Patent Profile: Nestec Receives Patent for Method of Predicting Risk of Celiac Disease

by McDonnell Boehnen Hulbert & Berghoff LLP
Contact

Phase I FlagellinEarlier this month, the U.S. Patent and Trademark Office issued U.S. Patent No. 8,409,819, entitled "Methods to predict risk for celiac disease by detecting anti-flagellin antibody levels."  The '819 patent is assigned to Nestec S.A. of Vevey, Switzerland, a research and testing subsidiary of Nestlé.  (Interestingly, the application from which the '819 patent issued was originally assigned to Prometheus Laboratories Inc., which then assigned the application to Nestec.)

Celiac disease is a relatively common disease with an estimated prevalence of approximately 0.5%-1% resulting from both environmental factors (e.g., exposure to gluten), and genetic factors (e.g., HLA-DQ2/8 genotypes).  Currently, the only effective treatment for celiac disease is a life-long strict gluten free diet.  The inventors demonstrated that a subset of at risk patients had elevated anti-CBir1 antibodies and that this correlated with HLA-DQ2.5 and HLA-DQ8 genotypes.

The patent has two independent claims (claims 1 and 9) reciting two methods to aid in predicting whether a patient (who either has a relative with celiac disease or is EMA positive) is at risk of developing celiac disease.  Claim 1 recites:

1.  A method for aiding in the prediction of whether an individual having a relative with celiac disease (CD) is at risk of developing CD, the method comprising:
    (a) contacting a sample from the individual with a CBir1 flagellin antigen under conditions suitable to form a complex of the CBir1 flagellin antigen and an anti-CBir1 flagellin antibody, wherein the CBir1 flagellin antigen comprises the amino terminal conserved region (amino acid residues 1-147) of the sequence set forth in SEQ ID NO:1;
    (b) contacting the complex with a labeled antibody to form a labeled complex;
    (c) detecting the level of the labeled complex with a detection device, thereby determining a level of anti-CBir1 flagellin antibodies in the sample; and
    (d) associating an elevated level of anti-CBir1 flagellin antibodies in the sample relative to a control with a high risk of developing CD, thereby aiding in the prediction of whether an individual having a relative with CD is at risk of developing CD.

Both claimed methods use the CBir1 flagellin antigen, specifically the N-terminal residues 1-147, to determine whether or not a sample from an at-risk patient contains anti-CBir1 flagellin antibodies.  Flagellin is a component of bacterial flagella, the molecular apparatus responsible for a propeller like motion in bacteria.  As billions of bacteria make up the intestinal microbiota, the theory is that individuals at risk for celiac disease may have an aggressive immune response to resident bacterial proteins, in this case flagellin.  There are a number of highly specific and sensitive serological tests that can be used in diagnosing celiac disease; however the gold standard for diagnosis is histological examination of a biopsy acquired by endoscopic evaluation.  As some patients may wish to avoid an endoscopic procedure, or at least have additional confirmatory diagnostics before doing so, the methods claimed here may help clinicians in making a diagnosis.  The '819 patent also notes that the method may be useful for identifying groups of patients at risk of developing celiac disease before showing any symptoms, which could help in the development of preventative interventions or other alternatives to a strict gluten free diet (e.g., enzyme supplements).

 

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© McDonnell Boehnen Hulbert & Berghoff LLP | Attorney Advertising

Written by:

McDonnell Boehnen Hulbert & Berghoff LLP
Contact
more
less

McDonnell Boehnen Hulbert & Berghoff LLP on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Privacy Policy (Updated: October 8, 2015):
hide

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.

Security

JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at info@jdsupra.com. In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at: info@jdsupra.com.

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.