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Diagnosing Bilski


COMMENTARY

By Brian Dorn

January 7, 2010 | The U.S. Federal Circuit’s In re Bilski decision provides a framework on patentable subject matter. This decision can and is having a profound impact upon certain biotechnology and medical diagnostic method claims (treatment claims are unaffected). In Bilski, the Federal Circuit said that a claimed process is patentable if (a) the process is tied to a particular machine or apparatus, or (b) the process transforms a particular article into a different state or thing (“The Machine-or-Transformation Test”). However, the involvement of the machine or transformation must not be insignificant, extra-solution activity (e.g., data gathering). Rather, the “transformation must be central to the purpose of the claimed process.” In assessing patentable subject matter, the claim is to be evaluated in its entirety and not by individual claim elements. Thereby, a claim simply to natural phenomena, mental processes, and/or abstract ideas is not patentable. Although the claims in Bilski are methods of hedging risk in commodities trading, these holdings have and will be applied to all technologies, including biotech process claims.

The U.S. Supreme Court agreed to review Bilski, and a decision should issue this Spring that could greatly affect the diagnostic industry.

Diagnostic Methods 
Diagnostic methods appear to be profoundly affected by the Bilski decision. The essence of many diagnostic methods claims is the recognition of an association between a biomarker and disease state. For example, a method of diagnosing a disease by simply correlating an increase in a biomarker with that disease is not patentable since it is purely a recognition of a natural phenomenon. The inventor has simply observed nature. This may have slipped through the patent office previously, but should not have been patentable even under previous caselaw.
Then there are claims where there is an activity followed by the recognition of the new observation. For example, a method of diagnosing a disease comprising detecting a biomarker in a sample, and correlating an increase of this biomarker with this disease may not be patentable.
Although this claim contains an active step (the “detecting”), the courts may find the “detecting” as data gathering and could still find the claim as just the recognition of a natural phenomenon.

A third type of claim includes a transformative activity followed by the recognition of the new observation. For example a method of determining immune protection to a disease comprising 1) administering an antigen to a subject; and 2) detecting an antibody titer to the antigen, wherein a titer correlates with protection. Under Bilski, this hypothetical claim may also not be patentable subject matter. Administering an antigen is a transformative step as it provokes an immune reaction. Whether this claim is patentable subject matter turns on the characterization of whether the claim as a whole is transformation or the recognition of natural phenomena.

What’s Next?
A. Bilski at the Supreme Court.  The case is being reviewed by the Supreme Court this term, and the decision should be evaluated before any strategies permanently yielding claimable subject matter are finalized. Also, the true state of the law probably will not be fully discernible for a few more years. As far as a prediction (solely the author’s opinion), the Bilski decision will be at least be reversed-in-part. Traditionally, the Supreme Court prefers to take an expansive view of patent law and will probably deny the “machine-or-transformation test” as being too rigid. 

B. Your Application Now.  In light of current case law, multiple contingencies for supporting claims of varying scope and subject matter should be included. 

“Determining” or “detecting” steps need to be supported with description in the specification as transformative in nature since observation of natural phenomena is not patentable. Emphasis should be provided that such a determination or detection is not available to the unaided eye without some transformation. Correlation between simple observations are not patentable subject matter (e.g., yellowing skin and jaundice). However, when a sample needs to be transformed to observe the biomarker (e.g., transforming the data gathered from a microarray), this is transformative. This step needs to be characterized so it does not get classified as “extra-solution” or mere “data gathering.”

Besides support in the specification, method claims should be drafted so the preamble emphasizes a transformative step. The preamble is more important for a method claim, and was used by the Federal Circuit to characterize the claim as a whole in a couple of cases subsequent to Bilski. Since part of the Bilski analysis is to look to the claim as a whole, the preamble can direct that analysis.

Specifications and claims should be drafted where the method(s) include more emphasis on applied steps and action steps, particularly noting transformative actions.

Brian Dorn Ph.D., J.D., is a patent attorney at IP firm Merchant & Gould.

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    How about "a method of detecting..." These seem to be quite common in arts outside of medical diagnostics.

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