PHOSITA

Authored by Elizabeth Isaac, July 25, 2016 at 1:17 pm
MAIN, USPTO

On July 14, 2016, the USPTO issued a Memorandum in response to two recent Supreme Court and Federal Circuit rulings in subject matter eligibility cases under 35 U.S.C. § 101 concerning life science method claims—Rapid Litigation Management v. CellzDirectand Sequenom v. Ariosa.

In Rapid Litigation Management, the Federal Circuit reversed a district court invalidation of a patent and held that a claimed method involving steps of fractionating, recovering, and cryopreserving hepatocyte is patent eligible under 35 U.S.C. § 101. In more lay-friendly terms, the patent was directed to an advance in providing liver cells for testing, diagnostic, and treatment purposes. According to the USPTO memorandum, the “the Federal Circuit highlighted several important points regarding subject matter eligibility analysis” in reasoning that the claimed methods were not directed to a judicial exception under the Office’s Step 2A of the Alice/Mayo framework.

As a recap, the USPTO’s Alice/Mayo framework directs an examiner to perform the following (rudimentary rendition) when evaluating whether a claim is drawn towards patent-eligible subject matter:

  • STEP 1: Is the claim directed to one of the statutory categories of patent-eligible subject matter (e.g., process, machine, manufacture, or composition of matter)?

NoReject the claim under 35 U.S.C. § 101 and continue examination for patentability

Yes → proceed to Step 2A

  • STEP 2A: Is the claim directed to one of the judicially recognized exceptions to patent-eligible subject matter (i.e., law of nature, a natural phenomenon, or an abstract idea, such as but not limited to, fundamental economic practices, certain methods of organizing human activities, and mathematical relationships or formulas)?

No→  Note the claim is eligible under 35 U.S.C. § 101 and continue examination for patentability

Yes → proceed to Step 2B

  • STEP 2B: Is there an element or combination of elements in the claim that is sufficient to ensure that the claim, as a whole, amounts to significantly more than the judicial exception? (Clear as mud? I would have aimed to nip the issue at 2A, too).

NoReject the claim under 35 U.S.C. § 101 and continue examination for patentability

Yes → Note the claim is eligible under 35 U.S.C. § 101 and continue examination for patentability

According to the USPTO memorandum, the Federal Circuit shed light on Step 2A by emphasizing that analysis of a process claim requires more than merely identifying a judicial exception, but instead requires an analysis of whether “the end result of the process, the essence of the whole was a patent-ineligible concept.” The Office reasoned that “because these claims were focused on a process for achieving a desired outcome [as opposed to a process for merely observing or identifying, See, Sequenom] the court determined that they, like thousands of other claims that recite methods of producing things or methods of treating disease, were not directed to a judicial exception.”

Survives 101? Check.

As for the Supreme Court’s denial of certiorari in Sequenom (in which the method claims died at Step 2B), the USPTO memorandum briskly notes that the Federal Circuit’s decision was “not elevate[d] in its significance in this regard.” After determining the method claims were directed to a natural phenomenon (namely, the presence of cffDNA in maternal serum or plasma) at STEP 2A, the Federal Circuit was unable to identify an element or combination of elements sufficient to ensure that the method claims amounted to significantly more than a natural phenomenon at STEP 2B because “the amplifying and detecting steps are routine and conventional.”

The bottom line from the USPTO:  The Office’s current subject matter eligibility guidance and training examples are “consistent” with the decisions and examiners should continue to employ them in evaluating life science method claims.