Managing IP is part of the Delinian Group, Delinian Limited, 8 Bouverie Street, London, EC4Y 8AX, Registered in England & Wales, Company number 00954730
Copyright © Delinian Limited and its affiliated companies 2023

Accessibility | Terms of Use | Privacy Policy | Modern Slavery Statement

USPTO updates patent subject matter eligibility guidance


The USPTO has added life science examples, a memorandum to the patent examining corps, an index of eligibility examples, and an appendix of court decisions to its guidance on patent subject matter eligibility


The USPTO has updated its interim guidance on patent subject matter eligibility, adding a memorandum, giving new examples for life sciences, adding a new set of life science examples, a memorandum to the patent examining corps, an index of eligibility examples, and an appendix of subject matter eligibility court decisions..

The examples provide exemplary subject matter eligibility analysis under Section 101 of hypothetical claims and claims drawn from case law. The examples are intended as a teaching tool to assist examiners and the public in understanding how the USPTO would apply the eligibility guidance in certain fact-specific situations.

Robert Bahr, deputy commissioner for patent examination policy at the USPTO, noted in a blog post that the examiner memorandum seeks to improve the quality and consistency of subject matter eligibility determinations and rejections by explaining that a reasoned rationale must be provided in the Office action, and provides guidance on how to effectively communicate that rationale to the applicant. 

“The memorandum also reinforces that examiners must carefully consider all of an applicant’s arguments and evidence rebutting the subject matter eligibility rejection, and either withdraw the rejection when the response is persuasive, or provide a rebuttal when the rejection is maintained,” Bahr said. “The guidance in the memorandum and subsequent training should lead to greater consistency throughout the patent examining corps in evaluating whether the claimed subject matter is eligible for patenting, more thorough office actions that will assist applicants in determining how to respond to subject matter eligibility rejections, and greater assurance that applicant responses are thoughtfully considered by the examiner in determining whether to maintain a subject matter eligibility rejection.”

The USPTO will provide training to examiners on the new guidance in interactive workshops. 

UPDATE: Foley & Lardner partner Courtenay Brinckerhoff on the PharmaPatents blog expressed surprise that most of the claims in the examples document relating to diagnostic methods and “nature-based” products are said to satisfy Section 101.

“The USPTO also published a Memorandum to the Examining Corps that provides guidance on how examiners should formulate subject matter eligibility rejections and evaluate applicant responses,” said Brinckerhoff. “Both documents have me wondering if the USPTO may be attempting to swing the patent eligibility pendulum back towards the centre, but until the Federal Circuit – or the Supreme Court – provides more coherent guidance, § 101 will continue to impact the scope of diagnostic and 'nature-based' product patents."

more from across site and ros bottom lb

More from across our site

IP counsel urge the government to restrict safe harbour exceptions available to intermediaries and clear up doubts with the existing law
A New York lawyer could face sanctions after citing fake judgments generated by ChatGPT, but that doesn’t mean practitioners should shy away from AI
Klaus Grabinski told delegates at a UPC inauguration event that the proposed SEP regulation would limit access to justice
We provide a rundown of Managing IP’s news and analysis coverage from the week, and review what’s been happening elsewhere in IP
Sukanya Sarkar shares her thoughts on this year’s annual meeting in Singapore, where debates ranged from AI opportunities to improving law firm culture
The court’s ruling is a good reminder that US parties aren’t guaranteed attorney fees just because they win, say sources
With business confidence in a shaky state, Rachel Tan and Lisa Yong of Rouse discuss how in-house IP teams can manage their trademark portfolios through uncertain times
The Court of Appeal had stern words for Med-El’s representatives after they highlighted a deputy judge’s background as a solicitor
Funders and NPEs say asserting patent portfolios can minimise risk at the USPTO’s PTAB, where procedure remains a controversial topic
The US Supreme Court’s ruling wasn’t a surprise and reflects a trend that had already been bubbling away for a while, say tech and pharma counsel