicates an alteration in the BRCA1 gene in said subject,

      detecting the presence of a hybridization product

      Just say how you do it.

      What difference are you claiming?

      And what are you doing to detect the presence?

      I get the result of those claims won’t be as broad, but they would have a much, much higher chance of surviving an Alice challenge.

  6. 7

    Dennis Crouch said: ” Namely, when applying the second step of the Alice/Mayo analysis, is it proper to consider the invention as a whole integrated invention or must the court first filter-out the excluded subject matter and then ask whether an inventive concept can be found in the remains.”

    There is no question that the claims “must” be considered as an “Integrated-Whole” from the first step to the second step to the final conclusion. This was the groundbreaking precedent set in Diehr and upheld in every 101 case since, including the Prometheus case (which introduced the term “Integrate”) and the subsequent Alice two step test. Furthermore this “Integration Analysis” is cemented in the permanent Official 101 Guidance for ALL categories. With that in mind let’s apply a text book ” Integration Analysis” to these claims using the law and the Office Guidelines.

    1. First determine whether the claim is directed to one of the four statutory categories of invention, i.e., process, machine, manufacture, or composition of matter.

    The answer is yes, it’s a “method”.

    2. Next, if the claim does fall within one of the statutory categories, determine whether the claim is directed to a judicial exception (i.e., law of nature, natural phenomenon, and abstract idea) using Part one of the two-part analysis .

    The method clearly “involves” a law of nature/ natural phenomenon but does it “cover” a law of nature/ natural phenomenon? Cover means , that no one else can use the law of nature/ natural phenomenon “involved” in the claim. I do not believe the claims cover a law of nature/ natural phenomenon, or what the Court says is pre-empting the Judicial Exception, therefore the question of 101 can legally stop right here and the examination can move on to 102, 103, and 112.

    However let’s say for the sake of argument and a thorough demonstration, that an expert witness for example, proved the claims did in fact cover a law of nature/ natural phenomenon. Now we proceed to step two and ask, “Do the claims as an “Integrated” whole achieve more than the sum of it’s individual parts or elements? (The court MUST look at each individual element and compare the results of each to the claims as a whole.) If the answer is yes this innovative combination legally transforms the claims into something significantly more, an inventive application of the law of nature/ natural phenomenon and the claims are thus statutory subject matter. And that’s how it’s done, by the book.

    1. 7.1

      The method clearly “involves” a law of nature/ natural phenomenon but does it “cover” a law of nature/ natural phenomenon? Cover means , that no one else can use the law of nature/ natural phenomenon “involved” in the claim.

      That is incorrect. The issue is not whether “no one else” can use the ineligible subject matter. The issue is whether any single person becomes an infringer because they use the ineligible subject matter but are otherwise acting lawfully.

      That’s why the recitation of a prior art data-gathering step does not (and never will) save a claim that recites only an additional ineligible “new” step of mentally processing the gathered data.

      1. 7.1.1

        MM: “That is incorrect..”

        According to SCOTUS it is correct.

        The Court calls it pre-emption.

        Look it up.

        MM: “That’s why the recitation of a prior art data-gathering step does not (and never will) save a claim that recites only an additional ineligible “new” step of mentally processing the gathered data.”

        Imagine your proposition as a big blue balloon and along comes this very sharp pin called “Integration”.

        Guess what happens next?

        1. 7.1.1.1

          According to SCOTUS it is correct.

          It’s only “correct” insofar that it represents one extreme in a continuum of different facts that will lead to a finding of ineligibility.

          There is no Supreme Court case that says that some substantial fraction of the public needs to be affected by a claim in order for a claim to be found ineligible and there never will be such a case.

          All that’s required to find a claim ineligible is for one single person to be turned into a infringer when he/she does nothing more than (1) practice the prior art and (2) practice the otherwise ineligible step recited in the claim. How could it possibly be otherwise? I guess the claim could be deemed unenforceable against that person and still be held eligible although I don’t see a court attempting to thread that needle anytime soon.

          Imagine your proposition as a big blue balloon and along comes this very sharp pin called “Integration”.

          Here’s a better idea: imagine that you’ve been asked for years to explain how an ineligible mental process can be “integrated” with a prior art data gathering step and every time you fail to provide an answer. What does that do to your credibility?

          Thanks.

          1. 7.1.1.1.1

            MM: “There is no Supreme Court case that says that some substantial fraction of the public needs to be affected by a claim in order for a claim to be found ineligible and there never will be such a case.”

            I never said there was such a case . Your response is a strawman argument that does not address the text book “Integration Analysis” I presented at 7 above. Try dealing with that why don’t you?

            MM: “Here’s a better idea: imagine that you’ve been asked for years to explain how an ineligible mental process can be “integrated” with a prior art data gathering step and every time you fail to provide an answer.

            And that is your answer and quite the point. When applying “Integration Analysis” you do not dissect, ignore, filter, (or whatever the latest code word is..) any elements/steps whatsoever. And you certainly do not strip a process down to ineligible sub processes etc. You MUST consider the claims as an “Integrated whole”.

            If I invent a process and one or more steps are mental, data gathering, or whatever you want to label them , then my claim can still be statutory subject matter because you MUST consider the claims as an “Integrated Whole”. That’s the law. Get it?

            MM: What does that do to your credibility?”

            My work speaks for itself. See my text book “Integration Analysis” at number 7. You can’t touch that.

            1. 7.1.1.1.1.1

              See my text book “Integration Analysis” at number 7. You can’t touch that.

              Well, I already did touch it.

              You wrote: Cover means , that no one else can use the law of nature/ natural phenomenon “involved” in the claim.

              In the context you provided, your statement is inaccurate, to say the least, and I explained why. If you need additional explanation, I am happy to write you a new short chapter for your “text book.”

              I never said there was such a case . Your response is a strawman argument

              There is no “strawman argument”. I asked you for a case because I was hoping you had some explanation for your definition of “cover” which, as I have noted, is incorrect in this context. Again: as long as your claim turns any single person who is otherwise acting lawfully (e.g., practicing the prior art) into an infringer when that person practices the ineligible subject matter (e.g., thinks about a new correlation), then the claim is ineligible. End of analysis.

              Perhaps, given your extraordinary expertise in this area, you can offer some practical advice to would-be innovators. Let’s say I discover a correlation between a previously known DNA sequence (let’s call it Sequence X) and the likelihood that a person will be diagnosed with Richter’s Disease. Two questions: How can I use the patent system to prevent other people from using that correlation? Can you show me a claim that will achieve that goal and also survive 101 scrutiny? Thanks!

              1. 7.1.1.1.1.1.1

                MM:”I asked you for a case because I was hoping you had some explanation for your definition of “cover” which, as I have noted, is incorrect in this context.”

                Okay, let’s get this straight.

                Dennis Crouch said: Namely, when applying the second step of the Alice/Mayo analysis, is it proper to consider the invention as a whole integrated invention or must the court first filter-out the excluded subject matter and then ask whether an inventive concept can be found in the remains.”

                101 Integration Expert Responds: There is no question that the claims “must” be considered as an “Integrated-Whole” from the first step to the second step to the final conclusion. ( I back my statement up at 7 with a detailed text book Integration Analysis right from the pages of the USPTO Official Guidance.) And somehow you, Malcolm Mooney think by simply disagreeing with the definition of one word in my analysis, ( cover ) you have invalidated my above answer to Dennis question and the application of the Supreme Courts Integration that followed?

                Well, you are going to have to do more than that to Invalidate the “Integration Analysis” I presented at 7. Furthermore I did provide the Courts pre-emption as the context for my use of the word, of cover. So rather than running off into left field with some new proposition of your own choosing which has no force of law or official backing what you must do now is demonstrate and prove that the Courts pre-emption is somehow wrong, and thus “Filtration”..aka the new dissection as opposed to Integration is the correct way to determine 101 statutory subject matter.

      2. 7.1.2

        “The issue is not whether “no one else” can use the ineligible subject matter. The issue is whether any single person becomes an infringer because they use the ineligible subject matter but are otherwise acting lawfully.”

        Both are kind of “the issue”. He’s right that preemption is definitely the rock bottom concern. Effective preemption (that you’re talking about) even though you didn’t entirely lock x down is likewise of concern.

        1. 7.1.2.1

          Both are kind of “the issue”. He’s right that preemption is definitely the rock bottom concern.

          Depends on how you define “pre-emption”. 101E says “look it up” (gosh that sounds familiar) but he doesn’t say where the definition is found.

          Again: I’m not suggesting that a claim which “pre-empts” everyone (or nearly everyone) in the world from studying some natural phenomenon is likely to be eligible.

          Rather, I am just stating a simple critical fact that was left out of 101E’s “textbook”: there is no requirement to provide evidence that some large fraction of people are “pre-empted” by a claim before that claim is deemed ineligible. All it takes is a showing that a single person who is practicing the prior art can be turned into an infringer when he/she practices an additional ineligible step in the claim.

          The “rock bottom” concern is the nullification of claims that protect ineligible subject matter, regardless of how narrowly that ineligible subject matter is claimed and regardless of how many people are “pre-empted” by the claim.

          1. 7.1.2.1.1

            “there is no requirement to provide evidence that some large fraction of people are “pre-empted” by a claim before that claim is deemed ineligible.”

            Oh, of course not.

          2. 7.1.2.1.2

            MM: “Rather, I am just stating a simple critical fact that was left out of 101E’s “textbook”: there is no requirement to provide evidence that some large fraction of people are “pre-empted” by a claim before that claim is deemed ineligible. ”

            You are stating another strawman argument because no one is arguing for or against the alleged fact you present above. At the end of the day you have still failed to invalidate the Integration Analysis I presented at 7.

            And as is your custom, you have not even tried to answer the question proffered by Dennis as to whether Integration or Filtration ( Dissection ) is the correct way to determine 101 statutory subject matter.

    2. 7.2

      I do not believe the claims cover a law of nature/ natural phenomenon

      The claim is clearly directed to a natural relationship, and even Myriad admits that. They aren’t arguing the judicial exception isn’t implicated, they’re arguing they beat step 2 because the claim as a whole is something more, so you’re way out on a limb by saying it doesn’t even get that far.

      Now we proceed to step two and ask, “Do the claims as an “Integrated” whole achieve more than the sum of it’s individual parts or elements?

      Well that’s clearly not the rule, but even under what you would consider the correct rule (that we consider the claim as a whole under 101) it would fail, because all it is claiming is an insignificant data gathering step and a calculation step that utilizes an ineligible relationship.

      I don’t think that you even consider it as an integrated whole though. All Diehr said is that when there is an invention (automated mold timing) which used a mathematical equation as a means of achieving the improvement, you don’t artificially segment out the math equation and call it ineligible. But that was a novel improvement which happened to rely upon an equation for its means. But this invention has no novel improvement other than the ineligible subject matter of the natural relationship. It’s perfectly reasonable to (as the court always has) consider all of the limitations, segment out which are the novel limitations and focus on them.

      These claims are similar to Mayo where the court took each limitation on its own and pointed out that the administering step was directed to a pre-existing audience, the wherein clauses were directed to the natural phenomena and the determining step was admittedly well-known in the art. So, like here, it is nothing more than conventional steps applied to a disclosed correlation. Here’s a direct quote from Mayo which applies equally well to these claims:

      The upshot is that the three steps simply tell doctors to gather data from which they may draw an inference in light of the correlations. To put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well-understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately. For these reasons we believe that the steps are not sufficient to transform unpatentable natural correlations into patentable applications of those regularities.

      1. 7.2.1

        >>The claim is clearly directed to a natural relationship,

        This is witch hunting talk. In every invention this is true. Your statement holds no more meaning than to say this invention is directed to innovation.

        1. 7.2.1.1

          >>The claim is clearly directed to a natural relationship,

          This is witch hunting talk. In every invention this is true.

          Most of us can read the statement in context and understand exactly what is being discussed. There is no “witch hunting.”

      2. 7.2.2

        Random: “The claim is clearly directed to a natural relationship, and even Myriad admits that..”

        Even if it true such an admission would not mean or prove that the claims as an “Integrated-Whole” are directed to a law of nature or natural phenomenon. Remember, that if the claims as a whole are directed to a law of nature/natural phenomenon or abstract idea you have claimed a Court created judicial exception and your claims are non statutory. I listened to the oral proceedings twice now and never heard the counsel make such an admission.

        Random:They aren’t arguing the judicial exception isn’t implicated,

        I am not saying they are. And why would they even need to make such an argument? Just because your claim “implicates” a Judicial exception does not make it non statutory. You understand this right?

        Random”…they’re arguing they beat step 2 because the claim as a whole is something more, so you’re way out on a limb by saying it doesn’t even get that far….”

        The example of “Integration Analysis” I made at 7 was not based on what the counsel did or did not say or argue. In fact, as far as I can tell they did not make a proper “Integration” argument at all! I gave an example of how the claims would be valid using the Alice Two step test at both one or two from an “Integration” as opposed to a so called Filtration ( dissection ) analysis. So your above statement is baseless and without merit.

      3. 7.2.3

        “those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately. For these reasons we believe that the steps are not sufficient to transform unpatentable natural correlations into patentable applications of those regularities.”

        In Mayo, the claim was to a manifestly evident law of nature in the form of a naturally occurring correlation. The Court did not need to dissect the claim or distill it down to a gist in order to determine this. However the claim was applied in a process consisting of a series of steps, which according to the statute would make the claim eligible subject matter. But again the Court has made law that says laws of nature/natural phenomenon, like abstract ideas are exceptions to statutory subject matter. So the Court took a closer look to see if any individual step or the claims as a whole were doing something more than simply stating the law of nature itself. As we know the steps did not add anything more. In the words of the Court, “… steps consist of well understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately. ” (Prometheus) BTW, this is the rule for step two of the two step test and where it comes from. The claims in Prometheus failed step two of the two step test.

        Unless you can get a SME to prove other wise, in the case of Myriad, at least at claim 7, there was no manifestly evident law of nature. The fact that you would have to filter out or ignore elements or parts of the claim to identify a law of nature would be proof of this. Therefore there is no need to even proceed to step two of the two step test. But as I demonstrated at 7, even at step two the claims are statutory subject matter when considered as an Integrated-Whole, as they must. Like I said, the Integration Analysis I present at 7 is untouchable.

      4. 7.2.4

        Random: “I don’t think that you even consider it as an integrated whole though. All Diehr said…”

        Wait, let Diehr speak for himself please…

        “In determining the eligibility of respondents’ claimed process for patent protection under §101, their claims must be considered as a whole. It is inappropriate to dissect the claims into old and new elements and then to ignore the presence of the old elements in the analysis. This is particularly true in a process claim because a new combination of steps in a process may be patentable even though all the constituents of the combination were well known and in common use before the combination was made. The “novelty” of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the §101 categories of possibly patentable subject matter.12

        12 It is argued that the procedure of dissecting a claim into old and new elements is mandated by our decision in Flook which noted that a mathematical algorithm must be assumed to be within the “prior art.” It is from this language that the Government premises its argument that if everything other than the algorithm is determined to be old in the art, then the claim cannot recite statutory subject matter. The fallacy in this argument is that we did not hold in Flook that the mathematical algorithm could not be considered at all when making the §101 determination. To accept the analysis proffered by the Government would, if carried to its extreme, make all inventions unpatentable because all inventions can be reduced to underlying principles of nature which, once known, make their implementation obvious. The analysis suggested by the Government would also undermine our earlier decisions regarding the criteria to consider in determining the eligibility of a process for patent protection. See, e.g., Gottschalk v. Benson, 409 U.S. 63, 175 USPQ 673 (1973); and Cochrane v. Deener, 94 U.S. 780 (1876).

        And to top it off 2012 Interim Procedure for Subject Matter Eligibility Analysis of Process Claims Involving Laws of Nature…

        “IV. SAMPLE ANALYSIS
        A. Sample Claim Drawn to a Patent-Eligible Practical Application – Diamond v. Diehr
        1. A method of operating a rubber-molding press for precision molded compounds with the
        aid of a digital computer, comprising:
        providing said computer with a data base for said press including at least, natural
        logarithm conversion data (ln), the activation energy constant (C) unique to each batch of
        said compound being molded, and a constant (x) dependent upon the geometry of the
        particular mold of the press,
        initiating an interval timer in said computer upon the closure of the press for
        monitoring the elapsed time of said closure,
        constantly determining the temperature (Z) of the mold at a location closely adjacent
        to the mold cavity in the press during molding,
        constantly providing the computer with the temperature (Z),
        repetitively calculating in the computer, at frequent intervals during each cure, the
        Arrhenius equation for reaction time during the cure, which is
        ln v = CZ + x where v is the total required cure time,
        repetitively comparing in the computer at said frequent intervals during the cure each
        said calculation of the total required cure time calculated with the Arrhenius equation and
        said elapsed time, and
        opening the press automatically when a said comparison indicates equivalence.
        The above claim was found to be a patent-eligible practical application in Diamond v. Diehr, 450
        U.S. 175 (1981). Recently, the Supreme Court looked back to this claim as an example of a
        patent-eligible practical application as explained in the following excerpt from Mayo:
        The Court pointed out that the basic mathematical equation, like a law of nature, was not
        patentable. But it found the overall process patent eligible because of the way the additional
        steps of the process “integrated” the equation into the process as a whole. Those steps included
        “installing rubber in a press, closing the mold, constantly determining the temperature of the
        mold, constantly recalculating the appropriate cure time through the use of the formula and a
        digital computer, and automatically opening the press at the proper time.” [ ] It nowhere
        suggested that all these steps, or at least the combination of those steps, were in context
        obvious, already in use, or purely conventional. And so the patentees did not “seek to preempt
        the use of [the] equation,” but sought “only to foreclose from others the use of that equation in conjunction with all of the other steps in their claimed process.” [ ] These other steps apparently added to the formula something that in terms of patent law’s objectives had
        significance—they transformed the process into an inventive application of the formula. See Mayo at 1969 (emphasis added).

        This claim would pass Inquiries 1-3 in the above analysis as it is a process that includes the Arrhenius equation as a limitation, with additional steps that “integrate” the Arrhenius equation
        into the process and are sufficient to narrow the scope of the claim so that others are not foreclosed from using the Arrhenius equation in different applications.

  7. 6

    “Namely, when applying the second step of the Alice/Mayo analysis, is it proper to consider the invention as a whole integrated invention or must the court first filter-out the excluded subject matter and then ask whether an inventive concept can be found in the remains.”

    If you catch yourself asking this question then you already messed up step 2. :/

  8. 5

    Dennis: does the filtration-approach block consideration of any step where the discovered gene itself is a critical aspect of the novelty?

    As alluded to by the Federal Circuit in the oral arguments, if the “discovered gene” was modified in some novel manner (with the modification recited in the claim) I think that eligibility becomes nearly certain. But that, arguably, doesn’t answer your question because “the discovered gene itself” is essentially written out of the claim.

    Also, because it’s a chemical, it is always possible for a “a discovered gene itself” to have unexpected useful properties. The use of “the discovered gene itself” in a method to achieve a transformation of matter that was previously unattainable or outside of the knowledge of skilled artisans would remain eligible for patenting.

    With respect to the facts in this case, it’s important to remember that the ability of one nucleic acid (e.g., a “gene probe”) to hybridize with its complement is entirely expected and that has been the case for a long, long time.

    What Myriad is doing here is essentially trying to run around the Supreme Court and the Federal Circuit’s previous decisions holding their claims to the “isolated” DNA sequences ineligible as well as the methods of “comparing” sequence information (those methods that can be carried out mentally after someone else has obtained the information).

    Permitting this kind of “end around” — where all the known methods of obtaining the (ineligible) sequence information are claimed — nullifies those holdings because the public is still prohibited from using public domain tools to obtain information about a genome. In other words, having been told that it could not own the gene, Myriad is now attempting to build a giant (and obvious) fence around the gene to prevent anyone else from looking at it.

    1. 5.1

      Or this may simply fulfill the Supreme Court’s “It is now commonplace that an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection”. Diamond v. Diehr, 450 U.S. 175, 187 (1981).

      While the public may be prohibited from using the BRCA gene in the manner set forth by the claim, the public is free to develop another method of using BRCA gene to detect cancer. I don’t think there is an issue of pre-empting every possible implementation of using BRCA including those not discovered by Myriad.

      The Supreme Court “judicial exception” is a device of statutory interpretation to avoid striking down 101 as being unconstitutional. Remember that the Supreme Court is simply trying to adhere to the plain language of the Constitution “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”.

      Under this clause, Federal patent laws passed by Congress must preserve the careful balance to promote the progress of science and useful art by limiting the granting of exclusive rights with scopes that cover only what the inventor discovered and nothing more. While Congression may have intended 101 to authorize patents whose scope exceeds what the plain language of the Constitution allowed, the judicial exceptions limited 101 within the confine of the Constitutional command.

      For example, Morse was the first to discover a particular machine implementation of using electro-magnetism for printing or marking characters at a distance. Nevertheless, Morse was not entitled to claim electro-magnetism for printing at a distance because the scope of the claim would include future discovery of less expensive and less complicated machine implementations that are not based on Morse’s implementation and that Morse did not discover. Here, granting Morse an exclusive privilege over the idea of using electromagnetism (which is a principle, a law of nature or natural phenomena) to print characters at a distance to cover both implementations that Morse discovered and unrelated implementations that Morse did not discover would exceed the balance struck by the plain language of the Constitution.

      Under this doctrine, claims are patent eligible if they are limited to a particular application of the judicial exception even if that application may be obvious under 103, so long as it is not purely conventional / obvious / generic.

      In contrast to Morse, this “end around” is actually an implementation of how to use a BRAC gene. While the public would be pre-empted from using this particular implementation, the public is free to use BRAC in other manner. This is unlike Morse claims to using electro-magenetism to print at a distance, however developed, or Myriad’s claim to isolated BRAC gene per se because the particular comparison steps exceeded a generic or purely obvious “compare it” or “compare it by hybridizing” or some other drafts-man tricks equivalent to “apply it”.

      1. 5.1.1

        In simple words, the scope of the claim is limited to only what Myriad discovered and there is little danger that it would pre-empt any and all use of the BRAC gene.

        1. 5.1.1.1

          the scope of the claim is limited to only what Myriad discovered and there is little danger that it would pre-empt any and all use of the BRAC gene.

          There’s a bigger picture that’s missed by any eligibility analysis that requires “any and all uses” to be pre-empted by a particular claim.

          Every one of the “uses” of the BRCA gene claimed by Myriad are obvious uses once you have the ineligible sequence information and/or the ineligible isolated gene in one’s possesssion. The claims could have been written (and probably were) without any knowledge of the specific BRCA gene sequences that are recited.

          Imagine that you discover that the existence of a microscopic hair in one’s ear is correlated with cancer. You can’t claim that fact. And you can’t claim “Detecting the existence of the microscopic hair by any detection means known in the art.” So why should one be allowed to achieve the same result (preventing anyone from looking at that microscopic hair) by writing four independent claims that, taken together, cover all known methods of looking at that microscopic hair? What’s the policy distinction?

          1. 5.1.1.1.1

            I agree you cannot claim “Detecting the existence of the microscopic hair by any detection means known in the art”. But that is not what Myraid is claiming here.

            Myriad claims a particular manner of doing that. Even if that particular manner may be known in the art under 103, the scope of the claim is not like “Detecting the existence of the microscopic hair by any detection means known in the art”, its more like a particular manner of detecting the existence.

            The policy distinction being that patents inherently pre-empts future development of judicial exceptions by others. However, when that development is based on the disclosure of patentee’s implementation, then the patentee should have an exclusive right to pre-empt that future development. In contrast, when the future development is not based on disclosure of patentee’s implementation, then whatever exclusive right the patentee has should not cover that development.

            So, it is not okay for Myriad to claim comparing BRCA genes, however developed. It is okay for patentee to claim using BRCA genes with method A (so long as method A is not something along the line of “compare it” or “compare by hybridizing” or something with that general breadth), even if method A is well known because such exclusive right would not pre-empt using BRCA genes with method B, C, or D.

            I have no more idea about “other manner” than the Supreme Court justices who held that Morse’s claim pre-empts future development of less complicated and less expensive implementations of printing at a distance not disclosed by Morse. Rather, my argument is that the claim is patent eligible because it only covers what Myriad disclosed and no more.

            1. 5.1.1.1.1.1

              I agree you cannot claim “Detecting the existence of the microscopic hair by any detection means known in the art”. But that is not what Myraid is claiming here.

              I never said otherwise. Read carefully what I wrote. Myriad’s broader independent claims with extraordinary breadth were already found ineligible. I asked you a more specific question and you didn’t answer it. I will ask you the question again (see below).

              The policy distinction being that patents inherently pre-empts future development of judicial exceptions by others. However, when that development is based on the disclosure of patentee’s implementation, then the patentee should have an exclusive right to pre-empt that future development.

              In your opinion, could Myriad claim “A method for isolating DNA to at least 10% purity, wherein said DNA is BRCA1 DNA”? Please explain your answer and square your answer with the Myriad decision. Does your answer change if the level of purity is at least 90%? If so, explain why.

              It is okay for patentee to claim using BRCA genes with method A (so long as method A is not something along the line of “compare it” or “compare by hybridizing” or something with that general breadth), even if method A is well known because such exclusive right would not pre-empt using BRCA genes with method B, C, or D.

              And what if they separately claim the use of methods B, C and D in addition to A. What then?

              my argument is that the claim is patent eligible because it only covers what Myriad disclosed and no more.

              That analysis can’t be correct, at least not as you’ve formulated it here. Such an argument could have been used to justify the eligibility of any of Myriad’s claims because all the claims are “limited”, directly or indirectly, to the gene sequences that Myriad allegedly discovered.

              It is okay for patentee to claim using BRCA genes with method A (so long as method A is not something along the line of “compare it” or “compare by hybridizing” or something with that general breadth)

              “Compare it by hybridizing” is exactly what claim 7 describes, isn’t it?

              1. 5.1.1.1.1.1.1

                “Myriad’s broader independent claims with extraordinary breadth were already found ineligible”. Extraordinary breadth per se is not concern of 101. Rather, 101 is only concerned with claims whose breadth covers more than what the specification disclosed and hence not discovered by the applicant. I understood your position but i think you are just wishing 101 to be more than what the Supreme Court decided.

                “In your opinion, could Myriad claim “A method for isolating DNA to at least 10% purity, wherein said DNA is BRCA1 DNA”? Please explain your answer and square your answer with the Myriad decision. Does your answer change if the level of purity is at least 90%? If so, explain why.”

                Myriad Decision invalidated claim to isolated BRCA1 gene per se but upheld the cDNA claim. I don’t recall any method claims.

                Anyway, Claims to method for isolating DNA to 10% or 90% purity where DNA is BRAC1 are patent ineligible. The Supreme COurt defined judicial exceptions as: laws of nature, natural phenomena, and abstract ideas; abstract ideas being a category consists of principles / fundamental truths, original cause, motives, algorithms and mental processes or abstract intellectual concepts. Diamond v. Diehr, 450 U.S. 175, 185-86 (1981). See also Gottschalk v. Benson, 409 U.S. 65, 67 (1972).

                The aforementioned claim simply states a principle or motive to isolate BRAC1 genes at 10% or 90% purity much like Fulton claiming the use of steam to propel a mechanical vessel, however developed. These claims do not pass under Alice Step One as it contains no useful claims of patentability other than the principle itself. Rather, the entire claim is treated as though it was a familiar part of the prior art and hence 101 “new and useful” was not enacted to protect them.

                “And what if they separately claim the use of methods B, C and D in addition to A. What then?”

                If they so claim, they are still patent eligible unless B, C, and D are super generic or purely obvious/conventional. Once they limit the scope of their exclusive right to a particular implementation such as B, C, or D, then the first door (101) is opened and we proceed to the second door (112) and the third door (102/103) to determine whether Myriad sufficiently disclosed enough to support the breadth of their claim (i.e., Lizardtech v. Earthmap Resources) and whether viewing B, C, or D as a whole with the judicial exception, it merits patentability under 102/103.

                “That analysis can’t be correct, at least not as you’ve formulated it here. Such an argument could have been used to justify the eligibility of any of Myriad’s claims because all the claims are “limited”, directly or indirectly, to the gene sequences that Myriad allegedly discovered. ”

                This is not my analysis. Rather, the Supreme Court precedents on Morse, MacKay, Flook, Diehr, Bilski, Mayo, Myriad and Alice stood for the proposition that if we interpret 101 in accordance to Congressional intent, then we are interpreting 101 to authorize exclusive privileges to cover what patentees did not discover. Therefore, Supreme Court read “new and useful” under 101 to exclude judicial exceptions to cover only what the patentee discovered. The key is, there is a difference between discovering something versus patenting that something.

                This is why “to promote the progress of science and useful art” is a limitation because it distinguishes the type of exclusive rights on discoveries that promote progress from the type of exclusive rights on discoveries that obstruct the progress. Here, the type of discoveries that obstruct the progress are those patents with scope so broad that cover what patentees did not discover.

                In Myriad, the Supreme Court struck down the claim to isolated BRAC gene because even though Myriad discovered the BRAC gene as being useful to detect cancer and discovered a method to isolate BRAC gene, Myriad cannot claim the isolated BRAC gene per se since the scope of the patent covers any and all use of BRAC gene including those uses Myriad did not disclose.

                For the same reason, Einstein cannot claim E = MC (square) because the claim includes any and all use E= MC (square) to include anti-matter rocket engine build by future innovators even when Einstein played no role in making such engine (if such patent is eligible, then USPTO may be liable for Fifth Amendment taking claims by engineers of anti-matter rocket engine for taking their property and give it to Einstein. public taking under Kelo? just compensation?).

                So the Constitutional command to limit exclusive privilege’s scope to what patentee discover is qualified by the command “to promote the progress of science and useful art” such that even though Myriad discovered the isolated BRAC gene, Myriad may not claim such isolated BRAC gene as it would cover isolation methods that Myriad did not discover.

                ““Compare it by hybridizing” is exactly what claim 7 describes, isn’t it?”

                No. This is equivalent to Compare it by hybridizing, however developed, which is in contrast to what Claim 7 said.

                1. Richard, you are going to need to step up the discussion here or I’ll have to abandon it.

                  Extraordinary breadth per se is not concern of 101.

                  I never said it was. Please try harder to address the points I’m actually making rather than the ones you wish I was making.

                  Myriad Decision invalidated claim to isolated BRCA1 gene per se but upheld the cDNA claim. I don’t recall any method claims.

                  The method claims were tanked by the Federal Circuit and properly so. They were methods of comparing sequence information for diagnostic purposes and were basically identical to claim 7 here except for not reciting “hybridization” using a relevant probe.

                  This is not my analysis.

                  Well, you stated your analysis plainly. Here it is again: the claim is patent eligible because it only covers what Myriad disclosed and no more. I explained to you why that analysis is impractical and unworkable. You are free to change your analysis, of course, and choose a different one …

                  Myriad cannot claim the isolated BRAC gene per se since the scope of the patent covers any and all use of BRAC gene including those uses Myriad did not disclose.

                  Again, every claim to a new useful composition covers “all uses” of that composition. There was more to the Supreme Court’s analysis than that.

                  This is equivalent to Compare it by hybridizing, however developed, which is in contrast to what Claim 7 said.

                  In a nutshell, claim 7 says determine the presence of BRCA1 allele by any old nucleic acid hybridization technique. There are no limits on the method of hybridization used.

                  “And what if they separately claim the use of methods B, C and D in addition to A. What then?”

                  If they so claim, they are still patent eligible unless B, C, and D are super generic or purely obvious/conventional.

                  As of the filing date of Myriad’s patent, there were perhaps no techniques in biochemistry more “super obvious” or “conventional” than nucleic hybridization and PCR.

                  So I guess we agree then on the ineligibility of Myriad’s claims?

                2. 101 is only concerned with claims whose breadth covers more than what the specification disclosed and hence not discovered by the applicant.

                  That sounds more like 112 than 101.

                  Incredibly narrow claims are as easily felled under 101 as incredibly broad claims when the claims protect ineligible subject matter. Breadth has nothing to do with it. I could discover or invent an incredibly narrowly described fact with no utility to anyone except for perhaps two or three people on earth. I still can’t protect the fact itself with a patent claim.

                3. “Well, you stated your analysis plainly. Here it is again: the claim is patent eligible because it only covers what Myriad disclosed and no more. I explained to you why that analysis is impractical and unworkable. You are free to change your analysis, of course, and choose a different one …”

                  You think i am the Supreme Court? I am not arrogant enough to think i could persuade the Supreme Court to adopt a different analysis.

                  However impractical and unworkable, this is something we all have to deal with. As my football coach used to say: suck it up.

                4. You think i am the Supreme Court?

                  Nope, and I have no idea how you arrived at that question.

                  Again: please try to address the points I am making and not the points that you wish I was making.

                  However impractical and unworkable, this is something we all have to deal with. As my football coach used to say: suck it up.

                  Fascinating. My football coach encouraged us to propose better rules if we felt that the existing rules were impractical or led to unjustice (e.g., death or permanent injury). “Suck it up” sounds like something you do in a “no win” situation.

                  In any event, it’s not clear what you mean by “this” when you say that “this is something we all have to deal it.”

                5. Richard: In Myriad, the Supreme Court struck down the claim to isolated BRAC gene because even though Myriad discovered the BRAC gene as being useful to detect cancer and discovered a method to isolate BRAC gene, Myriad cannot claim the isolated BRAC gene per se since the scope of the patent covers any and all use of BRAC gene including those uses Myriad did not disclose.

                  NO!

                  From the opinion:

                  In this case, by contrast, Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.

                  The paragraph in which this holding was placed, the Court observed,

                  In Chakrabarty, scientists added four plasmids to a bacterium, which enabled it to break down various components of crude oil. 447 U.S., at 305, and n. 1, 100 S.Ct. 2204. The Court held that the modified bacterium was patentable. It explained 2117*2117 that the patent claim was “not to a hitherto unknown natural phenomenon, but to a nonnaturally occurring manufacture or composition of matter — a product of human ingenuity `having a distinctive name, character [and] use.'” Id., at 309-310, 100 S.Ct. 2204 (quoting Hartranft v. Wiegmann, 121 U.S. 609, 615, 7 S.Ct. 1240, 30 L.Ed. 1012 (1887); alteration in original). The Chakrabarty bacterium was new “with markedly different characteristics from any found in nature,” 447 U.S., at 310, 100 S.Ct. 2204, due to the additional plasmids and resultant “capacity for degrading oil.”

                6. Re Ned, “NO! From the opinion: In this case, by contrast, Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.
                  The paragraph in which this holding was placed, the Court observed”

                  I am reading a different section of Myriad:
                  “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.” Id., at ___, 132 S.Ct., at 1305. We must apply this well-established standard to determine whether Myriad’s patents claim any “new and useful … composition of matter,” § 101,”, id. at 2116

                  “Nor are Myriad’s claims saved by the fact that isolating DNA from the human genome severs chemical bonds and thereby creates a nonnaturally occurring molecule. Myriad’s claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical changes that result from the isolation of a particular section of DNA. Instead, the claims understandably focus on the genetic information encoded in the BRCA1 and BRCA2 genes. If the patents depended upon the creation of a unique molecule, then a would-be infringer could arguably avoid at least Myriad’s patent claims on entire genes (such as claims 1 and 2 of the ‘282 patent) by isolating a DNA sequence that included both the BRCA1 or BRCA2 gene and one additional nucleotide pair. Such a molecule would not be chemically identical to the molecule “invented” by Myriad. But Myriad obviously would resist that outcome because its claim is concerned primarily with the information contained in the genetic sequence, not with the specific chemical composition of a particular molecule”. Id. at 2118

                  The Supreme Court appears to say that the claim to the isolated nonnaturally occurring molecule has a scope that covers or “concerned primarily with the information contained in the genetic sequence, not with the specific chemical composition of a particular molecule” so that it covers a would-be infringer’s isolation of BRCA1 gene and one additional nucleotide pair.

                  The plain language of the Constitution specified that the delicate balance limits the scope of exclusive rights to only what was discovered. The Supreme Court in Myriad effectively said that the scope of the claim to isolated non-naturally occurring DNA covers a would-be infringer’s isolation of BRCA1 gene and one additional nucleotide pair, which Myriad did not discover.

                7. Richard, in sum, they held the product of nature was not a new composition within the meaning of 101.

                  Not new.

                8. In MM

                  “Richard, you are going to need to step up the discussion here or I’ll have to abandon it.”

                  Sorry, i ran out of time yesterday and had to do some production. Here is my more detailed response.

                  “Extraordinary breadth per se is not concern of 101.
                  I never said it was. Please try harder to address the points I’m actually making rather than the ones you wish I was making.”

                  MM at 5.1.1.1.1.1 “Myriad’s broader independent claims with extraordinary breadth were already found ineligible”.

                  I read this comment to imply that Myriad claim was found ineligible strictly because of its extraordinary breadth. I disagree. It is ineligible because, in part, its breadth covers what Myriad did not discover; not that it is ineligible simply because it is too broad. See my response to Ned quoting the two sections of Myriad.

                  “Well, you stated your analysis plainly. Here it is again: the claim is patent eligible because it only covers what Myriad disclosed and no more. I explained to you why that analysis is impractical and unworkable. You are free to change your analysis, of course, and choose a different one”

                  Again, i need to point out that this is not my analysis, but that of the Supreme Court.

                  Benson mentioned Morse where the would be future innovator that builds a less expensive and less complicated machine to print characters at a distance using Electro-magnetism while Myriad mentioned a would be future infringer who isolated BRCA1 gene with additional pair of nucleotid. According to the Supreme Court, the breadth of Morse’s claim to electromagnetism and Myriad’s claim to isolated BRCA1 gene covers subject matters by the would be future innovator and infringer that Morse and Myriad did not discover. Accordingly, such claims exceeded the delicate balance set forth by the plain language of the Constitution, to balance the incentive to innovate and impeding the flow of information by limiting exclusive rights to only what the patentee discovered.

                  In effect, the Supreme Court concluded that claim pre-emption under 101 is not about whether the claim is extraordinarily broad, but whether the claim is broad enough to cover what patentee did not discover so as to break the delicate balance and obstruct the progress of science and useful art. Thus, Supreme Court’s 101 analysis stood for the proposition that if the scope of a claim is limited to what the patentee discovered, then it is ok under 101.

                  I agree with the Supreme Court’s analysis. While I would like to take credit and claim this as my analysis, i dare not so claim. Based on Supreme Court’s analysis, i argued that because Myriad’s comparison steps described a particular manner of comparing germline sequence of BRCA1 gene, the scope of a claim to such method covers only what Myriad discovered and that is proper under 101 even if it is “extraordinarily broad”.

                  “Again, every claim to a new useful composition covers “all uses” of that composition. There was more to the Supreme Court’s analysis than that.”

                  I disagree because the Supreme Court’s analysis is limited to only judicial exceptions that are not “new and useful”. Diamond v. Diehr, 450 U.S. 175, 189-90 (1981) (“‘new and useful’…is a general statement of the type of subject matter that is eligible for patent protection”). Id. at 185 (“Excluded from such patent protection are laws of nature, natural phenomena, and abstract ideas”). Only laws of nature, natural phenomena, and abstract ideas are not “new and useful” and thus subject to this type of balancing.

                  The fact that the Supreme Court did not think the examples of Morse’s future innovator and Myriad’s would be infringer are applicable to “new and useful” composition of matter implies “new and useful” non-judicial exceptions, even if claimed to cover all uses thereof, do not run afoul of the delicate balance the Constitution tries to preserve.

                  Further, i would differentiate “new and useful” man-made composition of matter from naturally-occurring composition of matter. For example, Myriad opinioned that Chakrabarty’s claim to bacterial was was “not to a hitherto unknown natural phenomenon, but to a nonnaturally occurring manufacture or composition of matter — a product of human ingenuity `having a distinctive name, character [and] use.'” Id. at 2116-17. Therefore, a claim to such composition of matter covers a particular use and any and all use of such composition of matter is effectively a variant of the use discovered by the patentee and thus the claim scope extends only to what the patentee discovered.

                  “In a nutshell, claim 7 says determine the presence of BRCA1 allele by any old nucleic acid hybridization technique. There are no limits on the method of hybridization used” and “As of the filing date of Myriad’s patent, there were perhaps no techniques in biochemistry more “super obvious” or “conventional” than nucleic hybridization and PCR”.

                  I disagree. Claim 7 must be treated as a whole. Parker v. Flook, 437 US 584, 594 n. 16 (1978)(explaining that 101 analysis should treat the claim as a whole, as one would under 103). Diamond v. Diehr, 450 U.S. 188 (1981) (“It is inappropriate to dissect the claims into old and new elements and then to ignore the presence of the old elements in the analysis.”).

                  Your position in a nutshell is that because the presence determination step may be any old method, there is no limit to the claim. Therefore, Claim 7 is inlegible.

                  Proceed with this analysis, comparison by hybridizing a gene is old and well known and in the alternative, hybridizing may be any known method, there is no limit to the claim. Hence, the entire step of comparing germline sequence of BRCA is known and therefore ineligible under 101.

                  This analysis is effectively a dissection of the claim into individual components, declare that each component is well known and old and not limited by further steps, and thus the whole claim is ineligible. The Supreme Court explicitly counseled against such analysis.

                  Rather, Claim 7 contains judicial exceptions consist of: a BRCA1 gene, and a principle of comparing germline sequence of BRCA1 gene to obtain a difference to indicate alteration of BRCA1 gene. We only treat these exceptions as though they are familiar parts of the prior art, even if they are in fact novel under 102, and no more.

                  The question under Step two is really whether “wherein a germline nucleic acid sequence is compared by hybridizing a BRCA1 gene probe which specifically hybridizes to a BRCA1 allele to genomic DNA isolated from said sample and detecting the presence of a hybridization product wherein a presence of said product indicates the presence of said allele in the subject” is a conventional step that one who compares germline sequences of genes must necessarily use this step. If not, then this is “something more” (i omit the purely obvious analysis because i don’t think this step is as purely obvious as having a LCD panel displaying an image, a computer to save data on a hard drive, to have a cell phone transmit data over network.

                  “So I guess we agree then on the ineligibility of Myriad’s claims?”

                  Negative, i disagree.

                9. Richard: I disagree. Claim 7 must be treated as a whole. Parker v. Flook, 437 US 584, 594 n. 16 (1978)(explaining that 101 analysis should treat the claim as a whole, as one would under 103). Diamond v. Diehr, 450 U.S. 188 (1981) (“It is inappropriate to dissect the claims into old and new elements and then to ignore the presence of the old elements in the analysis.”).

                  To the extent those cases forbid an analysis of claims based on the relationship of the claimed innovation to the prior art, those cases have plainly been overturned by Mayo and Alice.

                  With respect to Diehr, specifically, I’m hardly “ignoring” the old elements in my analysis. I’m not arguing that the claim is ineligible merely because it recites ineligible subject matter. The claim is ineligible because it adds nothing new to that old prior art except for ineligible subject matter and in this case it’s an ineligible probe identified only by its well-known property of specifically recognizing its complement.

                  That “innovation” wasn’t Myriad’s “innovation.” Myriad didn’t discover DNA hybridization. What Myriad is trying to claim is nothing more than an inherent function of every ineligible nucleic acid.

                10. Richard, the Supreme Court will not abide festooning a claim to nonstatutory subject matter with conventional, but statutory subject matter. Even Flook condemned the practice you now seem to advocate.

                11. Re Professor Crouch “Regarding the constitutionalization of Section 101, I don’t think that the court is there and I expect that it will not go there within the next decade.”

                  The following tactic isn’t working out so well: Bombarding the Supreme Court with all kind of theories as to why their analysis is bad and attempting to find reasons not to apply the judicial exception doctrine on the slightest difference in the fact pattern and once the Court reversed, throw up our hands and call the Supreme Court tyrants.

                  I would also suspect that if COngress passes a law to override judicial exception, the SUpreme Court would simply strike it down as being Unconstitutional.

                  If the Supreme Court would not do so within the next decade or so, i imagine there would be continuing resistance against the judicial exception doctrine, thereby forcing the Supreme Court to take up more certs until the Court finally explain the Constitutional basis for 101. Like keep poking a bear with a stick (last time when someone tried to do that, it didn’t work out so well…the Massive Resistence of Southern States against Brown v. Board of Ed.).

                  See “The Myriad Reasons to Hit ‘Reset’ on Patent-Eligibility Jurisprudence” by Alan Heinricj and Christopher Abernethy, published 5/22/2014, which boiled down Supreme court 101 precedents into a two-step test and used 135 pages of reasons to criticize how bad it is. The Supreme Court adopted the two-step test verbatim and effetively said “we find 135 pages of arguments unpersuasive” a la Alice.

                  Rather than flat out explain the basis for judicial exception, I would say the Supreme Court gave us “useful clues” as to what that basis is. Aside from referencing the would be future innovator with the less expensive and less complicated implementation that is not based on Morse’s implementation in Flook and the story about the would-be infringer who isolated BRCA1 gene + 1 additional nucleotide in Myriad, the author of Flook, Justice Stevens explained how “to promote the Progress of” is a limitation when deciding what is patentable under 101. Bilski, 130 S. Ct. at 3252-53 (Stevens, J., concurring) (explaining that “to promote the Progress of…” is both a grant of power and a limitation when deciding what is patentable under §101).

                  Isn’t it time for us to connect the dots, satisfied ourself with the fact that judicial exception is here to stay, stop our resistance, move on, and start developing the analytical approach needed to implement the two-step process?

                12. Richard, good post there in discussing constitutional policy and calling for acceptance of it by the patent bar.

                  Fat chance that, though. The grousing is PC, and anyone who does not grovel to siren songs being sung by the wounded leaders of the patent bar just have to keep their peace or be ostracized. Thank god for the courts, and for that matter, university professors.

        2. 5.1.1.2

          In simple words, the scope of the claim is limited to only what Myriad discovered and there is little danger that it would pre-empt any and all use of the BRAC gene.

          I think you’re getting some 112, 1st in your 101. The fact that Morse also violated 112 doesn’t mean he didn’t have a 101 issue apart from that.

          So by your logic, a specification that states “I have discovered that gene location X is an indicator for trait Y” can support a claim to “all standard ways of interrogating for a trait, wherein the trait is Y and standard way of interrogating includes searching for X” because the standard way of interrogating is non-exhaustive and can be designed around?

          It’s still directing your ownership to something you found rather than something you made, and that is not how the word “discovery” is used, that’s why you can’t patent natural plants or bugs or any other naturally occurring thing, despite you being the first to “discover” them – you never created it. Myriad didn’t create the relationship, it just stumbled over it. Myriad created neither the relationship, nor the probe as a vehicle to measure if it exists in a person.

          1. 5.1.1.2.1

            I think you are trying to disagree with me but i couldn’t find any argument that points out such disagreement. Please read my comment at 5.1.1.1.1.1.1.

            You can draw parallel of this claim with Mayo where Step (a) administers a drug containing 6-thioguanine to a human subject. Step (b) determines a level of 6-thioguanine in the human subject so as to increase or decrease the amount of the drug subsequently administered to the human subject based on defined mathematical relationships.

            Mayo is ineligible because it does not articulate how you would go about increasing or decreasing the amount for subsequent administration. In effect, the whole claims points to a judicial exception with “administer the drug, however developed” to increase or decrease the level of subsequent administration. However, things would be different if Mayo claim includes details as to how to increase or decrease the level of subsequent administration.

            Likewise, if Myriad simply claims “comparing germline sequence of a BRCA1 gene … from a tissue sample from said subject … with germline sequences of wild-type BRCA1 gene…” and “wherein a difference in the sequence of the BRCA1 gene … of the subject from wild-type indicates an alteration in the BRCA1 gene in said subject, [and]”, then it is patent ineligible because this is like claiming the equation of Flook and defining the various variables in the equation.

            Instead, the Myriad claim further specified how “germline sequence of a BRCA1 gene” are compared: wherein a germline nucleic acid sequence is compared by hybridizing a BRCA1 gene probe which specifically hybridizes to a BRCA1 allele to genomic DNA isolated from said sample and detecting the presence of a hybridization product wherein a presence of said product indicates the presence of said allele in the subject.

            Would everyone who compare germline sequence of BRCA1 gene necessarily use this comparison method so that the limitation preclude future innovators from developing less expensive and more efficient manner of comparison completely different from Myriad? The answer is no. The public is still free to figure out what other ways to use the BRCA1 gene or how to compare germline sequence. If they can’t, then pay Myriad (its not Myriad’s fault if the public couldn’t find a way around).

            1. 5.1.1.2.1.1

              Richard: You can draw parallel of this claim with Mayo where Step (a) administers a drug containing 6-thioguanine to a human subject. Step (b) determines a level of 6-thioguanine in the human subject so as to increase or decrease the amount of the drug subsequently administered to the human subject based on defined mathematical relationships.

              Mayo is ineligible because it does not articulate how you would go about increasing or decreasing the amount for subsequent administration.

              No, that’s not why Prometheus’ claims were ineligible. Prometheus’ claims were ineligible because there are no steps recited in the claim other than the old step of obtaining data and the “new” step of thinking about the correlation between the data and how much drug to administer. Prometheus could have recited another paragraphs worth of detailed “thinking” about exactly how much drug to administer and how and where and under what phase of the moon and none of that would make any difference.

              The public is still free to figure out what other ways to use the BRCA1 gene

              That’s only because “the public” asked the Supreme Court to tank Myriad’s claims to the gene.

              or how to compare germline sequence.

              The “public” already knew how to “compare germline sequences” long before Myriad existed. Given any nucleotide sequence, any high schooler who took a halfway decent biology class (even as far back as the 80s) could tell you how to determine whether or not that sequence was present in some unknown mixture of nucleic acid.

            2. 5.1.1.2.1.2

              “However, things would be different if Mayo claim includes details as to how to increase or decrease the level of subsequent administration.”

              Possibly.

              But consider Funk Bros. where the application (packaging) was not considered to be inventive by itself. Strip from Mayo any specifics of the particulars of any disease and consider the following process:

              1. Process comprising:

              administering a drug,

              testing for metabolites, and depending on the result,

              adjusting the dosage of the drug.

              If that process was novel and inventive, it should have been claimed. If the only novelty involved a specific drug and a specific correlation, then the only novelty was in something specifically ineligible.

            3. 5.1.1.2.1.3

              However, things would be different if Mayo claim includes details as to how to increase or decrease the level of subsequent administration.

              As usual, this statement may or may not be true, based on what the detail is.

              Instead, the Myriad claim further specified how “germline sequence of a BRCA1 gene” are compared

              Only using conventional steps though. While I agree that many times you can cure an overbroad functional claim by describing your particular way of doing it, here you cannot, as your particular way of doing it is entirely non-novel.

              Would everyone who compare germline sequence of BRCA1 gene necessarily use this comparison method so that the limitation preclude future innovators from developing less expensive and more efficient manner of comparison completely different from Myriad? The answer is no.

              I don’t even know what you’re doing here. Of course if someone goes out and invents a non-obvious method the previous method won’t stop them from practicing. That’s what invention is. But you’re saying it’s necessary, as if you couldn’t use the BRCA1 to cancer correllation (which is unpatentable) without further invention. That writes out the judicial exception altogether. People are not required to invent to have access to the judicial exception.

              If they can’t, then pay Myriad (its not Myriad’s fault if the public couldn’t find a way around).

              Myriad didn’t create the BRCA1-cancer link either, so why should people pay them to use a well-known method on it?

              Turning to your 5.1.1.1.1.1 –

              Rather, 101 is only concerned with claims whose breadth covers more than what the specification disclosed and hence not discovered by the applicant.

              No, that is what enablement and WD are for, 112. 101 is concerned with claims who are directed to things which only nominally contain something made by man and instead are really an effort to monopolize things which by right equally belong to all. It’s entirely possible to be fully enabling and in possession of an idea, for example, but that won’t stop 101 from preventing you from claiming it.

              If they so claim, they are still patent eligible unless B, C, and D are super generic or purely obvious/conventional.

              You must see that this is absurd. It suggests that you could get the subject matter of ABCD just so long as you split it into four patents of A B C and D. Eligibility does not depend on the draftsman’s skill, and it ought to be obvious that what is ineligible for one patent cannot be eligible for four.

              In reading the rest of your response, I agree there is a 112 component that functions along with 101, but 101 is not a strict 112 application. You don’t question whether the scope is equal to the discovery, that’s what 112 is for. Rather 101 asks if the scope is valid regardless of the discovery.

              If I claim an idea, and I limit it to a particular way of expression, and I limit it to a particular medium of writing, and a particular writing utensil and a particular … until I have an exact picture claim of a book I wrote, that claim still won’t pass 101. I still can’t patent that idea because ideas are beyond the purview of patent law. Congress lacks the authority to grant an exclusionary right to ideas (that ought to be clear from the first amendment if nothing else) no matter how narrowly tailored the claims are to them.

              While it is true an overbroad claim will make it easier to show that the claim intrudes upon subject matter that is outside the ability of Congress to regulate, it’s not a scope issue. The issue is that while Congress nominally allows one to patent pretty much anything, their grant of power is not unlimited, and the judicial exceptions are examples where the grant of power to Congress is less than what Congress wrote 101 to include.

              1. 5.1.1.2.1.3.1

                “I don’t even know what you’re doing here. Of course if someone goes out and invents a non-obvious method the previous method won’t stop them from practicing. That’s what invention is. But you’re saying it’s necessary, as if you couldn’t use the BRCA1 to cancer correllation (which is unpatentable) without further invention. That writes out the judicial exception altogether. People are not required to invent to have access to the judicial exception”.

                Mayo, 132 S.Ct. at 1298 (“Anyone who wants to make use of these laws must first administer…so the combination amounts to nothing significantly more than an instruction to doctors to apply the applicable laws…”); see also id. at 1299-30 (defining conventional steps as steps that must be taken in order to apply the laws in question).

                “No, that is what enablement and WD are for, 112. 101 is concerned with claims who are directed to things which only nominally contain something made by man and instead are really an effort to monopolize things which by right equally belong to all. It’s entirely possible to be fully enabling and in possession of an idea, for example, but that won’t stop 101 from preventing you from claiming it”.

                This argument is thrown by anti-judicial exception doctrine parties to justify their position that Supreme Court’s analysis is bad. From what i could gather, you are not in that camp so i am somewhat amused that you are making this argument against what i think why judicial exception is justified.

                I submit that 101 pre-emption is actually different from 112. As examiners, 112 rejections are made based on facts by comparing claim scope with specification. Since we don’t handle infringement, we don’t know if the claims are fully enabled. In litigation (if i remember my pat lit. class correctly), attorneys would conduct Markman hearings to do claim construction and then proceed to factual findings on whether claims are enabled. This is a form of ex-poste analysis where alleged infringement happened and it is necessary to determine whether the claim is in fact fully enabled and supported under 112 in view of the infringing product.

                In contrast, 101 pre-emption analysis makes no such finding. Rather, 101 simply takes the position that future innovator in Morse who discovered a less compliated implementation and would be infringer in Myriad with the BRAC1 gene + 1 additional pair of nucleotid would be covered by the breadth of the claims. This is an ex-ante analysis that pre-empts the possibility that the claim is not fully supported and enabled. Since the claim to judicial exceptions are necessarily broad under the Morse and Myriad examples such that pre-emption is apparent to all, pre-emption necessarily applies to all judicial exceptions not that all such claims in fact pre-empts, but that they necessarily pre-empts.

                Also 112 serves a different reason in that promotion of progress of science and useful art requires full disclosure in this quid pro quo exchange for exclusive rights, not necessarily to ensure applicant claims only what they discovered. 101 ensures that.

                For example, if Einstein claims E = MC (square) and describes the step by step process Einstein used to measure the energy of matter in his specification, then the full scope of how to measure energy of matter is enabled. Without judicial exception, Einstein’s attorney could argue that discovering this principle is like discovering or making a non-naturally occurring composition of matter that necessarily having a distinctive use as Chakabarty’s bacteria. Myriad, 133 S. Ct. at 2117. Hence, any use is simply a variation of the use full enabled by E=MC (square). Under that theory, anti-matter rocket engine would infringe not that Einstein discover a way to produce such engine, but that the use of E=MC(square) to design the anti-matter engine is a variation of use covered by E = MC(square) just like any use of Chakarbarty’s bacterial is necessarily a variation of the used enabled by the specification.

                Without 101, patents like that (remember Swing side-ways patent?) passes examination to allowance.

                1. This argument is thrown by anti-judicial exception doctrine parties to justify their position that Supreme Court’s analysis is bad. From what i could gather, you are not in that camp so i am somewhat amused that you are making this argument against what i think why judicial exception is justified.

                  I can imagine that. Some people, perhaps most, think Congress has plenary power so long as what they are doing is granting a patent. They do not. There are constitutional limitations on their power to grant a patent, and the court is correct to assert itself there. That is what judicial exceptions to 101 are.

                  Since we don’t handle infringement, we don’t know if the claims are fully enabled.

                  It’s entirely possible to determine whether someone has fully enabled or described the scope of their claims without having to compare them to a given infringer. If you go to the moon, you rode in a spaceship to get there. That ship can be described and enabled. What you cannot functionally claim is any spaceship, as you do not possess it nor can you build any spaceship. Thus your claim is overbroad under 112. It is also ineligible under 101 because a claim to a spaceship without further limitation is a claim to an idea. They are different analysis that often overlap when functional language is used.

                  Since the claim to judicial exceptions are necessarily broad under the Morse and Myriad examples…

                  But a broad scope is not necessary for the exceptions, and your logic breaks down when they are applied to small scopes. Your logic would suggest that if you limited the scope of 101 to a particular thought-of combination (such that a future inventor wouldn’t infringe it or could design around it) it would be okay. That is not the case. All you have to do is go back a few days on this website to see cases where the 101 scope is relatively small (online bingo playing, rules for digitizes faces or whatever) and it doesn’t stop a 101 issue.

                  Your Einstein argument is quintessentially a 112 argument, and I see you’re using language from Morse which today we would put in 112. Morse has 112 language in it, because Morse, though generally cited as a 101 case, raises 112 concerns as well, and you’re misreading it to improperly talk about breadth (a 112 issue) in 101. Morse did two things wrong – he had a claim which 1) claimed an (otherwise unbounded) application of electricity to print at a distance and 2) he didn’t possess every method to print at a distance. 1) is a 101 rejection, 2) is a 112 rejection. The fact that overbroad claiming often causes both 1) and 2) seems to confuse you to the point you’re including them together.

                  If I invent a bow, there is a scope problem in describing the bow as a “machine that performs the function of firing projectiles” because that scope includes a gun, which I don’t have. That’s a 112 rejection. But beyond that, there is a problem with describing my machine as a “machine that performs the function of firing projectiles” because that is, in actuality, a naked claim on the function of firing projectiles itself which is not something that Congress has the power to give to a person. 101 is offended when the novelty of a claim is directed to the ends to be achieved rather than the means of achieving it. The fact that claiming the ends is often an overbroad scope is a separate 112 issue.

                2. Re Professor Crouch “Regarding the constitutionalization of Section 101, I don’t think that the court is there and I expect that it will not go there within the next decade.”

                  The following tactic isn’t working out so well: Bombarding the Supreme Court with all kind of theories as to why their analysis is bad and attempting to find reasons not to apply the judicial exception doctrine on the slightest difference in the fact pattern and once the Court reversed, throw up our hands and call the Supreme Court tyrants.

                  I would also suspect that if COngress passes a law to override judicial exception, the SUpreme Court would simply strike it down as being Unconstitutional.

                  If the Supreme Court would not do so within the next decade or so, i imagine there would be continuing resistance against the judicial exception doctrine, thereby forcing the Supreme Court to take up more certs until the Court finally explain the Constitutional basis for 101. Like keep poking a bear with a stick (last time when someone tried to do that, it didn’t work out so well…the Massive Resistence of Southern States against Brown v. Board of Ed.).

                  See “The Myriad Reasons to Hit ‘Reset’ on Patent-Eligibility Jurisprudence” by Alan Heinricj and Christopher Abernethy, published 5/22/2014, which boiled down Supreme court 101 precedents into a two-step test and used 135 pages of reasons to criticize how bad it is. The Supreme Court adopted the two-step test verbatim and effetively said “we find 135 pages of arguments unpersuasive” a la Alice.

                  Rather than flat out explain the basis for judicial exception, I would say the Supreme Court gave us “useful clues” as to what that basis is. Aside from referencing the would be future innovator with the less expensive and less complicated implementation that is not based on Morse’s implementation in Flook and the story about the would-be infringer who isolated BRCA1 gene + 1 additional nucleotide in Myriad, the author of Flook, Justice Stevens explained how “to promote the Progress of” is a limitation when deciding what is patentable under 101. Bilski, 130 S. Ct. at 3252-53 (Stevens, J., concurring) (explaining that “to promote the Progress of…” is both a grant of power and a limitation when deciding what is patentable under §101).

                  Isn’t it time for us to connect the dots, satisfied ourself with the fact that judicial exception is here to stay, stop our resistance, move on, and start developing the analytical approach needed to implement the two-step process?

                3. In re RandomGuy, “Your Einstein argument is quintessentially a 112 argument, and I see you’re using language from Morse which today we would put in 112. Morse has 112 language in it, because Morse, though generally cited as a 101 case, raises 112 concerns as well, and you’re misreading it to improperly talk about breadth (a 112 issue) in 101. Morse did two things wrong – he had a claim which 1) claimed an (otherwise unbounded) application of electricity to print at a distance and 2) he didn’t possess every method to print at a distance. 1) is a 101 rejection, 2) is a 112 rejection. The fact that overbroad claiming often causes both 1) and 2) seems to confuse you to the point you’re including them together.”

                  Another example then. From the way Myriad characterized Chakrabarty, the Supreme Court essentially said that Chakrabarty took a bacterial that existed in nature, found a useful way to modify the bacterial, and claimed the modified bacterial. Since such claim is about a product having a distinctive use, any and all use of that modified bacterial is in effect a use of Chakrabarty’s process. Indeed, if one wants to use Chakrabarty’s bacterial, then one must modify the bacterial in accordance to the process of Chakrabarty. Under this theory, any use of the bacterial is fully enabled under 112 by Chakrabarty’s specification.

                  Instead, if Chakrabarty discovered the bacterial in nature and claims that, then the scope would include both whatever modification made to the bacterial including those not made by Chakrabarty and the natural form of the bacterial, which is presumably made by nature / god. Under 101, this claim is always ineligible. However, is it always not enabled under 112?

                  Remember, A claim will not be invalidated on section 112 grounds simply because the embodiments of the specification do not contain examples explicitly covering the full scope of the claim language. Lizardtech, Inc. v. Earth Reosurce Mapping, Inc., 424 F.3d 1335, 1345 (fed. Cir. 2005).

                  What if Chakarbarty discloses enough variation of the modifications made to the natural form of bacterial such that it satisfied the 112 requirement? Without 101, is there a scenario where it would satisfy 112 and pass to issue?

          2. 5.1.1.2.2

            In the example where Einstein patents E = MC (square) and asserst the claim against the anti-matter rocket engineers that uses his equation. Suppose Einstein’s specification disclosed his entire experiment and thought process he used to arrive at E = MC (square) and that claim is fully supported and enabled under 112 and the infringement is on the theory that the anti-matter rocket infringed E = MC (square), not that E = MC (square) taught every feature of the anti-matter rocket engine.

            Here, the breadth is not questionable under 112 but precluded by 101.

      2. 5.1.2

        While the public would be pre-empted from using this particular implementation, the public is free to use BRAC in other manner.

        What “other manner” did you have in mind?

      3. 5.1.3

        “I don’t think there is an issue of pre-empting every possible implementation of using BRCA including those not discovered by Myriad.”

        If there is only one known, commonplace method and there don’t appear to be any more on the horizon that are feasible then nah, you don’t cut the mustard here brosef. Your claim be going down. Just like Benson. Sure someone could have made something other than a shift register to do the operation, and the claim would not literally cover it. But at the time the claim wholly preempted and there was nothing on the horizon prompting people to think it would stop anytime soon.

        You have to address that question by looking to the time of filing. Not by dreaming up hypothetical future inventions.

        1. 5.1.3.1

          “You have to address that question by looking to the time of filing. Not by dreaming up hypothetical future inventions.”

          The Supreme Court said otherwise. If this claim can be maintained, it matters not by what process or machinery the result is accomplished. For aught that we now know, some future inventor, in the onward march of science, may discover a mode of writing or printing at a distance by means of the electric or galvanic current, without using any part of the process or combination set forth in the plaintiff’s specification. His invention may be less complicated—less liable to get out of order— less expensive in construction, and in its operation. But yet, if it is covered by this patent, the inventor could not use it, nor the public have the benefit of it, without the permission of this patentee. Gottschalk v. Benson, 409 U.S. 63, 68 (1972)

      4. 5.1.4

        “While the public would be pre-empted from using this particular implementation, the public is free to use BRAC in other manner. ”

        If there are plenty of “other manners” then the claim will be good to go. If there be none, or substantially no feasible or practical ones then you’re still going down. If all the “other manners” are hypothetical dreamy inventions planned for the future (past the time of filing) that is a no-go.

    2. 5.2

      One key aspect of this case (and also the fetal DNA detection case) that should not be ignored or forgotten — because it’s extremely important — is that the claims are directed to obtaining information about the existence of a particular state of a thing (e.g., does the thing have X) where (1) that fact is ineligible and (2) the claims recite the use of old methods to obtain that information. Such claims are problematic because they have the effect of protecting information and, simultaneously, creating hazards for members of the public who are using public domain tools.

      There is some lengthy discussion by Myriad’s counsel in the oral argument about certain cDNA molecules being eligible. I don’t see what the relevance is. If anything, that fact would tend to make Myriad’s claims (at least the representative claim above) less likely to be eligible.

      1. 5.2.1

        How is your position regarding (1) consistent with the Supreme Court’s holding that synthetically created DNA (cDNA), which contains the same protein coding information found in a segment of natural DNA but omits portions within the DNA segment that do not code for proteins, as being patent eligible?

        Further, is the old method purely (1) “obvious, conventional, well known” or generic in contrast to (2) “an application of a law of nature or mathematical formula to a known structure or process” that may well deserve a patent? Do you see a difference between (1) and (2) or are they the same to you?

        1. 5.2.1.1

          Richard you confuse applying a law of nature to a conventional process to improve the conventional process and applying a conventional process to a product of nature to determine its presence.

          1. 5.2.1.1.1

            The Supreme Court treated (laws of nature, product of nature and abstract ideas) as basic tools of technological and scientific work and they all should be treated as though they were familiar parts of the prior art regardless of whether they are in fact so under 102/103. We only have to figure out what steps are inherently, necessarily, purely obviously / conventionally, or generically assoicated with them. If there are steps in addition to those steps, then there is no danger that 101 authorizes a patent whose scope cover implementations that patentee did not discover.

          2. 5.2.1.1.2

            Richard you confuse applying a law of nature to a conventional process to improve the conventional process and applying a conventional process to a product of nature to determine its presence.

            Wow, that’s the most succinct and perfect way of explaining the issue I have heard. Good job.

            1. 5.2.1.1.2.1

              The fact that the Supreme Court took up so many certs on 101 over the last four years sends a clear message: stop playing peekaboo with the judicial exceptions. This applies to both the USPTO and the Patent Attorneys.

              “applying laws of nature to a conventional process” and “applying conventional process to a product of nature” requires the same analysis: Alice Two Step. You may certainly try, as the Federal Circuit has done, to distinguish the claims on such basis and avoid applying Alice Two Step. But we all know what will result, the Supreme Court takes up Cert and reverse.

                1. Then what is the point of making the distinction between “applying a law of nature to a conventional process to improve the conventional process” and “applying a conventional process to a product of nature to determine its presence”.

                  Are you implying that there are two different Step Two analysis depending on this distinction? The way that i read Supreme Court precedents on what is “something more” or “practical assurances” certainly does not suggest there is a difference in treatment based on whether the judicial exception is a law of nature, a product of nature, or abstract idea.

                2. The way that i read Supreme Court precedents on what is “something more” or “practical assurances” certainly does not suggest there is a difference in treatment based on whether the judicial exception is a law of nature, a product of nature, or abstract idea.

                  Maybe you should try reading them some other way, then.

        2. 5.2.1.2

          Richard: How is your position regarding (1) consistent with the Supreme Court’s holding that synthetically created DNA (cDNA), which contains the same protein coding information found in a segment of natural DNA but omits portions within the DNA segment that do not code for proteins, as being patent eligible?

          It’s consistent in every way, as far as I can tell. Do you see an inconsistency? If so, please explain what you believe that inconsistency to be.

          is the old method purely (1) “obvious, conventional, well known” or generic

          In this particular case, the answer is certainly “yes.”

          in contrast to (2) “an application of a law of nature or mathematical formula to a known structure or process” that may well deserve a patent? Do you see a difference between (1) and (2)

          I do see potential differences between (1) and (2) and certainly the Supreme Court does as well. For instance, I could discover that a certain ratio of chemicals in a mixture (determined with “math”) yields a desirable product in according to a previously unknown oxidation reaction. The mere fact that the chemicals were known (or even that mixtures of the same chemicals in other ratios were known) and oxidative manufacturing processes are old doesn’t render the claim ineligible.

          1. 5.2.1.2.1

            “Such claims are problematic because they have the effect of protecting information and, simultaneously, creating hazards for members of the public who are using public domain tools” at 5.2.

            Doesn’t making cDNA patent eligible protects the “same protein coding information found in a segment of natural DNA but omits portions within the DNA segment that do not code for proteins”? Does that create hazards for the public who are using these information, which you described as public domain tools? And yet the Supreme Court allow it. This indicates that certain form of information are indeed protected under 101, as long as such protection is limited to patentee’s use of that information and does not preclude all possible use of that information that the patentee did not discover.

            1. 5.2.1.2.1.1

              Doesn’t making cDNA patent eligible protects the “same protein coding information found in a segment of natural DNA

              Is your argument with me or with the Supreme Court’s opaque reasoning in Myriad? I’m no fan of the latter, by the way.

              The only discernable, defensible reason why –some– (but not all) so-called “cDNA molecules” are eligible for patenting and others are not is because that particular group of eligible “cDNA molecules” is structurally “more distinct” from similar polynucleotides found “in nature” as compared to, e.g., a DNA molecule with a sequence of continguous nucleotides identical to that found “in nature” but truncated at one or both ends. There’s nothing special about “cDNA” otherwise. Any DNA could be “cDNA” and for any protein of any significant length there may be millions of structurally distinct DNA molecules that encode that protein (with nearly all of them instantly discernable thanks to the standard genetic code).

    3. 5.3

      MM, there has to be a way to express these concepts simply.

      With computers, there is a difference between improving a computer and using a computer. When the computer is used in a nonstatutory process, that process is not made statutory.

      With chemical processes, applying a conventional process to a product of nature to produce nonstatutory information is not an improvement to the conventional process. In contrast, applying a product of nature to an otherwise conventional process to improve that process is eligible.

      1. 5.3.1

        Ned, I think that’s an interesting formulation.

        The twist here that your proposed analysis should take into account is that polynucleotides, because of their ability to hybridize with their complement and encode for proteins, are inherently useful for “producing non-statutory information”.

        Any DNA sequence can be used in a hybridization assay to detect its presence or absence, and any DNA sequence can be inserted into a cell to test its functionality. Does merely identifying a specific (but still ineligible) sequence really “improve” those assays? By what measure should “improvement” be evaluated? Should it matter if the sequence can be “correlated” with something else (I would think not given that just about anything can be correlated with something in some context)?

    4. 5.4

      “Permitting this kind of “end around” — where all the known methods of obtaining the (ineligible) sequence information are claimed — nullifies those holdings because the public is still prohibited from using public domain tools to obtain information about a genome.”

      Yep that’s my only concern in this case. Otherwise it should be fine. But if that be so, then yeah there’s a problem.

  9. 4

    Jeez. If this is the way claims are supposed to be analyzed, then nothing is patentable, because everything has naturally occurring elements and old elements.

    Whatever happened to looking at the claimed combination to determine patentability? I know, Scotus scuttled it, but it seems they scuttled all patents at the same time.

    1. 4.1

      Silicone, what are you talking about in particular? Assuredly you do understand the difference between Flook and Diehr? In Flook, the claim ended in a number with the general direction to use it in a field. In Diehr, the number was applied to improve the underlying statutory process.

      We get lost in words at times. It is good to look to the facts of cases to better understand distinctions.

      1. 4.1.1

        The distinctions are too great to draw conclusions. The Diehr claims, for instance, discuss actual opening of a rubber press based on the calculations. What happens if one isn’t opening a rubber press? For instance, cell phones don’t operate anything “physical”. Can one claim a machine (eg, a cell phone) that performs signal manipulation? That claim falls in between the claims in Flook and Dieher, as it recites a real machine (a cell phone) that is performing a new and useful technique, but nothing “physical” is happening (other than improvements in, eg, reception/transmission of data).

        1. 4.1.1.1

          For instance, claim 1 in Diehr:

          “opening the press automatically when a said comparison indicates equivalence.”

          Claim 11:

          “(i) opening said press when a said
          comparison of calculated total required cure time and monitored elapsed time indicates equivalence,
          and
          “(j) removing from said mold the resultant
          precision molded and cured rubber article.”

          What is the relevance of this to a claim for a machine that performs new and useful data manipulation but arguably does not cause anything “physical” to happen?

          A claim like this is between the claims in Flook/Benson and Diehr. Thus, Alice is unavailing for this fact pattern.

          1. 4.1.1.1.1

            Again Bob, I think the relevance of Alice is that if the otherwise statutory machine or process is claimed at such a high level of abstraction that the claim essentially is not to the statutory machine or statutory process but to the nonstatutory subject matter, then the claim as a whole is not patentable. Flook was an example of claiming the statutory processes at such a high level of abstraction that the claim was essentially abstract considered as a whole. Diehr was an example of a specific, otherwise statutory, process that was improved by the use of the nonstatutory subject matter.

            Alice is very pertinent to the analysis of the distinction between Flook and Diehr.

        2. 4.1.1.2

          Bob, well there is also the fact that Flook did not attempt to apply the mathematics to a particular process the claimed the mathematics with respect to all possible processes. The statutory subject matter, the process to which the mathematics was being applied, wasn’t claimed at a very high level of abstraction making the whole claim abstract. In contrast, the process in Diehr was a specific process, and the mathematics was used to improve that process.

          I don’t know how the claim could a properly been said to improve the process and less the timing of the opening the mold as a function of the mathematics was actually claimed.

          Regarding your other questions, it is essential that in otherwise statutory machine or process be modified and improved in order for the nonstatutory subject matter to be considered integrated. Thus if a computer is actually improved by the application of a mathematical algorithm, then we would have an improved computer. But just using a computer in its conventional manner to calculate the algorithm is hardly an improvement to the computer.

        1. 4.1.2.1

          Silicone,

          1. The process has to be specific as in Diehr and not generalized and non specific as in Flook.

          2. The math or LON or Product of nature must modify the process so as to improve it. Flook provided no modification. Diehr did.

          In 1, one can disregard the “old elements.”

          In 2, one cannot.

          Mayo and Alice are consistent.

          3.

    2. 4.2

      SVG If this is the way claims are supposed to be analyzed, then nothing is patentable, because everything has naturally occurring elements and old elements.

      When you say “this is the way that claims are supposed to be analyzed”, what is “the way” that you are referring to?

      There is no analysis that I’m aware of that simply says “this claim has naturally occuring elements and old elements therefore it’s unpatentable.”

      1. 4.2.1

        MM, Dennis’s post said:

        “That discovery itself is not patentable because it is a law of nature, or alternatively, an abstract idea or perhaps even a product of nature. … A problem for Myriad on this front is that the tools of hybridized screening were already known and were not themselves inventive concepts at the time.”

        That analysis throws out the discovery that is a law of nature and throws out the tools of hybridized screening because they are old.

        What else is there to claim? Everything is made of old elements.

        How about a claim to several old elements combined together and using a law of nature? Still gonna die by Dennis’s analysis.

        What do they mean by “something more”? The “somethings” they say are not enough seem to be all the candidates.

        1. 4.2.1.1

          How about a claim to several old elements combined together and using a law of nature? Still gonna die by Dennis’s analysis.

          I don’t see where Dennis’ “analysis” includes a discussion of what happens when a claim recites a new combination of old and otherwise eligible elements.

          There are two reasons that Myriad’s claims raise eligibility issues: (1) the claims recite elements which are, by themselves, ineligible subject matter; and (2) they are conventional methods directed to determining the existence of an otherwise ineligible fact.

          What do they mean by “something more”?

          For starters, either the recitation of new, separately eligible, objectively defined structure (e.g., a new combination that is not an ineligible nucleic acid) or a new step(s) that result in a transformation of matter that was previously not believed to be attainable in the art or was otherwise unknown.

          Plenty of eligible subject matter continues to be patented and asserted and there’s infinitely more waiting to be innovated. It might not seem that way, however, to someone who has become invested in the ineligible claims that have overwhelemed our broken patent system or who has never considered what the patent system used to look like before the floodgates were opened to the nonsense we see people trying to patent today.

          1. 4.2.1.1.1

            MM, your critique of my concern seems to be based on saying that “conventional methods” are different than “old elements.”

            I don’t see the difference between “old” and “conventional.” Can you enlighten me?

            1. 4.2.1.1.1.1

              your critique of my concern seems to be based on saying that “conventional methods” are different than “old elements.”

              No. My critique is based on saying that new combinations of old eligible elements (e.g., physically transformative steps or objectively defined structures) are neither “old” nor “conventional.” They are, in fact, new.

              The Supreme Court has expressly and repeatedly rejected any analysis for eligibility that would render ineligible every claim reciting only old elements, even when those elements are combined. The analysis is not that simple. It’s also not as simple as looking at a claim to see if any single element is eligible or ineligible. It’s also not as simple as looking for a “magic word.”

              Read Dennis’ posts and these threads carefully and you’ll learn that the analysis is usually not terribly difficult but it does require an understanding of what’s in the prior art and how the claimed invention (and not some actual device that falls within the scope of the claim) relates to the prior art.

    3. 4.3

      Whatever happened to looking at the claimed combination to determine patentability? I know, Scotus scuttled it, but it seems they scuttled all patents at the same time.

      When I look at the combinations of limitations, the most accurate description is “directing a standard probe, to my new location (idea/nature), which means something due to a natural relationship.” Thus his improvement comprises information about the new location and it’s relationship to cancer. The improvement consists of nothing more than the idea/natural law. It’s only if you want to over-include the previous art (i.e. his improvement + the old) that it could possibly be considered eligible.

  10. 3

    Maybe the term should be ‘obduction’ (according to Wikipedia, used in reference to conducting an autopsy).

  11. 2

    It’s difficult to argue that the integration choice is correct when a) the Supreme Court clearly dissected the claims in Alice, tossing out the “apply it on a computer” part, and b) why bother to say that an abstract idea is ineligible if one could assert non-novel application to make it eligible again?

    This case is irrelevant, as the Supreme Court has already said that eligibility doesn’t depend upon the draftsman’s art, so if they make the wrong holding and find it eligible it’s clear what the SC will do with it.

    The advance embodied by the University of Utah’s BRCA patents all center around the researchers’ discovery of the genetic sequence and location of the naturally occurring BRCA1 and BRCA2 genes and that the mutations correlate with a high risk of cancer.

    The fact that the claims can accurately be described in this manner ends the inquiry. If there was “something more” then it couldn’t be characterized as “center[ing] around the researcher’s discovery of the genetic sequence and location [of useful information].”

    However, clearly the invention as a whole is practical, transformative, and inventive.

    The “invention as a whole” is simply the discovery I just quoted Dennis saying, followed by the phrase “and apply it in the standard fashion.” The fact that the applicant chose to write out the standard fashion isn’t relevant. The applicant knew he didn’t invent the standard application, thus what applicant could regard as his invention could only be the location of the cancer risk genes. There is no difference, from a 101 standpoint, whether one states “idea + apply it”, or states idea + series of steps that one of ordinary skill would have known at the time to be an application of idea.

    1. 2.1

      Even if we are following the process of filtering-out the excluded subject matter, does that mean that we filter out anything related to BRCA?

      Although others had hybridized gene probes, one novel element in the claim is the step of hybridizing a BRCA1 gene probe. Nobody had ever done that step before. But, does the filtration-approach block consideration of any step where the discovered gene itself is a critical aspect of the novelty?

      1. 2.1.1

        .one novel element in the claim is the step of hybridizing a BRCA1 gene probe.

        That is obvious to anyone skilled in the art and relies on a natural phenomenon (annealing/reannealing od nucelic acids that is driven by base pairing). DNA-DNA and DNA-RNA hybridization have been known since the late 1960’s and serve as the basis for innumerable sequence based assays. The mere fact that one substitutes BRCA1 for any other targeted sequence is not novel, nor is the statistical inference that is made based on the presence or absence of a specific targeted gene as the basis for an assay.

        1. 2.1.1.1

          Was it obvious at the time of filing? No. Was it obvious in view of the disclosure? Of course. Everything is obvious in hindsight. Mayo critically said the elements of the method must be well-understood, routine and conventional AT THE TIME OF FILING. In other words, this is akin to an anticipation analysis rather than obviousness.

          If you’re saying that you completely remove any reference to or influence of anything at all relating to the ineligible natural law/product and then ask whether the resulting hollowed out shell would be obvious, then you’re invalidating a lot (what’s left in life sciences?).

          1. 2.1.1.1.1

            creyboyne: Was it obvious at the time of filing? No. Was it obvious in view of the disclosure? Of course. Everything is obvious in hindsight. Mayo critically said the elements of the method must be well-understood, routine and conventional AT THE TIME OF FILING.

            When you ask “was it obvious”, what is the “it” that you are referrring to? The issue here is that the only new element in this claim is an ineligible nucleic acid. That nucleic acid is performing a function that everybody knew it could do (regardless of its sequence): hybridize to its complement.

            If you’re saying that you completely remove any reference to or influence of anything at all relating to the ineligible natural law/product and then ask whether the resulting hollowed out shell would be obvious, then you’re invalidating a lot (what’s left in life sciences?).

            I don’t think anyone is proposing anything as remotely broad as that.

            But even if all claims whose patentability depended on the recitation of a newly discovered (but otherwise ineligible) nucleic acid were deemed ineligible, there’s still endless loads of eligible claims to be had (e.g., new objectively defined structures and new methods that result in new transformations of matter).

            The major problem with the sorts of methods being claimed by Myriad is that they represent an end-around the Supreme Court’s holding in Myriad. If a given nucleic acid is ineligible for protection by a patent, why should it be the case that one can protect methods of using old conventional techniques to observe, isolate and/or study that nucleic acid with claims that recite nothing else eligible and nothing else “new” other than the ineligible nucleic acid? It doesn’t make sense.

            It’s just as inconsistent as observing (correctly) that you can’t protect your new movie with a patent but then arguing that you can patent an old disk drive “configured to” play the new movie; or a method of watching the new movie, wherein said method comprises drinking coffee while watching the new movie; or a method of “storing data encoding the new movie on a computer”.

            It doesn’t (and shouldn’t) work to observe that people really, really, really loved the new movie, or that people really looked forward to the new movie for a long time, or that the modified disk drive represented an “improvement” over previous disk drives without the movie or that previous movie watching experiences or previous coffee-drinking methods yielded less satisfying results compared to the “new” claimed methods.

      2. 2.1.2

        Dennis, if the process is all old, including the use of probes, and the only thing that is new is the ineligible subject matter, then the novelty must be in the ineligible. But this still might be patentable per Diehr IF the ineligible is applied to improve the eligible.

        In listening to the oral argument, it seems that in this case there is no improvement in the statutory aspects of the old process, and the probe itself was in ineligible because its sequence was that of the wild DNA.

        The court did suggest at one point if the probe tag was placed at a novel location in the probe, that might be patentable.

        1. 2.1.2.1

          But there you are inconsistent in your analysis. Tagged probes were just as conventional as any other probe. The tag does nothing to make the claim less “routine.” It further does nothing to make the actual probe less “natural” since the probe is created synthetically in the laboratory (not “merely” extracted like the isolated DNA of AMP).

          1. 2.1.2.1.1

            crelboyne, on the tag issue, listen to the oral argument. The court seemed to suggest that if the inventors had come up with a novel way to tag a probe, perhaps even if limited to a specific gene, that such might be eligible.

            1. 2.1.2.1.1.1

              That may be, but I’m asking why this is a valid distinction under the analysis proposed by some on this board. Tagging is just as conventional and routine as the general use of probes.

              One can’t say that designing brand new probes that enabled an entirely new diagnostic process that has saved untold lives is trivial but then turn around say that adding completely routine and conventional tag to that probe would make the advance groundbreaking and patentable.

              And notice that Ambry’s answer to the court was that the tagged probe would still be ineligible.

              1. 2.1.2.1.1.1.1

                One can’t say that designing brand new probes that enabled an entirely new diagnostic process that has saved untold lives is trivial

                There is much that is wrong here. First, nobody has said what you just said. Second, there is nothing remotely close to an “entirely new diagnostic process” here. Third, the fact that an ineligible discovery “saved lives” is not relevant to the question of the eligibility of a claim protecting that discovery. Many, many, many life-saving discoveries are ineligible or otherwise unpatentable. That’s part of the reason the system denies eligibility to those discoveries: they are too important or fundamental to allow a private entity to control them merely because that entity had the money and foresight to file a piece of paper with the government.

                The policy argument I see is that once a method is taught to the public (e.g., a method for hybridizing DNA to its complement), one should not be able to patent a use of that method where the only difference between the old method and new method is the recitation of ineligible subject matter.

                Would-be patentees should be forced to contribute more otherwise the generically appicable detection and/or research techniques taught to the public become tied up by thousands or tens of thousand or hundreds of thousands of “improved” method claims, spread across gob knows how many entities, each describing the use of the old method to detect all those obvious (but not specifically described) things that everyone wanted to detect as soon as the method became available.

                As for how to deal with ineligible compositions that have been modified in obvious ways (e.g., attaching a probe) … that’s a Pandora’s box that the Supreme Court opened when they wrote their Myriad decision.

                Whatever analysis is used to render such claims ineligible, it should be very limited and carefully thought through. The system for removing obvious chemicals from the patent system is relatively very highly evolved and works well (I would not be suprised at all if Myriad’s broader composition claims have been or will be successfully challenged on grounds other than ineligibility in the US or other jurisdictions).

            2. 2.1.2.1.1.2

              By the way, I don’t think the court was talking about a novel way of tagging. It was talking about applying a routine tag to a new probe. I agree the court seemed to think this was eligible. And SCOTUS clearly thought so as well (see Kennedy’s question om this topic in the AMP oral argument). But under the analysis proffered here, I can’t see why that would be true.

      3. 2.1.3

        Although others had hybridized gene probes, one novel element in the claim is the step of hybridizing a BRCA1 gene probe.

        But the BRCA1 probe functions the same as the other probes. This is a book with new words in it, or a processor processing different code. I’d also caution against finding one novel element for the purposes of finding a claim eligible. While a novel element functionally written can find a claim ineligible, the converse is not necessarily true.

        1. 2.1.3.1

          It doesn’t function the same at all. It functions according to the same general principles, but it specifically hybridizes to and allows detection of a DNA molecule no other probe was previously capable of hybridizing to/detecting.

          If the BRCA1 probe is ineligible because it “functions the same as the other probes” as properly understood in the preceding sentence, then you have removed way too much from patentability under the “broad door” of s.101. Drug X kills cancer cells by antagonizing Receptor Z. Drug Y also kills cancer cells by antagonizing Receptor Z. Under your analysis, methods of using Drug Y to treat cancer are categorically ineligible (especially if Drug Y is derived from a natural compound, which frequently happens).

          Yet the Myriad claims are even better than the above hypothetical. They are more like Drug X and Drug Y antagonizing different receptors (Z and W, respectively). You are saying the methods of using Drug Y to treat cancer are ineligible simply because the chemical laws governing the binding of each Drug to its respective receptor are the same.

          Please contemplate the breathtaking scope of what you are arguing.

          1. 2.1.3.1.1

            crelboyne: Drug X kills cancer cells by antagonizing Receptor Z. Drug Y also kills cancer cells by antagonizing Receptor Z. Under your analysis, methods of using Drug Y to treat cancer are categorically ineligible (especially if Drug Y is derived from a natural compound, which frequently happens).

            That’s not the analysis.

            For starters, there’s no cancer being treated in Myriad’s claims. None. Zero. Nada.

            Second, in Myriad’s case, the recited nucleic acids are themselves ineligible, something not true of most drugs.

            Third, what’s being claimed by Myriad are just the obvious uses that could be claimed of virtually any “newly discovered” or newly synthesized polynucleotide. Those are the uses of the nucleic acid to, essentially, detect/isolate itself by direct hybridization or PCR, and the use of the nucleic acid in methods for studying the function/properties of that nucleic acid. Except for the specific sequence — an inevitable discovery, by the way, and one that can’t be protected with a patent — the claims could have been pre-written years earlier with no changes necessary.

            If it were true that Myriad discovered that the nucleic acid could be rubbed on your scalp to restore your lost hair or injected into your brain to cause tumors there to vanish instantly we likely would not be having this discussion about the eligibility of its claimed methods. But that’s not the situation here at all.

            I think we agree that whatever happens with Myriad’s claims (and it’s business model) the courts should be careful to acknowledge the role played by the specific facts at issue here, i.e., the self-detecting nature of DNA, the teaching in the prior art about that aspect of DNA and the widely used methods based on that understanding, the ineligibility of the polynucleotides(s) used in the methods, the ineligibility of the targets of the claimed methods, and the fact that granting such claims will lead to eons of “field of use” restrictions placed on otherwise ancient, generally applicable and extremely useful tools for basic research and information-gathering (i.e., PCR, DNA hybridization).

            1. 2.1.3.1.1.1

              So only methods of treating cancer are eligible. Methods of detecting (or predicting predisposition to) cancer are out the window. Makes sense. It’s called an analogy for a reason. It takes something slightly different (and likely more familiar) and uses that to illustrate a point. And these treatment claims are currently being rejected under this precise reasoning.

              Also, drugs are very often simply isolates from some natural source. Sometimes they are smaller moieties removed from the larger natural molecule. In either case, they would be ineligible under the incorrect analysis proffered here.

              As to your obviousness analysis, it is misplaced. It is not a question of whether implementation of the natural principle would be obvious after the inventor’s discovery. That is the primary mistake a lot of people make in reading Mayo. The Mayo Court said the “additional steps” needed to be routine and conventional at the time of filing, not after filing when taking the discovery into consideration.

              And the facts of Mayo bear this out, as the inventor there disclosed no new way of testing the metabolites. They instead claimed physical assays that were identical to that which was well known in the art in every particular and then they slapped on a statement (of fact) of the natural principle underlying the art method. I repeat, the assay was NOT obvious over the art method after applying the discovery; it was IDENTICAL.

              Myriad’s method claims are different. No one had ever run a PCR reaction with BRCA-specific primers to amplify BRCA-specific nucleic acids before Myriad. Entirely different from Mayo. Eligible.

    2. 2.2

      Random, I believe the question really is whether the ineligible subject matter is functional with respect to the eligible in a way that transforms the eligible, improves it, or whether the functional relationship between the ineligible and the eligible is unchanged such that one really is patenting the ineligible.

      This is the difference between Flook and Diehr.

        1. 2.2.1.1

          Ned, the functional improvement is that the hybridization could never before detect a cancer-gene and now it can.

          The hybridization could always detect whatever you pointed it at. The improvement is the knowledge of the location of where to point it, which is an advancement, just not a patentable one. The same argument was made in Alice and its parentage and rejected – the improvement to the processor was that it could now process X (wherein X was an idea). That’s not a new processor, it’s feeding new information through an old processor. Same thing here.

          1. 2.2.1.1.1

            You are thinking of Sequenom, which poses a closer case. That’s where the physical elements of the assay were identical but they were “pointed at” a new target by applying them to a new sample type (which the prior art taught would be worthless to “probe” in this way).

            You are analogizing to pointing an X-ray at a new target without modifying or adapting the X-ray in anyway to make it suitable for viewing that new target. It’s an inapt analogy. Myriad didn’t take pre-existing probes and simply “aim them” at the newly discovered gene. Myriad applied its new knowledge of the BRCA1 gene to design and create new probes with new structures that were now able (unlike any old probes) to specifically target the BRCA1 gene. Eligible.

            1. 2.2.1.1.1.1

              crelboyne, I must have missed that point about designing new probes in listening to the oral argument.

              Can you tell us about where in the oral argument this point was advanced?

              1. 2.2.1.1.1.1.1

                Can’t remember the part of the argument (if any) where this was discussed, but I would venture to say it’s uncontested that no one ever designed a BRCA-specific probe before Myriad’s filing. How could they? Each probe has a different chemical structure (nucleotide sequence) that determines its specificity and what DNAs it is capable of hitting.

                If you took a probe useful for specifically hybridizing to the p53 gene (these were available before Myriad’s filing) and tried to use it in the claimed methods, it wouldn’t work. Only a probe designed by a scientist in a lab utilizing the knowledge Myriad provided can be used in the claimed method.

                It’s a genus/species issue of sorts. People have trouble grasping the importance of the specific and tend to only focus on the generic.

                And there is a healthy dose of hindsight bias. At the time, this discovery was widely hailed as one of the most important advances in the history of cancer research. Yet we’ve now reached the point where people say things like “Myriad just used known probes in a routine process.”

                1. crelboyne, I am now over my head on the science here. I will take it on your representation that the probe by itself was novel and inventive.

                2. I would venture to say it’s uncontested that no one ever designed a BRCA-specific probe before Myriad’s filing. How could they?

                  Simple: by pumping out a random bunch of sequences, each of which is easily synthesized and each of which has the utilities of (1) detecting its presence in a mixture and (2) serving as the object for further study, e.g., what does it do in a cell?

                  Each probe has a different chemical structure (nucleotide sequence) that determines its specificity and what DNAs it is capable of hitting.

                  Sure, but remember again that the Supreme Court in Myriad swept aside all these considerations and rendered Myriad’s non-natural, man-made isolated polynucleotide compositions ineligible for protection by a patent. The (alleged) fact that nobody had previously “designed” Myriad’s claimed nucleotides did not seem to matter much to the Supreme Court then. Why do you suppose it should matter in the contexts recited in Myriad’s instant claims, which are merely the most obvious field of use restrictions imaginable?

                3. Only a probe designed by a scientist in a lab utilizing the knowledge Myriad provided can be used in the claimed method.

                  I don’t think I agree with this.

                  The inevitably of the sequencing of the entire human genome has been a forgone conclusion since about 1984 when planning for the Human Genome Project began and with that inevitably came the inevitable disclosure of all the corresponding probes for specifically detecting all those disclosed sequences and all the obvious methods of using those probes.

                  Note that claim 7 includes some very interesting self-serving functionality: it recites a “specific” probe for identifying “BRCA1” (again: a polynucleotide that is ineligible for protection by a patent) but it doesn’t describe that probe’s structure nor does it describe what conditions are necessary for achieving that “specificity”.

                  As I’ve already noted several times, the type of “innovations” recited in Myriad’s instant claims can be easily pre-written and directed to any otherwise ineligible gene. If the purpose of the restrictions on patenting set forth by the Court in Myriad was to preserve the public’s freedom to study “naturally occurring” DNA molecules, granting claims to well-known methods of detecting and isolating those DNA molecules would seem to undermine that decision. And if that wasn’t the Court’s purpose in Myriad, then I’m at a loss to understand what the purpose was.

                4. As to pumping out random probes (which are by definition not specific probes), this is the wrong analysis. Until the gene was known such a process would yield a population of probes that non-specifically hybridizes to every gene in the genome, thus being useless from a diagnostic perspective. And more importantly, useless in the various claimed methods (i.e., unable to help in detecting mutations specific to the BRCA1 gene, unable to help in evaluating the patient’s predisposition to cancer, etc.). It would be pure diagnostic noise.

                  As to what the Myriad Court held, they made it pretty clear when they emphasized that they “merely” held that genes (not oligonucleotides, not probes, not primers) were not patent eligible simply because they were isolated from their natural environment. Following the Roberts Court’s MO of issuing narrow, unanimous decisions, the Court struck down claims to genes extracted from a natural source. And central to the analysis was the fact the claims defined the composition explicitly and solely in terms of its natural function (encoding a gene). This was Funk Bros. redux (can’t claim any mixture of non-inhibitive bacteria because you didn’t give them that property).

                  MM and others make the mistake of taking for granted that the probes and primers are ineligible. The Court explicitly declined to decide the eligibility of probes and primers (and in fact suggested they would be eligible). SCOTUS at most suggested certain short fragments of extracted DNA MAY BE ineligible.

                  This is a classic case of people reading into a case way more than is in the text and, even worse, what was explicitly understood by the Court and parties to not be at issue or decided. s.101 is not the only thing that can be used as a “nose of wax”, twisted any which way to serve the ends deemed desirable.

        2. 2.2.1.2

          Dennis, are you suggesting that the specific gene identified could entirely be eliminated from the claim, and the remaining process would be novel?

          I didn’t hear that in the oral argument. I heard the opposite.

      1. 2.2.2

        Random, I believe the question really is whether the ineligible subject matter is functional with respect to the eligible in a way that transforms the eligible, improves it, or whether the functional relationship between the ineligible and the eligible is unchanged such that one really is patenting the ineligible.

        It’s not a binary test like that. As I just mentioned in response to Dennis, while the functional at the point of novelty test may be useful in one direction, the converse does not hold. Functional at the point of novelty is directly akin to saying “apply it” and therefore fails. Saying more than “apply it” does not necessarily make it eligible.

        The applicant has claim limitations, but not all of them have to do with his novelty. The only rule you can make is to determine what the invention is and judge the invention. When it’s clear from the circumstances that his invention is the addition of the information about location of something, that simply is not eligible information. You can’t claim a probe targeting a new genetic location any more than you can claim an old flashlight being shined on a new object, or a book holding new words.

        You tell me that he applied the location and tried to make a standard probe and had a problem and he overcame that problem by doing XYZ, now you’ve got an invention, but the invention is really using XYZ to overcome a problem in the context of the abstract idea. See at that point you’re not really claiming the idea at all, it’s only being used as a backdrop for his new XYZ method.

    3. 2.3

      “There is no difference, from a 101 standpoint, whether one states “idea + apply it”, or states idea + series of steps that one of ordinary skill would have known at the time to be an application of idea.”

      Actually there is. “It is now commonplace that an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection”. Diamond v. Diehr, 450 U.S. 175, 188 (1981).

      Remember, Section 101 “new and useful” analysis only treats a judicial exception as though “it were a familiar part of the prior art” whether or not the judicial exception was in fact known at the time of the invention. Parker v. Flook, 437 U.S. 584, 591-92(1978). This “new and useful” analysis must precede and it is distinct from “novelty” and “obviousness” under 102 and 103. Id. at 593 (“The obligation to determine what type of discovery is sought to be patented must precede the determination of whether that discovery is, in fact, new or obvious”). Mackay Radio & Telegraph Co. v. Radio Corp. of America, 306 U.S. 86, 94 (“But we do not stop to solve the problem whether it was more than the skill of the art to combine the teaching of Abraham with that of Lindenblad and others who had pointed out that the arrangement of the wires at an angle enhanced directional radio activity along their bisector. We assume, without deciding the point, that this advance was invention”).

      Indeed, the Supreme Court chose to use the term purely “conventional or obvious” for 101 analysis rather than just “obvious” under 103. According to the Supreme Court, “purely conventional” steps are steps that anyone who wants to use a judicial exception would necessarily use. See Ultramercial, Inc. v. HULU, LLC, 722 F.3d 1335, 1348 (Fed. Cir. 2013) (“whether implementing the abstract idea in the context of the claimed invention inherently requires the recited steps…steps were those that anyone wanting to use the natural law would necessarily use”). See also Mayo Collaborative Serv. v. Prometheus Labs, Inc., 132 S. Ct. 1289, 1298 (2012) (“Anyone who wants to make use of these laws must first administer…so the combination amounts to nothing significantly more than an instruction to doctors to apply the applicable laws…”); see also id. at 1299-30 (defining conventional steps as steps that must be taken in order to apply the laws in question).

      “Purely obvious” may be a higher level of obviousness than the one under 103. In the context of Flook and Alice, “pure obviousness” are characterized as generic “apply it” on a computer rather than the concept of obviousness. Otherwise, Diehr would not say “Arrhenius’ equation is not patentable in isolation, but when a process for curing rubber is devised which incorporates in it a more efficient solution of the equation, that process is at the very least not barred at the threshold by § 101” wherein “It is now commonplace that an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection”. Diamond v. Diehr, 450 U.S. 175, 187-88 (1981).

      My guess is that “pure obviousness” is a higher level of obviousness such as “sky is blue” obvious, “a LCD panel displays an image”, “a printer prints the resulting data”, “internet capable computer transmits the result over a network”, or “computer saves the result on a hard drive” obvious. I think this is where “purely obvious” under section 101 overlaps “obvious” under section 103. Mayo Collaborative Serv. v. Prometheus Labs, Inc., 132 S. Ct. 1289, 1304 (2012).

      Looking at the dependent claim limitation “wherein a germline nucleic acid sequence is compared by hybridizing a BRCA1 gene probe which specifically hybridizes to a BRCA1 allele to genomic DNA isolated from said sample and detecting the presence of a hybridization product wherein a presence of said product indicates the presence of said allele in the subject.”, this is rather like once you treat Diehr’s In v = CZ + x as though it was a familiar part of the prior art and other generic steps to obtain these individual variables, you still have (1) constantly determining the temperature Z of the mold at a location closely adjacent to the mold cavity; (2) constantly providing the computer with temperature Z; (3) the computer would repetitively compute the curing time at frequent intervals between each cure; (4) repetitively comparing the calculated cure time and measured elapsed time; and (5) opening the mold when the comparison indicated equivalence. Diehr, 450 U.S. at 179 n. 5.

      Even if these steps were obvious under 103, they are not purely obvious to precede patent eligbility under 101 and i think it is an eligible application of the judicial exception.

      1. 2.3.1

        Richard, you do recall that in Diehr the Supreme Court did cite the fact that the pre-existing process was improved? Don’t you believe this is important?

        From Diehr.

        “In contrast, the respondents here do not seek to patent a mathematical formula. Instead, they seek patent protection for a process of curing synthetic rubber. Their process admittedly employs a well-known mathematical equation, but they do not seek to pre-empt the use of that equation. Rather, they seek only to foreclose from others the use of that equation in conjunction with all of the other steps in their claimed process. These include installing rubber in a press, closing the mold, constantly determining the temperature of the mold, constantly recalculating the appropriate cure time through the use of the formula and a digital computer, and automatically opening the press at the proper time. Obviously, one does not need a “computer” to cure natural or synthetic rubber, but if the computer use incorporated in the process patent significantly lessens the possibility of “overcuring” or “undercuring,” the process as a whole does not thereby become unpatentable subject matter.”

        1. 2.3.1.1

          I believe this conclusion was premised upon the limitations “(1) constantly determining the temperature Z of the mold at a location closely adjacent to the mold cavity; (2) constantly providing the computer with temperature Z; (3) the computer would repetitively compute the curing time at frequent intervals between each cure; (4) repetitively comparing the calculated cure time and measured elapsed time; and (5) opening the mold when the comparison indicated equivalence. ” in addition to In v = CZ + x.

          In other words, the improvement to prevent curing and undercuring (“this being the improvement”) rubber comes from non-generic steps on top of generic / purely obvious and conventional steps required for In v = CZ + x.

          “On the other hand, when a claim containing a mathematical formula implements or applies that formula in a structure or process which, when considered as a whole, is performing a function which the patent laws were designed to protect (e. g., transforming or reducing an article to a different state or thing), then the claim satisfies the requirements of § 101” id. at 192.

      2. 2.3.2

        I’ve said it before and I’ll say it again: the more Diehr is relied on by practitioners to justify the eligibility of claims that bear little or no resemblance to Diehr, the less relevant Diehr will become to patent law generally.

        That’s a good thing, by the way, since Diehr’s claims should never have been granted in the first place.

      3. 2.3.3

        Actually there is. “It is now commonplace that an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection”. Diamond v. Diehr, 450 U.S. 175, 188 (1981).

        In Diehr, the standard process was improved. In this case, the standard process remains the same, it is only directed toward to a different place.

        “wherein a germline nucleic acid sequence is compared by hybridizing a BRCA1 gene probe which specifically hybridizes to a BRCA1 allele to genomic DNA isolated from said sample and detecting the presence of a hybridization product wherein a presence of said product indicates the presence of said allele in the subject.”

        My understanding is that this is how probes commonly work – you create something that will bond, you see if it bonds, and if it bonds you know it was present. The fact that you’re directing the probe to something you’ve newly discovered is irrelevant.

        1. 2.3.3.1

          It’s not directing an existing probe to a new location, but designing and creating a new probe with a novel structure to hit that new location. Eligible.

          1. 2.3.3.1.1

            designing and creating a new probe with a novel structure to hit that new location. Eligible.

            But the Supreme Court in Myriad already said that a “new” isolated polynucleotide with a contiguous sequence of nucleic acids identical to a sequence found “in nature” is ineligible for patenting. It doesn’t matter how such a polynucleotide was designed, nor does it matter why it was designed. Given those facts, why should it matter that this polynucleotide’s use is “limited” to the most obvious purposes imaginable: for detecting its complement and as a tool for further research into its functionality?

      1. 1.1.1

        “…(is the term not dissection?)”

        Yes the term is dissection but to argue dissection would be to argue against well settled law. So the courts must make up new code words like “filtering”.

          1. 1.1.1.1.1

            The problem with Flook was illustrated by Stevens dissent in Diehr. Stevens would have held the claim in Diehr invalid because in his view, the process besides the math was old. The Diehr majority added the concept that the math could be used to improve the underlying process.

            Thus the problem in Flook, revisited, was that the underlying process was too nonspecific, too abstract, such that there was no specific process defined in the claim that was being improved.

            1. 1.1.1.1.1.1

              “The Diehr majority added the concept that the math could be used to improve the underlying process.”

              Your use of the word/phrase “underlying process” is a bit of a misnomer because it implies that Diehr stood for dissecting claims, and ignoring elements, to distill the invention down to a gist (what you call underlying process) when in fact there was no “underlying process” even identified in Diehr. There was only one process for curing rubber that was considered as an “Intergated Whole. You can’t rewrite case law history no matter how hard you try.

            2. 1.1.1.1.1.2

              There is no “thus.” Stevens would hold almost everything to do with information processing ineligible. Good riddance to a man that did not modernize his thinking.

Comments are closed.