antigen forms the “filler.” Where the label on the antibody is an enzyme, the assay falls into a42
category of immunoassays known as Enzyme-linked Immunosorbent Assays (ELISA).43
II. Written description
During the preliminary motion period, David filed a motion for judgment under 37 CFR
§ 1.633(a). Paper 32. The motion asserted, inter alia, that Engvall's claims 8 to 27 were unpatentable
under 35 U.S.C. § 112, ¶ 1. Each of claims 8 to 27 include the limitation that the monoclonal
antibodies have a specific minimum “affinity for the antigenic substance. . . .” David asserted that the
minimum affinity constant limitation was not described in Engvall's specification. Paper 32, p. 8-18.
An Administrative Patent Judge granted the motion, but deferred judgment until judgment could be
awarded with respect to all claims corresponding to the count. Paper No. 77, p. 5-6. We find that
Engvall’s specification does not provide a written description for the lower limit of the affinity
constant specified in claims 8 to 27.
A. Proceedings
1. Proceedings before the patent examiner
Engvall filed application 06/285,477 on July 21, 1981. The application included seven
claims. After rejection of all claims by the examiner, the application was abandoned in favor of44
continuation application 06/539,754. The continuation was filed on October 6, 1983. On March
7. 1984, Engvall filed a preliminary amendment in the continuation. Engvall Application 06/539,754,
Paper 18. The amendment added claims 8 to 45. The amendment stated:
42
Engvall specification, pp 4-5; FUND, pp. 438-439.
43
FUND, pp. 438-440.
44
Claim 1, the only independent claim follows:
A method for the determination of an antigen (I) in solution, in which determination said antigen (I) is
reacted with antibody (II), which is directed against the antigen (I), and with an antibody (III), which
is directed against the antigen (I) and is labeled with an analytically indicatable atom or group and is
soluble in said solution in the presence of which the determination is carried out, to the formation of a
conjugate comprising said antigen (I) and said antibodies (II) and antibody (III), which conjugate is
insoluble or is made insoluble, whereafter the amount of said analytically indicatable atom or group
precipitated form said solution is determined, wherein the improvement comprises in using as
antibody (II) and antibody (III) in said determination antibodies which are monoclonal and react with
sterically spaced determinants of the antigen (I).
8
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