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Biotech Patents and Section 101 Rejections: Meeting Patent Eligibility Requirements

Leveraging Recent Decisions and USPTO Guidance to Overcome Rejections

Recording of a 90-minute premium CLE video webinar with Q&A

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Conducted on Thursday, March 25, 2021

Recorded event now available

or call 1-800-926-7926

This CLE course will guide patent counsel through strategies for overcoming Section 101 rejections of biotech patents. The panel will review recent case law and USPTO guidance on Section 101 patent eligibility and offer strategies to address Section 101 rejections.


The number of Section 101 rejections over all types of technologies, including biotechnology, has dramatically increased since the Supreme Court's decision in Mayo Collaborative Servs. v. Prometheus Labs., Inc. (U.S. 2012) and Alice Corp. v. CLS Bank (U.S. 2014).

A review of USPTO guidance documents and art unit-specific responses to Section 101 can help practitioners craft a strategy for overcoming subject matter eligibility rejections. The guidance documents attempt to summarize the specific facts and holdings of exemplary 101 cases and suggest analogous fact patterns presented in prosecution to identify eligible and ineligible claims. Case law has not clearly illuminated the line between eligible and ineligible subject matter. Still, it does provide helpful guidance regarding claim types to avoid because they have been found ineligible by the courts.

The panel will discuss these cases and their counterpoints, suggesting potential strategies for eligible patent protection under Section 101.

Section 101 rejections and appeals continue to mount in numbers as examiners and PTAB judges attempt to reconcile inconsistent case law. Applicants should anticipate Section 101 rejections and devise strategies to prevent or mitigate these rejections. Anticipating and properly planning for eligibility rejections can lead to success in avoiding or overcoming these rejections.

Listen as our authoritative panel of patent attorneys discusses the impact of the Mayo and Alice decisions and the USPTO's guidance on Section 101 rejections. The panel will offer best practices for patent counsel to avoid or overcome Section 101 rejections for biotech patents.



  1. Current guidance
    1. How the courts have applied Mayo and Alice and lessons learned from those decisions
    2. USPTO guidance
  2. Strategies for avoiding or overcoming 101 rejections in biotech patents
    1. Identifying and arguing deficiencies in examiner's characterization
    2. Examiner interviews
    3. Addressing the rationale behind a rejection
    4. Amending claims
    5. Improved drafting


The panel will review these and other relevant issues:

  • The impact of the Mayo, Myriad, Ariosa, and Vanda decisions on recent USPTO and Federal Circuit decisions addressing 101 rejections for biotech patents
  • The reliability of USPTO guidance documents
  • Robust patent specification and claim drafting tips, to help avoid 101 rejections
  • Potential strategies to overcome 101 rejections


Barker, M. Paul
M. Paul Barker

Finnegan Henderson Farabow Garrett & Dunner

Mr. Barker has a diverse practice, including interferences, post-grant proceedings, patent prosecution, arbitration,...  |  Read More

Browning, Paul
Dr. Paul W. Browning, Ph.D.

Finnegan Henderson Farabow Garrett & Dunner

Dr. Browning focuses on patent litigation and appeals. He has led teams as first chair at trial, at Markman...  |  Read More

Murphy, Amanda
Dr. Amanda K. Murphy, Ph.D.

Finnegan Henderson Farabow Garrett & Dunner

Dr. Murphy focuses her practice on client counseling and patent prosecution for a range of clients. She prepares new...  |  Read More

Leiman, Sara
Dr. Sara A. Leiman, Ph.D.

Finnegan Henderson Farabow Garrett & Dunner

Dr. Leiman prosecutes and provides strategic counseling on U.S. and foreign patent portfolios, provides validity and...  |  Read More

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