OPINION4
I. Technical background 5
The subject matter of the count is directed to an improvement in immunometric or sandwich
assays. Such assays are used to detect or quantitate the presence of specific antigens in a fluid.
Antigens are molecular configurations that the immune system recognizes as foreign substances and
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which elicit an immune response. Antigens are found on the surface of viruses, bacteria and other
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pathogens which invade mammalian bodies. The immune response to foreign substances includes
the production of antibodies. Antibodies, also called immunoglobulins (Ig), are proteins secreted into
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the bloodstream which seek out and mark antigens for destruction. All antibodies have the same
9 10
basic structure. The basic structure is shown in the picture below:
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Both Engvall and David have filed motions to suppress evidence. We address the specific decisions
as applied to the evidence upon which we have relied as part of the discussion of or reference to that specific evidence.
As to the matters raised at pages 17 to 22 of the David et al. Motion to Suppress Evidence (Paper 331) we consider the
objections to have been waived as noted on page 18 of that paper.
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In the discussion of the technology we refer to the following reference works of which we take official
notice of the scientific facts expressed therein (FRE 201):
Moore, Walter J., Physical Chemistry, 3d Ed., pp. 168-202, Prentice-Hall, Englewood Cliffs, New
Jersey, 1964 (PHYCHEM)
Lewis, John R., First-Year College Chemistry, 7th Ed., pp.136-37, Barnes & Noble, New York, 1964
(CHEM);
Paul, William E., Fundamental Immunology, 3d Ed., pp. 422-433, Raven Press, New York, 1993
(FUND);
Roitt, Ivan et al., Immunology, 3d Ed., pp. 1.6-1.7 and 6.1-6.7, Mosby, London, 1993 (IMMU);
Watson, James et al., Recombinant DNA, 2d Ed. 1982, Scientific American Books, distributed by
W.H.Freeman & Co., New York (DNA);
Darnell, James et al., Molecular Cell Biology, 2d Ed. 1990, Scientific American Books, distributed by
W.H.Freeman & Co., New York (CELL)
A copy of the cited portions of these references is attached in the appendix to this opinion These references are not
relied upon as prior art, but rather to assist the reader in the understanding the technology and terminology involved.
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DNA, pp. 293-94.
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IMMU, p. 1.7.
8
DNA, p. 293.
9
IMMU, p. 1.7
10
IMMU, p. 1.6-1.7.
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