A Look At The USPTO Patent Eligible Subject Matter Report

by Foley & Lardner LLP

On July 24, 2017, the USPTO issued a 48-page report on Patent Eligible Subject Matter. The report summarizes key court decisions interpreting and applying 35 USC § 101, international views on eligible subject matter, and public comments and recommendations for addressing recent changes in this foundational issue of U.S. patent jurisprudence. While some have criticized the USPTO Patent Eligible Subject Matter report for failing to take a position on the issues or suggest any solutions, others have commended the concise summary of where things stand today.

Overview of the USPTO Patent Eligible Subject Matter Report

As set forth in the “Overview,” the purpose behind the report is “to provide a comprehensive review of patent eligibility law and a record of public views on the impact of the recent Supreme Court patent eligibility jurisprudence and public recommendations for a path forward.” Thus, the report makes clear from the outset that it is not going to propose or promote a specific policy.

The report acknowledges that the Supreme Court decisions in Bilski, Mayo, Myriad, and Alice “shifted the dividing line between eligible and ineligible subject matter.” While that characterization may strike many as an understatement, the report does give specific attention to the impact on “life sciences” and “computer-related” technologies. However, true to its purpose, the report summarizes comments from stakeholders in these fields rather than taking a position on whether the “dividing line” has shifted too far.

Even the “Conclusion” of the report focuses on public views:

Members of the public who expressed their views either at the roundtable or in written submissions generally agreed that the Supreme Court’s recent jurisprudence altered the landscape of patent eligibility law. ….

Members of the public were split in their views on how best to respond to the Supreme Court’s recent jurisprudence. In general, supporters of the decisions, many of whom were from the software industry, recommended that the judiciary be given time to develop the case law further. …. Some commentators recommended administrative actions to address the impact of the Court’s decisions, for example, that the USPTO take steps to increase consistency between examiners and clarity of § 101 rejections in office actions. Several asked for additional guidance, examples, or revisions to the Manual of Patent Examining Procedure (MPEP). A majority, however, recommended legislative change. …. Finally, in addition to addressing the statutory requirements for eligibility, some recommended including a research exception to infringement to address the Court’s preemption concerns.

International Approaches To Subject Matter Eligibility

The section of the report summarizing international approaches to subject matter eligibility is well worth a read by anyone whose practice does not bring the stark differences to light. While the report doesn’t directly compare subject matter that can be patented in Europe, Japan, South Korea and China with that no longer eligible for patenting in the U.S., the summary of the types of diagnostic methods that can be patented in those countries reveals that the U.S. stands alone in its broad restrictions on the patent-eligibility of in vitro diagnostic tests. The contrast with regard to “products of nature” is even more striking:

As in most jurisdictions, naturally occurring products existing in their natural form generally are not patent eligible subject matter in Europe, Japan, Korea, and China. However, all of these jurisdictions allow the patenting of certain naturally occurring products that have been isolated from their natural environment. For example, in Japan and Korea, if naturally occurring substances are artificially isolated from their environment, they can be patent eligible.

That used to be the case in the U.S. as well, until the Supreme Court ruled otherwise in Myriad.

Public Support For Legislative Reform

As noted above, the USPTO Patent Eligible Subject Matter report recognizes a “push” for legislative reform:

While some commentators recommended either allowing the judiciary to develop the case law or taking administrative measures, many other commenters pressed for legislative change. Representatives from law firms, legal associations, industry groups, and life sciences companies agreed that the legislature is the appropriate body to recalibrate the proper scope of patent eligibility.

According to the report, many in the life sciences industry stopped hoping for a judicial correction after the Supreme Court denied certiorari in Sequenom, and since then have focused their efforts on “a legislative solution.”

The report reviews several specific legislative proposals:

  • replace the two-part Mayo/Alice test with a “technological” or “useful arts” requirement
  • eliminate “new” from § 101, to focus on the “useful” requirement
    For example, IPO proposed the following language to replace § 101:
    “Whoever invents or discovers, and claims as an invention, any useful process, machine, manufacture, composition of matter, or any useful improvement thereto, shall be entitled to a patent for a claimed invention thereof, subject only to the exceptions, conditions, and requirements set forth in this Title.”
  • focus on “practical utility” or expressly permit patents on “practical applications” of laws of nature, abstract ideas, and natural phenomena
  • expressly define limited categories of exceptions
    The AIPLA proposal on this point would provide that “[a] claimed invention is ineligible . . . only if the claimed invention as a whole exists in nature independent and prior to any human activity, or can be performed solely in the human mind.”
  • expressly distinguish the eligibility requirement from the other statutory requirements
    The IPO and AIPLA both proposed the following:
    “The eligibility of a claimed invention . . . shall be determined without regard as to the requirements or conditions of sections 102, 103, and 112 of this Title, the manner in which the claimed invention was made or discovered, or the claimed invention’s inventive concept.”

The report also acknowledges comments proposing a statutory “research exemption from patent infringement for experimentation conducted to better understand or improve a claimed invention,” which proponents suggested might “address the Supreme Court’s preemption concerns.”

Where Do We Go From Here?

Having lived through the long process that led to the America Invents Act, I know that legislative reform will not provide immediate relief to the patent eligibility hurdles facing the life science industry. Having followed the various judicial interpretations of the Biologics Price Competition and Innovation Act, I am wary of unintended consequences (and unintended interpretations) of any new statutory language. However, I count myself among those who lost hope for a judicial correction after Sequenom, and this report confirms that the USPTO is not inclined to take a stand on these issues. Thus, the long and winding road through Congress may be the industry’s best chance of redrawing the patent eligibility line to include more important diagnostic and personalized medicine technologies.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Foley & Lardner LLP | Attorney Advertising

Written by:

Foley & Lardner LLP

Foley & Lardner LLP on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
Privacy Policy (Updated: October 8, 2015):

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.


JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at info@jdsupra.com. In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at: info@jdsupra.com.

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.