MPEP § 2104 — Requirements of 35 U.S.C. 101 (Annotated Rules)
§2104 Requirements of 35 U.S.C. 101
This page consolidates and annotates all enforceable requirements under MPEP § 2104, 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.
Requirements of 35 U.S.C. 101
This section addresses Requirements of 35 U.S.C. 101. Primary authority: 35 U.S.C. 101, 35 U.S.C. 102, and 35 U.S.C. 102(f). Contains: 1 requirement, 2 guidance statements, 3 permissions, and 11 other statements.
Key Rules
Patent Eligibility
35 U.S.C. 101 requires that whoever invents or discovers an eligible invention may obtain only ONE patent therefor. Thus, it prevents two patents issuing on the same invention to the same inventor (i.e., the same inventive entity) or where there is a common (joint) inventor or common applicant/assignee. The “same invention” means that identical subject matter is being claimed. This requirement forms the basis for statutory double patenting rejections. If more than one patent is sought, a patent applicant will receive a statutory double patenting rejection for claims included in more than one application that are directed to the same invention.
35 U.S.C. 101 requires that whoever invents or discovers an eligible invention may obtain only ONE patent therefor. Thus, it prevents two patents issuing on the same invention to the same inventor (i.e., the same inventive entity) or where there is a common (joint) inventor or common applicant/assignee. The “same invention” means that identical subject matter is being claimed. This requirement forms the basis for statutory double patenting rejections. If more than one patent is sought, a patent applicant will receive a statutory double patenting rejection for claims included in more than one application that are directed to the same invention.
35 U.S.C. 101 requires that whoever invents or discovers an eligible invention may obtain only ONE patent therefor. Thus, it prevents two patents issuing on the same invention to the same inventor (i.e., the same inventive entity) or where there is a common (joint) inventor or common applicant/assignee. The “same invention” means that identical subject matter is being claimed. This requirement forms the basis for statutory double patenting rejections. If more than one patent is sought, a patent applicant will receive a statutory double patenting rejection for claims included in more than one application that are directed to the same invention.
35 U.S.C. 101 requires that whoever invents or discovers an eligible invention may obtain only ONE patent therefor. Thus, it prevents two patents issuing on the same invention to the same inventor (i.e., the same inventive entity) or where there is a common (joint) inventor or common applicant/assignee. The “same invention” means that identical subject matter is being claimed. This requirement forms the basis for statutory double patenting rejections. If more than one patent is sought, a patent applicant will receive a statutory double patenting rejection for claims included in more than one application that are directed to the same invention.
A claimed invention must be eligible for patenting. As explained in MPEP § 2106, there are two criteria for determining subject matter eligibility: (a) first, a claimed invention must fall within one of the four statutory categories of invention set forth in 35 U.S.C. 101, i.e., process, machine, manufacture, or composition of matter; and (b) second, a claimed invention must be directed to patent-eligible subject matter and not a judicial exception (unless the claim as a whole includes additional limitations amounting to significantly more than the exception). The judicial exceptions are subject matter which courts have found to be outside of, or exceptions to, the four statutory categories of invention, and are limited to abstract ideas, laws of nature and natural phenomena (including products of nature). Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 216, 110 USPQ2d 1976, 1980 (2014) (citing Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 66, 70, 106 USPQ2d 1972, 1979 (2013)). See also Bilski v. Kappos, 561 U.S. 593, 601, 95 USPQ2d 1001, 1005-06 (2010) (citing Diamond v. Chakrabarty, 447 U.S. 303, 309, 206 USPQ 193, 197 (1980)).
See MPEP § 2106 for a discussion of subject matter eligibility in general, and the analytical framework that is to be used during examination for evaluating whether a claim is drawn to patent-eligible subject matter, MPEP § 2106.03 for a discussion of the statutory categories of invention, MPEP § 2106.04 for a discussion of the judicial exceptions, and MPEP § 2106.05 for a discussion of how to evaluate claims directed to a judicial exception for eligibility. See MPEP § 2106.07(a)(1) for form paragraphs for use in rejections under 35 U.S.C. 101 based on a lack of subject matter eligibility. See also MPEP § 2105 for more information about claiming living subject matter, as well as the Leahy-Smith America Invents Act (AIA)'s prohibition against claiming human organisms.
Specific, Substantial, and Credible Utility
A rejection on the ground of lack of utility is appropriate when (1) it is not apparent why the invention is “useful” because applicant has failed to identify any specific and substantial utility and there is no well established utility, or (2) an assertion of specific and substantial utility for the invention is not credible. Such a rejection can include the more specific grounds of inoperativeness, such as inventions involving perpetual motion. A rejection under 35 U.S.C. 101 for lack of utility should not be based on grounds that the invention is frivolous, fraudulent or against public policy. See Juicy Whip Inc. v. Orange Bang Inc., 185 F.3d 1364, 1367-68, 51 USPQ2d 1700, 1702-03 (Fed. Cir. 1999) (“[Y]ears ago courts invalidated patents on gambling devices on the ground that they were immoral…, but that is no longer the law…Congress never intended that the patent laws should displace the police powers of the States, meaning by that term those powers by which the health, good order, peace and general welfare of the community are promoted…we find no basis in section 101 to hold that inventions can be ruled unpatentable for lack of utility simply because they have the capacity to fool some members of the public.”).
A rejection on the ground of lack of utility is appropriate when (1) it is not apparent why the invention is “useful” because applicant has failed to identify any specific and substantial utility and there is no well established utility, or (2) an assertion of specific and substantial utility for the invention is not credible. Such a rejection can include the more specific grounds of inoperativeness, such as inventions involving perpetual motion. A rejection under 35 U.S.C. 101 for lack of utility should not be based on grounds that the invention is frivolous, fraudulent or against public policy. See Juicy Whip Inc. v. Orange Bang Inc., 185 F.3d 1364, 1367-68, 51 USPQ2d 1700, 1702-03 (Fed. Cir. 1999) (“[Y]ears ago courts invalidated patents on gambling devices on the ground that they were immoral…, but that is no longer the law…Congress never intended that the patent laws should displace the police powers of the States, meaning by that term those powers by which the health, good order, peace and general welfare of the community are promoted…we find no basis in section 101 to hold that inventions can be ruled unpatentable for lack of utility simply because they have the capacity to fool some members of the public.”).
A rejection on the ground of lack of utility is appropriate when (1) it is not apparent why the invention is “useful” because applicant has failed to identify any specific and substantial utility and there is no well established utility, or (2) an assertion of specific and substantial utility for the invention is not credible. Such a rejection can include the more specific grounds of inoperativeness, such as inventions involving perpetual motion. A rejection under 35 U.S.C. 101 for lack of utility should not be based on grounds that the invention is frivolous, fraudulent or against public policy. See Juicy Whip Inc. v. Orange Bang Inc., 185 F.3d 1364, 1367-68, 51 USPQ2d 1700, 1702-03 (Fed. Cir. 1999) (“[Y]ears ago courts invalidated patents on gambling devices on the ground that they were immoral…, but that is no longer the law…Congress never intended that the patent laws should displace the police powers of the States, meaning by that term those powers by which the health, good order, peace and general welfare of the community are promoted…we find no basis in section 101 to hold that inventions can be ruled unpatentable for lack of utility simply because they have the capacity to fool some members of the public.”).
A rejection on the ground of lack of utility is appropriate when (1) it is not apparent why the invention is “useful” because applicant has failed to identify any specific and substantial utility and there is no well established utility, or (2) an assertion of specific and substantial utility for the invention is not credible. Such a rejection can include the more specific grounds of inoperativeness, such as inventions involving perpetual motion. A rejection under 35 U.S.C. 101 for lack of utility should not be based on grounds that the invention is frivolous, fraudulent or against public policy. See Juicy Whip Inc. v. Orange Bang Inc., 185 F.3d 1364, 1367-68, 51 USPQ2d 1700, 1702-03 (Fed. Cir. 1999) (“[Y]ears ago courts invalidated patents on gambling devices on the ground that they were immoral…, but that is no longer the law…Congress never intended that the patent laws should displace the police powers of the States, meaning by that term those powers by which the health, good order, peace and general welfare of the community are promoted…we find no basis in section 101 to hold that inventions can be ruled unpatentable for lack of utility simply because they have the capacity to fool some members of the public.”).
35 U.S.C. 101 – Patent Eligibility
35 U.S.C. 101 has been interpreted as imposing four requirements, which are described below.
See MPEP § 804 for a full discussion of the prohibition against double patenting. Use form paragraphs 8.30, 8.31 and 8.32 for statutory double patenting rejections.
See MPEP § 804 for a full discussion of the prohibition against double patenting. Use form paragraphs 8.30, 8.31 and 8.32 for statutory double patenting rejections.
Utility Requirement
A rejection on the ground of lack of utility is appropriate when (1) it is not apparent why the invention is “useful” because applicant has failed to identify any specific and substantial utility and there is no well established utility, or (2) an assertion of specific and substantial utility for the invention is not credible. Such a rejection can include the more specific grounds of inoperativeness, such as inventions involving perpetual motion. A rejection under 35 U.S.C. 101 for lack of utility should not be based on grounds that the invention is frivolous, fraudulent or against public policy. See Juicy Whip Inc. v. Orange Bang Inc., 185 F.3d 1364, 1367-68, 51 USPQ2d 1700, 1702-03 (Fed. Cir. 1999) (“[Y]ears ago courts invalidated patents on gambling devices on the ground that they were immoral…, but that is no longer the law…Congress never intended that the patent laws should displace the police powers of the States, meaning by that term those powers by which the health, good order, peace and general welfare of the community are promoted…we find no basis in section 101 to hold that inventions can be ruled unpatentable for lack of utility simply because they have the capacity to fool some members of the public.”).
A rejection on the ground of lack of utility is appropriate when (1) it is not apparent why the invention is “useful” because applicant has failed to identify any specific and substantial utility and there is no well established utility, or (2) an assertion of specific and substantial utility for the invention is not credible. Such a rejection can include the more specific grounds of inoperativeness, such as inventions involving perpetual motion. A rejection under 35 U.S.C. 101 for lack of utility should not be based on grounds that the invention is frivolous, fraudulent or against public policy. See Juicy Whip Inc. v. Orange Bang Inc., 185 F.3d 1364, 1367-68, 51 USPQ2d 1700, 1702-03 (Fed. Cir. 1999) (“[Y]ears ago courts invalidated patents on gambling devices on the ground that they were immoral…, but that is no longer the law…Congress never intended that the patent laws should displace the police powers of the States, meaning by that term those powers by which the health, good order, peace and general welfare of the community are promoted…we find no basis in section 101 to hold that inventions can be ruled unpatentable for lack of utility simply because they have the capacity to fool some members of the public.”).
The statutory basis for this rejection is 35 U.S.C. 101. See MPEP § 2107 for guidelines governing rejections for lack of utility. See MPEP §§ 2107.01 – 2107.03 for legal precedent governing the utility requirement. See MPEP § 2107.02, subsection IV, for form paragraphs to be used to reject claims under 35 U.S.C. 101 for failure to satisfy the utility requirement.
Statutory Categories of Invention
Patents are not granted for all new and useful inventions and discoveries. For example, the subject matter of the invention or discovery must come within the boundaries set forth by 35 U.S.C. 101, which permits a patent to be granted only for “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.”
A claimed invention must be useful or have a utility that is specific, substantial and credible.
Composition of Matter
Patents are not granted for all new and useful inventions and discoveries. For example, the subject matter of the invention or discovery must come within the boundaries set forth by 35 U.S.C. 101, which permits a patent to be granted only for “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.”
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Significantly More Analysis
A claimed invention must be eligible for patenting. As explained in MPEP § 2106, there are two criteria for determining subject matter eligibility: (a) first, a claimed invention must fall within one of the four statutory categories of invention set forth in 35 U.S.C. 101, i.e., process, machine, manufacture, or composition of matter; and (b) second, a claimed invention must be directed to patent-eligible subject matter and not a judicial exception (unless the claim as a whole includes additional limitations amounting to significantly more than the exception). The judicial exceptions are subject matter which courts have found to be outside of, or exceptions to, the four statutory categories of invention, and are limited to abstract ideas, laws of nature and natural phenomena (including products of nature). Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 216, 110 USPQ2d 1976, 1980 (2014) (citing Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 66, 70, 106 USPQ2d 1972, 1979 (2013)). See also Bilski v. Kappos, 561 U.S. 593, 601, 95 USPQ2d 1001, 1005-06 (2010) (citing Diamond v. Chakrabarty, 447 U.S. 303, 309, 206 USPQ 193, 197 (1980)).
A claimed invention must be eligible for patenting. As explained in MPEP § 2106, there are two criteria for determining subject matter eligibility: (a) first, a claimed invention must fall within one of the four statutory categories of invention set forth in 35 U.S.C. 101, i.e., process, machine, manufacture, or composition of matter; and (b) second, a claimed invention must be directed to patent-eligible subject matter and not a judicial exception (unless the claim as a whole includes additional limitations amounting to significantly more than the exception). The judicial exceptions are subject matter which courts have found to be outside of, or exceptions to, the four statutory categories of invention, and are limited to abstract ideas, laws of nature and natural phenomena (including products of nature). Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 216, 110 USPQ2d 1976, 1980 (2014) (citing Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 66, 70, 106 USPQ2d 1972, 1979 (2013)). See also Bilski v. Kappos, 561 U.S. 593, 601, 95 USPQ2d 1001, 1005-06 (2010) (citing Diamond v. Chakrabarty, 447 U.S. 303, 309, 206 USPQ 193, 197 (1980)).
AIA Effective Dates
The inventor(s) must be the applicant in an application filed before September 16, 2012, (except as otherwise provided in pre-AIA 37 CFR 1.41(b)) and the inventor or each joint inventor must be identified in an application filed on or after September 16, 2012. See MPEP § 2109 for a detailed discussion of inventorship and MPEP § 602.01(c) et seq. for details regarding correction of inventorship.
Pre-AIA 102(f) – Derivation (MPEP 2137)
In the rare situation where it is clear the application does not name the correct inventorship and the applicant has not filed a request to correct inventorship under 37 CFR 1.48, the examiner should reject the claims under 35 U.S.C. 101 and 115 for applications subject to AIA 35 U.S.C. 102 (see MPEP § 2157) or under pre-AIA 35 U.S.C. 102(f) for applications subject to pre-AIA 35 U.S.C. 102 (see MPEP § 2137).
Alice/Mayo Two-Step Framework
A claimed invention must be eligible for patenting. As explained in MPEP § 2106, there are two criteria for determining subject matter eligibility: (a) first, a claimed invention must fall within one of the four statutory categories of invention set forth in 35 U.S.C. 101, i.e., process, machine, manufacture, or composition of matter; and (b) second, a claimed invention must be directed to patent-eligible subject matter and not a judicial exception (unless the claim as a whole includes additional limitations amounting to significantly more than the exception). The judicial exceptions are subject matter which courts have found to be outside of, or exceptions to, the four statutory categories of invention, and are limited to abstract ideas, laws of nature and natural phenomena (including products of nature). Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 216, 110 USPQ2d 1976, 1980 (2014) (citing Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 66, 70, 106 USPQ2d 1972, 1979 (2013)). See also Bilski v. Kappos, 561 U.S. 593, 601, 95 USPQ2d 1001, 1005-06 (2010) (citing Diamond v. Chakrabarty, 447 U.S. 303, 309, 206 USPQ 193, 197 (1980)).
Process (Method)
Eligible subject matter is further limited by the Atomic Energy Act explained in MPEP § 2104.01, which prohibits patents granted on any invention or discovery that is useful solely in the utilization of special nuclear material or atomic energy in an atomic weapon.
Citations
| Primary topic | Citation |
|---|---|
| 35 U.S.C. 101 – Patent Eligibility Alice/Mayo Two-Step Framework Composition of Matter Patent Eligibility Pre-AIA 102(f) – Derivation (MPEP 2137) Significantly More Analysis Specific, Substantial, and Credible Utility Statutory Categories of Invention Utility Requirement | 35 U.S.C. § 101 |
| Pre-AIA 102(f) – Derivation (MPEP 2137) | 35 U.S.C. § 102 |
| Pre-AIA 102(f) – Derivation (MPEP 2137) | 35 U.S.C. § 102(f) |
| AIA Effective Dates | 37 CFR § 1.41(b) |
| Pre-AIA 102(f) – Derivation (MPEP 2137) | 37 CFR § 1.48 |
| Process (Method) | MPEP § 2104.01 |
| Patent Eligibility | MPEP § 2105 |
| Alice/Mayo Two-Step Framework Patent Eligibility Significantly More Analysis | MPEP § 2106 |
| Patent Eligibility | MPEP § 2106.03 |
| Patent Eligibility | MPEP § 2106.04 |
| Patent Eligibility | MPEP § 2106.05 |
| Patent Eligibility | MPEP § 2106.07(a)(1) |
| Utility Requirement | MPEP § 2107 |
| Utility Requirement | MPEP § 2107.01 |
| Utility Requirement | MPEP § 2107.02 |
| AIA Effective Dates | MPEP § 2109 |
| Pre-AIA 102(f) – Derivation (MPEP 2137) | MPEP § 2137 |
| Pre-AIA 102(f) – Derivation (MPEP 2137) | MPEP § 2157 |
| AIA Effective Dates | MPEP § 602.01(c) |
| 35 U.S.C. 101 – Patent Eligibility | MPEP § 804 |
| Alice/Mayo Two-Step Framework Patent Eligibility Significantly More Analysis | citing Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 66, 70, 106 USPQ2d 1972, 1979 (2013) |
| Alice/Mayo Two-Step Framework Patent Eligibility Significantly More Analysis | citing Diamond v. Chakrabarty, 447 U.S. 303, 309, 206 USPQ 193, 197 (1980) |
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 § 2104 — Requirements of 35 U.S.C. 101
Source: USPTO2104 Requirements of 35 U.S.C. 101 [R-07.2022]
Patents are not granted for all new and useful inventions and discoveries. For example, the subject matter of the invention or discovery must come within the boundaries set forth by 35 U.S.C. 101, which permits a patent to be granted only for “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.”
35 U.S.C. 101 Inventions patentable.
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
35 U.S.C. 101 has been interpreted as imposing four requirements, which are described below.
I. DOUBLE PATENTING PROHIBITED35 U.S.C. 101 requires that whoever invents or discovers an eligible invention may obtain only ONE patent therefor. Thus, it prevents two patents issuing on the same invention to the same inventor (i.e., the same inventive entity) or where there is a common (joint) inventor or common applicant/assignee. The “same invention” means that identical subject matter is being claimed. This requirement forms the basis for statutory double patenting rejections. If more than one patent is sought, a patent applicant will receive a statutory double patenting rejection for claims included in more than one application that are directed to the same invention.
See MPEP § 804 for a full discussion of the prohibition against double patenting. Use form paragraphs 8.30, 8.31 and 8.32 for statutory double patenting rejections.
II. NAMING OF INVENTORThe inventor(s) must be the applicant in an application filed before September 16, 2012, (except as otherwise provided in pre-AIA 37 CFR 1.41(b)) and the inventor or each joint inventor must be identified in an application filed on or after September 16, 2012. See MPEP § 2109 for a detailed discussion of inventorship and MPEP § 602.01(c)et seq. for details regarding correction of inventorship.
In the rare situation where it is clear the application does not name the correct inventorship and the applicant has not filed a request to correct inventorship under 37 CFR 1.48, the examiner should reject the claims under 35 U.S.C. 101 and 115 for applications subject to AIA 35 U.S.C. 102 (see MPEP § 2157) or under pre-AIA 35 U.S.C. 102(f) for applications subject to pre-AIA 35 U.S.C. 102 (see MPEP § 2137).
III. SUBJECT MATTER ELIGIBILITYA claimed invention must be eligible for patenting. As explained in MPEP § 2106, there are two criteria for determining subject matter eligibility: (a) first, a claimed invention must fall within one of the four statutory categories of invention set forth in 35 U.S.C. 101, i.e., process, machine, manufacture, or composition of matter; and (b) second, a claimed invention must be directed to patent-eligible subject matter and not a judicial exception (unless the claim as a whole includes additional limitations amounting to significantly more than the exception). The judicial exceptions are subject matter which courts have found to be outside of, or exceptions to, the four statutory categories of invention, and are limited to abstract ideas, laws of nature and natural phenomena (including products of nature). Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208, 216, 110 USPQ2d 1976, 1980 (2014) (citing Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 66, 70, 106 USPQ2d 1972, 1979 (2013)). See also Bilski v. Kappos, 561 U.S. 593, 601, 95 USPQ2d 1001, 1005-06 (2010) (citing Diamond v. Chakrabarty, 447 U.S. 303, 309, 206 USPQ 193, 197 (1980)).
See MPEP § 2106 for a discussion of subject matter eligibility in general, and the analytical framework that is to be used during examination for evaluating whether a claim is drawn to patent-eligible subject matter, MPEP § 2106.03 for a discussion of the statutory categories of invention, MPEP § 2106.04 for a discussion of the judicial exceptions, and MPEP § 2106.05 for a discussion of how to evaluate claims directed to a judicial exception for eligibility. See MPEP § 2106.07(a)(1) for form paragraphs for use in rejections under 35 U.S.C. 101 based on a lack of subject matter eligibility. See also MPEP § 2105 for more information about claiming living subject matter, as well as the Leahy-Smith America Invents Act (AIA)’s prohibition against claiming human organisms.
Eligible subject matter is further limited by the Atomic Energy Act explained in MPEP § 2104.01, which prohibits patents granted on any invention or discovery that is useful solely in the utilization of special nuclear material or atomic energy in an atomic weapon.
IV. UTILITYA claimed invention must be useful or have a utility that is specific, substantial and credible.
A rejection on the ground of lack of utility is appropriate when (1) it is not apparent why the invention is “useful” because applicant has failed to identify any specific and substantial utility and there is no well established utility, or (2) an assertion of specific and substantial utility for the invention is not credible. Such a rejection can include the more specific grounds of inoperativeness, such as inventions involving perpetual motion. A rejection under 35 U.S.C. 101 for lack of utility should not be based on grounds that the invention is frivolous, fraudulent or against public policy. See Juicy Whip Inc. v. Orange Bang Inc., 185 F.3d 1364, 1367-68, 51 USPQ2d 1700, 1702-03 (Fed. Cir. 1999) (“[Y]ears ago courts invalidated patents on gambling devices on the ground that they were immoral…, but that is no longer the law…Congress never intended that the patent laws should displace the police powers of the States, meaning by that term those powers by which the health, good order, peace and general welfare of the community are promoted…we find no basis in section 101 to hold that inventions can be ruled unpatentable for lack of utility simply because they have the capacity to fool some members of the public.”).
The statutory basis for this rejection is 35 U.S.C. 101. See MPEP § 2107 for guidelines governing rejections for lack of utility. See MPEP §§ 2107.01 – 2107.03 for legal precedent governing the utility requirement. See MPEP § 2107.02, subsection IV, for form paragraphs to be used to reject claims under 35 U.S.C. 101 for failure to satisfy the utility requirement.