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May 07, 2009


Ugh - Bilski/LabCorp alert! This claim is like the LabCorp claim. When you look closely, it seems to be drawn to a general process comprising (1) measuring changes of a specified antigen by any method, and (2) then correlating the result with a medical condition.

"(1) measuring changes of a specified antigen by any method"

Actually, moocow, this claim differs dramatically from the claim in LabCorp and you've grossly mischaracterized it. The claim here is limited to the use of what I presume is a new antibody as of the priority date of this patent. In contrast, the assay recited in LabCorp was old.

Nice try, though.

With that distraction put to the rest (we'll call moocow's comment 'sarcasm', to be generous), I note that the claim is certainly not drafted as well as it could be to avoid 101 issues.

All of the money, of course, is in the composition claim, i.e., the monoclonal antibody which must be claimed somewhere out there. And this patent had better share a priority claim with that patent.

Now cue up someone here to defend the practice of granting unrelated patents on methods of *thinking* about any of the trillion of non-obvious results that can be obtained with this antibody for the next, oh, 100 years. Because that's what will be attempted if the reasonable proscriptions in Bilski/LabCorp are ignored. Thus, one who purchased the monoclonal cell line or isolated antibody may find themselves infringing a later-issued claim merely by thinking about data obtained through the use of the antibody in a non-patented process.

no evil intent here, but I still don't see the limitation to the use of the specific antibody in that claim. Step one requires measuring levels of an antigen "recognizable by" the specific antibody. The recitation of the antibody limits what's being measured, not how it's being measured. Do you see the distinction? The claim doesn't care how the assay is done - any assay would meet the limitation, so long as what's being assayed is an antigen that would be recognized by that particular antibody.

Or, to put it differently: if we named "the- antigen-that's-recognizable-by-the monoclonal-antibody-that-is-produced-by-the hybridoma-cell-line-deposited-at-the American-Type-Culture-Collection-having accession-No.-PTA-450" simply "Antigen X," then the claim steps would read:

(a) measuring changes in the level of Antigen X in a bodily fluid sample from a patient undergoing therapy; and
b) correlating the change in the level with the effectiveness of said therapy, wherein a decrease in the level indicates a reduced tumor burden.

Now, it's quite possible that the assay step here is novel whereas the assay step in LabCorp was old, but novelty, as you recall, was not the issue in Labcorp or Bilski (and the novelty of a mere step should never be an issue anyway). The issue under these cases, rightly or wrongly, is whether the claim preempts all uses of a natural phenomenon. I think that's wrong, but it's still the issue.

But in defense of the claim, it is quite possible that the inventors had a narrower claim construction in mind and really did intend the antigen to be measured by use that particular antibody; you get that impression when you look at the dependent claims. In that case, however, the claim would be extremely narrow indeed.

Dear Keep and Moo:

Of course, another way of looking at things is that if the CAFC and Justice Breyer think this claim should be unpatentable, they are wrong (or else they think medical method claims should be per se unpatentable). I think that's a decision for Congress, not the judiciary (maybe we can put suggest it in the "patent reform" bill as part of harmonization with EPO/JPO).

Another distinction with Labcorp would be if the antigen was new; then even under Bilski/Labcorp the claim should be patentable (since Justice Breyer (mistakenly) thought that since the homocysteine assay was "old" the claim should be unpatentable for "merely" comprising the "correlating" step). I haven't taken the time to review the patent so it remains, for me, an open question.

Thanks for the comments.

Shouldn't this claim fail under Bilski?

Kevin, I'm not sure that novelty of the antigen or the antibody would get past Bilski, which is a 101 test, not a 102 test. I suppose one could argue that by limiting this case to the particular antigen or antigen mentioned, one is not preempting all other uses; but remember, the Bilksi decision substituted the test for preemption with a proxy, viz. the machine or transformation test. There's no particular machine recited in the claim, and there's no transformation, just data gathering. So I'm not sure that this claim passes muster under Bilski, even if the antibody or antigen is new.

Of course, I agree with you that this claim ought to be patentable, and that if it's dead under Bilski then a lot of similar research and commercialization may not happen in the future. Such non-research for lack of incentives would hardly serve to promote the progress of science. So I would love to have my circumspection about the validity of this claim under Bilski be proven unfounded.

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