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« Court Report | Main | AntiCancer, Inc. v. Pfizer, Inc. (Fed. Cir. 2014) »

October 20, 2014

Comments

"This subjectivity is of course the basis for the Court's apparent belief that its views on patent law should be superior to the Federal Circuit's, a view the Court did not espouse when the appellate court's opinions were penned by Judges Rich or Markey."

Kevin,

Never were truer words spoken with respect to the brazen constitutional overreach by the current Royal Nine in terms of patent law jurisprudence. The Royal Nine pays nothing but lip-service to the patent statutes, as written, Congress' intent, as expressed in those statutes, and the inconsistency of Mayo, Myriad, and Alice with its prior precedent, especially Diehr and Chakrabarty. Is it any wonder that the Rule of Law is being mishandled by the lower courts. Sorry, but the Royal Nine gets no pass from me.

Thank you for the excellent and thoughtful post. I am wondering about two things particularly. First, did I understand correctly that the (N.D. Cal.) court determined that Sequenom's patent was preemptive in part because 12 years later there are no commercially viable alternatives? Isn't this rationale directly opposed to Graham v. John Deere's secondary considerations of nonobviousness, particularly commercial success?

Second, at the recent BCP meeting webcast (I believe commented on in this blog by Dr. Zuhn?), I understood June Cohan of the PTO to state that in Alice the Supreme Court separated the claims into individual elements to perform the test for patentability, and that the PTO's guidance therefore followed the same approach, footnote 3 (?) of Alice apparently notwithstanding, because Ms. Cohan in her explanation seemed focused on what the court did and not necessarily what it characterized itself as doing. Even after the revised PTO guidance comes out soon, based on what Ms. Cohan said, this approach seems unlikely to change, and without consideration of the claims as a whole I think many more claims are likely to fail the test, and the damage you foresee to American biotech and pharma business to be inevitable.

Kevin,

One quick comment. Those two clauses at the end of Claim 1 in the Mayo v. Prometheus case are not merely "wherein" clauses. According to Breyer's decision, together those two clauses are a "wherein" step. See quote below from the decision:

"What else is there in the claims before us? The process that each claim recites tells doctors interested in the subject about the correlations that the researchers discovered. In doing so, it recites an 'administering' step, a 'determining' step, and a 'wherein' step. These additional steps are not themselves natural laws but neither are they sufficient to transform the nature of the claim."

This needs to be pointed out, because it shows just how sloppy the reasoning and decision was in Mayo v. Prometheus. The Supreme Court, if they had any shame, should be ashamed of themselves.

"Never were truer words spoken with respect to the brazen constitutional overreach by the current Royal Nine in terms of patent law jurisprudence. The Royal Nine pays nothing but lip-service to the patent statutes, as written, Congress' intent, as expressed in those statutes, and the inconsistency of Mayo, Myriad, and Alice with its prior precedent, especially Diehr and Chakrabarty. Is it any wonder that the Rule of Law is being mishandled by the lower courts. Sorry, but the Royal Nine gets no pass from me."

Oh the acrobatics thou want thy fantasies to perform. You have it inverted, dear jester. The Circuit of course believes its house to be in order, the rightful issuer of edicts, the arbiter of last resort. Be it the most grand of the court's fallacies, but truly the imagination of fools and kings have no bounds. The bastions of righteousness, the marvels of logic, those credentialed and honored members of this very bar, of course it is truth from their lips which pour like honey form the combs of the bee, for long live the queen until the last breath of the final of our brethren. Our coffers ever to be filled with the fruit of invention.

I am now seeing (elsewhere) a naked embrace that patent law is allowed to be newly written by the judicial branch - a view by a prominent academic, no less.

If this is being what is taught, how can there be any respect for the "rule of law," EG?

I see WAY too much bland acceptance and "let's make the best of it" mindset.

With all due respect to Mr. Cole, attorneys should take a close look at their oaths - we are called to support the constitution, not the judicial version of the constitution that a blind fealty to the top Court would produce.

Yes, that Court does get to decide the interpretation of the laws as written by Congress. But that interpretation simply is not the same as writing the law and then calling that writing an interpretation.

As you put it, EG - the Court does NOT get a free pass. Judge Rich understood this well, and is the main reason why In re Bergy was written as it was on the heels of the Supreme Court's Benson case (and historians, as well as others, should note how In re Bergy was subsumed into the Chakrabarty case) - the main reason why a lower court - with a judge understanding the law as written by Congress - did not kneel before the Royal Nine.

As attorneys we owe a duty to challenge the Court.

Let us not shirk that duty for "(patent) peace for our time" - this is no mere Justice of the Peace commission in the cross-hairs - this is the entire system of one of the key components of our innovation protection system.

@A Rational Person

"how sloppy the reasoning and decision ..."

Why don't you then enlighten us all on the black letter law of "wherein".

Kevin, since you have on a few occasions expressed some modicum of understanding of the issue presented to the court in Mayo v. Prometheus, i.e., whether ineligible subject matter can be protected by a patent claim that recites, in addition to ineligible subject matter, an old data-gathering step that is already in the public domain, why do you always seem to go out of your way to avoid educating your readers about that issue and why it was resolved in Mayo's favor?

You make it seem as if was arbitrary or, worse, capricious. But that's not true, Kevin, and you know it.

ARP: "his needs to be pointed out, because it shows just how sloppy the reasoning and decision was in Mayo v. Prometheus"

I couldn't follow your comment. Where is the "sloppy reasoning"?

Prometheus "discovered" some ineligible correlation. Their claim recites 1) gathering data with an old technique; 2) looking at the data; 3) thinking about what the data "indicates" in light of the ineligible correlation.

Prometheus admitted in court that the claim could be infringed by an employee looking at the recited blood measurements with the correlation in mind, without performing any additional act. Remember: making the blood measurements was old in the art!

If there's any "shame" to be felt here, that "shame" should be felt by people who refuse to acknowledge the mess that would be created by a system that permits such claims to be granted and enforced.

Kevin,

There's another way to look at the qualifications of "the case that a new use for an old (or otherwise unpatentable) compound can be patentable (and thus patent eligible)."

These existing qualifications to new uses of an old compound/device are the reason why the Supreme Court's legislating from the bench was even unnecessary to address their hypothetical fears of an inventor preempting a natural a law, i.e., the existing concepts of of "inherency", "normal operation", etc. have for decades put limits on the ability of an inventor to preempt a natural law.

The fact that the concept of "inherency" is not even mentioned in Myriad is an illustration of just how sloppy that decision was. At the very least, the Supreme Court should have explained why it thought the concept of "inherency" was not enough of a limit on products of nature.

@A Rational Person

"fact that the concept of "inherency" is not even mentioned"

Wherein your mouth, like your cup, runneth over, from a mind both full and empty at once.

@Hand

"Why don't you then enlighten us all on the black letter law of 'wherein.'"

It's not just a question of law, it's a question of how the English language works.

The "wherein clauses", either taken alone or together, do not recite a method step.

In the context of Claim 1, the wherein clauses modify step (b), i.e., the determining step.

@Jeff C.

"I couldn't follow your comment. Where is the 'sloppy reasoning'?"

A wherein clause is not a method step.

@Hand

"You make it seem as if was arbitrary or, worse, capricious. But that's not true, Kevin, and you know it."

Okay, to prove that the decision Mayo v. Prometheus was not arbitrary and capricious with respect to interpreting 35 USC 101, please provide an example of a patentable method claim in the fields of biotechnology or chemistry that:

(1) Does not apply a law of nature, AND

(2) Does not involve well-understood, well-understood, routine, conventional activity previously engaged in by scientists in the field.

Dear Jeff C.:

Actually, I can understand the way the Court applied the law in Mayo (even if I don't agree with it). This post is meant to illustrate how the district courts have been able to take the Delphic form of Justice Breyer's opinion to expand what is "routine, conventional and well-understood."

We are (because we have to be) beyond the actual decision in Mayo. How this law is applied is the point.

Thanks for the comment.

Mayo is another example of bad claims making bad law.

If we accept that the Court will use novelty as part of the 101 analysis, then we can see how the Court could characterize the Prometheus claims as being an old administration step, old characterization/measuring steps (being unlimited in scope), and the "natural law" comprising the correlations. (What the patentee thought the claims permitted her to do is not relevant to the issues.)

Compare this with the Isis claim in Sequenom. The existence of paternal DNA in maternal blood of a pregnant woman was not known in the prior art. The ability to diagnose fetal diseases and disorders by detecting such DNA was unknown, and there was no practice of any methods for detecting the unknown DNA for making such diagnoses. The amplification step in the Isis claim differs from the measuring step in the Prometheus claim because measuring blood in a Crohn's disease patient to monitor levels of 6-TG or its metabolites was practiced in the prior art; no one in the art amplified DNA from maternal blood to detect paternal DNA that was not known to be there.

That difference, it seems to me, means that the Mayo decision does not mandate that the Isis claim is patent eligible.

What is the logical argument (which does not include "Because the Mayo decisions requires it") that supports the district court's decision? Please let us all know

Kevin,

I think the fundamental problem is that the Mayo decision provides grounds for a judge or Examiner who wants to do so to reject virtually any method claim in the fields of biotechnology or chemistry under 35 USC 101.

Based on the reasoning provided by the court in the Mayo decision, virtually any conceivable method in biotechnology and chemistry is a combination of steps that are well-understood, well-understood, routine, conventional activity previously engaged in by scientists in the field and/or apply a law of nature.

The Court in Mayo not only analyzed the steps of the method independently from each other, but even sub-divided each step to find a part of the step that was "conventional" and another part of the step that applied a law of nature.

Furthermore, based to the decision of Mayo, even a reaction involving non-naturally occurring substances is an example of applying a law of nature.

Therefore, unless we believe that language 35 USC 101 was intended to prevent the patenting of any methods relating to chemistry or biotechnology, the Mayo standard is an exemplar of an arbitrary and capricious standard; whether a method claims in chemistry or biotechnology is considered now is now up to the whim of the Examiner and the judges.

Logically speaking, there is no possible example of something NOT applying 'a law of nature.'

@Skeptical,

Agreed.

A Rational Person: "A wherein clause is not a method step."

Prometheus asserted in court that the wherein clause covered the step of thinking about the relationship of the correlation to the measured data.

You seem very unfamiliar with the facts of Prometheus v. Mayo. That's unfortunate because you'll be confused and bitter for a long time until you figure it out.

Kevin: "What is the logical argument (which does not include "Because the Mayo decisions requires it") that supports the district court's decision? Please let us all know"

Happy to oblige, Kevin. Maybe in return you can oblige your regular readers and help them understand why the result in Mayo was necessary because they seem to be deeply confused. Does that concern you at all? It should. It's pretty clera where they are getting their information, after all.

The logic of Sequenom is that granting claims of such breadth threatens to take well-known, conventional data-gathering tools out of the public domain -- that was also true of the claims at issue in Prometheus v. Mayo.

Here are the facts as of the filing date:

Fact: PCR is old and well-known

Fact: PCR can be used to identify the presence of incredibly miniscule amounts of DNA

Fact: fetal DNA has paternal sequences (known)

Fact: fetal cells exist in maternal plasma (known)

Fact: fetal cell debris exists in maternal plasma (known)

Fact: where fetal cell debris exists, fetal DNA exists (application of basic logic)

Fact: fetal DNA can be detected by PCR because PCR can be used to identify the presence of incredibly miniscule amounts of DNA (see above)

Fact: you can't patent a natural fact (i.e., the existence of detectable amounts of fetal DNA in maternal plasma)

When viewed against this background, the problem with Sequenom's claims is readily apparent. Sequenom "discovered" that one could modify the PCR technique in a particular way such that those modifications would allow paternal DNA sequences to be amplied and identifiable from maternal plasma. But rather than claim those particular ways, they chose instead to broadly claim *all* practical uses of PCR which achieved that goal.

The problem with granting such claims is that they effectively take extremely useful and broadly applicable data gathering tools -- the same tools that were used to make the underlying discovery! -- out of the public domain. People discover new things with PCR every day. I discovered new things with PCR, and so did people I worked with. It never occurred to any of us to run to the patent office with a claim describing using PCR to see the "new" molecule that we saw and thank goodness for that. That sort of foaming at the mouth patent lawyering doesn't "promote progress in the useful arts." It just promotes litigation.

The analogy to Mayo is apt. Granting claims like those asserted by Prometheus (e.g., data gathering step plus mental step of thinking about the data) ends up creating endless patent thickets around public domain data gathering tools. Likewise, granting claims to the use of conventional data gathering tools limited only to the object to which the tool is directed puts too great a restriction on the public's ability to use those tools.

Anyway: that's the logic. You're free to disagree, of course, but I humbly sumit to you that there is way worse "logic" on display in your comments here all the time that you might want to address first (unless of course it's not really "logic" that bothers you but where that logic leads).

Also, you'll note that this analysis leads ample room for Sequenom to obtain a more limited claim without the pernicious effects I noted above. And, lastly, I'll grant you that this is a bit of a "closer case" than Mayo, for what's that worth.

"Fact: where fetal cell debris exists, fetal DNA exists (application of basic logic)"

That is an assumption not a fact and not a logical conclusion.

And if someone came up with a new way to detect minute amounts of DNA these claims would not preempt such methods.

And the claims don't prevent anyone from "discover[ing] new things with PCR every day."

Thanks for the comment

@Jeff C.

"A Rational Person: "A wherein clause is not a method step."

Prometheus asserted in court that the wherein clause covered the step of thinking about the relationship of the correlation to the measured data."

Prometheus' statement is consistent with my statement that the wherein clauses "modify" step (b), i.e., the determining step.

You have provided no evidence Prometheus argued that the wherein clauses were, by themselves, a separate method step.

Also, despite your defense of the Prometheus decision, you have also still not provided a single example of a method claim in the fields of chemistry or biotechnology that could not be rejected under 35 USC 101 based on the decision in Prometheus if a judge or Examiner chose to do so.

Therefore, you have failed to prove that Prometheus is not an arbitrary and capricious decision.

I have looked a couple of times now, but cannot find the logical argument that supports the district court's decision, as requested by Dr. Noonan.

All that I see is the vague hand-waiving and misstatements about "taking out of the public domain," among other well-worn cliches.

But that does not happen with claims as being discussed - as any sub-item of a claim that is in the public domain remains so.

The innuendo about "being confused" is out of place as well. "Jeff C." should not make such conclusory statements, and should not project any feeling of bitterness (or any other emotional ploy, such as "where the logic leads") onto others.

Kevin:

"if someone came up with a new way to detect minute amounts of DNA these claims would not preempt such methods."

Why should I need to come up with a "new" way? PCR is old, it's in the public domain, and it works great for detecting really tiny amonts of DNA. Everybody knows that. Of course, the protocol needs to be optimized for specific applications -- something that Sequenom's broadest claims (which aren't optimized) prevent me from doing if I want to try detect paternal DNA in maternal blood plasma.

"And the claims don't prevent anyone from "discover[ing] new things with PCR every day."

I never said they did. The problem is that if we grant claims *like these* claims every time someone discovers something new using PCR, then the use of PCR increasingly turns into a liability -- something that shouldn't be true of an old covnentional method in the public domain. That's the Mayo problem again.

"That is an assumption not a fact and not a logical conclusion."

Pretty safe assumption, to say the least, that when there is cell debris, the inside of the cell is floating around, at least in small amounts.

@Jeff C.

"A Rational Person: "A wherein clause is not a method step."

Prometheus asserted in court that the wherein clause covered the step of thinking about the relationship of the correlation to the measured data."

As I stated two wherein clauses modify the method step (b), i.e., the determining step. The assertion you have presented is consistent with what I have stated.

You have provided no evidence why the two wherein clauses are method steps, other than the fact that the Supreme Court says they are method steps.

Also, you have provided no example of any method claim related to biotechnology or chemistry that could not be rejected by an Examiner or a judge under 35 USC 101 based on the reasoning of Mayo v. Prometheus.

Therefore, the Mayo v. Prometheus decision was arbitrary and capricious, because based on its reasoning, whether a such a method claim is allowed or rejected is at the whim of the Examiner or the judge.

""Jeff C." should not make such conclusory statements,"

LOL.

[redacted]

A Rational Person: "the Mayo v. Prometheus decision was arbitrary and capricious,"

Hey, go ahead and keep telling yourself that!

Meanwhile the ship has sailed and even Kevin Noonan is on it, although he doesn't like talking about it.

A Rational Person: "you have provided no example of any method claim related to biotechnology or chemistry that could not be rejected by an Examiner or a judge under 35 USC 101 based on the reasoning of Mayo v. Prometheus."

Pretty sure that lots of eligible method claims in those fields are being granted every day.

It goes without saying but just because some [redacted] [redacted] on the Internet says "everything is ineligible now", that doesn't make it true.

[redacted]

Kevin Noonan: "I can understand the way the Court applied the law in Mayo (even if I don't agree with it). "

Now you're back to disagreeing with the result in Mayo, Kevin?

You're back to thinking that people should be able to protect methods of thinking about a correlation with a patent claim? Just by reciting some old data-gathering step? Really?

If so, you should try making that belief more explicit, Kevin, when you talk about this subject. That way people will know exactly where you're coming from. Or is that information that you would prefer not to spread around?

Dear Jeff:

Before we get back to the issues, please refrain from comments like the one at 4:21 or refrain from commenting on this site. "Jane, you ignorant slut" is not an argument

Dear Jeff:

On to the issues.

First, I mentioned the "methods other than PCR" point to refute the argument that claiming PCR was unduly preemptive. Compare the claim in Mayo (where the detecting step was any detecting step, including (at oral argument) Justice Breyer's hypo that his pinkie would turn red if administered excess 6TG), and the claim in Perkin Elmer (which also claimed any detecting step or method), with the Isis claim, which is limited to PCR. Preemption isn't the issue (all claims preempt their subject matter); what is prohibited are claims that "unduly preempt." My argument is that a claim limited to PCR does not unduly preempt - indeed, it encourages development of such alternative, non-infringing methods.

Regarding using PCR to discover other things - another example intended to rebut the "unduly preempt" argument.

Finally, my views are well known on this site, attached to my name and identity. I see no reason to reiterate my positions - you are entitled to review earlier posts if you want to review them. But I think the difference in explicitness between my posts and yours refute your insinuation that I have anything to hide. Start signing your posts and maybe we can compare the sizes of our transparencies.

Thanks for the comment.

The comments to this entry are closed.

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