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.
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!
Regarding “claim as a whole,” from Graham v. John Deere, at 34
In other words, the novel subject matter unless the old subject matter is somehow integrated that it cannot be ignored.
“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.
The same agenda that has been “discussed”*** before.
If you count the running away of valid counter points raised as “discussion.”
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.
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.
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.
I also wonder when the PTO will stop issues business method patents.
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).
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.
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.
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).
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.?
Henry Ford’s method is in the public domain.
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.
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.
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.
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.
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.
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.
“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.
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.
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.
I’d say that Alice kills hand-waving in claims. There are two limitations in this claim that should end this discussion.
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.
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.
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.
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?
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.
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.
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!
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.
“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.
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.
“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.
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.
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.
>>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.
>>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.”
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.
“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.
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.
“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. :/
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.
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”.
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.
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?
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.
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?
“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.
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?
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.
“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.
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.”
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:
The paragraph in which this holding was placed, the Court observed,
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.
Richard, in sum, they held the product of nature was not a new composition within the meaning of 101.
Not new.
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.
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.
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.
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?
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.
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.
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).
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.
“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.
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.
“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.
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.
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.
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?