MPEP § 2161 — Three Separate Requirements for Specification Under 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, First Paragraph (Annotated Rules)
§2161 Three Separate Requirements for Specification Under 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, First Paragraph
This page consolidates and annotates all enforceable requirements under MPEP § 2161, 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.
Three Separate Requirements for Specification Under 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, First Paragraph
This section addresses Three Separate Requirements for Specification Under 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, First Paragraph. Primary authority: 35 U.S.C. 112, 35 U.S.C. 112(a), and 37 CFR 112. Contains: 2 requirements and 6 other statements.
Key Rules
Enablement Support for Claims
The written description requirement is separate and distinct from the enablement requirement. Ariad Pharm., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1341, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010) (en banc) (If Congress had intended enablement to be the sole description requirement of § 112, first paragraph, the statute would have been written differently.) Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562, 19 USPQ2d 1111, 1115 (Fed. Cir. 1991) (While acknowledging that some of its cases concerning the written description requirement and the enablement requirement are confusing, the Federal Circuit reaffirmed that under 35 U.S.C. 112, first paragraph, the written description requirement is separate and distinct from the enablement requirement and gave an example thereof.); In re Barker, 559 F.2d 588, 194 USPQ 470 (CCPA 1977), cert. denied, 434 U.S. 1064 (1978). See also, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-685, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015) (reversing and remanding the district court's grant of summary judgment of invalidity for lack of an adequate written description and lack of enablement because there were genuine issues of material fact regarding 1) whether the claims had sufficient written description support (“[t]he fact that… the specification do[es] not speak in haec verba of accessing ‘disparate databases’ does not eliminate as a genuine issue of material fact that the existence of at least some discussion, and therefore, possession, of the accessing of disparate databases, as claimed”); and 2) whether the claims were enabled (“the effort it took the inventor to reduce the invention to practice does not conclusively show lack of enablement”). An invention may be described without the disclosure being enabling (e.g., a chemical compound for which there is no disclosed or apparent method of making), and a disclosure could be enabling without describing the invention (e.g., a specification describing a method of making and using a paint composition made of functionally defined ingredients within broad ranges would be enabling for formulations falling within the description but would not describe any specific formulation). See In re Armbruster, 512 F.2d 676, 677, 185 USPQ 152, 153 (CCPA 1975) (“[A] specification which ‘describes’ does not necessarily also ‘enable’ one skilled in the art to make or use the claimed invention.”). Best mode is a separate and distinct requirement from the enablement requirement. In re Newton, 414 F.2d 1400, 163 USPQ 34 (CCPA 1969).
The written description requirement is separate and distinct from the enablement requirement. Ariad Pharm., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1341, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010) (en banc) (If Congress had intended enablement to be the sole description requirement of § 112, first paragraph, the statute would have been written differently.) Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562, 19 USPQ2d 1111, 1115 (Fed. Cir. 1991) (While acknowledging that some of its cases concerning the written description requirement and the enablement requirement are confusing, the Federal Circuit reaffirmed that under 35 U.S.C. 112, first paragraph, the written description requirement is separate and distinct from the enablement requirement and gave an example thereof.); In re Barker, 559 F.2d 588, 194 USPQ 470 (CCPA 1977), cert. denied, 434 U.S. 1064 (1978). See also, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-685, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015) (reversing and remanding the district court's grant of summary judgment of invalidity for lack of an adequate written description and lack of enablement because there were genuine issues of material fact regarding 1) whether the claims had sufficient written description support (“[t]he fact that… the specification do[es] not speak in haec verba of accessing ‘disparate databases’ does not eliminate as a genuine issue of material fact that the existence of at least some discussion, and therefore, possession, of the accessing of disparate databases, as claimed”); and 2) whether the claims were enabled (“the effort it took the inventor to reduce the invention to practice does not conclusively show lack of enablement”). An invention may be described without the disclosure being enabling (e.g., a chemical compound for which there is no disclosed or apparent method of making), and a disclosure could be enabling without describing the invention (e.g., a specification describing a method of making and using a paint composition made of functionally defined ingredients within broad ranges would be enabling for formulations falling within the description but would not describe any specific formulation). See In re Armbruster, 512 F.2d 676, 677, 185 USPQ 152, 153 (CCPA 1975) (“[A] specification which ‘describes’ does not necessarily also ‘enable’ one skilled in the art to make or use the claimed invention.”). Best mode is a separate and distinct requirement from the enablement requirement. In re Newton, 414 F.2d 1400, 163 USPQ 34 (CCPA 1969).
The written description requirement is separate and distinct from the enablement requirement. Ariad Pharm., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1341, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010) (en banc) (If Congress had intended enablement to be the sole description requirement of § 112, first paragraph, the statute would have been written differently.) Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562, 19 USPQ2d 1111, 1115 (Fed. Cir. 1991) (While acknowledging that some of its cases concerning the written description requirement and the enablement requirement are confusing, the Federal Circuit reaffirmed that under 35 U.S.C. 112, first paragraph, the written description requirement is separate and distinct from the enablement requirement and gave an example thereof.); In re Barker, 559 F.2d 588, 194 USPQ 470 (CCPA 1977), cert. denied, 434 U.S. 1064 (1978). See also, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-685, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015) (reversing and remanding the district court's grant of summary judgment of invalidity for lack of an adequate written description and lack of enablement because there were genuine issues of material fact regarding 1) whether the claims had sufficient written description support (“[t]he fact that… the specification do[es] not speak in haec verba of accessing ‘disparate databases’ does not eliminate as a genuine issue of material fact that the existence of at least some discussion, and therefore, possession, of the accessing of disparate databases, as claimed”); and 2) whether the claims were enabled (“the effort it took the inventor to reduce the invention to practice does not conclusively show lack of enablement”). An invention may be described without the disclosure being enabling (e.g., a chemical compound for which there is no disclosed or apparent method of making), and a disclosure could be enabling without describing the invention (e.g., a specification describing a method of making and using a paint composition made of functionally defined ingredients within broad ranges would be enabling for formulations falling within the description but would not describe any specific formulation). See In re Armbruster, 512 F.2d 676, 677, 185 USPQ 152, 153 (CCPA 1975) (“[A] specification which ‘describes’ does not necessarily also ‘enable’ one skilled in the art to make or use the claimed invention.”). Best mode is a separate and distinct requirement from the enablement requirement. In re Newton, 414 F.2d 1400, 163 USPQ 34 (CCPA 1969).
Considerations for Best Mode (MPEP 2165.01)
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. [emphasis added].
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
AIA vs Pre-AIA Practice
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. [emphasis added].
35 U.S.C. 112(a) and pre-AIA 35 U.S.C. 112, first paragraph require that the specification include the following:
- (A) A written description of the invention;
- (B) The manner and process of making and using the invention (the enablement requirement); and
- (C) The best mode contemplated by the inventor of carrying out his invention.
AIA Effective Dates
The first paragraph of pre-AIA 35 U.S.C. 112 (applicable to applications filed before September 16, 2012) provides:
35 U.S.C. 112(a) – Written Description & Enablement
The written description requirement is separate and distinct from the enablement requirement. Ariad Pharm., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1341, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010) (en banc) (If Congress had intended enablement to be the sole description requirement of § 112, first paragraph, the statute would have been written differently.) Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562, 19 USPQ2d 1111, 1115 (Fed. Cir. 1991) (While acknowledging that some of its cases concerning the written description requirement and the enablement requirement are confusing, the Federal Circuit reaffirmed that under 35 U.S.C. 112, first paragraph, the written description requirement is separate and distinct from the enablement requirement and gave an example thereof.); In re Barker, 559 F.2d 588, 194 USPQ 470 (CCPA 1977), cert. denied, 434 U.S. 1064 (1978). See also, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-685, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015) (reversing and remanding the district court's grant of summary judgment of invalidity for lack of an adequate written description and lack of enablement because there were genuine issues of material fact regarding 1) whether the claims had sufficient written description support (“[t]he fact that… the specification do[es] not speak in haec verba of accessing ‘disparate databases’ does not eliminate as a genuine issue of material fact that the existence of at least some discussion, and therefore, possession, of the accessing of disparate databases, as claimed”); and 2) whether the claims were enabled (“the effort it took the inventor to reduce the invention to practice does not conclusively show lack of enablement”). An invention may be described without the disclosure being enabling (e.g., a chemical compound for which there is no disclosed or apparent method of making), and a disclosure could be enabling without describing the invention (e.g., a specification describing a method of making and using a paint composition made of functionally defined ingredients within broad ranges would be enabling for formulations falling within the description but would not describe any specific formulation). See In re Armbruster, 512 F.2d 676, 677, 185 USPQ 152, 153 (CCPA 1975) (“[A] specification which ‘describes’ does not necessarily also ‘enable’ one skilled in the art to make or use the claimed invention.”). Best mode is a separate and distinct requirement from the enablement requirement. In re Newton, 414 F.2d 1400, 163 USPQ 34 (CCPA 1969).
Scope Commensurate with Disclosure
The written description requirement is separate and distinct from the enablement requirement. Ariad Pharm., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1341, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010) (en banc) (If Congress had intended enablement to be the sole description requirement of § 112, first paragraph, the statute would have been written differently.) Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562, 19 USPQ2d 1111, 1115 (Fed. Cir. 1991) (While acknowledging that some of its cases concerning the written description requirement and the enablement requirement are confusing, the Federal Circuit reaffirmed that under 35 U.S.C. 112, first paragraph, the written description requirement is separate and distinct from the enablement requirement and gave an example thereof.); In re Barker, 559 F.2d 588, 194 USPQ 470 (CCPA 1977), cert. denied, 434 U.S. 1064 (1978). See also, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-685, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015) (reversing and remanding the district court's grant of summary judgment of invalidity for lack of an adequate written description and lack of enablement because there were genuine issues of material fact regarding 1) whether the claims had sufficient written description support (“[t]he fact that… the specification do[es] not speak in haec verba of accessing ‘disparate databases’ does not eliminate as a genuine issue of material fact that the existence of at least some discussion, and therefore, possession, of the accessing of disparate databases, as claimed”); and 2) whether the claims were enabled (“the effort it took the inventor to reduce the invention to practice does not conclusively show lack of enablement”). An invention may be described without the disclosure being enabling (e.g., a chemical compound for which there is no disclosed or apparent method of making), and a disclosure could be enabling without describing the invention (e.g., a specification describing a method of making and using a paint composition made of functionally defined ingredients within broad ranges would be enabling for formulations falling within the description but would not describe any specific formulation). See In re Armbruster, 512 F.2d 676, 677, 185 USPQ 152, 153 (CCPA 1975) (“[A] specification which ‘describes’ does not necessarily also ‘enable’ one skilled in the art to make or use the claimed invention.”). Best mode is a separate and distinct requirement from the enablement requirement. In re Newton, 414 F.2d 1400, 163 USPQ 34 (CCPA 1969).
Composition of Matter Claims
The written description requirement is separate and distinct from the enablement requirement. Ariad Pharm., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1341, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010) (en banc) (If Congress had intended enablement to be the sole description requirement of § 112, first paragraph, the statute would have been written differently.) Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562, 19 USPQ2d 1111, 1115 (Fed. Cir. 1991) (While acknowledging that some of its cases concerning the written description requirement and the enablement requirement are confusing, the Federal Circuit reaffirmed that under 35 U.S.C. 112, first paragraph, the written description requirement is separate and distinct from the enablement requirement and gave an example thereof.); In re Barker, 559 F.2d 588, 194 USPQ 470 (CCPA 1977), cert. denied, 434 U.S. 1064 (1978). See also, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-685, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015) (reversing and remanding the district court's grant of summary judgment of invalidity for lack of an adequate written description and lack of enablement because there were genuine issues of material fact regarding 1) whether the claims had sufficient written description support (“[t]he fact that… the specification do[es] not speak in haec verba of accessing ‘disparate databases’ does not eliminate as a genuine issue of material fact that the existence of at least some discussion, and therefore, possession, of the accessing of disparate databases, as claimed”); and 2) whether the claims were enabled (“the effort it took the inventor to reduce the invention to practice does not conclusively show lack of enablement”). An invention may be described without the disclosure being enabling (e.g., a chemical compound for which there is no disclosed or apparent method of making), and a disclosure could be enabling without describing the invention (e.g., a specification describing a method of making and using a paint composition made of functionally defined ingredients within broad ranges would be enabling for formulations falling within the description but would not describe any specific formulation). See In re Armbruster, 512 F.2d 676, 677, 185 USPQ 152, 153 (CCPA 1975) (“[A] specification which ‘describes’ does not necessarily also ‘enable’ one skilled in the art to make or use the claimed invention.”). Best mode is a separate and distinct requirement from the enablement requirement. In re Newton, 414 F.2d 1400, 163 USPQ 34 (CCPA 1969).
Determining Whether Application Is AIA or Pre-AIA
The written description requirement is separate and distinct from the enablement requirement. Ariad Pharm., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1341, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010) (en banc) (If Congress had intended enablement to be the sole description requirement of § 112, first paragraph, the statute would have been written differently.) Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562, 19 USPQ2d 1111, 1115 (Fed. Cir. 1991) (While acknowledging that some of its cases concerning the written description requirement and the enablement requirement are confusing, the Federal Circuit reaffirmed that under 35 U.S.C. 112, first paragraph, the written description requirement is separate and distinct from the enablement requirement and gave an example thereof.); In re Barker, 559 F.2d 588, 194 USPQ 470 (CCPA 1977), cert. denied, 434 U.S. 1064 (1978). See also, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-685, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015) (reversing and remanding the district court's grant of summary judgment of invalidity for lack of an adequate written description and lack of enablement because there were genuine issues of material fact regarding 1) whether the claims had sufficient written description support (“[t]he fact that… the specification do[es] not speak in haec verba of accessing ‘disparate databases’ does not eliminate as a genuine issue of material fact that the existence of at least some discussion, and therefore, possession, of the accessing of disparate databases, as claimed”); and 2) whether the claims were enabled (“the effort it took the inventor to reduce the invention to practice does not conclusively show lack of enablement”). An invention may be described without the disclosure being enabling (e.g., a chemical compound for which there is no disclosed or apparent method of making), and a disclosure could be enabling without describing the invention (e.g., a specification describing a method of making and using a paint composition made of functionally defined ingredients within broad ranges would be enabling for formulations falling within the description but would not describe any specific formulation). See In re Armbruster, 512 F.2d 676, 677, 185 USPQ 152, 153 (CCPA 1975) (“[A] specification which ‘describes’ does not necessarily also ‘enable’ one skilled in the art to make or use the claimed invention.”). Best mode is a separate and distinct requirement from the enablement requirement. In re Newton, 414 F.2d 1400, 163 USPQ 34 (CCPA 1969).
Citations
| Primary topic | Citation |
|---|---|
| 35 U.S.C. 112(a) – Written Description & Enablement AIA Effective Dates AIA vs Pre-AIA Practice Composition of Matter Claims Determining Whether Application Is AIA or Pre-AIA Enablement Support for Claims Scope Commensurate with Disclosure | 35 U.S.C. § 112 |
| AIA vs Pre-AIA Practice | 35 U.S.C. § 112(a) |
| 35 U.S.C. 112(a) – Written Description & Enablement Composition of Matter Claims Determining Whether Application Is AIA or Pre-AIA Enablement Support for Claims Scope Commensurate with Disclosure | In re Armbruster, 512 F.2d 676, 677, 185 USPQ 152, 153 (CCPA 1975) |
| 35 U.S.C. 112(a) – Written Description & Enablement Composition of Matter Claims Determining Whether Application Is AIA or Pre-AIA Enablement Support for Claims Scope Commensurate with Disclosure | In re Barker, 559 F.2d 588, 194 USPQ 470 (CCPA 1977) |
| 35 U.S.C. 112(a) – Written Description & Enablement Composition of Matter Claims Determining Whether Application Is AIA or Pre-AIA Enablement Support for Claims Scope Commensurate with Disclosure | In re Newton, 414 F.2d 1400, 163 USPQ 34 (CCPA 1969) |
| 35 U.S.C. 112(a) – Written Description & Enablement Composition of Matter Claims Determining Whether Application Is AIA or Pre-AIA Enablement Support for Claims Scope Commensurate with Disclosure | Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562, 19 USPQ2d 1111, 1115 (Fed. Cir. 1991) |
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 § 2161 — Three Separate Requirements for Specification Under 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, First Paragraph
Source: USPTO2161 Three Separate Requirements for Specification Under 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, First Paragraph [R-07.2015]
I. THE SPECIFICATION MUST INCLUDE A WRITTEN DESCRIPTION OF THE INVENTION, ENABLEMENT, AND BEST MODE OF CARRYING OUT THE CLAIMED INVENTION(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The first paragraph of pre-AIA 35 U.S.C. 112 (applicable to applications filed before September 16, 2012) provides:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. [emphasis added].
35 U.S.C. 112(a) and pre-AIA 35 U.S.C. 112, first paragraph require that the specification include the following:
- (A) A written description of the invention;
- (B) The manner and process of making and using the invention (the enablement requirement); and
- (C) The best mode contemplated by the inventor of carrying out his invention.
The written description requirement is separate and distinct from the enablement requirement. Ariad Pharm., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1341, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010) (en banc) (If Congress had intended enablement to be the sole description requirement of § 112, first paragraph, the statute would have been written differently.) Vas-Cath, Inc.v.Mahurkar, 935 F.2d 1555, 1562, 19 USPQ2d 1111, 1115 (Fed. Cir. 1991) (While acknowledging that some of its cases concerning the written description requirement and the enablement requirement are confusing, the Federal Circuit reaffirmed that under 35 U.S.C. 112, first paragraph, the written description requirement is separate and distinct from the enablement requirement and gave an example thereof.); In re Barker, 559 F.2d 588, 194 USPQ 470 (CCPA 1977), cert. denied, 434 U.S. 1064 (1978). See also, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-685, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015) (reversing and remanding the district court’s grant of summary judgment of invalidity for lack of an adequate written description and lack of enablement because there were genuine issues of material fact regarding 1) whether the claims had sufficient written description support (“[t]he fact that . . . the specification do[es] not speak in haec verba of accessing ‘disparate databases’ does not eliminate as a genuine issue of material fact that the existence of at least some discussion, and therefore, possession, of the accessing of disparate databases, as claimed”); and 2) whether the claims were enabled (“the effort it took the inventor to reduce the invention to practice does not conclusively show lack of enablement”). An invention may be described without the disclosure being enabling (e.g., a chemical compound for which there is no disclosed or apparent method of making), and a disclosure could be enabling without describing the invention (e.g., a specification describing a method of making and using a paint composition made of functionally defined ingredients within broad ranges would be enabling for formulations falling within the description but would not describe any specific formulation). See In reArmbruster, 512 F.2d 676, 677, 185 USPQ 152, 153 (CCPA 1975) (“[A] specification which ‘describes’ does not necessarily also ‘enable’ one skilled in the art to make or use the claimed invention.”). Best mode is a separate and distinct requirement from the enablement requirement. In reNewton, 414 F.2d 1400, 163 USPQ 34 (CCPA 1969).