Contributed by: Jack Snyder, MD, PhD, RAC, DABT, CPI
Asst. Managing Director
CATO Research Washington
United States Patent & Trademark Office Issues New Guidelines on Patent Eligibility for Subject Matter Derived from Nature
An important new guidance memorandum from the United States Patent and Trademark Office (USPTO) entitled Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products (Guidance) implements a new procedure to address changes in the law relating to patent subject matter eligibility under 35 U.S.C. § 101. This guidance addresses the impact of Association for Molecular Pathology v. Myriad Genetics, Inc., 569 __, 133 S. Ct. 2107, 2116, 106 USPQ2d 1972 (2013) (Myriad) on the Supreme Court’s long-standing “rule against patents on naturally occurring things”, as expressed in its earlier precedent including Diamond v. Chakrabarty, 447 U.S. 303 (1980) (Chakrabarty), and Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. __, 132 S. Ct. 1289, 101 USPQ2d 1961 (2012) (Mayo). See Myriad, 133 S. Ct. at 2116. Myriad relied on Chakrabarty as “central” to the eligibility inquiry, and re-affirmed the USPTO’s reliance on Chakrabarty’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). Id. at 2116-17. Myriad also 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. Id. at 2119. See also Mayo, 132 S. Ct. at 1294 (eligibility does not “depend simply on the draftsman’s art”). Thus, while the holding in 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.
In summary, all claims (i.e., machine, composition, manufacture and process claims) reciting or involving laws of nature/natural principles, natural phenomena, and/or natural products now should be examined using the Guidance. The new procedure set forth in the Guidance will assist patent examiners in determining whether a claim reflects a significant difference from what exists in nature and thus is eligible, or whether a claim is effectively drawn to something that is naturally occurring, like the claims found ineligible by the Supreme Court in Myriad.
According to the USPTO, the following factors should be used to analyze the claim to assist in answering Question 3 (in flowchart below) for claims reciting or involving judicial exceptions other than abstract ideas. On balance, if the totality of the relevant factors weigh toward eligibility, the claim qualifies as eligible subject matter. If the totality of the relevant factors weighs against eligibility, the claim should be rejected. The examiner’s analysis should carefully consider every relevant factor and related evidence before making a conclusion. The determination of eligibility is not a single, simple determination, but is a conclusion reached by weighing the relevant factors, keeping in mind that the weight accorded each factor will vary based upon the facts of the application. This factor-based analysis, which requires consideration and subsequent weighing of multiple factors, is similar to the Wands factor-based analysis used to evaluate whether undue experimentation is required to make and use a particular claimed invention. See, e.g., MPEP 2164.01(a) for an explanation of the Wands analysis. Not every factor will be relevant to every claim and, as such, need not be considered in every analysis.
According to the USPTO, factors that weigh toward eligibility (significantly different):
a) Claim is a product claim reciting something that initially appears to be a natural product, but after analysis is determined to be non-naturally occurring and markedly different in structure from naturally occurring products.
b) Claim recites elements/steps in addition to the judicial exception(s) that impose meaningful limits on claim scope, i.e., the elements/steps narrow the scope of the claim so that others are not substantially foreclosed from using the judicial exception(s).
c) Claim recites elements/steps in addition to the judicial exception(s) that relate to the judicial exception in a significant way, i.e., the elements/steps are more than nominally, insignificantly, or tangentially related to the judicial exception(s).
d) Claim recites elements/steps in addition to the judicial exception(s) that do more than describe the judicial exception(s) with general instructions to apply or use the judicial exception(s).
e) Claim recites elements/steps in addition to the judicial exception(s) that include a particular machine or transformation of a particular article, where the particular machine/transformation implements one or more judicial exception(s) or integrates the judicial exception(s) into a particular practical application. (See MPEP 2106(II)(B)(1) for an explanation of the machine or transformation factors).
f) Claim recites one or more elements/steps in addition to the judicial exception(s) that add a feature that is more than well-understood, purely conventional or routine in the relevant field.
According to the USPTO, factors that weigh against eligibility (not significantly different):
g) Claim is a product claim reciting something that appears to be a natural product that is not markedly different in structure from naturally occurring products.
h) Claim recites elements/steps in addition to the judicial exception(s) at a high level of generality such that substantially all practical applications of the judicial exception(s) are covered.
i) Claim recites elements/steps in addition to the judicial exception(s) that must be used/taken by others to apply the judicial exception(s).
j) Claim recites elements/steps in addition to the judicial exception(s) that are well-understood, purely conventional or routine in the relevant field.
k) Claim recites elements/steps in addition to the judicial exception(s) that are insignificant extra-solution activity, e.g., are merely appended to the judicial exception(s).
l) Claim recites elements/steps in addition to the judicial exception(s) that amount to nothing more than a mere field of use.
According to the USPTO, factors a) and g) concern the question of whether something that initially appears to be a natural product is in fact non-naturally occurring and markedly different from what exists in nature, i.e., from naturally occurring products. This question can be resolved by first identifying the differences between the recited product and naturally occurring products, and then evaluating whether the identified differences together rise to the level of a marked difference in structure. Not all differences rise to the level of marked differences, e.g., merely isolating a nucleic acid changes its structure (by breaking bonds) but that change does not create a marked difference in structure between the isolated nucleic acid and its naturally occurring counterpart. Instead, a marked difference must be a significant difference, i.e., more than an incidental or trivial difference.
As explained above (and in detail in the USPTO Guidance), the overall process for determining subject matter eligibility of all claims (i.e., machine, composition, manufacture and process claims) reciting or involving laws of nature/natural principles, natural phenomena, and/or natural products is to walk through the three questions in the flowchart below to determine whether the claim is drawn to patent-eligible subject matter. If not, then the claim is prima facie ineligible, and the claim should be rejected using revised form paragraph 7.05.13 (in Part IV of the Guidance). Importantly, the Guidance does not change 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).
Regulatory and legal practitioners now have a new tool for advising clients as to patent eligibility of claims relating to natural products, laws of nature, and natural phenomena. Courts may or may not agree with USPTO’s guidance, and USPTO may have to issue follow-up guidance that accords with new case law. Importantly, Myriad has asserted further claims relating to cDNA, primer pairs, and methods for detecting the BRCA1/2 mutation, while Counsyl and Quest Diagnostics have asked for declaratory judgments of invalidity and non-infringement of many of the same patents asserted by Myriad. For now, the biomedical world should watch USPTO’s handling of claims relating to natural products and laws of nature with great interest and vigilance.