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2107.02 MANUAL OF PATENT EXAMINING PROCEDURE
ance of the evidence exists when it suggests that it is
more likely than not that the 'assertion in question is
true. Herman v. Huddleston, 459 U.S. 375, 390
(1983). To do this, Office personnel must provide evidence
sufficient to show that the statement of asserted
utility would be considered "false" by a person of
ordinary skill in the art. Of course, a person of ordinary
skill must have the benefit of both facts and reasoning
in order to assess the truth of a statement. This
meansthatif the applicant has presented facts that
support the reasoning used in asserting a utility,
Office personnel must present countervailing facts
and reasoning sufficient to establish that a person of
ordinary skill would not believe the applicant's assertion
of utility. In re Brana, 51 F.3d 1560, 34 USPQ2d
1436 (Fed. Cir. 1995). The initial evidentiary standard
used duriug evaluation of this questiouis a prepouderance
of the evidence (i.e., the totality of facts and reasoningsuggestthat
it is more likely than not that the
statement of the applicant is false).
B. When Is an Asserted Utility Not Credible?
Where an applicant has specifically assertedthat an
invention has a particular utility, that assertion cannot
simply be dismissed by Office personnel as being
"wrong," even when there may be reason to believe
that the assertion is not entirely accurate. Rather,
Office personnel must determine if the assertion of
utility is credible (i.e., whether the assertion of utility
is believable to a person of ordinary skill in the art
based on the totality of evidence and reasoning provided).
An assertion is credible unless (A) the logic
underlying the assertion is seriously flawed, or (B) the
facts upon which the assertionis based are inconsistent
with the logic underlying the assertion. Credibility
as used in this context refers to the reliability of the
statement based on the logic and facts that are offered
by the applicant to support the assertion of utility.
One situation where an assertion of utility would
not be considered credible is where a person of ordinary
skill would consider the assertion to be "incredible
in view of 'contemporary knowledge" and where
nothing offered by the applicant would counter what
contemporary knowledge might otherwise suggest.
Office personnel should be careful, however, uot to
label certain types of inventions as "incredible" or
"speculative" as such labels do not provide the correct
focus for the evaluation of an assertion of utility.
August 2001
2100AO
"Incredible utility" is a conclusion, not a starting point
for analysis under 35 U.S.C. 101. A conclusion that
an asserted utility is incredible can be reached only
after the Office has evaluated both the assertion of the
applicant regarding utility and any evidentiary basis
of that assertion. The Office should be particularly
careful not to start with a presumption that an asserted
utility is, per se,"incredible" and then proceed to base
a rejection under 35 U.S.c. 101 on that presumption.
Rejections under 35 U.S.c. 101 have been rarely
sustained by federal courts. Generally speaking, in
these rare cases, the 35 U.S.C. 101 rejection was sustained
either because the applicant failed to disclose
any utility for the invention or asserted a utility that
could only be true if it violated a scientific principle,
such as the second law of thermodynamics, or a law
of nature, or was wholly inconsistent with contemporaryknowledge
in the art. In re Gazave, 379 F.2d 973,
978, 154 USPQ 92, 96 (CCPA 1967). Special care
therefore should be taken when assessing the credibility
of an asserted therapeutic utility for a claimed
invention. In such cases, a previous lack of success in
treating a disease or condition, or the absence of a
proven animal model for testing the effectiveness of
drugs for treating a disorder in humans, should not,
standing alone, serve as a basis for challenging the
asserted utility under 35 U.S.C. 101.
IV. INITIAL BURDEN IS ON THE OFFICE
TO ESTABLISH A PRIMA FACIE CASE
AND PROVIDE EVIDENTIARY SUPPORT
THEREOF
To properly reject a claimed invention under
35U.S.C. 101, the Office must (A) make a prima
facie showing that the claimed invention lacks utility,
and (E) provide a sufficient evidentiary basis for factual
assumptions relied upon in establishing theprima
facie showing. In te Gaubert, 524 F.2d 1222,1224,
187 USPQ 664, 666 (CCPA 1975) ("Accordingly, the
PTO must do more than merely question operability ­
it must set forth factual reasons which would lead one
skilled in the art to question the objective truth ofthe
statement of operability."). If the Office
cannot develop a proper prima facie case andprovide
evidentiary support for a rejection under 35 U.S.C.
101, a rejection on this ground should not be imposed.
See, e.g., In re Oetiker, 977 F.2d 1443, 1445,
24 USPQ2d 1443, 1444 (Fed.. Cir. 1992) ("[T]he