Patent Subject Matter Eligibility: Navigating the New USPTO Guidance

Analyzing Subject Matter and Avoiding Rejection Under the USPTO's Detailed Framework

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

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Conducted on Thursday, April 16, 2015

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Course Materials

This CLE course will examine the new USPTO Interim Guidance and the analysis for determining patent subject matter eligibility. The panel will provide best practices for applying the new guidelines in application drafting and prosecution, and will also provide insight into how the Interim Eligibility Guidance may impact strategies involving owned or in-licensed intellectual property.


On Dec. 16, 2014, the USPTO published its Interim Eligibility Guidance (“Interim Guidance”) intended "for use by USPTO personnel in determining subject matter eligibility under 35 U.S.C. 101." The Interim Guidance is significantly changed from its predecessor guidance, and gives practitioners insight into the eligibility evaluation process.

This guidance comes on the heels of the USPTO's March 2014 subject matter eligibility guidelines, nicknamed the "Myriad/Mayo Guidelines." The March guidelines introduced a new standard for practitioners, one of a "marked difference" or "significant difference" from a natural material, law or phenomenon.

The new Interim Guidance and accompanying examples differ in many important ways from those issued in March. Knowledge of these differences and the current USPTO viewpoint on section 101 is critical in litigation, prosecution, licensing, and evaluation of patent portfolios of inventions involving a natural material, law or phenomenon. Whether the guidance will withstand judicial review remains to be seen, but practitioners need to know how examiners will treat claims falling under these guidelines.

Listen as our authoritative panel of patent attorneys discusses the March and December guidance, flowchart and examples. The panel will offer strategic considerations for avoiding a section 101 rejection.



  1. Overview of new subject matter eligibility guidance
    1. December 2014 interim guidance
    2. March 2014 Myriad/Mayo Guidelines
  2. Flowchart
    1. Information practitioners need to address stages/decision points
    2. Factors to help establish prima facie subject matter eligibility/ineligibility
    3. What if you receive section 101 rejection anyway? (your analysis different from examiner's)
  3. Examples
    1. Biotech and what is missing from these examples
    2. Chemical and what is missing from these examples
    3. Guideline's impact on other industries
  4. Practical implications and best practices in light of the new guidance


The panel will review these and other key questions:

  • How do the Myriad/Mayo Guidelines and the new Interim Guidance change the landscape for patentable subject matter?
  • How can counsel show "significant difference" from a natural material, law or phenomenon?
  • How will examiners apply the new guidance?
  • What are best practices for drafting and prosecuting involved applications?
  • How does the Interim Guidance effect strategy involving owned and licensed IP?


Baur, Amelia
Amelia Feulner Baur, Ph.D

Founding Partner
McNeill Baur

Dr. Baur’s practice covers a broad spectrum of intellectual property issues, including patent preparation and...  |  Read More

McDonell, Leslie
Leslie A. McDonell

Finnegan Henderson Farabow Garrett & Dunner

Ms. McDonell provides strategic counseling on the procurement and protection of IP in the pharmaceutical,...  |  Read More

Donna M. Meuth
Donna M. Meuth
Associate General Counsel

Ms. Meuth has diverse experience in intellectual property law, including patent portfolio management, patent...  |  Read More

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