First appeared in AIPLA Biotech Buzz

Effective March 4, 2014 the USPTO Patent Examining Corps is instructed to follow a new procedure "in determining whether a claim reflects a significant difference from that which exists in nature and thus is eligible [subject matter], or whether it is effectively drawn to something that is naturally occurring" and thus ineligible for patenting.

The new procedure for determining subject matter eligibility under 35 U.S.C. § 101 is set forth in the Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products (Guidance). A quick reference document was also released. This Guidance expressly supersedes the June 13, 2013 memo titled "Supreme Court Decision in Association for Molecular Pathology v. Myriad Genetics, Inc." In practice, however, the Guidance appears to also supersede the 2012 Interim Procedure for Subject Matter Eligibility Analysis of Process Claims Involving Laws of Nature (2012 Interim Procedure for Laws of Nature), issued in view of the decision by the United States Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S_, 132 S.Ct. 1289, 101 USPQ2d 1961 (2012)(Mayo). 

The USPTO states that there is "no change to examination of claims reciting an abstract idea, which should continue to be analyzed for subject matter eligibility using the existing guidance in MPEP § 2106(II)." (Memorandum accompanyingGuidance (emphasis in original) and Guidance at 2.) Instead, the Guidance is intended to apply claims reciting a law of nature/natural principle, natural phenomena, or natural product.

For method claims encompassing "laws of nature and physical phenomena", the Guidance asks whether the claim as a whole recites something "significantly different" than the judicial exceptions. In the 2012 Interim Procedure for Laws of Nature, the USPTO stated that the test was whether a claim to such method includes additional elements/steps that "integrate the natural principle into the process" and "amount to significantly more than the natural principle itself." Thus, substantively, the "significantly different" analysis of the Guidance does not appear to be "significantly different" from the analysis articulated in the 2012 Interim Procedure for Laws of Nature. The Guidance mandates that Examiners go through specified factors and answer "whether the claimed subject matter is markedly different from what exists in nature (and thus not a judicial exception)" by weighing the totality of the relevant factors toward and against eligibility. [Guidance at 4] The Guidance states that this list originates from past eligibility factors, is not intended to be exclusive or exhaustive, and is to be treated much like Examiners treat the Wands factors when evaluating enablement. [Guidance at 4]

Biotechnology companies and the patent community working for those companies may be most interested in the USPTO's extrapolation of the holding Myriad beyond genomic DNA to apply to all natural products. The Guidance states that the Myriad Court's reliance on Chakrabarty "as 'central' to the eligibility inquiry . . . re-affirmed the Office's reliance onChakrabarty's criterion for eligibility of natural products (i.e., whether the claimed product is a non-naturally occurring product of human ingenuity that is markedly different from naturally occurring products." It then indicates that Myriad"clarified that not every change to a product will result in a marked difference and that the mere recitation of particular words (e.g., "isolated") in the claims does not automatically confer eligibility." (Guidance at 1, emphasis in original.) This is a significant departure from the USPTO's Memorandum on Myriad indicating that Examiners should now reject "product claims drawn solely to naturally occurring nucleic acids" regardless of whether they have been isolated and the Supreme Court's ultimate holding: "[w]e merely hold that genes and the information they encode are not patent eligible under § 101 simply because they have been isolated from the surrounding genetic material." (Myriad, 133 S. Ct. 2107, 2119, emphasis added.) The Guidance addresses this departure by stating that "while the holding of Myriad was limited to nucleic acids, Myriad is a reminder that claims reciting or involving natural products should be examined for a marked difference under Chakrabarty." (Guidance at 1.)

The "significantly different" test also applies to something that appears to be a natural product," including nucleic acids and proteins. (Guidance at 3.) In describing factors that weigh toward patent eligibility, the Guidance points to a product that, after analysis, is found to be (i) non-naturally occurring and (ii) markedly different from what exists in nature, rising to eligible subject matter. (Guidance at 3.) Thus, if there is any suggestion that a claimed product could be naturally occurring, a patent applicant will have to establish a "marked differences in structure" and even that, alone, might not suffice. (Guidance at 4.)

The Guidance does not specifically state that non-structural differences cannot be used to establish a marked difference. However, it is clear that under the Guidance, the mere recitation of "isolated" or "recombinant" or "synthetic" will not confer eligibility and suggests that this type of claim language will be considered "draftsman's art." (Guidance at 3).

Pointing to Myriad, the Guidance states that "merely isolating a nucleic acid" is insufficient to confer patent eligibility, "even though an isolated gene is a non-naturally occurring fragment of chromosomal DNA, it is not markedly different from the chromosomal DNA because its nucleotide sequence has not been changed." (Guidance at 5.) This conclusion is based on the holding of Myriad, which indicates that the structural differences between isolated DNA and naturally occurring DNA were not sufficient to confer patent eligibility because the claims were not written in terms of the differences in chemical structure. This raises another important question arises. Would the result be different for DNA claims that are not written in an information-centered manner but instead focused on the structure? Under Myriadperhaps, but under the Guidance, the answer appears to be no.

Myriad overruled years of USPTO and judicial tradition regarding the patent eligibility of isolated DNA. The new USPTOGuidance, now extends this change to a far broader category of subject matter, including subject matter that the USPTO has considered patent eligible for decades.