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« Follow-on Biologics News Briefs - No. 2 | Main | Will GSK Break the Doha Impasse in the Global Drug Pricing Crisis? »

February 19, 2009


This claim seems to be in jeopardy of a Classen/Metabolite challenge under Sec. 101.

Apparently the examiner didn't get John Love's memo about the machine-or-transformation test in the wake of Bilski. I don't see any difference between this claim and the one shot down in Classen.

Dear Dan:

There really isn't a difference that I can see. The practitioners representing Vermillion are good ones; I think they got caught in the recent changes in how we all have to think about these kinds of claims (their last response was filed some time last fall, maybe before Bilski came down).

Interesting times. Lucky us.

Thanks for the comment.

The last response in this case was filed on August 6, 2008, more than two months before Bilski was decided on October 30th. The Examiner's Amendment, however, was mailed on November 17th.

Well, we can't expect a diagnostic claim examiner to be aware of a CAFC decision on a business method that quickly, can we?

Maybe the Examiner could have waited a day:



The Federal Circuit needs to grab ahold of one of these "diagnostic method" cases soon, and lay out clearly (not like in Bilski) what will fly, and what won't. In fact, Chief Judge Michel has made that invitation, so let's take him up on it. We can't leave this area to the BPAI to mangle, as it's already done in the computer program/software area.

We really need this claim to be litigated. Prometheus v. Mayo will give us a glimpse of the answer to whether diagnostic patents will survive, but litigation on this type of patent would tell us clearly.

Of course, Justice Breyer and two other Supremes have already weighed in...

Dear Bruinjack:

Maybe Prometheus will help, but the Classen decision was 69 words long and said, "See Bilski." The PTO has already started thinking about how these cases are to be applied to diagnostic claims.

As for Breyer and his friends, we can only hope that the issue is more felicitously framed if it ever gets back to them.

Thanks for the comment.

I assume Bilski will kill this claim.

"I don't see any difference between this claim and the one shot down in Classen."

There is one major difference: Vermillion appears to have made a genuine discovery and described a method, in their claims, for using that that discovery, whereas Classen claims immunizing animals (old) and looking at the results of the immunization to see what happened (old). Thus, there is no "invention" whatsoever in Classen because nothing new happens, mentally or otherwise. Can we try a little harder not to pretend that Classen has a patentable invention or is representative of how most biotech companies and their attorneys do business? Please?

Whether Vermillion's claims actually have 101 problems depends, at least, on the prosecution history and how the claim terms (e.g., "correlating") are defined. But note also that Vermillion's application includes the following:

19. The method of any of claims 1-3, further comprising: (c) reporting the status to the subject.

20. The method of any of claims 1-3, further comprising: recording the status on a tangible medium.

21. The method of any of claims 1-3, further comprising: (c) managing subject treatment based on the status.

42. The method of claim 40, wherein the diagnosis is communicated to the subject via a computer-generated medium.

That's good stuff. It's been said before, but Bilski's holding was not unexpected and clearly certain practitioners were taking changes in the 101 weather into account.

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