Editing MPEP 2164
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Compliance with the enablement requirement of | Compliance with the enablement requirement of | ||
35 U.S.C. 112, first paragraph, does not turn on | 35 | ||
U.S.C. 112, first paragraph, does not turn on | |||
whether an example is disclosed. An example may be | whether an example is disclosed. An example may be | ||
“working” or “prophetic.” A working example is | |||
based on work actually performed. A prophetic example | based on work actually performed. A prophetic example | ||
describes an embodiment of the invention based | describes an embodiment of the invention based | ||
Line 196: | Line 197: | ||
An applicant need not have actually reduced the | An applicant need not have actually reduced the | ||
invention to practice prior to filing. | invention to practice prior to filing. In Gould v. Quigg, | ||
822 F.2d 1074, 1078, 3 USPQ 2d 1302, 1304 (Fed. | |||
Cir. 1987), as of Gould’s filing date, no person had | |||
built a light amplifier or measured a population inversion | |||
in a gas discharge. The Court held that “The mere | |||
fact that something has not previously been done | |||
clearly is not, in itself, a sufficient basis for rejecting | |||
all applications purporting to disclose how to do it.” | |||
822 F.2d at 1078, 3 USPQ2d at 1304 (quoting In re | |||
Chilowsky, 229 F.2d 457, 461, 108 USPQ 321, 325 | |||
(CCPA 1956)). | |||
The specification need not contain an example if | The specification need not contain an example if | ||
the invention is otherwise disclosed in such manner | the invention is otherwise disclosed in such manner | ||
that one skilled in the art will be able to practice it | that one skilled in the art will be able to practice it | ||
without an undue amount of experimentation. | without an undue amount of experimentation. In reBorkowski, 422 F.2d 904, 908, 164 USPQ 642, 645 | ||
(CCPA 1970). | |||
Lack of a working example, however, is a factor to | Lack of a working example, however, is a factor to | ||
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expect to be able to extrapolate that one example | expect to be able to extrapolate that one example | ||
across the entire scope of the claims. | across the entire scope of the claims. | ||
CORRELATION: IN VITRO/IN VIVO | |||
The issue of “correlation” is related to the issue of | |||
the presence or absence of working examples. “Correlation” | |||
as used herein refers to the relationship | |||
between in vitro or in vivo animal model assays and a | |||
disclosed or a claimed method of use. An in vitro or in | |||
vivo animal model example in the specification, in | |||
effect, constitutes a “working example” if that example | |||
“correlates” with a disclosed or claimed method | |||
invention. If there is no correlation, then the examples | |||
do not constitute “working examples.” In this regard, | |||
the issue of “correlation” is also dependent on the | |||
state of the prior art. In other words, if the art is such | |||
that a particular model is recognized as correlating to | |||
a specific condition, then it should be accepted as correlating | |||
unless the examiner has evidence that the | |||
model does not correlate. Even with such evidence, | |||
the examiner must weigh the evidence for and against | |||
correlation and decide whether one skilled in the art | |||
would accept the model as reasonably correlating to | |||
the condition. In re Brana, 51 F.3d 1560, 1566, 34 | |||
USPQ2d 1436, 1441 (Fed. Cir. 1995) (reversing the | |||
PTO decision based on finding that in vitro data did | |||
not support in vivo applications). | |||
Since the initial burden is on the examiner to give | |||
reasons for the lack of enablement, the examiner must | |||
also give reasons for a conclusion of lack of correlation | |||
for an in vitro or in vivo animal model example. | |||
A rigorous or an invariable exact correlation is not | |||
required, as stated in Cross v. Iizuka, 753 F.2d 1040, | |||
1050, 224 USPQ 739, 747 (Fed. Cir. 1985): | |||
[B]ased upon the relevant evidence as a whole, there is a | |||
reasonable correlation between the disclosed in vitro utility | |||
and an in vivo activity, and therefore a rigorous correlation | |||
is not necessary where the disclosure of | |||
pharmacological activity is reasonable based upon the | |||
probative evidence. (Citations omitted.) | |||
WORKING EXAMPLES AND A CLAIMED GENUS | WORKING EXAMPLES AND A CLAIMED GENUS | ||
For a claimed genus, representative examples | For a claimed genus, representative examples | ||
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where adequate reasons are advanced by the examiner | where adequate reasons are advanced by the examiner | ||
to establish that a person skilled in the art could not | to establish that a person skilled in the art could not | ||
use the genus as a whole without undue experimentation. | use the genus as a whole without undue experimentation. | ||
===2164.03Relationship of Predictability of the Art and the Enablement Requirement=== | ===2164.03Relationship of Predictability of the Art and the Enablement Requirement=== |