Prometheus Laboratories, Inc. v. Mayo Collaborative Services (Fed. Cir. 2010)

By Kevin E. Noonan --

On Friday, the Federal Circuit continued its explication of the metes and bounds of patent-eligible subject matter after the Supreme Court's Bilski v. Kappos decision by revisiting (and reconsidering) its decision in Prometheus Laboratories, Inc. v. Mayo Collaborative Services.  The Court in its earlier decision had reversed a District Court determination that the claims of the patents-in-suit (U.S. Patent Nos. 6,355,623 and 6,680,302) were invalid as being outside the scope of patent-eligible subject matter under 35 U.S.C. § 101, based on its application of the "machine or transformation" test enunciated in In re Bilski.  The Supreme Court granted Mayo's petition for certiorari, vacated the Federal Circuit's earlier decision, and remanded to the appellate court for reconsideration under the patent-eligibility standard(s) the Court announced in its Bilski decision.  A relevant part of that decision was the Court's direction that the Federal Circuit develop its case law on what would constitute an "abstract idea" for purposes of patent eligibility.  (And the importance of this case, if only as a stalking-horse for the upcoming AMP v. USPTO (Myriad) case, is illustrated by the lineup of amici filing briefs in this case, including Novartis, Myriad, the AIPLA, the American College of Medical Geneticists, Arup Labs, the Biotechnology Industry Organization (BIO), and biotech patent-knowledgeable academic Christopher Holman).

The panel opinion, by Judge Lourie joined by Chief Judge Rader and Judge Bryson, noted that there were two general types of claims at issue:  those that affirmatively recited an "administrative" step, exemplified by Claim 1 of the '623 patent:

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.

and claims that did not recite such a step, exemplified by Claim 46 of the '302 patent:

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.

(Relevant to the Federal Circuit's assessment of the claims was the District Court's construction of the claim term "indicates a need" to mean "a warning that an adjustment in dosage may be required."  "This construction did not require doctors to adjust drug dosage if the metabolite level reached the specified levels; rather, the court found the two 'wherein' phrases to mean 'that when the identified metabolites reach the specified level, the doctor is warned or notified that a dosage adjustment may be required, if the doctor believes that is the proper procedure.'")

Both types of claims were patent-eligible, according to the panel opinion.

The Court rejected the District Court's characterization that the claims consisted of three steps:  (1) administering the drug to a subject, (2) determining metabolite levels, and (3) being warned that an adjustment in dosage may be required, wherein the first two steps were "data-gathering," leaving the third step as merely an unpatentable mental step, comprising the correlation, because no step requiring a change in administered dose.  The Court agreed that the last (comparison) step was a mental step, but maintained (as it had in the original opinion) that this by itself cannot provide legitimate grounds for invalidating the claims (because the claims must be considered in their entirety).  Here, the Court again determined that the claims at issue satisfied the "machine or transformation" test and that this was sufficient; the Federal Circuit specifically rejected Mayo's contention that the Supreme Court had abrogated this test in favor of a "complete preemption" test.  In this regard, Mayo argued on remand that "'[b]ecause the claims cover the correlations themselves, it follows that the claims 'wholly pre-empt' the correlations.'"

The panel characterized the Supreme Court's opinion in Bilski to have rejected the machine-or-transformation test as the "sole, definitive test" (but did not reject it per se), and "declined to adopt any categorical rules outside the well-established exceptions for laws of nature, physical phenomena, and abstract ideas, and resolved the case based on its decisions in Gottschalk v. Benson, 409 U.S. 63 (1972), Parker v. Flook, 437 U.S. 584 (1978), and Diamond v. Diehr, 450 U.S. 175 (1981)."  According to the Federal Circuit, the Supreme Court has historically construed patent-eligibility broadly, limiting eligibility to exclude only laws of nature, physical phenomena, and abstract idea (based, the panel suggested, on historical precedent extending back to the 19th century; Le Roy v. Tatham, 55 U.S. (14 How.) 156, 174-75 (1853), and continued in the Court's most recent opinion on this issue (Bilski).  The panel also stated that while laws of nature, physical phenomena, and abstract ideas are ineligible for patenting, applications thereof can be patented, citing Bilski and Diehr.  Using this standard, the opinion recited its rationale expressly:  do the Prometheus claims recite and preempt a natural phenomenon, alá Benson and Flook, or are they merely a particular application thereof, alá Diehr?  Mayo argued that satisfaction of the machine or transformation (MOT) test was not "outcome determinative" under the Supreme Court's Bilski test.  Prometheus, on the other hand, argued that the Supreme Court's Bilski opinion mandated that claims that fail the MOT test are not necessarily unpatentable unless they totally preempt an abstract idea or natural law; thus its claims, which satisfied the MOT test, are patent-eligible.  Importantly, Prometheus also argued that these claims did not totally preempt an abstract idea or natural law, since they are a particular application of the natural phenomenon ("specific means of treating specific diseases using specific drugs").  This argument was persuasive to the panel, which held that application of the machine or transformation test "leads to a clear and compelling conclusion" in favor of patent-eligibility (being directed to "the treatment of a specific disease by administering specific drugs and measuring specific metabolites"):

The inventive nature of the claimed methods stems not from preemption of all use of these natural processes, but from the application of a natural phenomenon in a series of steps comprising particular methods of treatment.

While the Court recognized that some of the claims recited an administering step while others did not, the Court found both types of claims to be patent-eligible.  With regard to claims that recited an administering step, the Court found (as it had in its original decision) that treatment steps are "always transformative when one of a defined group of drugs is administered to the body to ameliorate the effects of an undesired condition."  The Court cited with approval the Prometheus argument that "quite literally every transformation of physical matter can be described as occurring according to natural processes and natural law [because] [t]ransformations operate by natural principles."  What is transformative in these claimed methods is administration of drugs (treatment) which is not a natural process; what is transformed is the human to whom the drugs are administered.  The panel also cited its Bilski opinion  that "[i]t is virtually self-evident that a process for a chemical or physical transformation of physical objects or substances is patent-eligible subject matter.'"  Bilski, 545 F.3d at 962.

Turning to the claims that do not recite an administering step, the Court found that they are also patent-eligible because the determining step is also transformative as well as being "central" to the claimed methods.  (The "central" characterization is in contrast to the argument that this is "mere" data-gathering.)  The Court's rationale was that at the end of the procedures used to determine metabolite levels, whatever was assayed has been transformed.  "The determining step, by working a chemical and physical transformation on physical substances, likewise sufficiently confines the patent monopoly, as required by the machine-or-transformation test."

The panel distinguished two earlier cases:  In re Grams, 888 F.2d 835 (Fed. Cir. 1989), which the Court called the "closest comparison," and In re Abele, 684 F.2d 902 (C.C.P.A. 1982).  The Grams case, according to the panel, involved a combination of data-gathering steps plus a fundamental principle.  In Grams, the method recited steps of performing a clinical test and then using an algorithm to determine whether an abnormality existed and possible causes thereof.  The Grams court found that this was "merely" an algorithm coupled with a data-gathering step, because the tests were not "transformative."  Here, the Court distinguished Grams by finding the administering and determining steps to be transformative.  This is in contrast to a method claim that does not contain administering or determining steps:  "a physician who only evaluates the result of the claimed methods, without carrying out the administering and/or determining steps that are present in all the claims, cannot infringe any claim that requires such steps."

The other case, In re Abele, involved claims related to X-ray attenuation data, which the Court said required the "production, detection and display [using] a CAT scan," and also involved an algorithm.  The Abele court found these claims to be patentable, according to this panel, because even without the algorithm step the claim contained all the CAT scan steps, which that court found was "manifestly statutory subject matter" despite the presence of the algorithm step.  The panel opinion cited its Bilski decision to again emphasize the proposition that a claim must be considered as a whole in making this determination (something that is directly contrary to Justice Breyer's manner of analysis in Laboratory Corp. v. Metabolite Labs., Inc. ("LabCorp")):

[I]t is inappropriate to determine the patent eligibility of a claim as a whole based on whether selected limitations constitute patent-eligible subject matter.  After all, even though a fundamental principle itself is not patent-eligible, processes incorporating a fundamental principle may be patent-eligible.  Thus, it is irrelevant that any individual step or limitation of such processes by itself would be unpatentable under § 101.

The implications of this decision may be significantly limited by the Court's emphasis on the "treatment" steps as being transformative and thus almost by-definition patent-eligible:

The crucial error the district court made in reaching the opposite conclusion was failing to recognize that the first two steps of the asserted claims are not merely data-gathering steps.  See Invalidity Opinion, 2008 WL 878910, at *6 (finding that "the 'administering' and 'determining' steps are merely necessary data-gathering steps for any use of the correlations").  While it is true that the administering and determining steps gather useful data, it is also clear that the presence of those two steps in the claimed processes is not "merely" for the purpose of gathering data.  Instead, the administering and determining steps are part of a treatment protocol, and they are transformative.  As explained above, the administering step provides thiopurine drugs for the purpose of treating disease, and the determining step measures the drugs' metabolite levels for the purpose of assessing the drugs' dosage during the course of treatment.

Ultimately, the Court seems to make a policy argument, which can be dangerously subjective ("we know it when we see it"):

Viewing the treatment methods as a whole, Prometheus has claimed therapeutic methods that determine the optimal dosage level for a course of treatment.  In other words, when asked the critical question, "What did the applicant invent?," Grams, 888 F.2d at 839 (citation omitted), the answer is a series of transformative steps that optimizes efficacy and reduces toxicity of a method of treatment for particular diseases using particular drugs.

This is a frankly utilitarian analysis, basing what is patent-eligible on whether it is useful, provided that what is claimed does not wholly preempt an abstract idea or natural law.

Finally (and according to some commentators, provocatively), the panel disagreed with Mayo's contention that the Supreme Court's Bilski decision somehow affirmed Justice Breyer's dissent in Metabolite:

Mayo, as did the district court, points to the opinion of three Justices dissenting from the dismissal of the grant of certiorari in Lab. Corp., 548 U.S. 124 (Breyer, J., dissenting from dismissal of certiorari as improvidently granted).  See Invalidity Opinion, 2008 WL 878910, at *8 (discussing the dissent in Lab. Corp. at length and finding Justice Breyer's reasoning persuasive).  Again, with respect, we decline to discuss a dissent; it is not controlling law, and it involved different claims from the ones at issue here.  Mayo further claims that five Justices in two concurrences cited Lab. Corp. with approval in Bilski, but such citations fail to transform a dissent into controlling law.  Moreover, one concurrence cites Lab. Corp. for the proposition that "too much patent protection can impede rather than 'promote the Progress of . . . useful Arts,'" in arguing for a categorical rule that business method patents do not qualify as patent-eligible processes under § 101. Bilski, 130 S. Ct. at 3255 (Stevens, J., concurring).  But this case does not involve business method patents.

That such sentiments will be sufficient to motivate the Supreme Court to revisit the question of the patent-eligibility of diagnostic method claims is at odds with the Court's mandate that the Federal Circuit in the first instance test the proper scope of patent-eligibility on a case-by-case basis.  Such an approach has the potential to adequately (or at least sufficiently) illuminate the relevant principles in the fire of litigation, to provide a collection of decisions that might assist the Court when (and if) it decides to reenter the patent-eligibility waters.  The Court in Bilski was properly prudent in its approach with regard to "new technologies" ("there are reasons to doubt whether the [machine or transformation] test should be the sole criterion for determining the patentability of inventions in the Information Age . . . the machine-or-transformation test would create uncertainty as to the patentability of software, advanced diagnostic medicine techniques, and inventions based on linear programming, data compression, and the manipulation of digital signals"), suggesting that the Court can only benefit from the Federal Circuit's exercise of "its sound judgment in this area of its special expertise."

Prometheus Laboratories, Inc. v. Mayo Collaborative Services (Fed. Cir. 2010)
Panel:  Chief Judge Rader and Circuit Judges Lourie and Bryson
Opinion by Circuit Judge Lourie

Comments

[Dan Feigelson]

Nice to see the CAFC is keeping the door wide open for the patent-eligibility of diagnostic methods. But the question of validity under 102, 103 and 112 wasn't before the CAFC. Do you know if Mayo pleaded on these grounds so that these questions will be heard on remand before the district court? If determining the levels of 6-thioguanine or 6-methylmercaptopurine in the blood after administration of the listed drugs was known in the art, that would leave the "wherein" clauses as the basis for patentability - but those clauses don't actually recite a step. It will be interesting to see how this case plays out.

[Gary Johnston]

Good stuff by the CAFC. SIlver lining (for people like me) is that the panel seems to characterize the claims as treatment methods, thus giving the court some wiggle room for later distinguishing claims like this and claims where there is no administration of a therapeutic prior to the assay (most diagnostic claims). Big winners are not diagnostic companies, but pharma companies. CAFC has just given pharma a road map for protecting old drugs. Man I love these judges!

[Kevin E. Noonan]

Dear Gary:

Agreed - the interesting decisions will be Classen (where there is no express requirement for an immunization step, just that the patient be immunized), and Myriad (if it reaches the merits), since those are classic diagnostic method claims.

Thanks for the comment.

[Kevin E. Noonan]

Dear Dan:

I would think it malpractice not to include defenses based on invalidity under one of the statutory sections, unless such an allegation fails Rule 11 (unlikely). So when it goes back the district court may be receptive to such arguments.

I agree with Gary, however, that this decision doesn't give much comfort to pure diagnostic method patent holders, since there is usually no treatment step in those claims (and the ones that might have them might also have Muniauction problems enforcing them).

Thanks for the comment.

[Ben Liu]

It seems that pure diagnostic method patents can seek refuge in the determining-deemed-transformation, although I don't fully understand the line drawn between "mere data-gathering" versus "transformative determination."

That the explanation is couched in terms of "insignificant extra-solution activity" versus "central to the claims" seem more like a conclusion bootstraped into the logic than a coherent explanation itself.

[EG]

Kevin,

Lourie's decision is not quite as "tortured" as the original, but I still see too much trying to "pigeon hole" methods like these into the "transformation" prong of the "machine or transformation" test. The patent-eligibility of Prometheus' method shouldn't even be in question. If the Federal Circuit would start with 35 USC 112 as others has suggested to screen claims like these, it would become evident that the Prometheus method is a "real world" drug dosage calibration method directed to a specific drug/metabolite. (In view of Prometheus, there's no question in my mind that the method in Metabolite is likewise patent-eligible)

Classen will be an interesting, especially as the Federal Circuit panel is a different one. The quesiton will be which side of the patent-eligibility equation the Classen method falls on: the patent-eligible Prometheus side or the patent-ineligible Grams side. BTW, the Grams method is eerily similar in format to the Bilski method.

[Patrick]

Kevin,
Very in depth coverage, as usual.

Classen will be the key. It's hard to imagine a way to test vaccines w/o performing the steps in Classen. While that may set up an easy 102, you could also easily argue this is exactly what SCOTUS meant when it talked about "wholly preempting" tue use of an idea.

[Supremely Ready to be Shot Down]

Kevin writes "The implications of this decision may be significantly limited by the Court's emphasis on the "treatment" steps as being transformative and thus almost by-definition patent-eligible"

Except that not all the claims required "treatment" steps (see claim 46). The Court goes out of its way, in fact, to state that the treatment steps are not necessary for 101 eligibility. All that is required is that the step of "determining" the levels of the metabolite is "transformative" and "related" to the "purpose" of the claim. Never mind that if one practices only the steps recited in the claim, one "transforms" precisely nothing that wasn't transformed in exactly the same way by the prior art.

This is one of the most poorly reasoned cases in recent memory (even worse than earlier CAFC decision in the same case).

[Skeptical]

"one "transforms" precisely nothing that wasn't transformed in exactly the same way by the prior art."

SRtbSD,

Not passing any judgment on the claim itself, but your analysis appears to be dissecting the parts of the claim, rather than looking at the claim as a whole. Transformation is simply not required in every element, but merely some element, and then, even not in the non-prior art element.

It appears that you are conflating issues.

[Supremely Ready to be Shot Down]

Skeptical "your analysis appears to be dissecting the parts of the claim, rather than looking at the claim as a whole."

Yes, I'm "dissecting" the claim and also reading the specification to determine what the invention is, i.e., what exactly is covered by this claim and what activities will be precluded by the claim? The invention of claim 46 is not a new method of measuring thioguanine in a subject. If you follow the claimed steps "as a whole", there are precisely zero transformations of matter that are new relative to the prior art, whether the steps (a single step, actually) are looked at individually or combined. All that is new here is a tacked on mental step of interpreting the results in a specified way. The only *relevant* transformation for 101 purposes the transformation of someone's brain such that it contains new information about a "need" to proceed in a certain manner. But the claimed method doesn't achieve *that* transformation. The specification achieved that transformation when it was published.

Or, if you prefer, the claim is simply anticipated/obvious because it can't be the case that tacking on a mental step at the end of an old claim suffices to lift the claim above the prior art. So which is it, "Skeptical"? It's time to "pass judgment on the claim." I look forward to your answer.

"Transformation is simply not required in every element, but merely some element, and then, even not in the non-prior art element."

Yes, that is what Lourie is saying and I think the Supreme Court will shortly be explaining to him why that simple-minded, strict test is wrong. They sort of indicated as much in Bilski, didn't they?

[Kevin E. Noonan]

All:

I think something we need to remember is the question is not whether this claim is patentable - it may well be that other sections of the statute (102, 103, 112) are capable of "shooting down" such a claim (and there is language in Bilski to the effect that courts are better off using those sections rather than 101). This is because 101 merely creates a threshold as to what is patent-eligible, and it a very blunt tool at that. You can read Bilski, Chakrabarty, and several other Supreme Court cases to mean that the Court would rather err on the side of being too inclusive on eligibility provided that the other sections of the statute (including the utility requirement of 101) were applied strictly. And there is a good policy argument to be made that this is the better course, since it minimizes the risk that a new technology (from the "Information Age" or otherwise) be precluded from patent-eligiblity just because it is "new" (like biotechnology once was). Indeed, Judge Rich said in Bergy, in making this distinction, that there were many things that were patent-eligible that were, nonetheless, not patentable. Perhaps that is the way it should be.

Thanks for the comments.

[Skeptical]

Kevin,

Your reply is on target, thus this is not the time to "pass judgment" on the claim, no matter how much SRtbSD wants to engage in such a discussion. That would simply be off track from the direction that CAFC is guiding the patent world. It's time to realize that 101 is a threshold question, a welcome mat to a wide open door. Once inside the door, then the rigors of 102/103/112 will play out.

SRtbSD,

I am skeptical about your intentions. Your eagerness you engage in a "THIS-patent-is-bad" discussion misses the most important point of the story. As to Bilski somehow indicating that Lourie is wrong in the dissection of claim analysis, I would say that the opposite is quite true. It is indeed quite clear that the Diehr view on claim dissection was strongly pronounced in Bilski (there is no "sort-of"). Do you have a personal problem with this Diehr holding?

[crelboyne]

The true distinction between Prometheus and Grams is that Grams claimed a general method of diagnostic testing (i.e., do a test to determine whether there is any undefined "abnormality," then use any undefined algorithm to determine the cause of the abnormality). What a ridiculous claim! If ever anyone claimed an abstract principle, Grams did.

In this way Grams is indeed much closer to Bilski than anything else. I just wish the CAFC had emphasized this part of the facts in Grams because I believe this is the true reason Grams's claim was patent-ineligible.

I agree that Classen will be interesting in shedding more light on the outer limits of patent-eligibility since Prometheus was pretty solidly patent-eligible. I'll need to look at the Classen claims again, but I seem to remember not being very impressed. Only slightly better (i.e. more specific) than Grams.

[Supremely Ready to be Shot Down]

Skeptical "I am skeptical about your intentions."

I'm skeptical about your intentions, too, and also Kevin's. Of course, that is irrelevant but now we're all on the record about our skepticism. For the record, I have no skin in the game other than a general loathing for the "think-about-the-result-of-an-old-method" claim format used by Prometheus (for the reasons provided above, among others). My own clients who invent diagnostic methods have been advised not to rely on such claims for years, for reasons that are obvious (to me, at least).

"It is indeed quite clear that the Diehr view on claim dissection was strongly pronounced in Bilski (there is no "sort-of")."

Please cite the passage from Bilski which says that under no circumstances can any claim element be ignored for 101 purposes, regardless of how tangential that element is to the actual contribution of the inventor to the art. Put another way, is it your belief that Bilski holds that ANY "transformative" or non-mental step preceding a novel mental step is sufficient to render a claim eligible under 101? That certainly seems to be what you are implying. Please clarify.

Skeptical: "It's time to realize that 101 is a threshold question, a welcome mat to a wide open door. Once inside the door, then the rigors of 102/103/112 will play out."

I find the apparent unwillingness of you or Kevin to address the 102/103 issues very ... interesting, particularly given the well-recognized tensions regarding the application of 101 versus these statutes. With respect to claim 46, knowing that the prior art taught that determining 6-MP levels can be used to evaluate clinical efficacy and tolerance (admitted in the patent itself), how can claim 46 not be obvious or anticipated when it recites no other step except determining those levels? I'm very curious about your answer. All the highly educated, scientifically trained attorneys I know who have considered the issue arrive at the same conclusion: the claim is DOA. I know at least Kevin has a decent education. Why so reluctant to address the issue, Kevin? Do you find it uninteresting?

[Kevin E. Noonan]

Dear Shot:

The answer is much more pedestrian and less nefarious that you might think. The court was asked to review one question - do these claims satisfy Section 101/subject matter requirements. That's pretty much it. It may well be that there are many reasons why other portions of the statute would invalidate the claims, and on remand I suspect Mayo will present that evidence. But the district court did not find these claims invalid on any ground other than non-statutory subject matter, so that's all the opinion says.

It isn't a question of whether the 102/103/112 issues are interesting or not. They may be interesting to you, or to me, but they are irrelevant to the decision the court made. That is a pretty conventional (and useful) conservation of judicial resources, and frankly it might violate the case-or-controversy provisions of the court's jurisdiction were it to opine prematurely on the 102/103/112 aspects of these claims (as well as raise due process concerns for the patentee). So rather than speculate on whether these claims are valid or not under Sections 102, 103, or 112, the court (and the post) focused on the question at hand - do these claims recite statutory subject matter? There is more than enough time to get to the other grounds/bases for invalidity.

Thanks for the comment.

[Supremely Ready to be Shot Down]

Kevin, are you unable to explain to me how it is possible that adding a mental step to an old method can result in a patentable claim? Or are you simply refusing to do so? If the latter, care to explain why? As I noted, it is a very interesting question and just the sort of thing that a patent blog such as this one would be expected to tackle with glee. Your silence on the issue is odd, to say the least. It's a remarkably straightforward set of facts, after all. One need not make any assumptions.

"That is a pretty conventional (and useful) conservation of judicial resources, and frankly it might violate the case-or-controversy provisions of the court's jurisdiction were it to opine prematurely on the 102/103/112 aspects of these claims (as well as raise due process concerns for the patentee)."

The Federal Circuit routinely opines on 102, 103 and/or 112 aspects of claims that it has construed before sending them down to the district court. You know, those cases about "being careful what you wish for" and the like. The Federal Circuit's reluctance to address the issue in this case remains striking, albeit a tad less striking than your own reluctance (and Skeptical's). I could of course speculate regarding "bias" here but I'l leave that to others.

[Kevin E. Noonan]

Shot:

Now, you're too smart to really not get what I'm saying -look at the last paragraph of your comment: "The Federal Circuit routinely opines on 102, 103 and/or 112 aspects of claims that it has construed before sending them down to the district court." Yes, because that's what they are reviewing in the context of claim construction.

We could speculate all day on whether these claims are patentable - but that isn't the question. The question is whether they are patent-eligible. I don't think the court's reluctance to opine on patentability is striking at all - I think they understand the issue.

For the record, I call them like I see them, biased or not.

Of course, if you want to talk about policy, then we have two competing policies, it seems to me. You can take the position that making these types of claims patentable is wrong, for all the reason that you have espoused in your comments. It is a defensible position, but one that looks at the question from the point of view of whether the applicants "deserves" or "has earned" the patent grant. Fair enough.

The other position is the public interest position - what is the consequence of making these types of claims not patentable? One easily imagined one is non-disclosure - I figure out the correlation and don't tell anyone about it. I just open my shop and say "I can predict whether you are getting enough of drug X" (or "Are likely to get cancer" or "Are likely to get Alzheimer's"). And I charge all that the market will bear for as long as I can until someone else figures it out, too. Could be 5 days, 5 months, 5-, 50- or 500 years later. Can't say - but what we can say is that for all the time greater than 20 years the public has not benefited - either from my disclosure of the test or the follow-on inventions that stem from my observation.

So there are pros and cons to each position. Ultimately, I think non-disclosure is worse than over-patenting, but that's my choice - my bias, if you will. I can defend that position. Beside spite or orneriness, can you?

All the joys and blessings of the holiday season to you.

[patent litigation]

The outcome of the Classen patent litigation should add further nuance to this line of cases. I look forward to learning details of that case's decision.
http://www.generalpatent.com/media/videos/patent-suits