United States: Federal Circuit Review - Issue 37

Specific Claim Limitation That Uses "Comprising" in an Unpredictable Art May Not Be Enabled; and "Active Inducement" Under § 271(f)(1) Does Not Require a Third Party.

Promega Corp. v. Life Techs. Corp., No. 2013-1011, -1029, -1376, 2014 U.S. App. LEXIS 23482 (Fed. Cir. Dec. 15, 2014) (Chen, J.) (Prost, C.J., dissenting).  Click Here for a copy of the opinion.

Promega sued Life Technologies on five patents related to a forensic DNA identification technique known as "short tandem repeat"(STR) profiling.  

Promega alleged direct infringement in the US, and also alleged indirect infringement under § 271(f)(1), because Life Technologies shipped one component of the accused STR kits (a polymerase used for the amplification reactions) from the US to the UK, where the kit was then assembled and sold worldwide.  Life Technologies argued that these shipments did not infringe under this statute, because it shipped a single component to itself and not to someone else.  Additionally, it said that the exported polymerase was not "all or a substantial portion of the components of a patented invention" as the statute requires.

STR profiling counts the number of times a particular DNA sequence is repeated at selected genome locations called STR loci.  This count can vary among individuals, creating distinct patterns called "alleles," or markers, of a particular locus.  A particular set of alleles at multiple loci within an individual's DNA can be used to create a DNA "fingerprint" unique to that individual.  From a DNA sample, multiple copies of the DNA at each STR locus in a set of multiple loci are made, in a process called "amplification."  Promega's patents relate to a co-amplification method that uses primer pairs to copy DNA at multiple STR loci simultaneously and (importantly) without overlap or interference between the primer pairs for different targeted loci.   

More specifically, some of the patent claims recited a kit for analyzing STR repeats in STR loci from a DNA sample comprising a container containing primers for each locus in a set of STR loci which can be co-amplified, comprising three specified STR loci (HUMCSF1PO, HUMTPOX, and HUMTH01). The district court concluded that Promega's second use of the word "comprising" in the "a set of . . . loci" limitation covered not only the three loci recited in the claim, but also any other loci combination containing those three recited loci.  

On summary judgment, the district court rejected Life Technologies' invalidity argument that the "open ended" claims were not enabled, because according to the defendant, the "comprising" language is open to every possible loci – a scope which the specification and the state of the art did not support.  According to the district court, "the asserted [open loci set] claims allow for unrecited loci" and such claims need not enable "unrecited elements."  The court granted summary judgment of infringement to Promega and held a trial on damages, but on JMOL it vacated the jury's finding of willful infringement and its damages award.  Both parties appealed.

The Federal Circuit reversed the district court's denial of summary judgment on invalidity, finding that the open-ended claim language rendered the affected claims invalid for lack of enablement.  The Court disagreed that these STR loci combinations are merely "unrecited elements." They are part of the claim scope under the undisputed claim construction.  This claim scope was not enabled because identifying such loci was "a complex and unpredictable challenge" and amounted to undue experimentation.  When arguing for patentability, Promega urged that STR loci combinations in the prior art "cannot be extended to predict the success of multiplexing unrelated combinations of loci" and could not "provide any direction as to which of many possible [STR loci combination] choices is likely to be successful."  In these circumstances, Promega's open-ended claims were too broad.  

Under MagSil Corp. v. Hitachi Global Storage Techs., Inc., 687 F.3d 1377, 1381 (Fed. Cir. 2012), the Court found that instead of tying the key claim limitation to what the specification enabled, the patentee sought to extend its scope in order to cover later invented devices."  Under  Wyeth & Cordis Corp. v. Abbott Labs., 720 F.3d 1380 (Fed. Cir. 2013), the Court found "undue experimentation" because the specification of the Promega patents provides only a starting point—specific STR loci combinations that successfully co-amplify—with no disclosure that would have allowed a skilled artisan, absent laborious testing, to add new loci to these recited STR loci combinations that would still successfully co-amplify.  In particular, the relevant usage of "comprising" was not in the preamble, it was within the claim limitation that lists combinations of co-amplifying STR loci, "combinations whose identification and discovery Promega itself asserts is a complex and unpredictable endeavor.  "While the term 'comprising' in a claim preamble may create a presumption that a list of claim elements

is nonexclusive, it 'does not reach into each [limitation] to render every word and phrase therein open-ended.' [citation omitted] 2007).  Promega's claims differ from customary 'open ended' claims in that Promega's usage of 'comprising' in its 'open loci set' limitation, as construed, expands the claims at a key limitation in order to cover what are indisputably advances in this unpredictable art." (emphasis added).

On infringement, the Federal Circuit reversed the district court's JMOL, finding that Life Technologies was liable under § 271(f)(1).  The Court held that no third party is required to "actively induce" an infringing combination outside the United States.  Here, "induce" in the statute simply means "to cause," and in this case, to cause the infringing combination.  The court reasoned that the statute could have required involving another party simply by requiring the "active inducement of another," but this language is absent and cannot be imposed.  Infringement could not be avoided by exporting components of a claimed combination for assembly overseas by shipping components to oneself instead of to some other party.

Finally, the Federal Circuit held that exporting only a single component  from the U.S. may be sufficient to violate  § 271(f)(1).  Life Technologies pointed to the plural term "components" in the statute, but the Court noted that the key requirement was to supply "all or substantial portion" of the components from the United States.  A single component may suffice, and did suffice here, because the polymerase manufactured in the U.S. and shipped abroad was an essential component, without which the products in question could not function.

The Federal Circuit remanded the case to the district court to determine damages owing to Promega under the remaining claims that did not use the open-ended term "comprising."  Chief Judge Prost filed a dissent to argue that "actively induce" should require a third party.

Goods and Services Not Generally Recognized as Having a Common Source of Origin Requires "Something More" Than a Showing That They Are "Used Together" to Establish Relatedness.

In re St. Helena Hospital, No. 2014-1009, 2014 U.S. App. LEXIS 23564 (Fed. Cir. Dec. 16, 2014) (Linn, J.).   Click Here for a copy of the opinion.

St. Helena Hospital applied to the PTO to register "TAKETEN," a service mark associated with its 10-day residential health improvement program. St. Helena identified the service as "[h]ealth care services, namely, evaluating weight and lifestyle health and implementing weight and lifestyle health improvement plans in a hospital-based residential program." The examiner rejected St. Helena's application, citing likelihood of confusion with the registered mark "TAKE 10!," which was registered for goods, specifically "printed manuals, posters, stickers, activity cards and educational worksheets dealing with physical activity and physical fitness" and "pre-recorded videocassettes featuring physical activity and physical fitness promotion programs." The TTAB affirmed, finding that such goods and services are sufficiently related to cause confusion because they are complementary; they can be used together.  

Likelihood of confusion involves a balancing of the relevant Dupont factors (Application of E.I. DuPont

DeNemours & Co., 476 F.2d 1357, 1361 (C.C.P.A. 1973)), which, in this case, include: (1) the similarity or dissimilarity of the marks in terms of appearance, sound, meaning, and commercial impression; (2) the similarity or dissimilarity and nature of the goods and services; and (3) the similarity or dissimilarity of established, likely-to-continue channels of trade; and (4) the degree of consumer care. 

With respect to the first Dupont factor, the Federal Circuit rejected St. Helena's argument and agreed with the Board that "TAKETEN" and "TAKE 10!" are similar "in appearance, sound, meaning, and commercial impression." For the second factor, the Court considered whether "the consuming public may perceive [the respective goods and services of the parties] as related enough to cause confusion about the source or origin of the goods and services." The PTO has the burden of providing sufficient evidence to establish relatedness between the registered goods and St. Helena's services.  Here, because the relatedness between the registered goods and St. Helena's services was obscure, the court required that the PTO show "something more" than "the mere fact that the goods and services can be 'used together.'" Because the PTO failed to show "something more," it had not satisfied its burden of establishing relatedness.

For the third factor, the Court agreed with the PTO that St. Helena's services and the registered goods are not necessarily in different channels of trade, because the registered goods are not limited by distribution to educators.  However, the court disagreed with PTO that the channels of trade are necessarily similar, just because the registered goods and St. Helena's services are promoted through websites. The Court held that "[a]dvertising on the Internet is ubiquitous and 'proves little, if anything, about the likelihood that consumers will confuse similar marks used on such goods or services.'"  Consequently, "Both sides' evidence regarding the channels of trade is lacking."

For the fourth factor, the Board conceded that customers of St. Helena's services "will exercise a high degree of care," but it found "no basis to conclude that the consumers would exercise that level of care in analyzing printed materials received while participating in the services." The Federal Circuit found no evidence to support the Board's finding.   

Balancing these Dupont factors, the Federal Circuit concluded that the PTO's refusal to register "TAKETEN" based on the registered mark "TAKE 10!" was unsubstantiated.  The similarities between the respective marks themselves were outweighed by the other factors.  The court therefore reverse and remanded.

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
Parker D. Hancock
 
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