On July 14, 2016, the U.S. Patent and Trademark Office (USPTO) issued a Memorandum to its Patent Examining Corps indicating that the recent court rulings in Rapid Litigation Management v. Cellzdirect and in Sequenom v. Ariosa are consistent with the subject matter eligibility framework employed by the USPTO in patent examination. As such, it proposes no changes to the framework. The Memorandum includes commentary on how the decision in Rapid Litigation Management clarifies the subject matter eligibility test for determining whether claims are directed to a patent ineligible concept such as a law of nature.
In Rapid Litigation Management, the illustrative claim held valid by the court as being directed to eligible subject matter is:
- A method of producing a desired preparation of multi-cryopreserved hepatocytes, said hepatocytes being capable of being frozen and thawed at least two times, and in which greater than 70% of the hepatocytes of said preparation are viable after the final thaw, said method comprising:
(a) subjecting hepatocytes that have been frozen and thawed to density gradient fractionation to separate viable hepatocytes from non- viable hepatocytes,
(b) recovering the separated viable hepatocytes, and
(c) cryopreserving the recovered viable hepatocytes to thereby form said desired preparation of hepatocytes without requiring a density gradient step after thawing the hepatocytes for the second time, wherein the hepatocytes are not plated between the first and second cryopreservations, and wherein greater than 70% of the hepatocytes of said preparation are viable after the final thaw.
In Sequenom, the illustrative claim held invalid for representing non-eligible subject matter is:
- A method for detecting a paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample from a pregnant female, which method comprises:
amplifying a paternally inherited nucleic acid from the serum or plasma sample and
detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample.
The subject matter eligibility test employed by USPTO patent examiners (which is known as the “Mayo/Alice framework”) includes as step 1, a determination of whether the claim is to a process, machine, manufacture or composition of matter. If the answer is no, the claim is not eligible subject matter under 35 U.S.C. Section 101. If the answer is yes, the second step (step 2A) is a determination of whether the claim is directed to a law of nature, a natural phenomenon or an abstract idea (judicial exceptions). If no, the claim is not eligible subject matter; if the answer is yes, step 2B is conducted wherein it is determined whether the claim recites additional elements that amount to significantly more than the judicial exception.
The Memorandum points out that in Rapid Litigation Management, 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.” It is further indicated in the Memorandum that “[b]ecause the claims [of Rapid Litigation Management] were focused on a process for achieving this desired outcome, 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.”
With respect to Sequenom, the Memorandum points out that application of the Mayo/Alice framework to the claims led to the ruling that the claims do not recite an inventive concept that transforms the DNA into a patentable invention because the amplifying steps are routine and conventional.
The Memorandum does not provide clear advice on claim drafting for inventions where USPTO examiners are likely to apply the Alice/Mayo framework. While the Memorandum concludes that the USPTO’s current subject matter eligibility and guidance training examples are consistent with these two cases, the two disparate outcomes indicate that it remains difficult to predict how rigidly the Alice/Mayo framework will be applied.
For biotechnology inventions, we posit that it will be helpful to avoid the appearance of monopolizing a natural phenomenon by framing a claim with process steps that contribute to preparation of a “non-conventional” product. With respect to a claim similar to the illustrative claim of Sequenom, one possible strategy is to recite that the amplifying step produces an amplification product and further reciting one or more steps relating to preparation of the amplification product for the detection step with due consideration given to the most commercially relevant detection methodologies.
For more information, please contact Mark Roach at mark.roach@hicksip.com.