USPTO Patent Eligibility Guidance In View Of CellzDirect And Sequenom

18 July 2016 PharmaPatents Blog
Author(s): Courtenay C. Brinckerhoff

On July 14, 2016, the USPTO issued a Memorandum to the Patent Examining Corps on patent eligibility in view of recent court decisions. The July 2016 Memorandum extracts more guidance for assessing patent eligibility from the Federal Circuit decision in CellzDirect, and notes that the Supreme decision denying certiorari in Sequenom “does not elevate” the significance of the panel decision in that case.

USPTO Patent Eligibility Guidance In View Of CellzDirect

As I noted in this article on CellzDirect, the Federal Circuit’s analysis in that case focused on Step 2A of the USPTO’s analytical framework for assessing patent eligibility–whether a claim is directed to law of nature. The July 2016 Memorandum highlights this aspect of the court’s decision. For example, the July 2016 Memorandum notes:

[T]he court emphasized that the “directed to” analysis of a process claim requires more than “merely identify[ing] a patent-ineligible concept underlying the claim” and instead requires an analysis of whether “the end result of the process, the essence of the whole,was a patent-ineligible concept.”

The July 2016 Memorandum explains that the claims at issue were determined to satisfy 35 USC § 101 because they “were focused on a process for achieving [a] desired outcome,” i.e., obtaining a preparation of multi-cryopreserved viable hepatocytes.

“[L]ike thousands of other claims that recite methods of producing things or methods of treating disease, [the claims] were not directed to a judicial exception.”

The July 2016 Memordum also notes that the Federal Circuit distinguished the CellzDirect claims from the claims in Mayo and Sequenom “that were found to be directed to a patent-ineligible concept when they ‘amounted to nothing more than observing or identifying the ineligible concept itself.'”

No Change To Existing Patent Eligibility Guidance

The July 2016 Memorandum concludes that “the USPTO’s current subject matter eligibility guidance and training examples are consistent with the Federal Circuit’s panel decisions” in these two cases, and notes that “[l]ife sciences method claims should continue to be treated in accordance with the USPTO’s subject matter eligibility guidance (most recently updated in May of 2016).”

This article reviews the May 2016 guidance on the patent eligibility of diagnostic methods.

This article reviews the May 2016 guidance on the patent eligibility of natural products.

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