United States: USPTO To Apply Myriad Beyond Isolated DNA

Today, the United States Patent and Trademark Office ("USPTO") issued a Guidance, advising examiners and the public of the factors for determining whether an invention satisfies the U.S. Supreme Court's interpretation of 35 U.S.C. §101, as applied to patent-eligibility. See Assn. for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __, 133 S. Ct. 2107 (2013) ("Myriad") and Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. __, 132 S. Ct. 1289 (2012) ("Prometheus"). The Guidance supersedes the USPTO's one page document issued the day the U.S. Supreme Court held that isolated DNA that is structurally no different from DNA in the human body, other than it is isolated from the human body, is not patent-eligible. (See the prior post of June 13, 2013.) In the Guidance, the USPTO advises examiners to apply the Myriad and Prometheus holdings to any subject matter that could be characterized as a judicial exception to patent-eligibility: a law of nature; a natural principle; a natural phenomena, or a natural product. If the claimed subject matter could fall within one of the judicial exceptions to patent-eligibility, examiners are instructed to evaluate the claimed subject matter, using the following factors, to determine if the claim recites something significantly differentthan the judicial exception(s).

Factors Weighing Toward Eligibility

The Guidance notes six factors that would indicate that the claimed subject matter is significantly differentfrom a judicial exception and therefore weighted toward eligibility:

  1. the 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. the 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;
  3. the 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. the 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. the 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; and
  6. the 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.

The Guidance indicates that in analyzing the claim using the above factors and that if, on balance the totality of the relevant factors weigh toward eligibility, the claim qualifies as eligible subject matter. If on the other hand, the factors weigh against eligibility, the claim should be rejected. The Guidance also notes that, the analysis as a whole is a factor based analysis, which requires consideration and subsequent weighing of multiple factors, and is to be applied similar to the Wands factor based analysis to evaluate whether undue experimentation is required to make and use a particular claimed invention, citing MPEP 2164.01(a).

The Guidance provides several examples applying the factors to subject matter that could be within the judicial exception(s). Today's post will review the illustrative examples that relate in whole or part to compositions of matter. Tomorrow's post will cover the Guidance examples that relate to processes.

Composition/Manufacture Claim Reciting a Natural Product

The hypothetical claims recite:

  1. A stable energy-generating plasmid, which provides a hydrocarbon degradation pathway.
  2. A bacterium from the genus Pseudomonas containing therein at least two stable energy-generating plasmids, each of said plasmids providing a separate hydrocarbon degradation pathway.

In applying the six factors, the Guidance indicates that the first claim should rejected under Section 101, because the claim does not recite structural differences between the claimed plasmid and naturally occurring plasmids and therefore does not claim a plasmid that is markedly different from what exists in nature.

In contrast the second claim, in reciting the two energy-generating plasmids, recites something significantly different than naturally occurring bacteria. The claim is determined to be markedly different in that it is both structurally different (the genetic modification to include plasmids that are not found in naturally occurring Pseudomonas bacterium) and functionally different (it is able to degrade at least two different hydrocarbons as compared to naturally-occurring Pseudomonas bacterium).

Composition vs. Method Claims, Each Reciting a Natural Product

The hypothetical claims recite:

  1. Purified amazonic acid.
  2. Purified 5-methyl amazonic acid.
  3. A method of treating colon cancer, comprising administering a daily dose of purified amazonic acid to a patient suffering from colon cancer for a period of time from 10 days to 20 days, wherein said daily dose comprises about 0.75 to about 1.25 teaspoons of amazonic acid.

The claimed amazonic acid is structurally identical to the amazonic acid in tree leaves from which it can be isolated. However, purification of the chemical is very difficult; only the inventor has successfully purified the amazonic acid. 5-methyl amazonic acid is a chemical derivative of the purified compound that was created in the laboratory. The 5-methyl amazonic acid is functionally different from the natural product in that it stimulates the growth of hair as well as treating cancer. While use of the tree leaves containing amazonic acid to treat breast cancer was known, its use for treating colon cancer was discovered by the inventor.

Claim 1 is not deemed patent-eligible because it is not structurally different from the compound as it exists in the tree leaves.

Claim 2 is deemed patent-eligible, because it is structurally different from the compound as it exists in the tree leaves, and the structural difference results in a functional difference. The Guidance notes that while a functional difference is not necessary to find a marked difference, the presence of the functional difference makes a stronger case for patent-eligibility.

The Guidance indicates that claim 3 is patent-eligibility because the claim satisfies factors 2 through 4 and 6, of the six factors. The claim elements of the particular dose and dosing schedule to the particular patient, is noted to limit the scope of the claim. In addition, prior usage of the tree leaves containing the compound was not for the treatment of the recited colon cancer.

Composition Claim Reciting Multiple Natural Products

The hypothetical claim recites:

  1. An inoculant for leguminous plants comprising a plurality of selected mutually non-inhibitive strains of different species of bacteria of the genus Rhizobium, said strains being unaffected by each other in respect to their ability to fix nitrogen in the leguminous plant for which they are specific.

The Guidance indicates the claim should be rejected under Section 101 because the claim as a whole does not recite significantly different than the natural product; it was not altered in any way.

Compositions vs. Method Claims, Each Reciting Two Natural Products

The Guidance provides two exemplary claims:

  1. A pair of primers, the first primer having the sequence of SEQ ID NO: 1 and the second primer having the sequence of SEQ ID NO: 2.
  2. A method of amplifying a target DNA sequence comprising:

providing a reaction mixture comprising a double-stranded target DNA, the pair of primers of claim 1 wherein the first primer is complementary to a sequence on the first strand of the target DNA and the second primer is complementary to a sequence on the second strand of the target DNA, Taq polymerase, and a plurality of free nucleotides comprising adenine, thymine, cytosine and guanine;

heating the reaction mixture to a first predetermined temperature for a first predetermined time to separate the strands of the target DNA from each other;

cooling the reaction mixture to a second predetermined temperature for a second predetermined time under conditions to allow the first and second primers to hybridize with their complementary sequences on the first and second strands of the target DNA, and to allow the Taq polymerase to extend the primers; and repeating steps (b) and (c) at least 20 times.

Claim 1 is deemed not to be patent-eligible because the isolated primes are are not structurally different from naturally occurring DNA.

Claim 2 is deemed patent-eligible, because the claim contains elements that narrow the scope of the claim and involve manipulation of the natural products.

Compositions and Their Use After Myriad and Prometheus

The U.S. Supreme Court's Myriad decision created uncertainty as to how far the holding would be applied beyond isolated DNA. The USPTO, without direction from the Federal Circuit, has indicated that it would apply the Myriad holding to any naturally occurring product of nature, and that isolation of the product from nature is insufficient, in and of itself, to confer patent-eligibility. Thus, patent applicants should expect to have "isolated" or "purified" naturally occurring products that are not structurally different from their natural counterparts rejected for failing to satisfy Section 101. Applicants should consider, where possible, noting structural and functional distinctions between the claimed subject matter and the natural counterparts and how the claim elements would not preempt all possible uses of the technology.

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
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 you may opt out by clicking here

    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.

    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.

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