Manual of Patent Examining Procedure (MPEP)
Chapter 2100: Patentability

Ninth Edition of the MPEP, Revision 08.2017, Last Revised in January 2018

Chapter 2100: Patentability

2101-2102: [Reserved]

2103: Patent Examination Process

2104: Inventions Patentable - Requirements of 35 U.S.C. 101

2105: Patent Eligible Subject Matter — Living Subject Matter

2106: Patent Subject Matter Eligibility

2106.01: [Reserved]

2106.02: [Reserved]

2106.03: Eligibility Step 1: The Four Categories of Statutory Subject Matter

2106.04: Eligibility Step 2: Whether a Claim is Directed to a Judicial Exception

2106.04(a): Abstract Ideas

2106.04(a)(1): Examples of Claims That Are Not Directed To Abstract Ideas

2106.04(a)(2): Examples of Concepts The Courts Have Identified As Abstract Ideas

2106.04(b): Laws of Nature, Natural Phenomena & Products of Nature

2106.04(c): The Markedly Different Characteristics Analysis

2106.05: Eligibility Step 2B: Whether a Claim Amounts to Significantly More

2106.05(a): Improvements to the Functioning of a Computer or To Any Other Technology or Technical Field

2106.05(b): Particular Machine

2106.05(c): Particular Transformation

2106.05(d): Well-Understood, Routine, Conventional Activity

2106.05(e): Other Meaningful Limitations

2106.05(f): Mere Instructions To Apply An Exception

2106.05(g): Insignificant Extra-Solution Activity

2106.05(h): Field of Use and Technological Environment

2106.06: Streamlined Analysis

2106.06(a): Eligibility is Self Evident

2106.06(b): Clear Improvement to a Technology or to Computer Functionality

2106.07: Formulating and Supporting Rejections For Lack Of Subject Matter Eligibility

2106.07(a): Formulating a Rejection For Lack of Subject Matter Eligibility

2106.07(b): Evaluating Applicant's Response

2106.07(c): Clarifying the Record

2107: Guidelines for Examination of Applications for Compliance with the Utility Requirement

2107.01: General Principles Governing Utility Rejections

2107.02: Procedural Considerations Related to Rejections for Lack of Utility

2107.03: Special Considerations for Asserted Therapeutic or Pharmacological Utilities

2108-2110: [Reserved]

2111: Claim Interpretation; Broadest Reasonable Interpretation

2111.01: Plain Meaning

2111.02: Effect of Preamble

2111.03: Transitional Phrases

2111.04: “Adapted to,” “Adapted for,” “Wherein,” “Whereby,” and Contingent Clauses

2111.05: Functional and Nonfunctional Descriptive Material

2112: Requirements of Rejection Based on Inherency; Burden of Proof

2112.01: Composition, Product, and Apparatus Claims

2112.02: Process Claims

2113: Product-by-Process Claims

2114: Apparatus and Article Claims — Functional Language

2115: Material or Article Worked Upon by Apparatus

2116: [Reserved]

2116.01: Novel, Unobvious Starting Material or End Product

2117: Markush Claims

2118-2120: [Reserved]

2121: Prior Art; General Level of Operability Required to Make a Prima Facie Case

2121.01: Use of Prior Art in Rejections Where Operability is in Question

2121.02: Compounds and Compositions — What Constitutes Enabling Prior Art

2121.03: Plant Genetics — What Constitutes Enabling Prior Art

2121.04: Apparatus and Articles — What Constitutes Enabling Prior Art

2122: Discussion of Utility in the Prior Art

2123: Rejection Over Prior Art’s Broad Disclosure Instead of Preferred Embodiments

2124: Exception to the Rule That the Critical Reference Date Must Precede the Filing Date

2124.01: Tax Strategies Deemed Within the Prior Art

2125: Drawings as Prior Art

2126: Availability of a Document as a “Patent” for Purposes of Rejection Under 35 U.S.C. 102(a) or Pre-AIA 35 U.S.C. 102(a), (b), and (d)

2126.01: Date of Availability of a Patent as a Reference

2126.02: Scope of Reference’s Disclosure Which Can Be Used to Reject Claims When the Reference Is a “Patent” but Not a “Publication”

2127: Domestic and Foreign Patent Applications as Prior Art

2128: “Printed Publications” as Prior Art

2128.01: Level of Public Accessibility Required

2128.02: Date Publication Is Available as a Reference

2129: Admissions as Prior Art

2130: [Reserved]

2131: Anticipation — Application of 35 U.S.C. 102

2131.01: Multiple Reference 35 U.S.C. 102 Rejections

2131.02: Genus-Species Situations

2131.03: Anticipation of Ranges

2131.04: Secondary Considerations

2131.05: Nonanalogous or Disparaging Prior Art

2132: Pre-AIA 35 U.S.C. 102(a)

2132.01: Publications as Pre-AIA 35 U.S.C. 102(a) Prior Art

2133: Pre-AIA 35 U.S.C. 102(b)

2133.01: Rejections of Continuation-In-Part (CIP) Applications

2133.02: Rejections Based on Publications and Patents

2133.03: Rejections Based on “Public Use” or “On Sale”

2133.03(a): “Public Use”

2133.03(b): “On Sale”

2133.03(c): The “Invention”

2133.03(d): “In This Country”

2133.03(e): Permitted Activity; Experimental Use

2133.03(e)(1): Commercial Exploitation

2133.03(e)(2): Intent

2133.03(e)(3): “Completeness” of the Invention

2133.03(e)(4): Factors Indicative of an Experimental Purpose

2133.03(e)(5): Experimentation and Degree of Supervision and Control

2133.03(e)(6): Permitted Experimental Activity and Testing

2133.03(e)(7): Activity of an Independent Third Party Inventor

2134: Pre-AIA 35 U.S.C. 102(c)

2135: Pre-AIA 35 U.S.C. 102(d)

2135.01: The Four Requirements of Pre-AIA 35 U.S.C. 102(d)

2136: Pre-AIA 35 U.S.C. 102(e)

2136.01: Status of U.S. Application as a Reference

2136.02: Content of the Prior Art Available Against the Claims

2136.03: Critical Reference Date

2136.04: Different Inventive Entity; Meaning of “By Another”

2136.05: Overcoming a Rejection Under Pre-AIA 35 U.S.C. 102(e)

2137: Pre-AIA 35 U.S.C. 102(f)

2137.01: Inventorship

2137.02: Applicability of Pre-AIA 35 U.S.C. 103(c)

2138: Pre-AIA 35 U.S.C. 102(g)

2138.01: Interference Practice

2138.02: “The Invention Was Made in This Country”

2138.03: “By Another Who Has Not Abandoned, Suppressed, or Concealed It”

2138.04: “Conception”

2138.05: “Reduction to Practice”

2138.06: “Reasonable Diligence”

2139-2140: [Reserved]

2141: Examination Guidelines for Determining Obviousness Under 35 U.S.C. 103

2141.01: Scope and Content of the Prior Art

2141.01(a): Analogous and Nonanalogous Art

2141.02: Differences Between Prior Art and Claimed Invention

2141.03: Level of Ordinary Skill in the Art

2142: Legal Concept of Prima Facie Obviousness

2143: Examples of Basic Requirements of a Prima Facie Case of Obviousness

2143.01: Suggestion or Motivation To Modify the References

2143.02: Reasonable Expectation of Success Is Required

2143.03: All Claim Limitations Must Be Considered

2144: Supporting a Rejection Under 35 U.S.C. 103

2144.01: Implicit Disclosure

2144.02: Reliance on Scientific Theory

2144.03: Reliance on Common Knowledge in the Art or “Well Known” Prior Art

2144.04: Legal Precedent as Source of Supporting Rationale

2144.05: Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions

2144.06: Art Recognized Equivalence for the Same Purpose

2144.07: Art Recognized Suitability for an Intended Purpose

2144.08: Obviousness of Species When Prior Art Teaches Genus

2144.09: Close Structural Similarity Between Chemical Compounds (Homologs, Analogues, Isomers)

2145: Consideration of Applicant’s Rebuttal Arguments

2146: Pre-AIA 35 U.S.C. 103(c)

2147-2149: [Reserved]

2150: Examination Guidelines for 35 U.S.C. 102 and 103 as Amended by the First Inventor To File Provisions of the Leahy-Smith America Invents Act

2151: Overview of the Changes to 35 U.S.C. 102 and 103 in the AIA

2152: Detailed Discussion of AIA 35 U.S.C. 102(a) and (b)

2152.01: Effective Filing Date of the Claimed Invention

2152.02: Prior Art Under AIA 35 U.S.C. 102(a)(1) (Patented, Described in a Printed Publication, or in Public Use, on Sale, or Otherwise Available to the Public)

2152.02(a): Patented

2152.02(b): Described in a Printed Publication

2152.02(c): In Public Use

2152.02(d): On Sale

2152.02(e): Otherwise Available to the Public

2152.02(f): No Requirement of "By Others"

2152.03: Admissions

2152.04: The Meaning of "Disclosure"

2153: Prior Art Exceptions Under 35 U.S.C. 102(b)(1) to AIA 35 U.S.C. 102(a)(1)

2153.01: Prior Art Exception Under AIA 35 U.S.C. 102(b)(1)(A) To AIA 35 U.S.C. 102(a)(1) (Grace Period Inventor Or Inventor-Originated Disclosure Exception)

2153.01(a): Grace Period Inventor Disclosure Exception

2153.01(b): Grace Period Inventor-Originated Disclosure Exception

2153.02: Prior Art Exception Under AIA 35 U.S.C. 102(b)(1)(B) to AIA 35 U.S.C. 102(a)(1) (Inventor Or Inventor-Originated Prior Public Disclosure Exception)

2154: Provisions Pertaining to Subject Matter in a U.S. Patent or Application Effectively Filed Before the Effective Filing Date of the Claimed Invention

2154.01: Prior Art Under AIA 35 U.S.C. 102(a)(2) “U.S. Patent Documents”

2154.01(a): WIPO Published Applications

2154.01(b): Determining When Subject Matter Was Effectively Filed Under AIA 35 U.S.C. 102(d)

2154.01(c): Requirement Of “Names Another Inventor”

2154.02: Prior Art Exceptions Under 35 U.S.C. 102(b)(2) to AIA 35 U.S.C. 102(a)(2)

2154.02(a): Prior Art Exception Under AIA 35 U.S.C. 102(b)(2)(A) to AIA 35 U.S.C. 102(a)(2) (Inventor-Originated Disclosure Exception)

2154.02(b): Prior Art Exception Under AIA 35 U.S.C. 102(b)(2)(B) to AIA 35 U.S.C. 102(a)(2) (Inventor or Inventor-Originated Prior Public Disclosure Exception)

2154.02(c): Prior Art Exception Under AIA 35 U.S.C. 102(b)(2)(C) to AIA 35 U.S.C. 102(a)(2) (Common Ownership or Obligation of Assignment)

2155: Use of Affidavits or Declarations Under 37 CFR 1.130 To Overcome Prior Art Rejections

2155.01: Showing That the Disclosure Was Made by the Inventor or a Joint Inventor

2155.02: Showing That the Subject Matter Disclosed Had Been Previously Publicly Disclosed by the Inventor or a Joint Inventor

2155.03: Showing That the Disclosure was Made, or That Subject Matter had Been Previously Publicly Disclosed, by Another Who Obtained the Subject Matter Disclosed Directly or Indirectly From the Inventor or a Joint Inventor

2155.04: Enablement

2155.05: Who May File an Affidavit or Declaration Under 37 CFR 1.130

2155.06: Situations in Which an Affidavit or Declaration Is Not Available

2156: Joint Research Agreements

2157: Improper Naming of Inventors

2158: AIA 35 U.S.C. 103

2159: Applicability Date Provisions and Determining Whether an Application Is Subject to the First Inventor To File Provisions of the AIA

2159.01: Applications Filed Before March 16, 2013

2159.02: Applications Filed on or After March 16, 2013

2159.03: Applications Subject to the AIA but Also Containing a Claimed Invention Having an Effective Filing Date Before March 16, 2013

2159.04: Applicant Statement in Transition Applications Containing a Claimed Invention Having an Effective Filing Date on or After March 16, 2013

2160: [Reserved]

2161: Three Separate Requirements for Specification Under 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, First Paragraph

2161.01: Computer Programming, Computer Implemented Inventions, and 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, First Paragraph

2162: Policy Underlying 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, First Paragraph

2163: Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, first paragraph, “Written Description” Requirement

2163.01: Support for the Claimed Subject Matter in Disclosure

2163.02: Standard for Determining Compliance With the Written Description Requirement

2163.03: Typical Circumstances Where Adequate Written Description Issue Arises

2163.04: Burden on the Examiner with Regard to the Written Description Requirement

2163.05: Changes to the Scope of Claims

2163.06: Relationship of Written Description Requirement to New Matter

2163.07: Amendments to Application Which Are Supported in the Original Description

2163.07(a): Inherent Function, Theory, or Advantage

2163.07(b): Incorporation by Reference

2164: The Enablement Requirement

2164.01: Test of Enablement

2164.01(a): Undue Experimentation Factors

2164.01(b): How to Make the Claimed Invention

2164.01(c): How to Use the Claimed Invention

2164.02: Working Example

2164.03: Relationship of Predictability of the Art and the Enablement Requirement

2164.04: Burden on the Examiner Under the Enablement Requirement

2164.05: Determination of Enablement Based on Evidence as a Whole

2164.05(a): Specification Must Be Enabling as of the Filing Date

2164.05(b): Specification Must Be Enabling to Persons Skilled in the Art

2164.06: Quantity of Experimentation

2164.06(a): Examples of Enablement Issues-Missing Information

2164.06(b): Examples of Enablement Issues — Chemical Cases

2164.06(c): Examples of Enablement Issues – Computer Programming Cases

2164.07: Relationship of Enablement Requirement to Utility Requirement of 35 U.S.C. 101

2164.08: Enablement Commensurate in Scope With the Claims

2164.08(a): Single Means Claim

2164.08(b): Inoperative Subject Matter

2164.08(c): Critical Feature Not Claimed

2165: The Best Mode Requirement

2165.01: Considerations Relevant to Best Mode

2165.02: Best Mode Requirement Compared to Enablement Requirement

2165.03: Requirements for Rejection for Lack of Best Mode

2165.04: Examples of Evidence of Concealment

2166-2170: [Reserved]

2171: Two Separate Requirements for Claims Under 35 U.S.C. 112 (b) or Pre-AIA 35 U.S.C. 112, Second Paragraph

2172: Subject Matter Which the Inventor or a Joint Inventor Regards as The Invention

2172.01: Unclaimed Essential Matter

2173: Claims Must Particularly Point Out and Distinctly Claim the Invention

2173.01: Interpreting the Claims

2173.02: Determining Whether Claim Language is Definite

2173.03: Correspondence Between Specification and Claims

2173.04: Breadth Is Not Indefiniteness

2173.05: Specific Topics Related to Issues Under 35 U.S.C. 112(b) or Pre-AIA 35 U.S.C. 112, Second Paragraph

2173.05(a): New Terminology

2173.05(b): Relative Terminology

2173.05(c): Numerical Ranges and Amounts Limitations

2173.05(d): Exemplary Claim Language (“for example,” “such as”)

2173.05(e): Lack of Antecedent Basis

2173.05(f): Reference to Limitations in Another Claim

2173.05(g): Functional Limitations

2173.05(h): Alternative Limitations

2173.05(i): Negative Limitations

2173.05(j): Old Combination

2173.05(k): Aggregation

2173.05(l): [Reserved]

2173.05(m): Prolix

2173.05(n): Multiplicity

2173.05(o): Double Inclusion

2173.05(p): Claim Directed to Product-By- Process or Product and Process

2173.05(q): “Use” Claims

2173.05(r): Omnibus Claim

2173.05(s): Reference to Figures or Tables

2173.05(t): Chemical Formula

2173.05(u): Trademarks or Trade Names in a Claim

2173.05(v): Mere Function of Machine

2173.06: Practice Compact Prosecution

2174: Relationship Between the Requirements of 35 U.S.C. 112(a) and (b) or Pre-AIA 35 U.S.C. 112, First and Second Paragraphs

2175-2180: [Reserved]

2181: Identifying and Interpreting a 35 U.S.C. 112(f) or Pre-AIA 35 U.S.C. 112, Sixth Paragraph Limitation

2182: Search and Identification of the Prior Art

2183: Making a Prima Facie Case of Equivalence

2184: Determining Whether an Applicant Has Met the Burden of Proving Nonequivalence After a Prima Facie Case Is Made

2185: Related Issues Under 35 U.S.C. 112(a) or (b) and Pre-AIA 35 U.S.C. 112, First or Second Paragraphs

2186: Relationship to the Doctrine of Equivalents

2187-2189: [Reserved]

2190: Prosecution Laches