United States: USPTO Guidance For Examiners Takes Expansive View Of Myriad And Prometheus Decisions

Last Updated: March 11 2014
Article by Muriel M Liberto

On March 4, 2014, the U.S. Patent and Trademark Office ("USPTO") issued a memorandum to the Patent Examining Corps with guidance for determining the patent eligibility of claims relating to products of nature and laws of nature ("the Guidance") in view of the U.S. Supreme Court decisions in Assoc. for Molecular Pathology v. Myriad Genetics ("Myriad") and Mayo Collaborative Services v. Prometheus Laboratories, Inc. ("Prometheus").  While the Guidance does not have the force or effect of law, it will have a significant impact on the prosecution of pending U.S. applications having claims falling within its scope.  And that scope is extremely broad.

The question of patent eligibility touches upon whether or not the claimed subject matter is something for which a patent can be granted.  Although the language of the U.S. statute broadly defines the scope of this subject matter, the U.S. Supreme Court has, over the years, carved out three general exceptions:  products of nature, laws of nature, and abstract ideas. The Guidance deals with the first two of these, products of nature and laws of nature.  We can expect a further memo dealing with abstract ideas following the Supreme Court decision in CLS Bank later this year.

Products of Nature

In its Myriad decision, the U.S. Supreme Court held that isolated genomic DNA molecules were products of nature and therefore not patent eligible subject matter.  That conclusion was grounded in the rationale that "what is patented must be made different by human hands."  But how different must it be?  From the Myriad decision itself, we know that isolated genomic DNA is not sufficiently different from the naturally occurring DNA in the human body.  And we know that mammalian cDNA, which is generally not naturally occurring, is sufficiently different.  But between those two extremes lies uncertainty.  For example, what about isolated proteins, or isolated stem cells, or even isolated small molecules that are natural products?  The Myriad court did not address these issues, but the rationale excluding isolated genomic DNA from patentability as products of nature would seem applicable to any "isolated" or "purified" natural product. Indeed, the implication of the Myriad decision is that none of these would be patent eligible unless it was sufficiently altered by human hands.

The Guidance issued by the USPTO makes clear that the Office has indeed adopted this expansive view of the Myriad decision and will be examining claims directed to anything that can be considered a "natural product" under a "significantly different" standard.  Examples of natural products in the memo include bacterial plasmids, small molecules, minerals (e.g., calcium chloride in a firework), antibodies, and primer pairs (e.g., for use in amplifying a target gene via the polymerase chain reaction ("PCR")).

What is the "significantly different" standard?  With respect to natural products, the Guidance offers that what is claimed should be "non-naturally occurring and markedly different in structure from the naturally occurring products".  Again, it is unclear at this point how different "markedly different" will be.  How different it needs to be will be worked out on a case-by-case basis, beginning at the level of the patent examiner at the USPTO.

So how can you protect your IP if it involves subject matter that could be considered a "product of nature" by a US examiner?  Since we don't yet really know how different "markedly different" is, one prudent strategy would be to include multiple claims having varying degrees of modifications relative to the naturally occurring thing, to the extent these makes sense commercially and scientifically.  The more different your claimed product is from the naturally occurring thing, the more likely it is to be considered patent eligible by the USPTO.

But don't forget to also include your broadest claims in the application, the ones you would have written before Myriad and before the Guidance.  This is because other jurisdictions, such as the European Patent Office, do not impose these same restrictions on patent eligible subject matter.

Patent practice in Europe has been unchanged by the Myriad decision or by the USPTO's guidelines issued earlier this week.  The rules to the European Patent Convention explicitly exclude from patentability the human body, at various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene.  However, an element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element; on condition that the industrial application of the claimed element, gene or partial gene sequence must be disclosed in the patent application.  Therefore the scope of subject matter now deemed patentable, when considering products of nature like molecules isolated from the body, would appear to be broader in Europe than in the US.  Claims embracing modified molecules to satisfy the new more restrictive USPTO approach would also provide useful additional claims in Europe.

Laws of Nature

In its Prometheus decision, the Supreme Court held that a method for adjusting medications based upon a relationship between dose and blood levels of a metabolite was not patent eligible.  The Supreme Court arrived at this conclusion by finding that the relationship between dose and metabolite blood levels was a naturally occurring relation or correlation and the claimed process amounted to nothing more than a claim to that natural phenomenon.  This decision sent shivers through the biotech and healthcare industries which rely heavily on patents relating to diagnostic methods.  This is because those methods often involve a natural phenomenon or a naturally occurring relation or correlation.  For example, claims directed to methods for determining the presence of disease, or susceptibility to a disease, or prognosis of a disease by detecting a genetic marker (e.g. SNP) or biomarker (protein) would all fall under the Prometheus analysis.  And of course, methods of adapting a therapeutic regimen based on the presence of a biomarker (metabolite) or genetic mutation would also fall under this analysis.

The Guidance provides that such claims are to be reviewed under the "significantly different" standard and that this difference can be shown "in multiple ways".  The example given is including in the claimed process "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."

The Guidance provides two examples that give an indication of what kind of particularity the examiners will be looking for.  The first deals with a method for diagnosing a disease by detecting a protein biomarker with an antibody.  In this hypothetical, the antibody is new and has been developed by the inventors. The claim specifies both the particular antibody used in the method and the particular method of "detecting" as flow cytometry.  The claim is patent-eligible, but the implication is that a generic claim without these specific elements is likely to be rejected.  The second example is a method of amplifying a target DNA sequence with a specified primer pair.  The method recites all of the elements of a typical PCR reaction.  Again, this claim is patent-eligible but it suggests a higher level of detail will be required in order to satisfy the examiner that your claim is not pre-empting all uses of the natural product.

So how do you protect your IP that involves a natural law as understood by the USPTO?  First you must be sure to claim more than the natural law itself.   Rather, your claims should be directed to a particular, useful application of the natural law, for example, a particular solution to an identified problem.  Second, do not preempt all uses of the natural law.  Limit your claims to a particular application of the principle such that other applications are not foreclosed.  And, third, include unconventional steps that integrate the natural law into the claimed process which applies it.  These are all good strategies for protecting your IP involving laws of nature in the US.  But again, be careful to also include your broadest claims, the ones you would have written before Prometheus and before the Guidance because other jurisdictions, such as the European Patent Office, do not contain the same restrictions on patent eligible subject matter.  However, the EPO does have some restrictions not found in the US (such as methods of medical treatment and methods of diagnosis that rely on a step of treating or interacting with the human or animal body).  So the best strategy would be to have both a US and European attorney review the application before it is filed in order to ensure that your IP can be adequately protected worldwide.

Just as the USPTO excludes laws of nature from being patentable inventions, the EPO does not regard discoveries or scientific theories as being inventions.  However, an invention involving the practical application of a discovery or theory to provide a beneficial outcome always has been, and remains, patentable in Europe.  For example the invention behind the Prometheus decision in the US was claimed before the EPO as an in vitro method for determining the efficacy of a treatment.  The practical application of detecting whether the blood levels of a metabolite of the drug were in an efficacious range, and the relationship between drug dose and blood levels of a metabolite of the drug, was considered to be patentable.

In summary, the Guidelines indicate that the USPTO has taken a broad view of both the Myriad and Prometheus decisions.  It is now more important than ever to identify whether or not your IP involves subject matter that may be considered a product of nature or a law of nature, as those terms are understood by the USPTO.  If it does, you should take steps to ensure that your patent strategy optimizes the chances of securing meaningful patent protection in both the US and Europe.

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.

Similar Articles
Relevancy Powered by MondaqAI
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please 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