MPEP § 2164.01(b) — How to Make the Claimed Invention (Annotated Rules)
§2164.01(b) How to Make the Claimed Invention
This page consolidates and annotates all enforceable requirements under MPEP § 2164.01(b), including statutory authority, regulatory rules, examiner guidance, and practice notes. It is provided as guidance, with links to the ground truth sources. This is information only, it is not legal advice.
How to Make the Claimed Invention
This section addresses How to Make the Claimed Invention. Primary authority: 35 U.S.C. 112. Contains: 2 permissions and 2 other statements.
Key Rules
Enablement Support for Claims
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).
Claims
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).
Test of Enablement (MPEP 2164.01)
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).
Deposit of Biological Materials
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.
Citations
| Primary topic | Citation |
|---|---|
| Claims Enablement Support for Claims Test of Enablement (MPEP 2164.01) | 35 U.S.C. § 112 |
| – | In re Breslow, 616 F.2d 516, 521, 205 USPQ 221, 226 (CCPA 1980) |
| Claims Enablement Support for Claims Test of Enablement (MPEP 2164.01) | In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) |
| – | In re Ghiron, 442 F.2d 985, 991, 169 USPQ 723, 727 (CCPA 1971) |
| – | In re Howarth, 654 F.2d 103, 105, 210 USPQ 689, 691 (CCPA 1981) |
| Claims Enablement Support for Claims Test of Enablement (MPEP 2164.01) | Spectra-Physics, Inc. v. Coherent, Inc., 827 F.2d 1524, 1533, 3 USPQ2d 1737, 1743 (Fed. Cir. 1987) |
Source Text from USPTO’s MPEP
This is an exact copy of the MPEP from the USPTO. It is here for your reference to see the section in context.
Official MPEP § 2164.01(b) — How to Make the Claimed Invention
Source: USPTO2164.01(b) How to Make the Claimed Invention [R-08.2012]
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).