Patent Profile: Vermillion Announces Allowance of Ovarian Cancer Biomarker Application

    By Donald Zuhn --

Last week, Vermillion, Inc. announced that the U.S. Patent and Trademark Office had issued a Notice of Allowance for its application directed to diagnostic methods using hepcidin as a biomarker for ovarian cancer.  The patent that eventually issues from the allowed application will be the Fremont, CA-based molecular diagnostics company's third U.S. patent.

A search of the USPTO Published Applications database and Public PAIR suggests that the Notice of Allowance described in Vermillion's press release was mailed for U.S. Application No. 11/373,833, which is entitled "Biomarker for Ovarian and Endometrial Cancer: Hepcidin," and which was published on March 8, 2007 as U.S. Patent Application Publication No. 2007/0054329.  The Public PAIR record for this application indicates that the Notice of Allowance was mailed on November 17, 2008.  Vermillion's patent is expected to issue sometime within the next four months.

According to the statement released by Vermillion, "the discovery of hepcidin as a biomarker for ovarian cancer . . . could ultimately lead to the development of an improved, next-generation assay that might provide physicians with additional, valuable information to diagnose ovarian cancer."  Ovarian cancer leads to approximately 15,000 deaths each year in the United States, with approximately 20,000 new cases of ovarian cancer being diagnosed per year.  The majority of new diagnoses are made in patients with late stage disease, where the cancer has spread beyond the ovary.  The prognosis for these patients is, unfortunately, poor.  However, when detected in stage 1, ovarian cancer has up to a 90% cure rate following surgery and/or chemotherapy.

The '833 application claims the benefit of U.S. Provisional Application No. 60/662,090, filed March 11, 2005.  Allowed claim 1 of the '799 application, which includes amendments introduced by Examiner's Amendment, recites:

1.  A method for qualifying ovarian cancer status in a subject comprising: (a) measuring the level of hepcidin in a biological sample from the subject being screened for ovarian cancer; and (b) correlating the measurement of an increased level of hepcidin in the biological sample from the subject as compared to the level of hepcidin in a biological sample from a healthy subject with the diagnosis of ovarian cancer.

The claim, as presented in Vermillion's last response, recited:

1.  A method for qualifying ovarian cancer status in a subject comprising: (a) measuring one or more biomarkers in a biological sample from the subject, wherein at least one biomarker is hepcidin; and (b) correlating the measurement or measurements with an ovarian cancer status selected from ovarian cancer and a benign ovarian tumor, wherein an increase in level of hepcidin is indicative of ovarian cancer.

Comments

[Kevin E. Noonan]

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

[Dan Feigelson]

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.

[Kevin E. Noonan]

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.

[Donald Zuhn]

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.

[Kevin E. Noonan]

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

[Donald Zuhn]

Maybe the Examiner could have waited a day:

http://www.patentdocs.org/2008/11/the-relevance-of-in-re-bilski-to-the-patentability-of-the-metabolite-claim.html

[EG]

Kevin,

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.

[bruinjack]

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...

[Kevin E. Noonan]

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.

[Pacific Reporter]

I assume Bilski will kill this claim.

[St. Ives]

"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.