Isolating and Measuring a Natural Phenomenon

by Dennis Crouch

Ex Parte Simons, APPEAL 2016-002684 (Patent Tr. & App. Bd. Jan. 31, 2018) (Decision on Rehearing)

In this case pending before the USPTO, Australian company Haplomic Technologies is seeking to patent a method of mapping whether methylated DNA bases are cis or trans.

16. A method for improving methylation mapping, comprising,

substantially isolating a DNA molecule from the biological sample, wherein the DNA molecule is an individual metaphase chromosome or a chromatid, or a fragment obtained therefrom;

analyzing the DNA molecule to determine the presence or absence of one or more methylated bases in the DNA molecule and

determining whether any two methylated bases are present in cis on the DNA molecule.

In its original decision, the PTAB affirmed an examiner rejection – finding the claim ineligible as directed toward a natural phenomenon.  However, the patentee requested a rehearing – arguing that the PTAB had failed to properly identify the natural phenomenon being claimed.  On reharing though, the PTAB reaffirmed the decision of no patentable subject matter.

In its analysis, the Board first noted that the claims are not directed toward any transformation of the isolated DNA, but rather simply detecting its parts.  We know from prior cases that isolated DNA remains a product of nature (Myriad) and that detecting DNA sequence is also a phenomenon of nature (Ariosa).  Similarly here, the PTAB ruled:

because the DNA is methylated in its cis or trans configuration prior to isolation, and because Appellant’s claims are directed merely to determining the configuration that exists prior to such isolation, Appellant’s claims are directed to a naturally-occurring phenomenon, i.e., a “phenomenon of nature,” and, therefore, to a judicially-created exception to Section 101.

Looking to step two of the Alice/Mayo analysis, the court found that the claims were written so broadly as to preempt the entire area — and did not including any saving inventive concept application.  “In short, Appellant’s claims are directed to determining, by any means, including means well known in the art, the naturally-occurring cis or transposition of methylated sites on a sequence of isolated DNA.”

Part of the applicant’s argument here was essentially that it combined two different ineligible concepts (isolating the DNA and cis testing) to somehow leave the invention patent eligible. The PTAB though rejected that argument.

It will be interesting to see whether the patentee pushes this case to a District Court or the Federal Circuit for review. Although those options are fun, the more likely outcome is that the patentee will narrow the claims and try again. Mark Nuell at Roberts Mlotkowski argued the case for the applicant.