Skip to Content

We invite you to try out our new beta eCFR site at We’ve made big changes to make the eCFR easier to use. Be sure to leave feedback using the 'Feedback' button on the bottom right of each page!


Prospective Grant of an Exclusive Patent License: Field-Deployable Mass Spectrometer Diagnostic for SARS, SARS-CoV-2 and Other Viruses, Bacteria and Bacterial Serovar, and Drug Impurities

Document Details

Information about this document as published in the Federal Register.

Document Statistics
Document page views are updated periodically throughout the day and are cumulative counts for this document. Counts are subject to sampling, reprocessing and revision (up or down) throughout the day.
Enhanced Content

Relevant information about this document from provides additional context. This information is not part of the official Federal Register document.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble


Food and Drug Administration, HHS.




The Food and Drug Administration (FDA) is contemplating the grant of an Exclusive Patent License to practice the invention embodied in the U.S. Patent listed in the Supplementary Information section of this notice to Advion, Inc. located in Ithaca, New York.


Only written comments and/or applications for a license which are received by the Food and Drug Administration's Technology Transfer Program on or before November 30, 2020 will be considered.


Inquiries and comments relating to the contemplated Exclusive Patent License should be directed to: Ken Millburne, Food and Drug Administration Technology Transfer Program, Bldg. 1, Rm. 4213, Silver Spring, MD 20993, 240-478-1662; email:

End Preamble Start Supplemental Information


Intellectual Property

FDA Reference No.: E-2011-021: “Direct Impact Ionization (DII) Mass Spectrometry.”

I. U.S. Non-Provisional Application 13/271,182, filed October 11, 2011 (FDA Reference No.: E-2011-021/US-02).

II. U.S. Patent granted April 22, 2014: U.S. Patent 8,704,169 B2 (FDA Reference No. E-2011-021/U.S.-02)

The patent rights in this invention have been assigned to the Government of the United States of America.

The prospective exclusive license territory may be worldwide and in fields of use that may be limited to manufacture and commercialization of a field-deployable mass spectrometer diagnostic for the rapid detection of SARS, SARS-CoV-2 and other viruses, bacteria and bacterial serovar, and drug impurities.

Above listed patent covers inventions directed to a mass spectrometer for analyzing samples suspected of having microorganisms. It is also directed to methods for generating a mass spectrum profile of a sample.

This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive license will be royalty bearing. The prospective exclusive license may be granted unless within 15 days from the date of this published notice, FDA receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.

In response to this notice, the public may file comments or objections. Comments and objections, other than those in the form of a license application, will not be treated confidentially, and may be made publicly available.

License applications submitted in response to this notice will be presumed to contain business confidential information and any release of information in these license applications will be made only as required and upon a request under the Freedom of Information Act, 5 U.S.C. 552.

Start Signature

Dated: November 9, 2020.

Lauren K. Roth,

Acting Principal Associate Commissioner for Policy.

End Signature End Supplemental Information

[FR Doc. 2020-25142 Filed 11-12-20; 8:45 am]