By Kevin E. Noonan --
Castigating the Supreme Court, at least in patent circles, has become as prevalent as the Court's forays into patent law have been to overrule the Federal Circuit. While even those who give the Court the benefit of the doubt and appreciate the parsimony with which many of its decisions are written, the cultural and institutional differences between the way the Court addresses issues, and the higher certainty that those who rely on intellectual property protection need to justify the investment that turns innovation into commercialization, frustrate both.
These differences are illustrated in the standards the Court enunciated in its Mayo v. Prometheus regarding diagnostic method claims. In particular, the Court's reliance on what is "routine, conventional and well-understood" in deciding that the claims at issue were not patent eligible provide a focus for this analysis. In the Mayo case, the Supreme Court reversed the Federal Circuit's determination that the following claim recited patent-eligible subject matter:
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.
(U.S. Patent No. 6,355,623). In Justice Breyer's opinion for a unanimous Court, the "administering" step "simply refer[s] to the relevant [preexisting] audience, namely doctors who treat patients" with thiopurine drugs. The "determining" step provided non-limiting disclosure, encompassing all methods for determining drug or metabolite levels, and according to the Court the step embodied "well-understood, routine, conventional activity previously engaged in by scientists who work in the field." All that was left for these claims was the "wherein" clauses, which merely recite a law of nature regarding how a drug is metabolized (with it being unknown, of course, whether a new drug would lead to a different conclusion.)
Having set forth the general principles contained in its Mayo opinion, the Court as is its wont left it to lower courts to explicate the scope of the instances where a claim is not patent eligible. And this is where the mischief begins; while there are few instances where what is claimed includes administration of a new drug, in several instances district courts (and perhaps the Federal Circuit) have interpreted what is "routine, conventional and well-understood" far beyond the circumstances that gave rise to the Court's invalidation of the claims in Mayo.
The first instance is the Federal Circuit's decision in Perkin Elmer Inc. v. Intema Ltd. (Fed. Cir. 2012). The claims of the patent-at-issue, U.S. Patent No. 6,573,103 were directed to prenatal diagnostic testing for Down's syndrome, intended to avoid the need for invasive testing like chorionic villus sampling that incurs the risk of miscarriage:
1. A method of determining whether a pregnant woman is at an increased risk of having a fetus with Down's syndrome, the method comprising the steps of:
measuring the level of at least one screening marker from a first trimester of pregnancy by:
(i) assaying a sample . . . ; and/or
(ii) measuring at least one first ultrasound screening marker from an ultrasound scan . . . ;
measuring the level of at least one second screening marker from a second trimester of pregnancy, the at least one second screening marker from the second trimester of pregnancy being different from the at least one first screening marker from the first trimester of pregnancy, by:
(i) assaying a sample . . . ; and/or
(ii) measuring at least one second ultrasound screening marker from an ultrasound scan . . . ;
and determining the risk of Down's syndrome by comparing the measured levels of both the at least one first screening marker from the first trimester of pregnancy and the at least one second screening marker from the second trimester of pregnancy with observed relative frequency distributions of marker levels in Down's syndrome pregnancies and in unaffected pregnancies.
In reversing the District Court, the Federal Circuit opined that In its view, the claimed methods do not contain an "inventive concept" (defined as in Mayo as "other elements or a combination of elements [] sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself") because these claims "contain[] nothing more than 'well-understood, routine, conventional activity previously engaged in by researchers in the field.'" The opinion states that the "measuring" steps are insufficient to supply the ineffable "something more" required by the Supreme Court, because (as in Mayo) the method steps encompass any and all methods for measuring the markers. The panel stated that "'[t]he individual measurements are obtained through known methods. . . ." and thus the panel characterized the measuring steps as encompassing "well-understood, routine, conventional activity previously engaged in by scientists who work in the field."
A similar result (albeit using a more logically strained and expansive analysis) was obtained in Ariosa v. Sequenom (N.D. Cal. 2013) over claims for identifying and characterizing paternal DNA in blood from a pregnant woman (and making diagnoses therefrom); claim 1 of U.S. Patent No. 6,258,540 is illustrative:
A method for detecting a paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample from a pregnant female, which method comprises
amplifying a paternally inherited nucleic acid from the serum or plasma sample and
detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample.
Here, the District Court's opinion frankly relied on the proposition that amplifying and detecting DNA from plasma or serum was well known at the time the invention was made and thus these were "routine, well-understood and conventional" methods that disqualified them from positively affecting the patent eligibility analysis under Mayo. The court further stated that:
Because the claimed processes at issue -- apart from the natural phenomenon of paternally inherited cffDNA -- involve no more than well-understood, routine, conventional activity, previously engaged in by those in the field, they are not drawn to patent eligible subject matter and are invalid under § 101.
(Of course, "the claimed process at issue" here differed in a major way from the processes in the claims at issue in Mayo: the process recited by the claim as a whole was not "routine, conventional and well-understood"; unlike in Mayo, the prior art did not teach detecting paternal DNA in maternal blood for any purpose.)
The Ariosa District Court also extended the requirements for what would not be "routine, well-understood and conventional" steps to be only those for which there were commercially available alternatives for practicing the invention at the time it was made:
In support of [the] argument [that the claims do not impermissibly preempt all methods for detecting paternal DNA (cffDNA) in maternal blood], Sequenom has presented the Court with scientific articles describing methods for detecting cffDNA. Ariosa argues that even if these articles disclose alternative methods of detecting cffDNA, Sequenom has failed to present any evidence showing that any of these alternative methods are practical and commercially viable. In response, Sequenom argues that it is only relevant that the alternative methods can be practiced, not that they are commercially viable alternatives. The Court disagrees. If the alternative methods are not commercially viable, then the effect of the patent in practice would be to preempt all uses of the natural phenomenon. It is important to note that the '540 patent does not merely claim uses or applications of cffDNA, it claims methods for detecting the natural phenomenon. Because generally one must be able to find a natural phenomenon to use it and apply it, claims covering the only commercially viable way of detecting that phenomenon do carry a substantial risk of preempting all practical uses of it. It is also important to note the age of the patent. The '540 patent was issued in July 2001. That twelve years have passed since the issuance of the patent but Sequenom does not present the Court with any evidence of a commercially viable alternative method of detecting cffDNA reflects the broad scope of the '540 patent's claims and the great risk that the patent could preempt the use of cffDNA. Indeed, Sequenom itself has acknowledged the preemptive effect of its patent. (albeit supported by some improvident statements by Sequenom in the record).
Thus, in addition to not being "routine, well-understood and conventional" the only method claims patent eligible in the District Court's opinion would be those that could be practiced without infringement on the day the patent application was filed.
Finally, in Genetic Technologies Ltd. v. LabCorp. (D. Del. 2014), the District Court adopted a magistrate judge's recommendation that the claims in U.S. Patent No. 7,615,342 were patent ineligible; claim 1 is representative:
1. A method to predict potential sprinting, strength, or power performance in a human comprising:
a) analyzing a sample obtained from the human for the presence of one or more genetic variations in α-actinin-3 (ACTN3) gene;
b) detecting the presence of two 577R alleles at the loci encoding amino acid number 577 of the α-actinin-3 (ACTN3) protein; and
c) predicting the potential sprinting, strength, or power performance of the human, wherein the presence of two copies of the 577R allele is positively associated with potential sprinting, strength, or power performance.
The magistrate judge's reasoning was consistent with (and relied upon) the California District Court's Ariosa decision; what was unique in this case is that it was decided on the pleadings under Fed. R. Civ. Pro. 12(b)(6), denying the patentee of any opportunity to present the Court with evidence contrary to its prejudices and defendant's arguments.
Finally, similar sentiments were voiced by the panel at oral argument in Myriad Genetics v. Ambry Genetics (heard on October 6, 2014; discussed more fully in a later post).
There are several reasons that these decisions are a cause for deep concern. Despite occasional appearances to the contrary, it is unlikely that the Supreme Court has intended to do serious violence to well-established principles of patent law in Mayo, AMP v. Myriad Genetics, or any of the other cases decided in recent years. However, by making the decisions it has made, using "less than pellucid" language and by failing to recite examples of what the Court does not intend to do, the Court has permitted lower courts to do such violence (perhaps because these lower courts are no more versed in the minutiae of patent law than the Court itself). One example is the ease with which courts have ignored or eluded the principle that claims must be interpreted as a whole. (It is clear that the Supreme Court understands, or has come to understand this principle: the Court, albeit in a footnote, made this clear in its Alice v. CLS Bank opinion.) Perhaps lower courts will take this cue to address claims as a whole in performing their patent eligibility assessment.
Another reason that the current methods for determining patent ineligibility are disquieting is that it has always been the case that a new use for an old (or otherwise unpatentable) compound can be patentable (and thus patent eligible). In re Hack, 245 F.2d 246 (CCPA 1957). This is a qualified statement, because the mere recognition of a property or principle of an old compound, see, In re May, 574 F.2d 1082 (CCPA 1978), or the realization that the practice of a method has a particular effect, see, In re Tomlinson, 363 F.2d 928 (CCPA 1966), can defeat patentability (and eligibility) on principles of inherency. As the Federal Circuit stated in In Re William J. King, 801 F.2d 1324 (Fed. Cir 1986):
[T]he law is, and long has been, that "if a previously patented device, in its normal and usual operation, will perform the function which an appellant claims in a subsequent application for process patent, then such application for process patent will be considered to have been anticipated by the former patented device." In re Ackenbach, 45 F.2d 437, 439, 7 USPQ 268, 270 (CCPA 1930) (citing with approval Claude Neon Lights v. E. Machlett & Son, 27 F.2d 702, 707-08 (2d Cir.1928)). Accord In re Watson, 44 F.2d 868, 870, 7 USPQ 113, 115 (CCPA 1930); In re Ernst, 150 F.2d 133, 135, 66 USPQ 71, 73 (CCPA 1945) (citing with approval In re Ackenbach, supra). See generally Carnegie Steel Co. v. Cambria Iron Co., 185 U.S. 403, 22 S.Ct. 698, 46 L.Ed. 968 (1902) (prior art device anticipates later process if device carries out process in normal operation). Cf. In re Tarczy-Hornoch, 397 F.2d 856, 158 USPQ 141 (CCPA 1968) (a process claim, otherwise patentable, should not be rejected merely because the application of which it is part discloses apparatus which will inherently carry out the recited steps).
But that is not the situation in any of the cases discussed here. In each case, the claim as a whole was (undisputedly) novel, and the putative "routine, well-understood and conventional" methods were used in new, inventive ways. Only by taking a categorical approach for the individual steps recited in these claims are "routine, well-understood and conventional" have courts been able to come to the conclusion that the claims are not patent eligible.
It is the categorical approach, sanctioned generally by the Supreme Court in its preference for the "well settled" law of Section 101 of the Patent Statute (rather than the more objective and specific portions of the law such as Sections 102, 103 and 112), that encourages if not mandates the conclusions of the courts discussed above. Permitted to apply merely their subjective views of whether a claim recited "something more" than a judicial exception to patent eligibility (laws of nature, natural phenomena and abstract ideas) and detached from art or other reality-based considerations available in the §§ 102/103 analysis, it should not be surprising that courts have exercised their authority to strike down claims that they have been convinced should not be patent eligible. 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. And such subjectivity is perhaps required for a Court that believes that courts in general need to play Goldilocks for the patent system, making sure the amount of patents is "just right" to avoid the purported evils of too much or too little patenting. But as the cases discussed herein illustrate, what these subjective measures are certain to do is make the patent grant less reliable and patent protection less predictable, and this outcome will harm the economy, innovation, and American's quality of life, as investors leave the less predictable arts like medicine, pharma, and biotechnology to invest in the latest "iSomething." It is hard to believe that this is the outcome desired by the Court, but if its members are paying attention perhaps they will take the likelihood of these outcomes into consideration when next they deign to opine on patent law.
"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.
Posted by: EG | October 21, 2014 at 07:12 AM
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.
Posted by: Barrow | October 21, 2014 at 08:19 AM
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.
Posted by: A Rational Person | October 21, 2014 at 08:58 AM
"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.
Posted by: W.S. | October 21, 2014 at 10:10 AM
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.
Posted by: Skeptical | October 21, 2014 at 10:12 AM
@A Rational Person
"how sloppy the reasoning and decision ..."
Why don't you then enlighten us all on the black letter law of "wherein".
Posted by: Hand | October 21, 2014 at 10:55 AM
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.
Posted by: Jeff C. | October 21, 2014 at 12:54 PM
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.
Posted by: Jeff C. | October 21, 2014 at 01:04 PM
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.
Posted by: A Rational Person | October 21, 2014 at 01:12 PM
@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.
Posted by: W.S. | October 21, 2014 at 03:32 PM
@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.
Posted by: A Rational Person | October 21, 2014 at 04:52 PM
@Jeff C.
"I couldn't follow your comment. Where is the 'sloppy reasoning'?"
A wherein clause is not a method step.
Posted by: A Rational Person | October 21, 2014 at 04:59 PM
@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.
Posted by: A Rational Person | October 21, 2014 at 06:16 PM
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.
Posted by: Kevin E. Noonan | October 21, 2014 at 10:12 PM
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
Posted by: Kevin E. Noonan | October 21, 2014 at 10:24 PM
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.
Posted by: A Rational Person | October 22, 2014 at 09:02 AM
Logically speaking, there is no possible example of something NOT applying 'a law of nature.'
Posted by: Skeptical | October 22, 2014 at 10:22 AM
@Skeptical,
Agreed.
Posted by: A Rational Person | October 22, 2014 at 11:12 AM
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.
Posted by: Jeff C. | October 22, 2014 at 11:34 AM
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.
Posted by: Jeff C. | October 22, 2014 at 12:14 PM
"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
Posted by: Kevin E. Noonan | October 23, 2014 at 06:45 AM
@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.
Posted by: A Rational Person | October 23, 2014 at 08:51 AM
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.
Posted by: Skeptical | October 23, 2014 at 09:08 AM
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.
Posted by: Jeff C. | October 23, 2014 at 10:22 AM
@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.
Posted by: A Rational Person | October 23, 2014 at 10:46 AM
""Jeff C." should not make such conclusory statements,"
LOL.
[redacted]
Posted by: Jeff C. | October 23, 2014 at 04:21 PM
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.
Posted by: Jeff C. | October 23, 2014 at 04:23 PM
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]
Posted by: Jeff C. | October 23, 2014 at 04:26 PM
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?
Posted by: Jeff C. | October 23, 2014 at 04:30 PM
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
Posted by: Kevin E. Noonan | October 23, 2014 at 09:10 PM
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.
Posted by: Kevin E. Noonan | October 23, 2014 at 09:19 PM