[Federal Register Volume 66, Number 38 (Monday, February 26, 2001)]
[Notices]
[Pages 11595-11596]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-4618]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Co-Exclusive License: Homogeneous Tests for 
Sequentially Determining Lipoprotein Fractions

AGENCY: National Institutes of Health, Public Health Service, DHHS.

ACTION: Notice.

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SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 
CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), 
Department of Health and Human Services, is contemplating the grant of 
a co-exclusive worldwide to practice the inventions embodied in US 
Patent Application Serial Number (60/136,709 (PCT/US00/14827) entitled 
``Homogeneous Tests for Sequentially Determining Lipoprotein 
Fractions'', provisionally filed May 28, 1999 and PCT filed May 26, 
2000, to Genzyme Diagnostics, having a place of business

[[Page 11596]]

in Cambridge, Massachusetts, and J&S Medical Associates, having a place 
of business in Framingham, Massachusetts. The United States of America 
is an assignee to the patent rights of this invention.
    The contemplated co-exclusive license may be limited to the 
development of homogeneous sequential tests for determination of 
lipoprotein subfractions in biological fluids, with applications to 
clinical chemistry analyzers. The license may not include the use for 
Patient-Initiated Diagnostics (PID) in conjunction with the SerSite\TM\ 
remote-site mailable device or its equivalents, all covered by claims 
of US Patent Number 6,036,659.

DATES: Only written comments and/or applications for a license which 
are received by he NIH Office of Technology Transfer on or before April 
27, 2001 will be considered.

ADDRESSES: Requests for a copy of the patent application, inquiries, 
comments and other materials relating to the contemplated license 
should be directed to: Uri Reichman, Ph.D., Technology Licensing 
Specialist, Office of Technology Transfer, National Institutes of 
Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; 
Telephone: (301) 496-7056, ext. 240; Facsimile: (301) 402-0220; E-mail: 
[email protected]. A signed Confidential Disclosure Agreement will be 
required to receive copies of the patent application.

SUPPLEMENTARY INFORMATION: The measurement of the cholesterol content 
of the lipoproteins subfraction in blood has become the gold standard 
in the clinical assessment of the risk of coronary artery disease. 
Current commercial tests involve two or three separate determinations 
and some of them are rather cumbersome. The subject invention provides 
a new, homogeneous assay for the sequential determination of the HDL-C 
and of total cholesterol present in blood. The test can be performed in 
a single tube and can readily lend itself to automation. The method 
comprises complexing of the non-HDL-C fraction, performing a first 
measurement of the cholesterol content of the unbound fraction, 
disrupting the complex and performing a second measurement of total 
cholesterol. Subtraction of the first reading from the second provides 
the value of the cholesterol in the non-HDL subfractions. Optionally, a 
triglyceride assay can then also be performed on the sample in the same 
tube.
    The prospective co-exclusive license will be royalty-bearing and 
will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 
404.7. The prospective co-exclusive license may be granted unless, 
within 60 days from the date of this published Notice, NIH 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 404.7.
    Properly filed competing applications for a license filed in 
response to this notice will be treated as objections to the 
contemplated license. Comments and objections submitted in response to 
this notice will not be made available for public inspection, and, to 
the extent permitted by law, will not be released under the Freedom of 
Information Act, 5 U.S.C. 552.

    Dated: February 15, 2001.
Jack Spiegel,
Director, Division of Technology, Development and Transfer, Office of 
Technology Transfer.
[FR Doc. 01-4618 Filed 2-23-01; 8:45 am]
BILLING CODE 4140-01-M