How to Make the Claimed Invention

As long as the specification discloses at least one method for

making and using the claimed invention that bears a reasonable correlation to the

entire scope of the claim, then the enablement requirement of

35 U.S.C. 112

is satisfied.

In re Fisher,

427 F.2d 833, 839, 166 USPQ 18, 24

(CCPA 1970). Failure to disclose other methods by which the claimed invention may be

made does not render a claim invalid under

35 U.S.C. 112

.

Spectra-Physics, Inc. v. Coherent, Inc

., 827 F.2d 1524, 1533, 3

USPQ2d 1737, 1743 (Fed. Cir. 1987),

cert. denied,

484 U.S. 954

(1987).

Naturally, for unstable and transitory chemical intermediates, the

“how to make” requirement does not require that the applicant teach how to make the

claimed product in stable, permanent or isolatable form.

In re

Breslow,

616 F.2d 516, 521, 205 USPQ 221, 226 (CCPA 1980).

A key issue that can arise when determining whether the

specification is enabling is whether the starting materials or apparatus necessary to

make the invention are available. In the biotechnical area, this is often true when

the product or process requires a particular strain of microorganism and when the

microorganism is available only after extensive screening.

The court in

In re Ghiron,

442 F.2d 985, 991, 169

USPQ 723, 727 (CCPA 1971), made clear that if the practice of a method requires a

particular apparatus, the application must provide a sufficient disclosure of the

apparatus if the apparatus is not readily available. The same can be said if certain

chemicals are required to make a compound or practice a chemical process.

In

re Howarth,

654 F.2d 103, 105, 210 USPQ 689, 691 (CCPA 1981).