Deciphering the Patent-Eligibility Message in Prometheus, Myriad and Classen

By Kevin E. Noonan --

A little more than one year after the Supreme Court issued its opinion on the patent-eligibility of (business) method claims in Bilski v. Kappos, the Court has granted certiorari in one case (Prometheus Laboratories, Inc.  v. Mayo Collaborative Services) and may consider two others (Classen Immunotherapies, Inc. v. Biogen Idec. and Association for Molecular Pathology v. U.S. Patent and Trademark Office) relating to diagnostic methods.  The Court handed down its decision in Bilski on the last day of the 2010 term (June 28, 2010), and shortly thereafter granted certiorari, vacated the Federal Circuit opinion, and remanded both the Prometheus and Classen cases.  The Federal Circuit decided the Prometheus case on remand on December 17, 2010, and on June 20, 2011, the Court again granted certiorari.  Since the question of patent eligibility is completely dependent on the scope and meaning of properly construed claims (see "Is Claim Construction the Key to Patent-eligibility of Isolated DNA?"), a comparison of the claims in Prometheus, Myriad, and Classen might shed some light on the reasoning used by the Federal Circuit in arriving at the answers to the patent-eligibility question posed in each of these cases.

Perhaps the most clear-cut decision by the Federal Circuit involves the method claims in the patents at issue in the Myriad case.  These claims all require the steps of "analyzing" or "comparing" a mutated BRCA gene sequence with the wildtype, "normal" sequence without any express claim language requiring that either sequence be determined as part of the claim:

U.S. Patent No. 5,709,999:

1.  A method for detecting a germline alteration in a BRCA1 gene, said alteration selected from the group consisting of the alterations set forth in Tables 12A, 14, 18 or 19 in a human which comprises analyzing a sequence of a BRCA1 gene or BRCA1 RNA from a human sample or analyzing a sequence of BRCA1 cDNA made from mRNA from said human sample with the proviso that said germline alteration is not a deletion of 4 nucleotides corresponding to base numbers 4184-4187 of SEQ ID NO:1.

U.S. Patent No. 5,710,001:

1.  A method for screening a tumor sample from a human subject for a somatic alteration in a BRCA1 gene in said tumor which comprises gene comparing a first sequence selected form the group consisting of a BRCA1 gene from said tumor sample, BRCA1 RNA from said tumor sample and BRCA1 cDNA made from mRNA from said tumor sample with a second sequence selected from the group consisting of BRCA1 gene from a nontumor sample of said subject, BRCA1 RNA from said nontumor sample and BRCA1 cDNA made from mRNA from said nontumor sample, wherein a difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA from said tumor sample from the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA from said nontumor sample indicates a somatic alteration in the BRCA1 gene in said tumor sample.

U.S. Patent No. 5,753,441:

1.  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 or BRCA1 RNA from a tissue sample from said subject or a sequence of BRCA1 cDNA made from mRNA from said sample with germline sequences of wild-type BRCA1 gene, wild-type BRCA1 RNA or wild-type BRCA1 cDNA, wherein a difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA of the subject from wild-type indicates an alteration in the BRCA1 gene in said subject.

U.S. Patent No. 6,033,857:

1.  A method for identifying a mutant BRCA2 nucleotide sequence in a suspected mutant BRCA2 allele which comprises comparing the nucleotide sequence of the suspected mutant BRCA2 allele with the wild-type BRCA2 nucleotide sequence, wherein a difference between the suspected mutant and the wild-type sequences identifies a mutant BRCA2 nucleotide sequence.

2.  A method for diagnosing a predisposition for breast cancer in a human subject which comprises comparing the germline sequence of the BRCA2 gene or the sequence of its mRNA in a tissue sample from said subject with the germline sequence of the wild-type BRCA2 gene or the sequence of its mRNA, wherein an alteration in the germline sequence of the BRCA2 gene or the sequence of its mRNA of the subject indicates a predisposition to said cancer.

Significantly, other diagnostic method claims, including ones using antibodies to detect altered BRCA proteins, were not recited in the complaint and thus not at issue.  Also not recited in these claims were "additional, transformative steps," including "the steps of (1) extracting DNA from a human sample, and (2) sequencing the BRCA DNA molecule, . . . steps [that] necessarily precede the step of comparing nucleotide sequences."

The Federal Circuit panel unanimously agreed that these claims do not satisfy the "machine or transformation" (MOT) test under Bilski.  These claims "recite[] nothing more than the abstract mental steps necessary to compare two different nucleotide sequences:  look at the first position in a first sequence; determine the nucleotide sequence at that first position; look at the first position in a second sequence; determine the nucleotide sequence at that first position; determine if the nucleotide at the first position in the first sequence and the first position in the second sequence are the same or different, wherein the latter indicates an alternation; and repeat for the next position," according to Judge Lourie's majority opinion.  Also significant for the Court is that the specification required the term "sequence" to refer "more broadly to the linear sequence of nucleotide bases of a DNA molecule" per se.  The panel found that Myriad's method claims can be satisfied (i.e., infringed) by "mere inspection" alone, and thus encompass merely an abstract idea.

In contrast, on remand, the Federal Circuit found the claims in Prometheus to satisfy the MOT test and thus recite patent-eligible subject matter, whether the claim recites an affirmative administration step or not:

U.S. Patent No. 6,355,623:

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.

46.  A method of optimizing therapeutic efficacy and reducing toxicity associated with treatment of an immune-mediated gastrointestinal disorder, comprising:
    (a)  determining the level of 6-thioguanine or 6-methylmercaptopurine in a subject administered a drug selected from the group consisting of 6-mercaptopurine, azathiop[u]rine, 6-thioguanine, and 6-methyl-mercaptoriboside, 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 or a level of 6-methylmercaptopurine greater than about 7000 pmol per 8x10⁸ red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

The distinction between the claims in Myriad and claim 1 of the '623 patent can be appreciated in light of the difference in what is being detected in each claim:  a naturally occurring nucleic acid in the Myriad claims and an administered drug or its metabolite in Prometheus.  Insofar as patent eligibility for method claims must either satisfy the Bilski machine or transformation test or otherwise not be so abstract as to entirely preempt an abstract idea, law of nature, or natural phenomenon, the absence of the drug or its metabolite without administration of the drug would appear to provide the Federal Circuit with its rationale regarding the patent eligibility of claim 1 of the '623 patent.  Claim 46 of the '623 patent does not have an affirmatively recited administration step.  However, the "detecting" step recites that 6-thiopurine or one of its metabolites is performed on "a subject administered [one of the recited] drug[s]," again encompassing only those patients who have been transformed by drug administration.  It would seem that the Court refused to exalt form over substance in making a distinction between claims that recite administration of the drug to a subject and claims that are restricted to detecting a drug or its metabolites only in that subset of subjects to whom the drug has been administered; in either case, the Federal Circuit discerned a transformation.  Neither of these considerations are likely to be before the Supreme Court, however, since defendant's certiorari petition focused on the purported interference with the practice of medicine and the non-inventiveness of the portions of the claim that recited the transformation step.  In this regard it should be remembered that the case that raised this aspect of medical diagnostic method claims, Laboratory Corp. v. Metabolite Labs., Inc. (LabCorp), was like Myriad, directed at detecting a naturally occurring metabolite, homocysteine, and not an administered drug as in the Prometheus claims.

The most surprising Federal Circuit decision relating to diagnostic method claims is the most recent, in the Classen case.  There, a divided panel (Judge Newman joined by Chief Judge Rader, with Judge Moore dissenting) found a distinction between the claims of U.S. Patent No. 5,723,283:

A method of determining whether an immunization schedule affects the incidence or severity of a chronic immune-mediated disorder in a treatment group of mammals, relative to a control group of mammals, which comprises immunizing mammals in the treatment group of mammals with one or more doses of one or more immunogens, according to said immunization schedule, and comparing the incidence, prevalence, frequency or severity of said chronic immune-mediated disorder or the level of a marker of such a disorder, in the treatment group, with that in the control group.

Which the majority found not to be patent-eligible, with the claims of U.S. Patent Nos. 6,420,139 and 6,638,739 (claim 1 of the '739 patent being representative):

1.  A method of immunizing a mammalian subject which comprises:
    (i)  screening a plurality of immunization schedules, by
        (a)  identifying a first group of mammals and at least a second group of mammals, said mammals being of the same species, the first group of mammals having been immunized with one or more doses of one or more infectious disease-causing organism-associated immunogens according to a first screened immunization schedule, and the second group of mammals having been immunized with one or more doses of one or more infectious disease-causing organism-associated immunogens according to a second screened immunization schedule, each group of mammals having been immunized according to a different immunization schedule, and

        (b)  comparing the effectiveness of said first and second screened immunization schedules in protecting against or inducing a chronic immune-mediated disorder in said first and second groups, as a result of which one of said screened immunization schedules may be identified as a lower risk screened immunization schedule and the other of said screened schedules as a higher risk screened immunization schedule with regard to the risk of developing said chronic immune mediated disorder(s),

    (ii)  immunizing said subject according to a subject immunization schedule, according to which at least one of said infectious disease-causing organism-associated immunogens of said lower risk schedule is administered in accordance with said lower risk screened immunization schedule, which administration is associated with a lower risk of development of said chronic immune-mediated disorder(s) than when said immunogen was administered according to said higher risk screened immunization schedule.

Which the panel found were patent-eligible.  Judge Moore, on the other hand, found no difference.  The difference appears to be in whether the determination of an appropriate immunization schedule directs an affirmative (and transformative) step or steps.  In the '283 claim, the majority construed the scope of the claim to encompass mere comparison of the results of immunization schedules that produce a conclusion (i.e., information) without any further steps in the claimed method.  The claims in the '739 patent, in contrast, require that an appropriate immunization schedule be determined, and then that a mammal or mammals be immunized according to that schedule to achieve the beneficial result of immunization with the least "incidence, prevalence, frequency or severity" of deleterious side effects.

Seen in this light, the question can be framed (according to Supreme Court precedent) as whether immunizing according to different immunization schedules in the '283 patent is considered "mere data gathering" activity and could be performed by evaluating previously performed immunizations, and whether the immunization step recited in the '739 patent can be considered to be "insignificant post-solution activity."  It is evident that the first proposition is better supported that the second; as in the Myriad claims, the structure of the '283 patent claim encompasses activity (immunization according to a plurality of immunization schedules) not performed in the practice of the claimed method (as opposed to the comparison, in this view the only active step in the claim).  The immunization step in the '739 patent claim is harder to construe as "insignificant post-solution activity" since the claim is directed towards "a method for immunizing a mammalian subject."

This analysis may seem like an exercise in counting dancing angels on the head of a pin, but it is the path set out by the Supreme Court in Benson v. Gottschalk, Parker v. Flook, Diamond v. Diehr, and Bilski v. Kappos (and for some members of the Court and commentators, LabCorp).  While Judge Moore recites a common-sense conclusion that the scope of the '283 and '739 claims should not logically be different, they must be when considered under the relevant Supreme Court rubrics, which give significance (no matter how undeserved) to these distinctions.  That is not to say that reciting the immunization step should be enough to render the '739 patent claims patent eligible, but like drug administration in Prometheus, immunization is transformative (as Judge Moore recognized by expressly equating immunization with drug administration).

Perhaps another way of performing the analysis is to recognize that another salient difference between the Myriad claims and the '283 claim in Classen on the one hand, and the Prometheus claims and the '739 patent claims in Classen, on the other, is that the former claims involve producing intangible information, while the latter use the information to direct the claim practitioner to perform a tangible, transformative step.  Claims that produce information may not be patent-ineligible per se (see "Patenting Information"); however, as in Bilski (and Benson and Flook) they are more likely to raise patent eligibility concerns.  Indeed these considerations arose in the concurring Justices' opinion in Bilski:

For even when patents encourage innovation and disclosure, "too much patent protection can impede rather than 'promote the Progress of . . . useful Arts.'" Laboratory Corp. of America Holdings v. Metabolite Laboratories, Inc., 548 U. S. 124, 126–127 (2006) (BREYER, J., dissenting from dismissal of certiorari).  . . .  Patents "can discourage research by impeding the free exchange of information," for example, by forcing people to "avoid the use of potentially patented ideas, by leading them to conduct costly and time-consuming searches of existing or pending patents, by requiring complex licensing arrangements, and by raising the costs of using the patented" methods.  Id., at 127.

While the Supreme Court gave the Federal Circuit precious little time or opportunity to flesh out its patent eligibility jurisprudence after the Bilski v. Kappos decision by granting certiorari in Prometheus, the Supreme Court's Bilski decision provided no clear instruction for resolving the different results in the Prometheus and Classen cases.  Thus, its guidance may be necessary (provided that such guidance is more "pellucid" than the Court's opinion in Bilski).

For biotechnology, it remains the case that including active, technology-dependent steps in method claims is prudent, and to draft claims that minimize the likelihood that the invention will be characterized as merely an "abstract idea."

Comments

[6]

"Deciphering the Patent-Eligibility Message in Prometheus, Myriad and Classen"

Oh come come Kev, the message is clear. The CAFC simply doesn't like the USSC's analysis and the results to which it leads.

You don't need more than a paragraph to flesh that out.

[EG]

Kevin,

A valiant effort at trying to render "order" out of utter "chaos." As you observed, SCOTUS is the primary "culprit" in the "tragedy" that patent-eligibility determinations have become. (And I've said as much in the article I posted on the Classen remand: http://ipwatchdog.com/2011/09/01/cafc-patent-eligibility-firestorm-of-opinions-in-classen/id=18927/ .) Frankly, SCOTUS would do well to simply "torch" Gottschalk v. Benson, Parker v. Flook, Bilski v. Kappos, and even Diehr v. Diamond, and replace the nebulous, undefined (and apparently undefinable), and completely subjective "abstract idea" standard, and replace it with the objective "tangible, concrete, and useful result" standard unfortunately discarded by the Federal Circuit in Bilski. In fact, SCOTUS would do us all a big favor by ditching the "abstract idea" standard and adopting/resurrecting the TCU standard (and I realize we've probably got a "snowball's chance in hell" of that happening).

[6]

"In fact, SCOTUS would do us all a big favor by ditching the "abstract idea" standard and adopting/resurrecting the TCU standard (and I realize we've probably got a "snowball's chance in hell" of that happening)."

Excepting of course all those of ordinary skill in the art that would like to practice on abstract ideas unencumbered whom EG desires power over.

[Kevin E. Noonan]

Dear 6:

I think the Federal Circuit is trying (with little success sometimes) to put into practice the Supreme Court's teachings on patent eligibility. That means trying to distill Benson, Flook, Diehr and Bilski, which frequently contradict one another, and looking over their shoulders at Labcorp. It isn't always pretty, but showing the Court how hard it has made the process is necessary if the problem is ever going to get fixed.

Look at the government's amicus brief in Prometheus (post coming) - the argument is that the Court should not use 101 to invalidate claims just as easily invalidated using 102 or 103. (I have heard an academic talk about how efficient it would be to use 101 as a scythe, having in mind (I think) reducing the burdens on the Office. Aphorisms about babies and bathwater inevitably come to mind.)

Thanks for the comment

[EG]

"I have heard an academic talk about how efficient it would be to use 101 as a scythe, having in mind (I think) reducing the burdens on the Office. Aphorisms about babies and bathwater inevitably come to mind."

Way to go, Kevin! Couldn't have said it better myself.

[6]

"but showing the Court how hard it has made the process is necessary if the problem is ever going to get fixed."

Well it isn't that hard. At least not in the cases they've had so far. And they get paid enough to bother themselves for a whole hour or so per case.

"Look at the government's amicus brief in Prometheus (post coming) - the argument is that the Court should not use 101 to invalidate claims just as easily invalidated using 102 or 103."

A very lawlyerly argument. The USSC will have none of it. The lawl is the lawl is the lawl. It doesn't matter which statute you use "first", and even more so relevant to me, it doesn't matter which statute the office uses "first".

Also, I note that even should we lose some thousand babies it is worth it in this case to get rid of the tens of thousands of bathwater drowning the other ~390k babies (per year). The needs of the many and the needs of the one and all that. Especially since these aren't really babies. They're just poorly drafted applications at worst that could undesirably be lost. Who gives a dam? Hire a better lawyer.

[EG]

Hey 6, I would be careful about what you say in response to Kevin's points. I've warned you before about the Harry Callaghan Principle of Patent Law: "a man's got to know his limitations." You're stepping into deep patent legal "water." Over your head in my opinion.

[Gary Johnston]

Kevin:

This whole debate is dumb. There is no possible way that a process comprising an old "determining" step and a new "inferring" step is eligible for a patent under current law. None. Saying otherwise is the product of mental incapacity. If you and EG want this to be the law, then lobby Congress to create a statute that says so. And all this weirdness about scythes and babies and bathwater is just that -- weirdness. Relying on 101 to keep out this stuff is perfectly fine. By the way, did you catch the latest episode of Real Time? At the end of the show, Bill and his guest Keith Olbermann did a skit called "Typical Republican Voter." Bill and Keith came out to the front part of the stage and began shouting things like "Taxes are at their lowest level in 50 years" and "Reagan raised taxes 11 times" and "Wrestling is fake" to a guy on stage (the purported "Typical Republican Voter") who was sitting on a chair inside a literal bubble. Very good stuff, and reminded me of much of the debate on these patent-related blogs about Benson/Flook/Diehr/Bilski, "claim dissection," mental steps, Beauregard claims, etc. I mean, the truth just doesn't matter to some people. They literally believe that some dude lived inside the belly of a whale. It's all quite amusing.

[EG]

"There is no possible way that a process comprising an old "determining" step and a new "inferring" step is eligible for a patent under current law. None. Saying otherwise is the product of mental incapacity."

GJ,

For those of us of alleged "mental incapacity," it might be nice to say what the "current law" (i.e., case law) is that supports your position instead of simply making the bald statement/conclusion that you did. I'm open to your differing point of view, but only if you support that point of view appropriately (i.e., with case law), not simply state it.

Also, questioning the "reasoning capability" of those who hold different views is totally unnecessary and doesn't help your credibility (not in my book at least). I don't mind debating with you, but please leave out the "personalities."

[Kevin E. Noonan]

Dear Gary:

Your position may be the correct one. Until it is the one adopted by the Supreme Court we will need to deal with (and apply) Benson/Flook/Diehr/Bilski.

[Gary Johnston]

EG, there is no point in debating with you. For you it's a matter of belief. I can't convince you that a woman was not created from the rib taken from a man if that's what you believe, however delusional your belief is. The bottom line is that these "old determine/new infer" processes are not processes by any definition of that term. They are abstractions. They seek to exclude others from thinking. I'm pretty sure that's not constitutional. The best hope for exclusivity for diagnostic/theranostic methods is a marketing exclusivity such as for NCEs and orphans.

[6]

"They literally believe that some dude lived inside the belly of a whale. It's all quite amusing."

Are you implying that Jonah did not in fact live in the belly of a whale?

[6]

" I'm open to your differing point of view, "

No you're not bro, you spend entire articles telling us how not open you are to that differing point of view.

[Tim G]

Kevin, back in August I asked you some questions arising out of the Classen facts (a similar issue arises out of the Prometheus facts). You indicated that you would get around to answering the question after you had completed your analysis of Classen. Well, here we are.

Here's my original comment, which I've edited for clarity. The quoted part at the beginning is a quote from your analysis of Classen. The key question is highlighted by "++" before and after the question.

Thank you for your consideration.

----------
"[T]he '139 and '739 patents in suit are directly infringed when a physician, hospital or other health care provider reads the relevant literature and selects an immunization schedule and immunizes a patient in accordance with the schedule which appears to have minimal risk."

In fact, according to Classen, the claims are infringed by a "reader" of the "relevant literature" even if the "reader" has been practicing the same immunizing schedule with "minimal risk" for decades and doesn't change the schedule.

Have you thought about this much, Kevin? Does anything about that result strike you as problematic? Does that result appear to raise any issues related to the eligibility of claims under 101? It certainly raises some flags for me, and I believe Judge Moore was also troubled.

What do you think?

++Do you think that one should be liable for patent infringement merely because one has *considered* a patent-ineligible "new" fact but has otherwise not engaged in any novel acts?++

I suppose one could shrug this "hypothetical" off and say that nobody would ever sue you if you were practicing the prior art while "considering" some new discovery. Except that Classen did exactly that, and he's still doing it.

What do you think, Kevin?

[Kevin E. Noonan]

Dear Tim:

What I think was in the post - what Classen (the inventor) thinks is irrelevant. The Federal Circuit construed the claim so that merely thinking about the correlation doesn't satisfy Section 101 - that would be the claims in the '283 patent - while doing something after you thought, like immunizing people according to the schedule you thought about in the first place - that would be the claims in the '739 and '139 patents - would satisfy the section. Judge Moore doesn't see the difference, because for her the distinction drawn by the majority is a distinction without a difference.

Now, I would have bet that these claims were not patent-eligible in view of how they were drafted, but I was wrong (according to the majority). I think claims to merely thinking are not patent-eligible, and all the judges on this panel agree. Whether the active step of immunizing according to the schedule should be enough will depend on what the Supreme Court says when and if they grant cert.

I certainly think that reciting an active step, like immunizing, according to a schedule should pass Section 101. Whether it is novel or non-obvious is another matter entirely, but that is the basis for the categorical versus specific argument. While it is possible that claims that would fail the categorical test may get past the Section 101 filter, there is little chance they will get past the other parts of the statute unless they are in fact inventions.

And, you will note that the case is based entirely on Section 101 - on remand the claims may clearly fail for precisely the reasons you mention - that they are not novel. In fact, if the preferred immunization schedule was in the prior art, the claims are anticipated even if the art did not recognize that, or if, the immunization method was preferred.

Which is what I think.

Thanks for the comment.

[6]

Do I hear you right that your position is that we simply ignore the mental steps in deciding novelty (and presumptively obviousness as well)?

[Kevin E. Noonan]

6:

No; like the court in Prometheus, the mere inclusion of a mental step is not sufficient to make a claim patent-ineligible under Section 101. A claim that recites only mental steps, on the other hand, probably does have Section 101 problems (I can't be definitive since I don't subscribe to the categorical viewpoint).

On the other hand, if the prior art taught practice of the claimed method (including mental steps or not) that certainly implicates novelty and obviousness standards. Which may be why, ultimately, these claims are not valid. But that's a different, albeit inportant, question.

[Tim G.]

Kevin, I didn't see an answer to my question. Here it is again:

++Do you think that one should be liable for patent infringement merely because one has *considered* a patent-ineligible "new" fact but has otherwise not engaged in any novel acts?++

In case you didn't notice, it's a "yes" or "no" question. You can provide additional explanation of your direct answer, if you like (i.e., "Yes, because ..." or "No, because ..."). I'm rather shocked that you didn't answer directly because you promised you would. Okay, I'm not shocked. I think you have a conflict that prevents you from answering forthrightly. That's okay.

You also write: "like the court in Prometheus, the mere inclusion of a mental step is not sufficient to make a claim patent-ineligible under Section 101."

We also know from the court in Prometheus (and Classen) that the mere inclusion of a transformative step is not necessarily sufficient to turn an ineligible mental process into an eligible claim.

The more interesting and obvious question is the following: is the mere addition of a novel mental step EVER sufficient to turn an unpatentable but eligible method into a patentable method (unpatentable method = a method in the prior art)? Yes or no, Kevin? Please explain your answer. I believe the answer must be "no" because such claims are indistinguishable from claims to mental steps, at least when asserted against those who are practicing the prior art. They therefore can't be both eligible and patentable ... unless they are also held to be unenforceable per se.

"In fact, if the preferred immunization schedule was in the prior art, the claims are anticipated even if the art did not recognize that"

The only transformative step in Prometheus' broadest claims (determining level of the metabolite in blood) was also in the prior art (see the background section of Prometheus' patent). According to your own logic, then, Prometheus' claims are therefore anticipated because it doesn't matter what one "thinks" about the result of the transformative step. Isn't this true in all such cases, Kevin, where the prior art teaches the identical transforming step but not the mental step? If you disagree, please explain why or provide an example of a claim that survives the analysis.

"A claim that recites only mental steps, on the other hand, probably does have Section 101 problems (I can't be definitive since I don't subscribe to the categorical viewpoint)."

Kevien, is your view that a completely mental process is eligible for patenting in the United States? If that is not what you are saying, what do you mean by "a claim that recites only mental steps PROBABLY has 101 problems"? What is the "categorical viewpoint" you refer to? Are subscriptions free? Where do you sign up?