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 webinar with Q&A

Conducted on Tuesday, February 12, 2019

Recorded event now available

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Program Materials

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


The number of Section 101 rejections over all types of technologies, including biotechnology and software-related patents, has dramatically increased since the Supreme Court's decision in Alice Corp. v. CLS Bank (U.S. 2014).

Review of USPTO guidance documents and art unit specific responses to Section 101 are helpful in crafting a strategy for overcoming rejections. The guidance documents attempt to summarize holdings of specific factual 101 cases and suggest a comparison of these cases to fact patterns as suitable material to support a prima facia case of ineligibility and provide guidance on eligible claims. Case law has not given sufficient information as to the test for finding the line between eligible and ineligible subject matter. It is desirable to avoid claim types that have been found ineligible by the courts. The panel will discuss these cases as well as their counterpoints, suggesting potential strategies for eligible for 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 and disregard for the language of the §101 statutes. Applicants should anticipate Section 101 rejections and devise strategies to prevent or mitigate these rejections. The anticipation of an eligibility rejection and proper planning of a deliberate eligibility strategy can lead to an implementation strategy for overcoming these rejections.

Listen as our authoritative panel of patent attorneys discusses the impact of the Alice Corp. decision and the USPTO's guidance on §101 rejections. The panel will offer best practices for patent counsel on ways to overcome §101 rejections for biotech patents.



  1. Current guidance
    1. How the courts have applied Alice Corp. and lessons learned from those decisions
    2. USPTO guidance
  2. Strategies for 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 to avoid rejections


The panel will review these and other relevant issues:

  • The impact of the Mayo, Myriad, and Ariosa decisions on recent USPTO and Federal Circuit decisions addressing §101 rejections for biotech and other technological patents
  • Problems with the USPTO guidance documents and examiner training
  • Potential strategies to overcome §101 rejection
  • Robust patent specification and claim drafting tips


Murphy, Amanda
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

O’Connor, Steven
Steven P. O'Connor, Ph.D.

Finnegan Henderson Farabow Garrett & Dunner

Dr. O’Connor leads the firm’s biotechnology and pharmaceutical practice group. He provides IP counseling...  |  Read More

Sukduang, Sanya
Sanya Sukduang

Finnegan Henderson Farabow Garrett & Dunner

Mr. Sukduang concentrates on patent litigation before the federal district courts and the U.S. Court of Appeals for the...  |  Read More

Leiman, Sara
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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