New USPTO Guidance On Patent Eligibility Of Diagnostic Methods

09 May 2016 PharmaPatents Blog
Authors: Courtenay C. Brinckerhoff

The patent eligibility examples published by the USPTO on May 5, 2016 include two new examples relating to diagnostic methods and two new examples relating to “nature-based” products. This article will consider the diagnostic methods examples and ask whether they are consistent with recent Federal Circuit decisions, or whether the USPTO is taking a stand against the court’s recent decisions invalidating diagnostic method patents.

Diagnostic Methods Examples

The new examples add Examples 28-33 to the USPTO’s body of patent eligibility examples, of which Examples 29 and 31 relate to diagnostic methods.

Example 29 relates to the diagnosis and treatment of a fictitious disease called “julitis” by detecting a newly identified protein marker. Out of the seven sample claims, six are said to be “eligible” and one is said to be “ineligible.” Themes that emerge from this example include:

  • a method of detecting a newly identified protein marker satisfies § 101 even if the method is recited at a high level of generality {Claim 1}
  • a method of diagnosing a disease by detecting a newly identified protein marker does not satisfy § 101 when the detection steps are recited at a high level of generality, i.e., adding a “diagnosing …” step to a patent-eligible method of detecting claim will render the claim ineligible {Claim 2}
  • a method of diagnosing a disease by detecting a newly identified protein marker satisfies § 101 if the claim recites the use of agents (e.g., antibodies) that are novel or at least are not “well-understood, routine and conventional” {Claim 3, Claim 4}
  • a personalized medicine method of diagnosing and treating a disease that involves detecting a newly identified protein marker satisfies § 101 even if the detection method is recited at a high level of generality and the recited treatment is a conventional treatment for the condition {Claim 5, Claim 6}
  • a method of treating a disease satisfies § 101 {Claim 7}
    (That should go without saying, but certain district courts may need this reminder!)

Example 31 relates to screening for genetic markers, and is based loosely on the claims of Myriad’s U.S. Patent 5,753,441. Out of the five sample claims, four are said to be “eligible” and one is said to be “ineligibile.” The “ineligible” claim mirrors the claim that was invalidated by the Federal Circuit under the “abstract idea” paradigm. Themes that emerge from this example include:

  • a screening method claim based on “comparing” sequences does not satisfy § 101 when the comparison is recited at a high level of generality such that it could read on a mental process {Claim 1 }
  • a screening method claim satisfies § 101 if the claim recites the use of a technique that is not “well-understood, routine and conventional” {Claim 70, Claim 75, Claim 80, Claim 85}

I am hesitant to draw broader conclusions from the examples, because that would assume a level of reason that may still be lacking. For example, I would like to conclude that the USPTO believes that a method of detecting a newly identified genetic marker satisfies § 101 if the method is recited at a high level of generality as long as it is does not read on a mental process, but it did not include a claim similar to Claim 2 of Example 29 in the set of claims for Example 31.

Comparison To Federal Circuit Decisions

I find it difficult to reconcile the USPTO’s detection method examples with recent Federal Circuit decisions including Ambry, Sequenom, and GTGbut maybe that’s the point. The USPTO cites the following passage from Mayo in support of the “eligible” detecting claims:

[Each claim] recites an “administering” step, a “determining” step, and a “wherein” step. These additional steps are not themselves natural laws ….

Perhaps the Federal Circuit lost track of this Supreme Court guidance when it determined that claim 1 of Sequenom’s U.S. Patent 6,258,540 “begins and ends with a natural phenomenon” and is invalid as being “directed to matter that is naturally occurring.” Although some claims at issue in Sequenom recited a diagnosis step, claim 1 was focused on “detecting the presence of a paternally inherited nucleic acid of fetal origin” in “a maternal serum or plasma sample from a pregnant female.”

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