Five Things You Should Know About the USPTO Patent Subject Matter Eligibility Guidelines

14 March 2014 PharmaPatents Blog

The new USPTO patent subject matter eligibility guidelines set forth a detailed analytical framework for evaluating whether claims satisfy the patent subject matter eligibility requirement of 35 USC § 101. If you are an examiner, patent agent, patent attorney, or applicant overseeing patent portfolios in chemical, biotechnology, or life sciences technologies, you should read and study the Guidelines. (You can start with this summary.) But even if the Guidelines are not likely to impact your daily practice, there are five things you should know about them. 

5. The Guidelines do not apply to claims that raise “abstract idea” issues.

If your patents typically face subject matter eligibility issues for allegedly reciting abstract ideas, the Guidelines won’t help or hurt you. Instead, the Guidelines provide that ”claims reciting an abstract idea … should continue to be analyzed for subject matter eligibility using the existing guidance in MPEP § 2106(II).”

4. The Guidelines apply to all types of claims.

Other than the “abstract idea” exception, the Guidelines apply to all types of claims that “recite or involve laws of nature/natural principles, natural phenomena, and/or natural products.” This means that even article of manufacture and composition claims are subject to analysis under the Guidelines. (If you missed it, please see this article about the treatment of pharmaceutical compositions under the Guidelines.)

3. The Guidelines do not shed much new light on Prometheus-type claims.

Although the Guidelines apply to all types of claims, they do not include any new examples on diagnostic or personalized medicine type claims, although they repeat some examples from the initial Prometheus guidelines.

2. The Guidelines define “natural product” broadly.

The Guidelines define “natural product” as including “chemicals derived from natural sources” and “other substances found in or derived from nature.” The Guidelines read the Myriad and Funk Brothers Supreme  Court decisions together, and provide that a product must be both “non-naturally occurring” and “markedly different in structure from naturally occurring products” in order to be patent eligible.

1. The Guidelines are not the final word on patent subject matter eligibility.

The Guidelines reflect the USPTO’s interpretation of Supreme Court case law addressing patent subject matter eligibility. As such, the Guidelines are subject to challenge in a court proceeding and are subject to modification by future court decisions. If the Guidelines are used to reject your claims, and you disagree with the USPTO’s interpretation and application of governing law, you should consider appealing the rejection to the Federal Circuit.

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