United States: New USPTO Guidance On Patent Eligibility Of Natural Products

The new USPTO patent eligibility examples include two examples for "natural products" based inventions which appear to be consistent with the examples provided in the December 2014 set of patent eligibility examples. Although the new examples include additional discussion and guidance that could be helpful in some cases, they largely remain perplexing. Unfortunately, although the new diagnostic methods examples appear to take a stand against unreasonable court decisions, the new natural products examples continue to rely on Funk Brothers for a guiding principle.

Natural Products Examples

The new examples add Examples 28-33 to the USPTO's body of patent eligibility examples, of which Examples 28 and 30 relate to natural products.

Example 28 relates to vaccines. Out of the seven sample claims, six are said to be "eligible" and one is said to be "ineligible." Themes that emerge from this example include:

  • structurally-altered variants of natural products satisfy § 101; no "significantly more" analysis is required {Claim 1, Claim 2}
  • compositions comprising a natural product (or a fragment of a natural product, such as a peptide antigen) and other components that are structurally-altered as compared to their naturally-occurring counterparts (e.g., a cream, emulsion, gel, liposome, nanoparticle, or ointment carrier) satisfy § 101; no "significantly more" analysis is required, but it could be important that the other components impact properties of the composition as a whole in a relevant way {Claim 4}
  • compositions comprising a natural product (or a fragment of a natural product) and another component that impacts the function of the natural product (e.g., an effective amount of an adjuvant) satisfy § 101; no "significantly more" analysis is required {Claim 5, Claim 6}
  • compositions comprising a natural product (or a fragment of a natural product") and other components (e.g., a pharmaceutically acceptable carrier) do not satisfy § 101 if the components do not impart a different structure or function to each other, unless the claims can survive a "significantly more" analysis {Claim 3}
  • devices (e.g., microneedles) comprising a natural product (or a fragment of a natural product") do not satisfy § 101 unless the use of the device with the natural product was not well-understood, routine or conventional (e.g., unless the claims can survive a "significantly more" analysis) {Claim 7}

Example 30 relates to nature-based sweetener compositions. Out of the six sample claims, four are said to be "eligible" and two are said to be "ineligible." Themes that emerge from this example include:

  • compositions comprising specified amounts (or ranges of amounts) of a natural product (e.g., a small molecule) and a carrier (e.g., water) do not satisfy § 101 where it was well-understood, routine and conventional to use that type of carrier with that type of product and to vary the relative amounts of each (e.g., where the claims do not survive a "significantly more" analysis) {Claim 2 }
  • compositions comprising a natural product and other naturally-occurring components satisfy § 101 if the combination as a whole has properties that are different in a way that is "relevant to the nature of the invention" (e.g., organoleptic properties or flavor profile); no "significantly more" analysis is required {Claim 3, Claim 4}
  • compositions comprising a natural product having specific physical characteristics (e.g., a specific particle size distribution) satisfy § 101 if the physical characteristic is associated with a different property that is "relevant to the nature of the invention"; no "significantly more" analysis is required {Claim 5 }
  • compositions comprising a natural product in a controlled release formulation satisfy § 101 if the controlled release is "relevant to the nature of the invention"; no "significantly more" analysis is required {Claim 6 }

Markedly Different Versus Significantly More

When reviewing these examples, it is important to keep in mind that the USPTO has mapped the two-part Mayo/Alice analysis onto Step 2a and Step 2b of its analytical framework. Thus, the USPTO's Step 2a asks whether the claim is directed to a judicial exception (e.g., a natural product), while its Step 2b asks "whether any element, or combination of elements, ... is sufficient to ensure that the claim amounts to significantly more than the judicial exception." The USPTO's "markedly different" test is used in Step 2a, to determine whether a claim that recites a nature-based product really is "directed to" a natural product such that it needs to be subjected to a "significantly more" analysis.

These examples indicate that a "marked" difference can be a structural or functional difference in the nature-based product or composition as a whole. On the other hand, the examples indicate that in order to satisfy the "significantly more" test, the additional component(s) at issue must not be "well-understood, routine or conventional" in the field of the invention. This distinction may work within the USPTO's Step 2a/Step 2b framework, but a district court applying the Mayo/Alice framework should be able to find that a vaccine composition comprising an immunogenic protein and an adjuvant is directed to something "significantly more" that is eligible for patenting, even if the adjuvant is conventional.

Another question that arises from these examples is whether the "markedly different" test requires a difference that is "relevant to the nature of the invention." The examples only discuss that concept when the nature-based product is not structurally different from its naturally-occurring corollary. Does that mean that any structural difference will suffice but functional differences only support eligibility if they are "relevant" to the invention?

Creams Versus Microneedles

How can a peptide formulated in a cream be patent-eligible with no further inquiry, while a peptide coated on a microneedle array only is patent-eligible if it was not conventional to do so?

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.

In association with
Related Topics
Related Articles
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
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

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 or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq 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 of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions