Canada: USPTO Issues New Subject Matter Guidance Post-Myriad And Prometheus

Last Updated: March 10 2014
Article by Carmela De Luca and Amar Rana

The United States Patent and Trademark Office (USPTO) issued a new guidance document for Examiners on March 4, 2014, effective immediately, describing revised procedures for assessing subject matter eligibility of claims involving or reciting laws of nature, natural principles, natural phenomena, and/or natural products (hereinafter "2014 Guidelines"). The 2014 Guidelines are intended to reflect changes to the law arising from recent Supreme Court decisions in Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. _, 133 S. Ct. 2107, 2116, 106 USPQ2d 1972 (2013) ("Myriad"), and Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. _,132 S. Ct. 1289, 101 USPQ2d 1961 (2012) ("Prometheus"). The Myriad decision, which we have previously discussed, was limited to the patent-eligibility of human DNA sequences. While acknowledging the limitations of the Myriad decision, the USPTO argues that: "[...] while the holding in Myriad was limited to nucleic acids, Myriad is a reminder that claims reciting or involving natural products should be examined for a marked difference under Chakrabarty" (Diamond v. Chakrabarty, 447 U.S. 303 (1980) ("Chakrabarty")) (2014 Guidelines, pg. 1). 

Under the new 2014 Guidelines, all claims (whether directed to a machine, composition, manufacture or process) which recite or involve laws of nature/natural principles, natural phenomena, and/or natural products will be examined for subject matter eligibility according to the framework provided in the 2014 Guidelines. These guidelines supersede previous guidance issued by the USPTO on June 13, 2013 in response to Myriad, which singled out claims involving nucleic acid molecules for greater scrutiny with respect to subject matter eligibility. Accordingly, the 2014 Guidelines represent a departure from both the Myriad decision and the USPTO's previous guidance.

The 2014 Guidelines suggest a 3-step approach for assessing subject matter eligibility of a claim. The steps comprise asking the questions:

  1. Is the claimed invention directed to one of the four statutory patent-eligible subject matter categories: process, machine, manufacture, or composition of matter?
  2. Does the claim recite or involve one or more judicial exceptions, for example, abstract ideas, laws of nature/natural principles, natural phenomena, and natural products?
  3. Does the claim as a whole recite something significantly different than the judicial exception(s)?

Steps 1 and 2 are directed to determining the threshold question of whether the claims in any way recite or involve a judicial exception. In situations where there is uncertainty whether this threshold has been met, Examiners are required to nevertheless proceed to the next inquiry. The core of the analysis occurs at Step 3, which assesses whether the claim as a whole recites something that renders it "significantly different" from the excluded subject matter. 

Importantly the 2014 Guidelines identify "claimed subject matter that must be analyzed under Question 3" as including but "not limited to: chemicals derived from natural sources (e.g. antibiotics, fats, oils, petroleum derivatives, resins, toxins, etc.); foods [...]; metals and metallic compounds that exist in nature; minerals; natural materials [...]; nucleic acids; organisms (bacteria, plants and multicellular animals); proteins and peptides; and other substance found in or derived from nature" [emphasis added] (pg. 3) [emphasis added]. 

In assessing Step 3, the 2014 Guidelines encourage Examiner's to consider all relevant factors and to reach a determination by weighing the factors in favor of eligibility against those factors against eligibility. A non-exhaustive and non-exclusive list of factors to be considered by Examiners is provided in the guidelines and reproduced here.

The factors are applied in a series of Examples which in some instances provide for tempered optimism that not everything will be rejected. Example A suggests that a claim directed to a naturally occurring organism comprising a combination of naturally occurring plasmids is patent eligible since "the claimed bacterium is markedly different". It is both "structurally different" since it is genetically modified to include more plasmids than are found in a single naturally occurring Pseudomonas bacterium and "functionally different" as it is able to degrade at least two different hydrocarbons compared to the naturally occurring Pseudomonas bacteria that can only degrade a single hydrocarbon. Example B confirms that method of treatment claims using a natural product (amazonic acid in the Example) will continue to be allowed, although it appears that additional limitations may be needed as "a general instruction to use amazonic acid" may be insufficient. Example E unfortunately suggests that a pair of primers having specified sequences, which consist of sequences naturally occurring in human DNA, will not be considered patentable subject matter but methods of amplifying a target DNA using the pair of primers will pass the test. 

The 2014 Guidelines also clarify that the fact that "a marked difference came about as a result of routine activity or via human manipulation of natural process does not prevent the marked difference from weighing in favour patent eligibility" (at pg. 5) and confirm that a hybrid plant that "is markedly different from naturally occurring plants is eligible subject matter, even though it was created via routine manipulation of natural processes such as pollination and fertilization" (at pg. 5).

As should be clear from the foregoing, the 2014 Guidelines represent a marked departure from traditional Office practice in relation to subject matter eligibility analysis. As a result of these guidelines, claims reciting or involving any natural products found in or derived from natural sources, not just "naturally-occurring nucleic acids", will be subject to an analysis to determine if a "significant difference" from the naturally occurring product exists. Echoing the caution suggested in Myriad with respect to nucleic acids, according to the 2014 Guidelines, the use of terms like "isolated", "recombinant", or even "synthetic" will not shield a claim reciting or involving any natural product from being subjected to a full subject matter analysis under the new guidelines.

One significant concern is the lack of clarity on when a product becomes "significantly different" or "markedly different" from a natural occurring form, so as to be patent eligible. Myriad and Chakrabarty offer some guidance. 

In Myriad the court suggested that mere isolation of a naturally occurring nucleic acid, where the isolation does not result in chemical changes to the nucleic acid, is insufficient to confer patentability (at 14). However, the Court held that a nucleic acid which does not naturally occur, such as certain cDNAs, are sufficiently distinct from the natural products to be patent-eligible subject matter (at 16-17). In Chakrabarty, a genetically engineered microorganism was held to be patent eligible on the basis that the engineered bacteria was non-naturally occurring. While the case law is helpful, much will depend on how expansively the definition of substances "found in or derived from nature" is interpreted. Also, many complicated questions remain unresolved, such as, whether a therapeutic protein derived from a transgenic animal is "naturally occurring", or what change in a cell strain that has been lab adapted to show beneficial properties, will be sufficient for the strain to be considered "significantly different" from the parent strain. 

Patent professionals and prospective patentees will need to be mindful of these concerns when applying for patents in the United States, particularly in fields related to biotechnology. 

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
Carmela De Luca
Amar Rana
 
In association with
Related Topics
 
Related Articles
 
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 (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.

Disclaimer

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.

General

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