United States: The USPTO Announces New Guidelines For Determining Subject Matter Eligibility Under 35 U.S.C. §101 In View Of "Myriad", "Prometheus" And "Chakrabarty"

Last Updated: March 14 2014
Article by John Iwanicki

March 10, 2014 – On March 4, 2014, the United States Patent & Trademark Office issued guidelines for the examination of "all claims (i.e., machine, composition, manufacture and process claims) reciting or involving laws of nature/natural principles, natural phenomena, and/or natural products" in view of the U.S. Supreme Court decisions in Myriad, Prometheus and Chakrabarty. The goal of the Examiners is to determine "whether a claim reflects a significant difference from what exists in nature and thus is eligible, or whether a claim is effectively drawn to something that is naturally occurring."

The guidelines emphasize "the Office's reliance on Chakrabarty's criterion for eligibility of natural products (i.e., whether the claimed product is a non-naturally occurring product of human ingenuity that is markedly different from naturally occurring products)" and that "claims reciting or involving natural products should be examined for a marked difference under Chakrabarty.

THE TEST

The Examiners are instructed to follow the flowchart below to determine whether a claim should be rejected as ineligible subject matter under 35 U.S.C. §101.

The flowchart requires the Examiner to assess whether the claim includes a law of nature/natural principle, natural phenomena or natural product, i.e. a judicial exception. Examples include:

the law of gravity, F=ma, sunlight, barometric pressure, etc.;

a citrus fruit, uranium metal, nucleic acid, protein etc.;

chemicals derived from natural sources (e.g., antibiotics, fats oils, petroleum derivatives, resins, toxins, etc.); foods (e.g., fruits, grains, meats and vegetables); metals and metallic compounds that exist in nature; minerals, natural minerals (e.g., rocks, sands, soils); nucleic acids; organisms (e.g., bacteria, plants and multicellular animals); proteins and peptides; and other substances found or derived from nature.

If the claim includes a law of nature/natural principle, natural phenomena or natural product, then the Examiner is required to determine whether the claim as a whole recites something significantly different than the law of nature/natural principle, natural phenomena or natural product. According to the guidelines, a significant difference can be shown in multiple ways. For example:

(1) the claim includes elements or steps in addition to the judicial exception that practically apply the judicial exception in a significant way, e.g., by adding significantly more to the judicial exception; and/or (2) the claim includes features or steps that demonstrate that the claimed subject matter is markedly different from what exists in nature (and thus not a judicial exception).

GUIDING FACTORS

Factors that weight toward eligibility (significantly different):

  1. Claim is a product claim reciting something that initially appears to be a natural product, but after analysis is determined to be non-naturally occurring and markedly different in structure from naturally occurring products.
  2. Claim recites elements/steps in addition to the judicial exception(s) that impose meaningful limits on claim scope, i.e., the elements/steps narrow the scope of the claim so that others are not substantially foreclosed from using the judicial exception(s).
  3. Claim recites elements/steps in addition to the judicial exception(s) that relate to the judicial, exception in a significant way, i.e., the elements/steps are more than nominally, insignificantly or tangentially related to the judicial exception(s).
  4. Claim recites elements/steps in addition to the judicial exception(s) that do more than describe the judicial exception(s) with general instructions to apply or use the judicial exception(s).
  5. Claim recites elements/steps in addition to the judicial exception(s) that include a particular machine or transformation of a particular article, where the particular machine/transformation implements one or more judicial exception(s) or integrates the judicial exception(s) into a particular practical application. (See MPEP 2106(II)(B)(1) for an explanation of the machine or transformation factors.)
  6. Claim recites one or more elements/steps in addition to the judicial exception(s) that add a feature that is more than well-understood, purely conventional or routine in the relevant field.

Factors that weigh against eligibility (not significantly different):

  1. Claim is a product claim reciting something that appears to be a natural product that is not markedly different in structure from naturally occurring products.
  2. Claim recites elements/steps in addition to the judicial exception(s) at a high level of generality such that substantially all practical applications of the judicial exception(s) are covered.
  3. Claim recites elements/steps in addition to the judicial exception(s) that must be used/taken by others to apply the judicial exception(s).
  4. Claim recites elements/steps in addition to the judicial exception(s) that are well-understood, purely conventional or routine in the relevant field.
  5. Claim recites elements/steps in addition to the judicial exception(s) that are insignificant extrasolution activity, e.g., are merely appended to the judicial exception(s).
  6. Claim recites elements/steps in addition to the judicial exception(s) that amount to nothing more than a mere field of use.

EXAMPLES

For product or composition claims, the Examiners are provided with examples for determining eligibility of subject matter under 35 U.S.C. §101 that focus on whether the claimed subject matter is markedly different in structure from a natural product. The guidelines note that the structural changes to nucleic acids resulting from their isolation are not markedly different from naturally occurring nucleic acids. "[A] marked difference must be a significant difference, i.e., more than an incidental or trivial difference."

cDNA, hybrid plants and genetically modified bacteria are given as examples of being markedly different in structure from naturally occurring DNA or naturally occurring plants even though the methods of making such cDNA or hybrid plants may be considered routine manipulation of natural processes.

An isolated compound from a natural source is not markedly different from the natural product. However, a synthetic derivative of the compound that has a different property from the natural product may be markedly different from the natural compound. Also, a use of the product in its isolated form according to a dosage amount and regimen to treat a particular disease that otherwise could not be treated by the compound in its natural form may be markedly different subject matter.

Articles of manufacture including naturally occurring substances are considered statutory subject matter where the article includes "something significantly different from the natural products themselves." The example given is a firework including a cardboard body, sparking composition, and ignition fuse in addition to the naturally occurring calcium chloride and gunpowder formulations. This amounts to a specific practical application of the natural products.

Compositions of multiple natural products may not be statutory subject matter where the combination does not result in properties markedly different from what exists in nature. For example, where different species of naturally occurring bacteria are combined and each species is unaffected in its properties by the other species, then the composition may not be markedly different from the individual naturally occurring bacteria.

A claim to primers of specific sequences is not statutory subject matter where the sequences are naturally occurring sequences found on a human chromosome. However, a claim to the use of the primers to amplify target DNA using a template, a polymerase, nucleotides and reaction conditions may be statutory subject matter because the claim amounts to a practical application of the natural product primers.

A method claim to diagnosing whether an individual has a degenerative disease may not be statutory subject matter where a natural principle, i.e., a mere correlation between a degenerative disease and the presence of a metabolite, is all that is required by the claims However, when the claimed method uses an antibody that does not exist in nature and is not purely conventional or routine in the art, i.e., it was created by the inventors, then the method may be statutory subject matter because the claim recites something significantly different from the natural principle and amounts to a practical application of the natural principle.

A method claim to treating an individual by subjecting the individual to natural principle or natural phenomena without more may not be statutory subject matter. The guidelines present an example where an individual is treated with sunlight to alter neuronal activity, which leads to mitigation of a mood disorder. It is known that white light changes neuronal activity and affects a person's mood and that sunlight is a natural source of white light. Therefore, the use of sunlight is purely conventional and routine in the art of treating mood disorders. Even if the source of white light is synthetic and not natural, the use of a synthetic source is not significantly different from the natural principle itself and does not amount to a practical application of the natural principle. However, where conditions such as filtering ultraviolet rays from a white light source, positioning a patient a distance from the white light source and other treatment conditions are recited in a claim, the claim may recite something significantly different from the natural principle such that the claim is a practical application of the natural principle.

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.

Authors
 
In association with
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
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
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
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.

Disclaimer

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.

Registration

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.

Cookies

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.

Links

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.

Mail-A-Friend

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.

Emails

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 .

Security

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.