Appeal No. 1999-1433
Application 08/453,852
In view of its brevity, we reproduce the examiner’s enablement rejection in its
entirety. The examiner argues:
Claim 5 is directed to a method of enhancing an immune response to a
substance native to the animal, rather than foreign to the animal. While auto-
immune diseases are known, it is not art-recognized that animals can be
administered a native substance that their immune system should recognize as
“self” and have an immune response. The specification does not teach how to
accomplish this method that is not art recognized. Therefore, this method is not
enabled [Answer, p. 5].
We find the examiner’s position untenable.
The first paragraph of § 112 requires, inter alia, that the specification enable
those skilled in the art to which it pertains to make and use the claimed invention. PPG
Indus. Inc. v. Guardian Indus. Corp., 75 F.3d 1558, 1564, 37 USPQ2d 1618, 1623 (Fed.
Cir. 1996); In re Wright, 999 F.2d 1557, 1561, 27 USPQ 1510, 1513 (Fed. Cir. 1993); In
re Vaeck, 947 F.2d 488, 495, 20 USPQ2d 1448, 1444 (Fed. Cir. 1991). Although the
statute does not so state, our appellate reviewing court has held that enablement
requires that the specification teach such persons to make and use the claimed
invention without “undue experimentation.” In re Vaeck, 947 F.2d at 495, 20 USPQ2d
at 1444. The court also set forth the factors to be considered in determining whether a
disclosure would require undue experimentation. In re Wands, 858 F.2d 731,737, 8
USPQ2d 1400, 1404 (Fed. Cir. 1988). Those factors include:
(1) the quantity of experimentation necessary, (2) the amount of direction or
guidance presented, (3) the presence or absence of working examples, (4) the
nature of the invention, (5) the state of the prior art, (6) the relative skill of those
in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of
the claims.
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