United States: IP Newsflash - March 25, 2016


Sequenom Seeks Supreme Court Review of Diagnostic Claims Held Invalid Under § 101

On Monday, March 21, 2016, Sequenom, Inc. filed a petition for writ of certiorari in Sequenom, Inc. v. Ariosa Diagnostics, Inc., et al., No. 141139 (Fed. Cir. June 12, 2015). The question posed to the Supreme Court centers around the patentability of diagnostic claims applied to newlydiscovered natural phenomena.

The claimed work dates back to 1996, when two doctors discovered paternal cellfree fetal DNA (cffDNA) in maternal blood serum and plasma. With that discovery, the doctors developed a method of testing fetal DNA to determine, among other things, the risk of certain birth defects in a manner far less invasive than conventional techniques, which required DNA samples to be taken directly from the fetus or placenta. The doctors obtained U.S. Patent No. 6,258,540 covering the methods.

Sequenom filed an infringement suit against Ariosa. The district court granted Ariosa's motion for summary judgment that asserted claims were invalid for failure to claim patentable subject matter under 35 U.S.C. § 101. A panel of the Federal Circuit affirmed. The Federal Circuit applied the twopart test set forth in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012), and held that (1) the asserted claims were directed to naturally occurring phenomena, and (2) the practice of the claimed method did not transform that natural phenomenon into patenteligible subject matter. Judge Linn concurred, explaining that Mayo compelled such an outcome, even though the patent at issue claimed a meritorious invention. The Federal Circuit denied rehearing en banc with several judges authoring opinions.

In its petition, Sequenom presents a single issue to the Supreme Court:

Whether a novel method is patenteligible where: (1) a researcher is the first to discover a natural phenomenon; (2) that unique knowledge motivates him to apply a new combination of known techniques to that discovery; and (3) he thereby achieves a previously impossible result without preempting other uses of the discovery.

Sequenom explains that the doctors did not try to patent cffDNA itself or preempt all uses of it by others. Instead, the doctors claimed an application of their discovery and taught others new combinations and techniques that are now available. According to Sequenom, the Federal Circuit reads Mayo so broadly that the only solution is Supreme Court intervention. Sequenom argues that multiple judges and amici agree that the result in this case is untenable and that, in light of Mayo, only the Supreme Court can fix the problem.

Petition for Writ of Certiorari, Sequenom, Inc. v. Ariosa Diagnostics, Inc., et al., No. 15__ (Mar. 21, 2016).


Jason Weil


Allegedly Cumulative Prior Art Does Not Create An Estoppel Under 35 U.S.C. 315(e)(2)

Clearlamp, LLC filed a patent infringement action against LKQ Corporation (LKQ), who, in turn, counterclaimed seeking declaratory judgments of noninfringement and invalidity. During the pendency of this case, the parties participated in an inter partes review (IPR), during which the Patent Trial and Appeal Board found that several claims of the patentatissue were unpatentable as obvious in view of three prior art references. In the instant opinion, the Court grants LKQ's motion for summary judgment on invalidity and denies the parties' remaining motions on validity and noninfringement. The key issue addressed by the Court in deciding these summary judgment motions was whether LKQ was estopped under 35 U.S.C. § 315(e)(2) from combining the datasheet of a prior art product, which was not raised during the IPR proceeding, with the three prior art references used to invalidate other patent claims.

The Court examined the language of § 315(e)(2) and interpreted the phrase "reasonably could have been raised" to mean that the scope of estoppel applies to "prior art which a skilled searcher conducting a diligent search reasonably could have been expected to discover." However, rather than establishing that a skilled search would have found the product's datasheet, Clearlamp argued that a skilled search would have found cumulative pieces of prior art. The Court rejected Clearlamp's argument and found that cumulative prior art does not invoke § 315(e)(2) estoppel. Therefore, LKQ could rely on the product's datasheet combined with the three prior art references to establish the asserted claims were obvious.

Clearlamp, LLC v. LKQ Corp., No. 12cv2533 (N.D. Ill. Mar. 18, 2016).


Melissa Gibson


ITC ALJ Holds That the Presumption of Validity Does Not Apply to Section 101 Challenges

In granting a summary determination motion, ALJ Lord found that the patent owner's (Owner) patents were directed to ineligible subject matter under 35 U.S.C. § 101. This was the first successful challenge to patentability under Section 101 at the International Trade Commission (ITC) since the Supreme Court's decision in Alice Corporation Pty. Ltd. v. CLS Bank International.

Owner's patents were directed to (1) a system for providing feedback for an individual's weightloss goals, including a wearable sensor that has a processing unit for balancing the wearer's caloric intake and activity levels; and (2) a method and device for setting and modifying targets, such as health and activity targets. In holding that Owner's patents were directed to unpatentable abstract ideas, ALJ Lord applied the twostep test set forth in the Supreme Court's Mayo decision: (1) are the claims directed to an abstract idea, and, if so, (2) do the claims "transform that abstract idea into a patenteligible application." For the first step, the ALJ found that Owner's patents were directed to the abstract idea of collecting and recording information related to weight loss and general health programs. For the second step, the ALJ found that the recited generic sensors and processors did not add sufficient meaningful limitations to the claims. Thus, the ALJ held that the claims are directed to ineligible subject matter.

ALJ Lord stated that, "[f]or the purposes of deciding whether the claims meet the demands of section 101, no presumption of eligibility applies." This is the first time that an ITC ALJ has held that there is no presumption of validity in a Section 101 challenge. Further, ALJ Lord cited to a district court case holding the same, which in turn cited Judge Mayer's concurrence in Ultramercial. Judge Mayer's concurrence stated: "Although the Supreme Court has taken up several Section 101 cases in recent years, it has never mentioned — much less applied — any presumption of eligibility. The reasonable inference, therefore, is that while a presumption of validity attaches in many contexts, no equivalent presumption of eligibility applies in the section 101 calculus." (Internal citations omitted). As a result of ALJ Lord's holding, more respondents are likely to challenge patentability under Section 101 at the ITC.

Certain Activity Tracking Devices, Systems, and Components Thereof, Inv. No. 337TA963, Order No. 40 (March 3, 2016), Initial Determination Granting Respondents' Motion for Summary Determination that the '546 and '257 Patents Are Directed to Ineligible Subject Matter (ALJ Lord).


Michael Durbin

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