MPEP § 2121 — Prior Art; General Level of Operability Required to Make a Prima Facie Case (Annotated Rules)
§2121 Prior Art; General Level of Operability Required to Make a Prima Facie Case
This page consolidates and annotates all enforceable requirements under MPEP § 2121, 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.
Prior Art; General Level of Operability Required to Make a Prima Facie Case
This section addresses Prior Art; General Level of Operability Required to Make a Prima Facie Case. Primary authority: 35 U.S.C. 132, 35 U.S.C. 102, and 37 CFR 132. Contains: 1 requirement, 1 permission, and 5 other statements.
Key Rules
Anticipation/Novelty
“Consistent with the statutory framework and our precedent, we therefore hold that, during patent prosecution, an examiner is entitled to reject claims as anticipated by a prior art publication or patent without conducting an inquiry into whether or not that prior art reference is enabling. As long as an examiner makes a proper prima facie case of anticipation by giving adequate notice under § 132, the burden shifts to the applicant to submit rebuttal evidence of nonenablement.”
“Consistent with the statutory framework and our precedent, we therefore hold that, during patent prosecution, an examiner is entitled to reject claims as anticipated by a prior art publication or patent without conducting an inquiry into whether or not that prior art reference is enabling. As long as an examiner makes a proper prima facie case of anticipation by giving adequate notice under § 132, the burden shifts to the applicant to submit rebuttal evidence of nonenablement.”
A prior art reference provides an enabling disclosure and thus anticipates a claimed invention if the reference describes the claimed invention in sufficient detail to enable a person of ordinary skill in the art to carry out the claimed invention; “proof of efficacy is not required for a prior art reference to be enabling for purposes of anticipation.” Impax Labs. Inc. v. Aventis Pharm. Inc., 468 F.3d 1366, 1383, 81 USPQ2d 1001, 1013 (Fed. Cir. 2006) (citing Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318, 1326, 75 USPQ2d 1297, 1302 (Fed. Cir. 2005)). See also MPEP § 2122.
A prior art reference provides an enabling disclosure and thus anticipates a claimed invention if the reference describes the claimed invention in sufficient detail to enable a person of ordinary skill in the art to carry out the claimed invention; “proof of efficacy is not required for a prior art reference to be enabling for purposes of anticipation.” Impax Labs. Inc. v. Aventis Pharm. Inc., 468 F.3d 1366, 1383, 81 USPQ2d 1001, 1013 (Fed. Cir. 2006) (citing Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318, 1326, 75 USPQ2d 1297, 1302 (Fed. Cir. 2005)). See also MPEP § 2122.
Types of Foreign Patents
The level of disclosure required within a reference to make it an “enabling disclosure” is the same no matter what type of prior art is at issue. It does not matter whether the prior art reference is a U.S. patent, foreign patent, a printed publication or other. There is no basis in the statute (35 U.S.C. 102 or 103) for discriminating either in favor of or against prior art references on the basis of nationality. In re Moreton, 288 F.2d 708, 129 USPQ 227 (CCPA 1961).
The level of disclosure required within a reference to make it an “enabling disclosure” is the same no matter what type of prior art is at issue. It does not matter whether the prior art reference is a U.S. patent, foreign patent, a printed publication or other. There is no basis in the statute (35 U.S.C. 102 or 103) for discriminating either in favor of or against prior art references on the basis of nationality. In re Moreton, 288 F.2d 708, 129 USPQ 227 (CCPA 1961).
Prior Art
Where a reference appears to not be enabling on its face, however, an applicant may successfully challenge the cited prior art for lack of enablement by argument without supporting evidence. In re Morsa, 713 F.3d 104, 110, 106 USPQ2d 1327, 1332 (Fed. Cir. 2013).
35 U.S.C. 103 – Obviousness
When the reference relied on expressly anticipates or makes obvious all of the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on applicant to rebut the presumption of operability. In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA 1980). See also MPEP § 716.07. See also In re Antor Media Corp., 689 F.3d 1282, 103 USPQ2d 1555 (Fed. Cir. 2012). Specifically, in In re Antor Media Corp., the court stated:
Rebutting Prima Facie Case
When the reference relied on expressly anticipates or makes obvious all of the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on applicant to rebut the presumption of operability. In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA 1980). See also MPEP § 716.07. See also In re Antor Media Corp., 689 F.3d 1282, 103 USPQ2d 1555 (Fed. Cir. 2012). Specifically, in In re Antor Media Corp., the court stated:
Establishing Prima Facie Case
When the reference relied on expressly anticipates or makes obvious all of the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on applicant to rebut the presumption of operability. In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA 1980). See also MPEP § 716.07. See also In re Antor Media Corp., 689 F.3d 1282, 103 USPQ2d 1555 (Fed. Cir. 2012). Specifically, in In re Antor Media Corp., the court stated:
Citations
| Primary topic | Citation |
|---|---|
| Types of Foreign Patents | 35 U.S.C. § 102 |
| Anticipation/Novelty | 35 U.S.C. § 132 |
| Anticipation/Novelty | MPEP § 2122 |
| 35 U.S.C. 103 – Obviousness Establishing Prima Facie Case Rebutting Prima Facie Case | MPEP § 716.07 |
| Types of Foreign Patents | In re Moreton, 288 F.2d 708, 129 USPQ 227 (CCPA 1961) |
| Prior Art | In re Morsa, 713 F.3d 104, 110, 106 USPQ2d 1327, 1332 (Fed. Cir. 2013) |
| 35 U.S.C. 103 – Obviousness Establishing Prima Facie Case Rebutting Prima Facie Case | In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA 1980) |
| Anticipation/Novelty | citing Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318, 1326, 75 USPQ2d 1297, 1302 (Fed. Cir. 2005) |
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 § 2121 — Prior Art; General Level of Operability Required to Make a Prima Facie Case
Source: USPTO2121 Prior Art; General Level of Operability Required to Make a Prima Facie Case [R-01.2024]
I. PRIOR ART IS PRESUMED TO BE OPERABLE/ENABLINGWhen the reference relied on expressly anticipates or makes obvious all of the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on applicant to rebut the presumption of operability. In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA 1980). See also MPEP § 716.07. See also In re Antor Media Corp., 689 F.3d 1282, 103 USPQ2d 1555 (Fed. Cir. 2012). Specifically, in In re Antor Media Corp., the court stated:
“Consistent with the statutory framework and our precedent, we therefore hold that, during patent prosecution, an examiner is entitled to reject claims as anticipated by a prior art publication or patent without conducting an inquiry into whether or not that prior art reference is enabling. As long as an examiner makes a proper prima facie case of anticipation by giving adequate notice under § 132, the burden shifts to the applicant to submit rebuttal evidence of nonenablement.”
In re Antor Media Corp., 689 F.3d at 1289, 103 USPQ2d at 1559.
Where a reference appears to not be enabling on its face, however, an applicant may successfully challenge the cited prior art for lack of enablement by argument without supporting evidence. In re Morsa, 713 F.3d 104, 110, 106 USPQ2d 1327, 1332 (Fed. Cir. 2013).
See also MPEP § 716.07.
II. WHAT CONSTITUTES AN “ENABLING DISCLOSURE” DOES NOT DEPEND ON THE TYPE OF PRIOR ART THE DISCLOSURE IS CONTAINED INThe level of disclosure required within a reference to make it an “enabling disclosure” is the same no matter what type of prior art is at issue. It does not matter whether the prior art reference is a U.S. patent, foreign patent, a printed publication or other. There is no basis in the statute (35 U.S.C. 102 or 103) for discriminating either in favor of or against prior art references on the basis of nationality. In re Moreton, 288 F.2d 708, 129 USPQ 227 (CCPA 1961).
III. EFFICACY IS NOT A REQUIREMENT FOR PRIOR ART ENABLEMENTA prior art reference provides an enabling disclosure and thus anticipates a claimed invention if the reference describes the claimed invention in sufficient detail to enable a person of ordinary skill in the art to carry out the claimed invention; “proof of efficacy is not required for a prior art reference to be enabling for purposes of anticipation.” Impax Labs. Inc. v. Aventis Pharm.Inc., 468 F.3d 1366, 1383, 81 USPQ2d 1001, 1013 (Fed. Cir. 2006) (citing Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318, 1326, 75 USPQ2d 1297, 1302 (Fed. Cir. 2005)). See also MPEP § 2122.