United States: PTO Releases Updated Examiner Guidelines On Subject Matter Eligibility In Life Sciences Space

The US Patent and Trademark Office (PTO) released its May 2016 Subject Matter Eligibility Update to improve examiner correspondence with regard to subject matter eligibility rejections. The update reflects the PTO's response to public comments on the July 2015 Update on Subject Matter Eligibility ( IP Update, Vol. 18, No. 8). The 2016 update includes six new subject matter eligibility examples, five of which are directed to life sciences subject matter. 

The new examples, which include hypothetical claims that would and would not be found subject matter eligible, should help life sciences patent prosecutors in attempting to draft claims in such a manner as to avoid § 101 rejections. The examples include claims directed to a vaccine; a method of diagnosing and treating a disease; a dietary sweetener; methods for screening for gene alterations, hybridizing gene sequences and amplifying gene sequences; and a process for hydrolyzing fat molecules. The examples offer some controversy as well, however. One example discusses a specific method of detecting a disease in a patient that would be subject matter eligible, while a narrower method of diagnosing the disease in a patient would not be subject matter eligible.  

The PTO also issued a memorandum to the patent examiners providing examination instructions relating to subject matter eligibility under § 101. When formulating § 101 rejections, the examiners are to follow the two-step analysis set forth in the 2014 Interim Guidance on Patent Subject Matter Eligibility. According to the PTO memorandum, under Step 2 of the Interim Guidance, an examiner should

  • Identify the applicant judicial exception (law of nature, natural phenomenon, abstract idea) to the patent eligible categories under § 101 by referring to what is recited in the claim, and explain why it is considered an exception (emphasis in original)
  • Identify, with specificity, any additional elements in the claims beyond the identified judicial exception
  • Explain the reason(s) that the additional elements taken "individually . . . and as a combination," do not result in the claims as a whole amounting to significantly more than the judicial exception (emphasis in original)

When the claims do not expressly recite the applicable judicial exception, the rejection must also explain what subject matter the claim limitations describe and explain why the described subject matter is directed to a judicial exception. 

Examiners are instructed to cite to appropriate court decisions to support a finding that the subject matter recited in the claim language is an abstract idea. If an examiner determines that a claim recites a law of nature or a natural phenomenon, the rejection should identify the specific law of nature or natural phenomenon. If an examiner determines that a claim recites a product of nature, the examiner should explain why the product does not have markedly different characteristics from its naturally occurring product.

If an examiner determines that particular claim elements are well-understood, routine, conventional activities to those in the relevant field, the rejection should explain why the courts have recognized, or those in the relevant field of art would recognize, that those claim limitations are well-understood, routine, conventional activities. While examiners are instructed not to use the PTO examples of subject matter eligibility for a rejection, applicants can use the examples in support of their arguments for patentability.

If an applicant properly challenges the eligibility rejection, the examiner must provide a rebuttal in the next office action if the rejection is maintained. If an applicant challenges an abstract idea identification and the office action did not cite a decision by the Supreme Court of the United States or the US Court of Appeals for the Federal Circuit finding a similar abstract idea, the examiner is instructed to cite such a decision in rebuttal (if the rejection is maintained). If an applicant provides evidence or a specific argument that additional elements are not well-understood, conventional or routine activities, examiners are instructed to reevaluate whether the additional elements are well understood, conventional or routine.

The PTO memorandum concluded with a reminder that an amendment that merely adds a generic computer, generic computer components or a programmed computer to perform generic computer functions would not, for that reason at least, overcome an eligibility rejection.

Practice Note: The May 2016 Subject Matter Eligibility Update, PTO memorandum and subject matter eligibility examples do not constitute substantive rulemaking and do not have the force of law. Therefore, drafting claims in accordance with the subject matter eligibility examples is not a guarantee that a federal court will hold that an allowed claim is subject matter eligible under § 101.

PTO Releases Updated Examiner Guidelines on Subject Matter Eligibility in Life Sciences Space

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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