The Guidance document issued by USPTO on 4 March 2014 provides much needed clarification regarding the procedure to be used for evaluating subject matter eligibility of claims considered to relate to laws of nature, natural phenomena or natural products. Our earlier news article: USPTO issues guidance can be found here.
In producing the Guidance the USPTO aims to address changes in the law relating to subject matter eligibility in view of the recent court decisions in this area including Association for Molecular Pathology v. Myriad Genetics Inc. and Mayo Collaborative Services v. Prometheus Laboratories Inc. All claims which relate to laws of nature/natural principles, natural phenomena and/or natural products are to be examined using the procedure outlined in the Guidance.
The Guidance sets out a three-part test for examiners to use in order to assess whether a claim relates to patent-eligible subject matter. The first question asks whether the claim is directed to one of the four statutory patent-eligible subject matter categories, i.e., a process, machine, manufacture, or composition of matter. If the answer is yes, the examiner is to proceed to question 2 to assess whether the claim recites or involves one or more judicial exceptions, which include abstract ideas, laws of nature/natural principles, natural phenomena, and natural products. Natural products include chemicals derived from natural sources (e.g. antibiotics, oils, toxins etc.), foods, nucleic acids, organisms, proteins and peptides. If there is any doubt as to whether the claim recites a judicial exception, the examiner is required to move on to the critical third question of whether the claim as a whole recites something significantly different than the judicial exception. If the answer is no then the claim will be rejected as not patent eligible. Alternatively, if the claim is determined to be significantly different the claim is deemed patent eligible.
The Guidance provides nearly fifteen pages, including seven practical examples, detailing how to analyse the third question. The Examiner is to analyse multiple factors and make a conclusion balancing the totality of the relevant factors. A list of six factors that weigh toward eligibility (i.e., significantly different) and six factors that weigh against eligibility (i.e.,not significantly different) is provided. Not every factor will be relevant to every claim, and the list is not intended to be exhaustive.
Factors that weigh toward eligibility include where a product is markedly different in structure from naturally occurring products, as well as other factors related to the addition of extra elements or steps to a claim. With regard to the meaning of “markedly different” the Guidance specifies that “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”. The fact that a difference came about as a result of routine activity does not prevent it from being a marked difference. For Example, the Guidance states that “cDNA having a nucleotide sequence that is markedly different from naturally occurring DNA is eligible subject matter, even though the process of making cDNA is routine in the biotechnology art”.
Factors that weigh against eligibility include, for example, where the claim recites elements or steps that are at a high level of generality such that substantially all practical applications of the judicial exceptions are covered, and where the claim recites elements or steps in addition to the judicial exceptions that are well-understood, purely conventional or routine in the relevant field.
The practical examples provided in the Guidance confirm that the eligibility question will apply to all natural products and combinations (including proteins). In one example, the eligibility factors are used to conclude that a claim to a pair of DNA primers would not pass the eligibility threshold as they are not markedly different to what exists in nature. On the other hand, an amplification process utilising the pair of primers with a particular polymerase and requiring at least 20 cycles is considered patent eligible. One factor behind this reasoning is that the limitations in the claim are meaningful such that others are not substantially foreclosed from using the natural products in other ways. Thus, on balance, and in spite of the fact that the steps in addition to the judicial exception are well understood, conventional and routine, the factors weigh towards eligible subject matter.
In a further example, a claim to a method for determining whether a patient has a disease X by detecting misfolded protein ABC using antibody XYZ and flow cytometry is considered eligible subject matter. The use of the particular antibody and detection method narrow the scope of the claim so that others are not foreclosed from using other means to detect misfolded protein ABC.
A positive for applicants attempting to pursue method claims at the USPTO is that it appears that conventional steps may be sufficient to overcome the eligibility threshold. However, the emphasis on limitations in claim scope such that others are not prevented from using the natural products in other ways may require a balance to be struck between ensuring subject matter eligibility while avoiding narrowing a claim such that easy work-arounds are left open.
The wording of the Guidance is general enough that there is plenty of scope for individual Examiners to adopt differing stances as to the patent eligibility of particular types of claims. Thus, it will take time before the full impact of the Guidance is apparent. Moreover, the outcomes of pending cases in which Myriad is attempting to enforce claims relating to cDNA, primer pairs, and methods for detecting mutations may require further Guidance to be issued.