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[patentatt]

http://www.pharmapatentsblog.com/supreme-court-decisions/supreme-court-grants-cert-in-mayo-v-prometheus/

http://www.youtube.com/watch?v=IUH3JQjcweM

[JimIvey]

Interesting....

There are a couple of things Justice Breyer did that I find disturbing.  And, I hope better reasoning prevails in the next decision.

First, he suggested that the claim should fail 101 because otherwise the claim would stop people from practicing the invention.  I certainly hope that it's a requirement of Section 101 that the claim not prevent anyone from doing something useful.  In fact, I'm pretty sure 101 means exactly the opposite -- if the thing you want to prevent others from making, using, selling, etc. is not useful, you fail 101.

Second, he did the somewhat naive thing of reducing a claim to some silly level of simplicity, typically using the transition word, "essentially" -- that the claim essentially recited obtaining lab results and thinking about them.  I think that's a reasonably clearly specious argue, albeit a popular one, to reject a claim because an unreasonably abstract summary of the claim is unreasonably abstract.

Third, the step of "obtaining lab results" -- despite being grossly over-simplified -- passes muster under the overly restrictive machine-or-transformation test, requiring specific machines that transform matter, as noted by the Federal Circuit.

I have to admit that I'm surprised that medical diagnostic techniques are even in doubt of being statutory subject matter under 101, though I don't practice in that technology.

Regards.

[patentatt]

Interesting....

There are a couple of things Justice Breyer did that I find disturbing.  And, I hope better reasoning prevails in the next decision.

Are you talking about the dissent from denial of cert. in Metabolite?

Cert. was just granted in Prometheus today.  There is no decision yet.

First, he suggested that the claim should fail 101 because otherwise the claim would stop people from practicing the invention.  I certainly hope that it's a requirement of Section 101 that the claim not prevent anyone from doing something useful.  In fact, I'm pretty sure 101 means exactly the opposite -- if the thing you want to prevent others from making, using, selling, etc. is not useful, you fail 101.

Yes.  This is a major problem with the "preemption" doctrine of Benson/Flook.

[JimIvey]

Are you talking about the dissent from denial of cert. in Metabolite?

The link isn't working now, but it was at the blog you linked to above -- either in the denial of cert or in a similar case mentioned in the blog -- either the article you linked to or one of two other articles linked to by that article.  I think it was mentioned twice in the 3 articles I read.

Regards.

P.S.  The links are now working.  The articles were both referring to Breyer's Metabolite dissent.
http://www.pharmapatentsblog.com/federal-circuit-decisions/federal-circuit-upholds-personalized-medicine-claims/index.html
http://www.pharmapatentsblog.com/federal-circuit-decisions/cruisin-for-a-bruisin-on-metabolite/index.html

[JimIvey]

First, he suggested that the claim should fail 101 because otherwise the claim would stop people from practicing the invention.  I certainly hope that it's a requirement of Section 101 that the claim not prevent anyone from doing something useful.  In fact, I'm pretty sure 101 means exactly the opposite -- if the thing you want to prevent others from making, using, selling, etc. is not useful, you fail 101.

Yes.  This is a major problem with the "preemption" doctrine of Benson/Flook.

Yes, sort of....

Benson ruled that the claimed invention would preempt pretty much every use of a mathematical algorithm, never mind the facts of the case that the claim recited bit-wise shifts in electrical impulses stored in a hardware register.

The problem I have with Breyer's Metabolite dissent is that (i) it's not mathematical algorithm that is being preempted and (ii) that it's not being wholly preempted in all disciplines, just in medical diagnosis.

Though, as I think about it, Breyer did argue that the relationship between a medical condition and a symptom is a law of nature and that the claim(s) leave no practical use of that law of nature unprotected as all practical use of that law is in medical diagnosis.  I don't have enough of a pharma/life-sciences background to know if that the basis for that argument is technologically accurate.

If it is, the facts might lie outside of Benson and Breyer might have a point. 

The more I come up against Benson and Flook, the more I wish I had filed an amicus brief arguing for overturning those decisions or at least reconciling the decisions.  Benson was just wrongly decided given the rule(s) it laid down and the facts of the case.  I don't have much of a problem with law as articulated by the court but rather as applied to the facts of the case. 

Regards.

[JustAnotherExaminer]

1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:
(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and
(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,
wherein the level of 6-thioguanine less than about 230 pmol per 8x108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and
wherein the level of 6-thioguanine greater than about 400 pmol per 8x108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

The CAFC imports limitations into the claims to make their determination that it is statutory.

I could make a very solid argument this doesn't pass 101.  First off, the "transformation" argument CAFC makes (which is: eating something inherently causes some type of transformation of the body), makes the transformation test absolutely useless because everything under the sun is now a transformation.  Me thinking about something abstract just transformed neurons in my brain, 101 eligible!

The big elephant in the room regarding 101, and I believe I've said this before, is that you have two sets that claims can be in.  Set1: claims that should be patent eligible under 101; and Set2: claims that should not be patent ineligible under 101.  Every couple years the courts create some "test" that defines the boundaries of the Set3: set of patent eligible claims, which also defines Set4: set of patent ineligible claims.  And the test(s), which define the Set3 and Set4, allegedly creates Set3 and Set4 so that they are identical (or near as can be) to sets Set1 and Set2, respectively.  But every couple years a court realizes the deficiencies of a prior "test" by recognizing something in Set3 or Set4 that should or should not be in Set1 or Set2, respectively.  And so they change or create tests all willynilly.


Well I can create tests too.  For me, one thing I like to think about, especially when analyzing a method claim, is "Can a human being, by themselves, perform this method?"

Now, I don't have any idea what 6-thioguanine is, I'm not a chemical guy.  But a couple things I notice about this claim that are red flags:
1) It makes no difference whether the subject has or doesn't have a particular disorder because the subject will either have or not have the disorder.
2) The wherein clauses at the end aren't positive steps to the method, and the numbers listed (pmol per blood cell) aren't a necessary accuracy amount for anything within the claim.  That is, no measurement with a particular accuracy is occurring, these numbers just... exist... and "indicate" something.
3) The "determining" step doesn't require a machine as the CAFC alleges because there is no recitation as to what degree or accuracy or relativity the level is being determined.
4) The words "administrating" and "drug" may import particular definitions depending on the art and specification.  I'm going to give them a fairly broad interpretation (I'm not one skilled in the art).

Now let's assume that 6-thioguanine is naturally occurring and that the phrase "administering a drug" could be a step based on a naturally occurring substance, maybe a person eating a plant or... sunlight hitting a person.  So yes, let's assume 6-thioguanine is something that can be administered via sunlight.  So step 1, we've got a person standing in the sunlight.

Then we've got a determining step that determines a level of that 6-thioguanine.  No regard to accuracy or anything.  So I get some sunlight which I know has 6-thioguanine, and now I determine I have more 6-thioguanine than I previously did 2 seconds ago, so I just determined the level of my 6-thioguanine relative to my prior level of 6-thioguanine.  Specifically, I determined the current level is "more than" the last level.  So step 2, we've got a person thinking about how much substance they have.

Now the wherein clauses, they've got some particular accuracy, but aren't positive step recitations, they're just knowledge that exists in the claim.  So let's assume I'm the person and I just happen to know and keep in my brain that information.  I know that my 6-thioguanine level (if I could measure it with awesome accuracy) should be more than 230 pmol per 8x108 and less than 400 pmol per 8x108 red blood cells.

So I just described to you a person, that stands in the sunlight (or eats some plant), that knows that the sunlight (or plant) contains 6-thioguanine and so they determine their level increases.  And the person is also smart and knows their 6-thioguanine level (if they could measure it) should be more than 230 pmol per 8x108 and less than 400 pmol per 8x108 red blood cells.

Is that 101 eligible?

[JimIvey]

I could make a very solid argument this doesn't pass 101.  First off, the "transformation" argument CAFC makes (which is: eating something inherently causes some type of transformation of the body), makes the transformation test absolutely useless because everything under the sun is now a transformation.  

First, Section 101 makes "everything under the sun made by man" statutory subject matter.  That's from the Supreme Court and has not been changed.

Second, the machine-or-transformation test is not the test for 101 compliance; it's a test.

Third, it's machine or transformation, not machine and transformation.  Are you going to tell me that you can determine a person's 6-thioguanine level without a rather specific machine?

Fourth, the drug itself is transformed.  If it's injected, it's transformed from a liquid in a syringe into a liquid distributed through a human body.  It's is in pill form, its various binding agents are dissolved in the stomach and digestive system and its constituent chemicals and substances are distributed throughout a human body.

Fifth, the human subject is transformed from a person with a given level of 6-thioguanine in their blood to a person with a higher level of 6-thioguanine in their blood.

Sixth, eating does in fact transform matter.  So, move on to novelty and obviousness.

Me thinking about something abstract just transformed neurons in my brain, 101 eligible!

That's quite a leap without requisite intervening steps of logic.  Thought is an abstraction of neural state/activity.  However, who's to say where medical technology will lead?  What if it's discovered that thinking of apples 3 hours per day for 3 months straight stimulates a part of the brain that can repair neural damage of Parkinson's disease?  Do you really want the law to tell people not to bother with very expensive research in that area to come up with some cures?

The big elephant in the room regarding 101, and I believe I've said this before, is that you have two sets that claims can be in.  Set1: claims that should be patent eligible under 101; and Set2: claims that should not be patent ineligible under 101.  Every couple years the courts create some "test" that defines the boundaries of the Set3: set of patent eligible claims, which also defines Set4: set of patent ineligible claims.  And the test(s), which define the Set3 and Set4, allegedly creates Set3 and Set4 so that they are identical (or near as can be) to sets Set1 and Set2, respectively.  But every couple years a court realizes the deficiencies of a prior "test" by recognizing something in Set3 or Set4 that should or should not be in Set1 or Set2, respectively.  And so they change or create tests all willynilly.

I've read that several times and I honestly don't understand it.

Well I can create tests too.  For me, one thing I like to think about, especially when analyzing a method claim, is "Can a human being, by themselves, perform this method?"

Well, of course you can!  Except that's not a test used to measure compliance with Section 101 and never has been. 

Many patents have issued on inventive methods that can be performed solely by a human being.  Surgical techniques is one, though I understand such patents are not enforceable (by statutory exemption, I believe).  The 3-way comb-over is another.  I understand recipes are sometimes patented.

There are only 3 categorical exclusions to Section 101:

• Laws of nature.
• Naturally occurring phenomena.  Either categorically never novel or simply manifestations of laws of nature.
• Mathematical algorithms.  Effectively natural truths in the realm of mathematics.

How do you get "can be infringed by a person" from that?  That's just not the law.

Regards.

[Robert K S]

What if it's discovered that thinking of apples 3 hours per day for 3 months straight stimulates a part of the brain that can repair neural damage of Parkinson's disease?  Do you really want the law to tell people not to bother with very expensive research in that area to come up with some cures?

Not the best example, because such a patent even if valid would be unenforceable.

[JustAnotherExaminer]

Are you going to tell me that you can determine a person's 6-thioguanine level without a rather specific machine?

Yes, I am.  The claim recites "determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder".

I watch you (or me, if I'm my own subject) do something (let's say stand in the sunlight, but maybe eat something as well) that I mentally know increases your (or my) 6-thioguanine.

I now determine your level of 6-thioguanine to be "higher than 1 minute ago".  I have just mentally determined the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder.

It doesn't require a particular machine as the CAFC alleges, because they're reading limitations into the claim.  They're assuming the determination is occurring to a particular degree, or requires the use of some specialized equipment.  And maybe this is because there is a lack of antecedent basis for "the level of 6-thioguanine" and therefore a 112 second rejection would be appropriate. 

And if you make an "it has an inherent level" argument, I'm going to 112 you again because you can't possibly determine "the inherent actual level of 6-thioguanine".  You can determine a value representative of the level, but you can't determine the actual level.

Fourth, the drug itself is transformed.  If it's injected, it's transformed from a liquid in a syringe into a liquid distributed through a human body.  It's is in pill form, its various binding agents are dissolved in the stomach and digestive system and its constituent chemicals and substances are distributed throughout a human body.

Fifth, the human subject is transformed from a person with a given level of 6-thioguanine in their blood to a person with a higher level of 6-thioguanine in their blood.

True, like I said, everything is a transformation to some extent and viewed in the right context.  Which makes the "is this a transformation?" test absolutely useless.

Even the determining step requires a transformation of "a person not knowing the level of 6-thioguanine" to "a person knowing the level of 6-thioguanine".

And I'm aware of the 3 exceptions to 101.  You haven't really persuaded me that "sitting in the sunlight; and thinking about my 6-thioguanine level" is not a combination of a law of nature and an abstract idea, with no practical application.

[Robert K S]

Claims are to be interpreted as they would by someone skilled in the art, not as they would by a paranoid person.

[dablueman]

Claims are to be interpreted as they would by someone skilled in the art, not as they would by a paranoid person.

I have to agree on this one. I think the broadest reasonable interpretation of level given this claim is a measurement in pmol/8 x 10(. Reasonableness is part of BRI and the BRI must be informed by the claim language. This claim has two wherein clauses referring to the level as being measured in pmol/8 x 10(. To take an interpretation that flies in the face of the claim language itself I think is unreasonable.  Also, I think determining the level is "higher than 1 minute ago" would actually require 2 determinations of the numerical level rather than the 1 the step the claim requires. Otherwise you wouldn't actually be able to determine the level is higher.

JMHO.