Appeal No. 95-4691
Application 08/021,652
over Duffy, Isaacs, Dussourdd’Hinterland and EP 198321 is reversed.
New Ground of Rejection
Under the provisions of 37 CFR § 1.196(b), we make the following new grounds of rejection.
Claims 1-17 are rejected under 35 U.S.C. § 112, first and second paragraphs, as being indefinite for failing
to particularly point out and distinctly claim the subject matter which applicants regard as the invention and
because the specification, while enabling for t-PA, does not reasonably provide enablement for derivatives
of t-PA. Claims 1 and 2, from which all remaining claims depend, recite the plasminogen activator as being
a “tissue type plasminogen activator or a derivative thereof.” Applicants have not defined or provided by
way of examples what constitutes a derivative of t-PA which can be combined with an amine and an
anionic polymer to improve the solubility of t-PA in solution over a broad range of salt solutions. Thus, the
meaning of the claims is in doubt. Amgen Inc. v. Chugai Pharmaceutical Co., Ltd., 927 F.2d at 1217,
18 USPQ2d at 1030. The specification does not enable any person skilled in the art to which it pertains,
or with which it is most nearly connected, to make the invention commensurate in scope with claims 1-17.
Applicant has not provided any guidance as to what derivatives of t-PA are intended and how the solubility
of such derivatives would be affected by the addition of an amine and an anionic polymer. We find that
as to the derivatives of t-PA, the specification lacks any teaching or guidance as to how to formulae the
claimed compositions without undue experimentation. Genentech, Inc. v. Novo Nordisk A/S,
108 F.3d 1361, 1367, 42 USPQ2d 1001, 1005 (Fed. Cir. 1997).
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