United States: USPTO Issues Interim Guidance On Patent Eligibility Under §101: Framework For Considering Whether Patents Are Eligible For US Patent Protection Significantly Improved

The United States Patent and Trademark Office (USPTO) has issued revised guidance to its examiners relating to determination of patent eligibility under 35 U.S.C. §101. This "Interim Guidance" provides more specific advice for use in evaluating claims directed to any technical field, but is of particular relevance to patent applications relating to software, business methods, and "nature-based" technologies. The previously issued guidelines relating to these subjects had resulted in a great deal of uncertainty about the appropriate standard for examination of pending patent applications. While no bright line rule yet exists, the newly issued Interim Guidance does provide a significantly improved framework for consideration of issues related to patent eligibility.

Patent eligibility, specifically, what types of subject matter should be eligible for patent protection in the United States, has been the focus of heightened attention of late. The requirements for receiving patent protection in the United States are set forth in 35 U.S.C. §§101, 102, 103, and 112, which respectively address patent eligibility, novelty, inventiveness (e.g., non-obviousness), and disclosure and other formal requirements (e.g., enablement, written description, and clarity/definiteness). The patent eligibility requirements of 35 U.S.C. §101 had been viewed for many years as a relatively low hurdle for a patent application to overcome. However, a number of more recent Supreme Court decisions, beginning with Bilski (Bilski v. Kappos, 561 U.S. 593 (2010)) and followed by Myriad (Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013)), Mayo (Mayo v. Prometheus, 132 S. Ct. 1289 (2012)) and Alice (Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 134 S. Ct. 2347 (2014)), have defined the proper analysis under §101 as a threshold issue that requires substantive analysis. The shifting approaches to determining subject matter eligibility stem at least in part from concerns about patent claims that seek to broadly cover certain fundamental concepts (e.g., laws of nature, natural phenomena, or abstract ideas) in a manner that potentially preempts the application of such concepts in any field.

In 2014, the USPTO has issued to its examination corps three sets of examination instructions relating to patent eligibility under §101. First, on March 4, 2014, the USPTO issued a "Procedure For Subject Matter Eligibility Analysis Of Claims Reciting Or Involving Laws Of Nature/Natural Principles, Natural Phenomena, And/Or Natural Products" (the "Myriad-Mayo Guidance"). Following Alice, the USPTO issued "Preliminary Examination Instructions in view of the Supreme Court decision in Alice Corp." (the "Alice Guidance") on June 25, 2014. Earlier this week, on December 16, 2014, the USPTO issued new Guidance on Patent Subject Matter Eligibility (the "Interim Guidance") that supplements the Alice Guidance and supersedes the Myriad-Mayo Guidance.

The Interim Guidance is intended to provide "consistency across all technologies" and will be used by USPTO Examiners in determining whether claims are directed to patent eligible subject matter. This inquiry is relevant to inventions in all fields, but has had the greatest impact on patent applications relating to computer-implemented inventions (e.g., software, business methods, etc.) and "nature-based" inventions. The expected impacts of these changes are discussed below.

The Interim Guidance provides a basic flowchart for guiding the inquiry regarding patent eligibility. The examiner must first determine whether a claim is directed to one of the statutory categories of patent-eligible subject matter (e.g., process, machine, manufacture, or composition of matter). If a claim passes this initial test, the two-part test first set forth in Mayo and held by the Supreme Court in Alice to be applicable to claims directed to any type of subject matter is then applied.

As outlined in the Alice Guidance and reiterated in the Interim Guidance, the two-part test instructs examiners to first determine whether the claim, as a whole, is directed to at least one of several judicial exceptions, which include laws of nature, natural phenomena, and abstract ideas. Non-limiting examples of abstract ideas include fundamental economic practices, certain methods of organizing human activities, an "idea of itself," and mathematical relationships or formulas. If the examiner determines that the claim is directed to one of the judicial exceptions, the second part of the two-part test requires determining whether any element, or combination of elements, in the claim is sufficient to ensure that the claim, as a whole, amounts to significantly more than the judicial exception.

Claims Directed to Abstract Ideas

While the basic framework for this analysis as it relates to software, business methods, and other similar technologies remains unchanged in the Interim Guidance relative to the Alice guidance, the Interim Guidance goes significantly further than the Alice guidance did in providing concrete criteria and illustrative examples to assist examiners in reviewing and assessing subject matter eligibility. These improvements are a result of both public comments and the holdings of a number of recent cases decided by the U.S. Court of Appeals for the Federal Circuit.

The Alice Guidance presented a significant challenge for examiners due to the lack of substantive examples of what constitutes or does not constitute the "significantly more" than an abstract idea that is required by the second inquiry of the two-part test to render a claim directed to an abstract idea patent eligible. For example, the Alice Guidance noted only that limitations that may be enough to qualify as "significantly more" when recited in a claim with an abstract idea include, as non-limiting or non- exclusive examples, improvements to another technology or technical field, improvements to the functioning of the computer itself, and meaningful limitations beyond generally linking the use of an abstract idea to a particular technological environment, and further noted that limitations that are not enough to qualify as "significantly more" when recited in a claim with an abstract idea include, as non-limiting or non-exclusive examples, adding the words "apply it" (or an equivalent) with an abstract idea, or mere instructions to implement an abstract idea on a computer, and requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry.

Unfortunately, these criteria lacked specificity, and the somewhat murky divide between what may be enough to qualify as the required "significantly more" and what is not enough was quite substantial. In practice, examiners in many art units at the USPTO appeared to default to a finding of patent ineligibility on nearly all claims and to thereby shift the burden of establishing patent eligibility back to patent applicants. Many practitioners reported being unofficially advised by examiners during interviews that it would be wise to delay as much as possible in filing responses to rejections under 35 U.S.C. §101 based on the Alice Guidance in hopes that revised guidelines would be more helpful.

Now that the Interim Guidance has been released, this advice seems prescient. In place of the relatively non-specific criteria in the Alice Guidance, the Interim Guidance provides further examples of claim features that may be enough to qualify as "significantly more" in the second part of the two-part test for claims found to be directed to a judicial exception. For example, features relating to "applying the judicial exception with, or by use of a particular machine; effecting a transformation or reduction of a particular article to a different state or thing; adding a specific limitation other than what is well-understood, routine and conventional in the field, or adding unconventional steps that confine the claim to a particular useful application; or other meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment" are listed as potentially being sufficient to establish patent eligibility. The Interim Guidance also provides additional examples of claim limitations that are not likely to be enough to qualify as "significantly more," which include (in addition to those noted in the Alice Guidance) simply appending well-understood, routine and conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry; adding insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with a law of nature or abstract idea; and generally linking the use of the judicial exception to a particular technological environment or field of use.

The Interim Guidance also advises that, if a claim includes a plurality of judicial exceptions, each of them should be overweighed by at least one additional limitation that elevates the judicial exception to "significantly more." It also summarizes a streamlined eligibility analysis of claims whose eligibility is self-evident – i.e., when a claim, viewed as a whole, "clearly does not seek to tie up any judicial exception such that others cannot practice it." Such claims need not be formally subjected to the second part of the two-part test, thereby allowing examiners to devote more attention to claims that are not as clearly patent eligible.

Claims Directed to Nature-Based Products

After the Myriad-Mayo Guidance received overwhelming public criticism and the USPTO itself admitted that that it raised several controversial issues while being unnecessarily broad, the Interim Guidance was long-anticipated by practitioners in the biological and pharmaceutical arts. The complicated framework of the Myriad-Mayo Guidance is now replaced by a more straightforward analysis.

According to the Interim Guidance, patent eligibility of a claim including a nature-based product is determined under the same two-part test discussed above. First, an examiner determines whether the claim is directed to "a product of nature" exception (e.g., a law of nature or a naturally occurring phenomenon). This analysis requires comparing the nature-based product in the claim to its naturally occurring counterpart (or a closest naturally occurring counterpart) in its natural state to identify "markedly different" characteristics based on structure, function, and/or properties. Even a small change can render the claimed nature-based product "markedly different." The Interim Guidance notes that "[c]are should be taken not to overly extend the markedly different characteristics analysis to products that when viewed as a whole are not nature-based" and directs examiners to utilize the streamlined analysis approach discussed above "[f]or claims that recite a nature-based product limitation (which may or may not be a 'product of nature' exception) but are directed to inventions that clearly do not seek to tie up any judicial exception. In such cases, it would not be necessary to conduct a markedly different characteristics analysis."

Just as the Interim Guidance improves on the Alice Guidance regarding patent eligibility of claims directed to abstract ideas, the Interim Guidance also addresses some difficulties identified in public comments regarding the "markedly different" analysis, which was originally introduced in the Mayo-Myriad Guidance. Specifically, the Interim Guidance liberalizes the requirements laid out in the Mayo-Myriad Guidance by specifying that "functional characteristics and other non-structural properties can evidence markedly different characteristics." In the now superseded Mayo-Myriad Guidance, "only structural changes were sufficient to show a marked difference." Moreover, the Interim Guidance excludes a process claim from the markedly different analysis for nature-based products used in the process, "except in the limited situation where a process claim is drafted in such a way that there is no difference in substance from a product claim (e.g., 'a method of providing an apple.')."

As an example of how this new analysis should be applied, a product that is purified or isolated may be patent eligible when there is a resultant change in characteristics sufficient to show a marked difference from the product's naturally occurring counterpart. When the nature-based product in the claim has markedly different characteristics and is thus not a "product of nature" judicial exception, the claim can be found patent eligible. Moreover, the Interim Guidance states that "[w]hen the nature-based product is produced by combining multiple components, the markedly different characteristics analysis should be applied to the resultant nature-based combination rather than its component parts." Thus, a combination of nature-based products may be patent-eligible if it has markedly different characteristics than any naturally occurring counterparts of the combination or the individual components.

Only if no "markedly different" characteristics are found, the analysis proceeds to the second step of determining if the claim recites additional elements that amount to "significantly more" than the judicial exception. The "significantly more" finding is based on what has been termed as an "inventive concept" based on the Supreme Court's Alice decision, and is performed in the same manner as described above for other judicial exceptions. In rejecting a claim during examination, the Examiner is asked to "identify the exception by referring to where it is recited . . . in the claim and explain why it is considered an exception. Then, if the claim includes additional elements, identify the elements in the rejection and explain why they do not add significantly more to the exception." Thus, the Interim Guidelines provide that "[i]f there are no meaningful limitations in the claim that transform the exception into a patent-eligible application, such that the claim does not amount to significantly more than the exception itself, the claim is not patent-eligible."


While the additional examples in the Interim Guidance of limitations that might or might not be enough to qualify as "significantly more" stop well short of providing a bright line test for what is and is not patent eligible, such a bright line rule appears unlikely to be forthcoming from the courts in the near future. Patent practitioners and applicants can take some comfort, however, in the broader base of potential arguments available for rebutting a rejection based on alleged lack of patent eligibility.

With regard to software claims, the statements in the Interim Guidance relating to limitations "adding a specific limitation other than what is well-understood, routine and conventional in the field" or "adding unconventional steps that confine the claim to a particular useful application" being potentially enough to add "significantly more" to an abstract idea or other judicial exception should be quite helpful in many cases.

With regard to the "product of nature" exception, claims including biological or pharmacological functions or activities, for example, would be patent eligible unless the claim is also directed to another judicial exception, such as an abstract idea or a natural phenomenon (e.g., use of a correlation in a diagnostic claim), or a different natural phenomenon. In the latter instance, the eligibility will then turn on whether the claim includes limitations "adding a specific limitation other than what is well-understood, routine and conventional in the field" or "adding unconventional steps that confine the claim to a particular useful application" being potentially enough to add "significantly more" to an abstract idea.

Certainly, the onus remains on practitioners and applicants to present claims that highlight such features and/or that truly add meaningful limitations recited in a manner that does not give the appearance of precluding any way of practicing a concept that is amenable to characterization as one of the judicial exceptions. However, the Interim Guidance provides what appears to be a more workable framework that, if applied properly, can be expected to bring some much-needed balance to analyses of patent eligibility under 35 U.S.C. §101.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Michael D. Van Loy, PhD
Inna Dahlin
In association with
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement

Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of www.mondaq.com

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


From time to time Mondaq may send you emails promoting Mondaq services including new services. You may opt out of receiving such emails by clicking below.

*** If you do not wish to receive any future announcements of services offered by Mondaq you may opt out by clicking here .


This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at enquiries@mondaq.com.

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.