[REPRINTED with permission from the excellent Patent Docs Blog]
Board Finds Metabolite Claim to be Patentable
By Kevin E. Noonan –
The most significant non-decision from the Supreme Court in recent memory is Justice Breyer's dissent over the Court's decision to dismiss its granted certiorari petition (as improvidently granted) in the Laboratory Corp. v. Metabolite Laboratories, Inc. case regarding the patent-eligibility of this claim:
13. A method for detecting a deficiency of cobalamin or folate in warm-blooded animals comprising the steps of: assaying a body fluid for an elevated level of total homocysteine; and correlating an elevated level of total homocysteine in said body fluid with a deficiency of cobalamin or folate.
The bases for the dissenters' objections to the patentability of this claim has been discussed in prior Patent Docs posts (see "The Supreme Court,In re Bilski and the Lingering Question of Labcorp v. Metabolite"). Today, the Board of Patent Appeals and Interferences issued its decision in an appeal from a final rejection of this claim in reexamination, reversing the Examiner's assertion that the claim was unpatentable for obviousness.
The ex parte reexamination, Control No. 90/008,305, of U.S. Patent 4,940,658was requested on October 23, 2006, and claims 13, 15-17 and 33 were finally rejected for obviousness over the following references:
• Refsum et al., "Radioenzymic Determination of Homocysteine in Plasma and Urine," Clinical Chemistry 34: 624-28 (1985), cited for teaching methods for determining homocysteine levels in plasma by converted total homocysteine to radiolabeled S-adenosylhomocysteine and then quantifying;
• Kass, "Cytochemical Detection of Homocysteine in Pernicious Anemia and in Chronic Erythremic Myelosis," American Journal of Clinical Pathology 67: 53-56 (1977), cited for teaching chemical methods of homocysteine detection in permicious anemia to detect B12 deficiency, but which test showed cross-reactivity with Coenzyme A;
• Wilcken et al., "Homocysteinemia, Ischemic Heart Disease, and the Carrier State for Monocystinuria," Metabolism 32: 363-70 (1983), cited for teaching homocysteine detection in a twin study showing different folate and B12 levels consistently detected from RBCs; and
• Westhyyzen et al., "Plasma amino acids and tissue methionine levels in fruit bats (Rousettus aegyptiacus) with nitrous oxide-induced vitamin B12 deficiency," British Journal of Nutrition 53: 657-62 (1985), cited for showing in correlation between plasma methionine levels and vitamin B12 deficiency.
The Examiner rejected the claims in reexamination for obviousness, citing the Refsum reference as the primary reference (showing a method for detecting plasma homocysteine) combined with the other references showing a correlation with vitamin deficiency. It would have been obvious to combine the teachings of these references, according to the Examiner, "[b]ased on the correlation between the elevated levels of homocysteine (free and/or complexed) in blood and urine samples with deficiency of cobalamin or folate taught by Kass, Wilcken . . . and Westhuyzen."
Saith the Board: We disagree. The panel first stated the principle, enunciated in KSR International Co. v. Teleflex Inc., requiring "some articulated reasoning with some rationale underpinning to support the legal conclusion of obviousness" (550 U.S. 398, 418 (2007)). Here, the Board opined that the claimed invention requires assaying for "total" homocysteine, which comprises four species (homocysteine, homocystine, homocysteine-cysteine disulfides, and protein-homocysteine mixed disulfides), based on specific findings of fact, and correlating elevated levels with folate and/or vitamin B12 deficiency (without discriminating between the two). The panel then distinguished the cited secondary references (which the Examiner used to establish the correlation between elevated homocysteine levels and vitamin deficiency) from the claimed invention. According to the Board, Kass teaches a chemical reaction test that measures not only homocysteine (and not "total" homocysteine) but also Coenzyme A and further distinguishes between B12 and folate deficiency (contrary to the claimed invention). The Board further opined that the ordinarily skilled worker would not have "reasonably" read the Wilcken reference as teaching a correlation between elevated total homocysteine levels and either folate or B12 deficiency, since neither twin was reliably deficient in either folate or B12. The Westhuyzen reference does suggest a correlation between elevated plasma homocysteine and B12 deficiency, the Board conceded, but only detects homocysteine, not total homocysteine, and there is no evidence that the detected increased in homocysteine would "necessarily mean an increase in 'total' homocysteine." In addition to these deficiencies, the Board found that none of the cited references show any correlation between plasma homocysteine levels and folate deficiency.
The Board then held that "[t]he Examiner has failed to provide a sufficient factual basis to support her conclusion of obviousness i.e. that the applied prior art teaches or suggests all of the claim limitations" (phraseology applying — but not rigidly applying — the traditional TSM test remaining as one option underKSR and the Patent Office Guidelines for implementing the KSR decision).
This decision cannot be appealed by the third-party requester, and at least with regard to claim 13 provides no basis for appeal by the patentee (since the patentability of this claim was affirmed in unamended fashion by the Board's decision). It is unlikely that this determination would change Justice Breyer's mind, in any event, since he is on record as believing that:
At most, respondents have simply described the natural law at issue in the abstract patent language of a "process." But they cannot avoid the fact that the process is no more than an instruction to read some numbers in light of medical knowledge. Cf. id., at 192 (warning against "allow[ing] a competent draftsman to evade the recognized limitations on the type of subject matter eligible for patent protection"). One might, of course, reduce the "process" to a series of steps, e.g., Step 1: gather data; Step 2: read a number; Step 3: compare the number with the norm; Step 4: act accordingly. But one can reduce any process to a series of steps. The question is what those steps embody. And here, aside from the unpatented test, they embody only the correlation between homocysteine and vitamin deficiency that the researchers uncovered. In my view, that correlation is an unpatentable "natural phenomenon," and I can find nothing in claim 13 that adds anything more of significance.
The Board's decision properly addresses the legal flaw in Justice Breyer's reasoning, as explicated by Judge Rich in In re Bergy: the question of patent eligibility is distinct from whether an invention satisfies the statutory requirement for patentabity. The Board has affirmed that Claim 13 is patentable; perhaps the Supreme Court will use its review of In re Bilski to address the question of whether the claim is also patent-eligible.
Ex parte Competitive Technologies, Inc. (B.P.A.I. 2009)
Panel: Administrative Patent Judges Spiegel, Adams, and Delmendo
Opinion by Administrative Patent Judge Spiegel
But, Andrew Dhuey, don’t waste your time with MM-trollbot. He maintains a persistent ignorance and will only waste your time.
>>if you are the first to show a novel and non->>obvious therapeutic
Yes. Figuring out how the human body works is not science. We are a machine. I, for one, want methods of determining and correlating to be patent eligible. It is as if we owned an automobile and didn’t know that the oil had to be changed.
The problem is that these terms theory, science, abstract, etc. are simply not well defined nor understood. And, in the end they are nothing more than words that we used to tie into something in our brains. Newton’s Laws of Physics. What are those? What is math? What is an abstraction? What is an idea? Idea is one of those that is magically conjured up to remove something from patent eligibility.
Mr. Mooney, if you are the first to show a novel and non-obvious therapeutic use of a very old compound, do you have a patent-eligible method, or have you simply noticed a “scientific relationship” between the administration of that compound into a living creature and the therapeutic effect? It’s the latter, right? After all, you haven’t invented anything — all you have done is notice a natural phenomenon that has existed for ages.
**and the amendment introduced a 101 that did not exist prior to the amendment**
ok, thanks
curious: I’d revise your statement like this …
thus some claims in a reexam are subject to 101 rejections (because they were amended **and the amendment introduced a 101 that did not exist prior to the amendment**) but other very similar claims in the SAME reexam are not subject to 101 rejections (because they were not amended)
anonymous — thus some claims in a reexam are subject to 101 rejections (because they were amended) but other very similar claims in the SAME reexam are not subject to 101 rejections (because they were not amended)?
My understanding (from a conversation I had with a USPTO official about USPTO practice generally and not in the context of this or any other particular case) is that examiners in reexamation are instructed NOT to raise any 101 rejections unless the 101 issues arise out of an amendment to the claims. Thus, if the claims aren’t amended, no 101. And if the amendments don’t give rise to a 101 (that is, the 101 already existed), no 101.
Don’t infer anything here about 101.
News flash for Judge Rader: you could not ever legally patent a “scientific relationship” so nothing is lost there.
Just learn how to write claims, people.
It’s also noteworthy that the Metabolite patent was specifically discussed by Judge Rader in his Bilski dissent, noting that, like Breyer’s dissenting opinion in Lab Corp, “this court inadvertently advises investors that they should divert their unprotectable investments away from discovery of ‘scientific relationships” within the body that diagnose breast cancer or Lou Gehrig’s disease or Parkinson’s or whatever.’
Kevin has confused the TSM test with teaching or suggesting all the elemnts. They are two different things, the TSM test regards combining the cited art, the teaching or suggestion of the elements is the requirement that the cited art combined already teaches/suggests all the elements. KSR said nothing about the “teaching or suggesting”.
“13. A method for detecting a deficiency of cobalamin or folate in warm-blooded animals comprising the steps of: assaying a body fluid for an elevated level of total homocysteine; and correlating an elevated level of total homocysteine in said body fluid with a deficiency of cobalamin or folate.”
Still as crappy as it ever it was. Who cares if it’s obvious or not? This decision is juicy red meat for Breyer & Co., and I can’t think of a better way to tee up Bilski for the Supremes.
Now … watch this drive!
I predict that Justices Breyer and/or Stevens will write one or two separate opinions in Bilski, partly to take a swipe at the Metabolite patent, either directly or indirectly. If I’m right about that, I’ll be sure to mention it next year. If I’m wrong, never mind.
It certainly appears that the Board thought that it could not address the 101 issue due to the limited scope of reexamination. And there is a good argument to support that interpretation of the statute. But I wonder whether it can be reconciled with Comiskey’s command that 101 must be considered before addressing a 103 argument, and Bilski’s gloss that 101 “should generally” be considered before addressing a 103 argument.
“Mark I thought you were more or less for IP?”
I’m for better IP.
Paul –
You’re mostly right. The Board had no choice here but to deal only with the 103 issue that was the subject of the reexamination. 101 simply could not have been raised. Occasionally you will see a 112 rejection (or even a 101, I suppose) raised by the examiner or the Board, but only if the claim had been amended during reexamination (i.e., it was not expired). Otherwise, their hands are tied by the limited scope of reexaminations.
So there’s really nothing to learn here on the 101 front. [On the other hand, there were a couple other BPAI decisions that day that are much more instructive/puzzling for 101 — see Ex parte Haworth (instructive) and Ex parte Casati (puzzling)]
Board “does not have jurisdiction to consider 101 issues in a reexamination of an issued patent”
Is that true?
Re: “In appeals the board reviews adverse decisions of the examiner and is not required to pontificate upon other potential issues or rationales (although it may and does sometimes).”
Not entirely without criticism. The CAFC has noted more than once that the PTO [a federal agency, not a court] has a duty not to knowingly issue invalid patents.
But the Board here might have been taking the view that it does not have jurisdiction to consider 101 issues in a reexamination of an issued patent in view of the limited scope of issues which can be raised in a reexamination [publication or patent prior art].
[They could have simply said that, and avoided unnecessary speculation that they were ignoring the prior litigation on the same claim and the 101 issue raised but not decided at the Sup. Ct.]
NSFW!
link to myspace.com
We should hire this chick, she’d blow up the backlog lickety split.
cool tunes on her page btw, if you guys have netflix you can catch her in a newly out movie.
Btw Noise, if the presumption is so “integral” to what it means to have a patent, then why did it take several years before the legislation giving you one came out? Why was the stated purpose for the legislation merely to provide the legal standard for the burden of going forward (as before this legislation it had been tossed around by the courts)?
Short answer is that the presumption isn’t an integral part, it’s a legal add on. Patent holders were still patent holders before it was enacted.
Furthermore, it is a legal add on which has gotten out of hand in some situations and cases, such as in the cases where the CAFC misinterpret 112 2nd just to make it jive with the presumption (that means any case where “insolubly ambiguous” saved a claim).
“skilled worker would not have “reasonably” read the Wilcken reference as teaching a correlation between elevated total homocysteine levels and either folate or B12 deficiency,”
Protip: if you want to make a rejection like that you’re going to have to go to the NPL to find the EXACT correlation and thus have it established that the person of ordinary skill understood such.
That is, if I understand what they’re doing in this rejection.
Breyer’s opinion is slightly off since the “assaying” step isn’t a natural phenom (so far as I’m aware) and thus I would say that the method involves more than reading numbers since you have to perform the test (whatever test that is I don’t know).
However, I do believe that the case where the CAFC held that all portions of a claim that are merely natural processes are rendered per se obvious touches on what Breyer was trying to get at. I think it was Comiskey ver. 1? Idk I don’t remember.
Mark I thought you were more or less for IP?
I wouldn’t extract too much on 101 from this. The opinion is neither precedential nor informative. It looks like the panel merely decided a specific 103 issue, the only issue apparently raised in the appeal. In appeals the board reviews adverse decisions of the examiner and is not required to pontificate upon other potential issues or rationales (although it may and does sometimes).
A couple of items to note which Paul F. Morgan raised….
First, this case involved a 103(a) issue — not 101.
Second, Bilski is not found in the Board’s decision.
Reexaminations require patent owners to disclose related litigation on the patent, but I don’t see even a reference to that in this Board decision, nor any mention of any possible 101 isssue. It just reads like a routine Board 103 decision. ??
OT
Editing Wikipedia article on Sweden’s Patent Pirate Party link to bit.ly Important movement now has EU parliment seat.
Not sure I’ve got the whole picture here. Did the CAFC affirm or reverse?
Anyway, the real problem seems to me to be not prior art but that the claim is statutorily stuupid; i.e. 112.2 indefinite.
This is a method for detecting a deficiency of cobalamin/folate in which the second step is correlating elevated homosystenine with a deficiency of comalamin/folate.
So we have a claimed method in which a step of the method requires performing the method itself.
The Red Queen would love this one. I presume this is what Breyer was referring to when he said:
“Even were I to assume (purely for argument’s sake) that claim 13 meets certain general definitions of process patentability, . . .”
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