Biotech Patents and Section 101 Rejections: Meeting Patent Eligibility Requirements

Leveraging Recent Decisions and USPTO Guidance to Overcome Rejections

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

Conducted on Thursday, June 8, 2017
Recorded event now available

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


The number of §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 (2014). Using Section 101 as a blunt instrument, district courts have invalidated approximately 70% of patents challenged under §101.

Review of USPTO guidance documents and art unit specific responses to 101 are helpful in crafting a strategy for overcoming rejections. The Guidance documents attempt to summarize holdings of specific factual 101 cases, and suggest 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 their counterpoints, suggesting potential strategies for eligible for patent protection under §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 statute. Applicants should anticipate 101 rejections and devise strategies to prevent or mitigate these rejections. 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 rationale behind rejection
    4. Amending claims
    5. Improved drafting to avoid rejections


The panel will review these and other key 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 rejections;
  • Robust patent specification and claim drafting tips.


Denise M. Kettelberger, Ph.D.

Dr. Kettelberger is a patent attorney with deep experience in bioscience industries. She has special expertise in IP procurement and enforcement strategies, portfolio management and review, and IP analysis and opinions. Dr. Kettelberger also participates in litigation as a strategist and has been responsible for reexamination of U.S. patents.

Katherine M. Kowalchyk, Ph.D., Partner
Merchant & Gould, Minneapolis

Dr. Kowalchyk concentrates her practice in IP law, with a particular emphasis in biotechnology. She is experienced in patentability assessment, strategic filing, and coordinated prosecution of worldwide patent applications, including prior art management, PTO examiner interviews, appeals, and oppositions. She also handles licensing transactions, IP due diligence for technology and licensing transactions, M&As, product launches, and public offerings.


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