Patent Profile: EXACT Sciences Announces Issuance of Colorectal Cancer Screening Patent

    By Sherri Oslick --

EXACT Sciences Corp. announced today the issuance of U.S. Patent No. 7,485,420, entitled "Methods and Compositions for Detecting Colon Cancers," which is directed toward the use of differentially methylated vimentin as a marker of colorectal cancer.  The patent is assigned to Case Western Reserve University, and licensed exclusively by EXACT Sciences.

The claims are directed to assays for assessing the likelihood of colorectal cancer in a patient through the detection of methylation within a vimentin nucleotide sequence.  The invention is based in part on the inventor's discovery that methylation of vimentin DNA is associated with the presence of colorectal cancer, or more specifically, that vimentin is differentially methylated in tissues from colon cancer and unmethylated in normal human tissues.  Claim 1 of the patent recites:

1.  A method for detecting the likelihood that a human patient has colon neoplasia, comprising:
    a) obtaining a sample from a human patient; and
    b) assaying said sample for the presence or absence of methylation within a nucleotide sequence selected from the group consisting of SEQ ID NOs: 40-45, wherein the presence of methylation within any one of said nucleotide sequence is indicative of the likelihood that the human patient has colon neoplasia.  [SEQ ID NOs 40-45 are vimentin sequences.]

This patent adds to EXACT's patent estate around non-invasive colorectal cancer screening.

Comments

[martin j.]

Can this patent pass the In Re Bilski test?

[Dan Feigelson]

I second Martin's question. How does the assay physically transform the sample - does it result in the nucleotide sequence folding in a particular way?

According to an informed source who peruses the USPTO Gazette every week, there are still many patents being granted with claims that don't pass muster under Bilski. Presumably these had already been allowed or the issue fee paid before Bilski was handed down.

Of course, it for the sake of claims like this one that I'm hoping the decision in Bilski gets deeped-sixed down the road.

[Mike Ram]

Looks like this application was allowed BEFORE Bilski. There is no 101 rejection in the last office action in early 2008.

[Kevin E. Noonan]

Dear Martin, Dan and Mike:

For what it's worth (since there is no clear answer), we posted a discussion of this issue today.

Thanks for the comments.

[Pacific Reporter]

I think Bilski would invalidate this claim now.