11. Applicants allege (specification, page 1,
lines 22-25):
No liquid stabilised formulations of gonadotropins have
been described until now. It is highly desirable to obtain
such liquid formulations so as to have the compositions
ready to be injected and to avoid the reconstitution of
lyophilised powder, thus simplifying the way of use.
12. Our reading of the specification reveals that
applicants believe that they have found that a liquid formulation
of recombinant hCG [also referred to as rec-hCG or r-hCG]
stabilized with mannitol (1) has a decent shelf-life and (2) can
be directly used as a liquid in injectable form without the need
to reconstitute a lyophilized powder.
13. The preparation of a liquid formulation of rec-hCG
and mannitol is described (specification, page 5, lines 17-29).
14. In their Appeal Brief (Paper 15, page 3),
applicants call attention to Tables 10, 11, 12, 13, 14 and 15
as evidence of the patentability of their claimed invention.
Data in the Tables is apparently based on experimental work.4
Applicants rely on experimental data set out in the specification in
support of the appeal. We likewise have relied on the data and found it
material in rendering our decision. Moreover, in reaching our decision, we
have made the following assumptions: (1) the data set out in the specification
upon which applicants rely is based on actual experimentation, (2) the data is
accurately set out in the specification and (3) the data is not based on
prophetic examples [see Hoffmann-La Roche, Inc. v. Promega Corp., 1999 U.S.
Dist. LEXIS 19059, Civil Action C-93-1748-VRW (N.D. Cal. Dec. 7, 1999)
(Findings of Fact 56-60, 63-66, 69, 105-106, 112, 131 and 136 and Conclusions
of Law 32 and 35)]. We also have relied on the fact that there is no other
data known to applicants or the real party in interest which (1) would tend to
contradict the experimental data set out in the specification and (2) was not
called to our attention in the brief and/or reply brief on appeal [see 37 CFR
§ 1.56(b)(2)]. If any of our assumptions are not correct, applicants should
immediately notify the board in the form of a request for reconsideration.
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