Chapter 2100 Patentability - uspto.gov

1 Chapter 2100 Patentability [Reserved]2101-2102 Patent Examination Process2103 Requirements of 35 1012104 Barred by Atomic Energy Patent Eligible Subject Matter Living Subject Matter2105 Patent Subject Matter Eligibility2106 [Reserved] [Reserved] Eligibility Step 1: The FourCategories of Statutory Subject Eligibility Step 2A: Whether a Claimis Directed to a Judicial Abstract (a) Examples of Claims That DoNot Recite Abstract (a)(1) Abstract Idea (a)(2) Tentative Abstract (a)(3) Laws of Nature, NaturalPhenomena & Products of (b) The Markedly DifferentCharacteristics (c) Integration of a JudicialException Into A (d) Evaluating Improvements inthe Functioning of (d)(1) Computer, or anImprovement to Any OtherTechnology or TechnicalField in Step 2A Prong TwoParticular Treatment andProphylaxis in Step 2A (d)(2)

2 Eligibility Step 2B: Whether a ClaimAmounts to Significantly Improvements to the Functioningof a Computer or To Any OtherTechnology or Technical (a) Particular (b) Particular (c) Well-Understood, Routine,Conventional (d) Other Meaningful (e) Mere Instructions To Apply (f) Insignificant (g) Field of Use and (h) Streamlined Eligibility is Self (a) Clear Improvement to aTechnology or to (b) Formulating and SupportingRejections For Lack Of SubjectMatter Formulating a Rejection For Lackof Subject Matter (a)

3 Form Paragraphs for use inLack of Subject MatterEligibility (a)(1) Evaluating Applicant's (b) Clarifying the (c) Guidelines for Examination ofApplications for Compliance with theUtility Requirement2107 General Principles Governing Procedural Considerations Related toRejections for Lack of Special Considerations for AssertedTherapeutic or [Reserved]2108 Inventorship2109 Joint [Reserved]2110 Claim Interpretation; BroadestReasonable Interpretation2111 Plain Effect of Transitional Adapted to, Adapted for, Wherein, Whereby, andContingent Functional and NonfunctionalDescriptive Requirements of Rejection Based onInherency; Burden of Proof2112 Composition, Product, and Process Product-by-Process Claims2113 Apparatus and Article Claims Functional Language2114 Material or Article Worked Upon byApparatus2115 [Reserved]2116 Rev.

4 , June 20202100-1 Novel, Nonobvious Starting Materialor End Markush Claims2117 [Reserved]2118-2119 Rejection on Prior Art2120 Rejections Under 35 102(a)(1)and (a)(2) and Pre-AIA 35 102(a), (b), or (e): Printed Publicationor PatentRejections Under 35 102(a)(1)or Pre-AIA 35 102(a) or (b) Knowledge by Others, or Public Use,or On SalePrior Art; General Level of OperabilityRequired to Make a Prima Facie Case2121 Use of Prior Art in Rejections WhereOperability is in Compounds and Compositions What Constitutes Enabling Prior Plant Genetics What ConstitutesEnabling Prior Apparatus and Articles WhatConstitutes Enabling Prior Discussion of Utility in the Prior Art2122 Rejection Over Prior Art s BroadDisclosure Instead of PreferredEmbodiments2123 Exception to the Rule That theReference Must be Prior Art2124 Tax Strategies Deemed

5 Within thePrior Drawings as Prior Art2125 Availability of a Document as a Patent for Purposes of Rejection2126 Under 35 102(a) or Pre-AIA 102(a), (b), and (d)Date of Availability of a Patent as Scope of Reference s DisclosureWhich Can Be Used to Reject When the Reference Is a Patent butNot a Publication Domestic and Foreign PatentApplications as Prior Art2127 Printed Publications as Prior Art2128 Level of Public Date Publication Is Available as Admissions as Prior Art2129 [Reserved]2130 Anticipation Application of 35 Multiple Reference 35 Genus-Species Anticipation of Secondary Nonanalogous or Disparaging Pre-AIA 35 102(a)

6 2132 Overcoming a Pre-AIA 35 (a) Rejection based on a PrintedPublication or Pre-AIA 35 102(b)2133 Rejections of Continuation-In-Part(CIP) Rejections Based on Publications Overcoming a Pre-AIA 35 (b) Rejection Based on aPrinted Publication or (a) Rejections Based on Public Use or On Sale Public Use (a) On Sale (b) The Invention (c) In This Country (d) Permitted Activity; (e) Commercial (e)(1) (e)(2) Completeness of (e)(3) Factors Indicative of anExperimental (e)(4) Experimentation and Degreeof Supervision and (e)(5) Permitted ExperimentalActivity and (e)(6) Activity of an IndependentThird Party (e)(7) Pre-AIA 35 102(c)2134 Pre-AIA 35 102(d)2135 The Four Requirements of Pre-AIA35 102(d) Pre-AIA 35 102(e)2136 Status of Unpublished or Publishedas Redacted Application as Reference Under Pre-AIA 35 (e)2100-2 Rev.

7 , June 2020 MANUAL OF PATENT EXAMINING PROCEDUREC ontent of the Prior Art AvailableAgainst the Critical Reference Different Inventive Entity; Meaningof By Another Overcoming a Rejection UnderPre-AIA 35 102(e) Antedating a Pre-AIA 35 (e) (a) Showing The Reference IsDescribing An Inventor's Or (b) Least One Joint Inventor's OwnWorkPre-AIA 35 102(f)2137 [Reserved] [Reserved] Pre-AIA 35 102(g)2138 Interference The Invention Was Made in ThisCountry By Another Who Has NotAbandoned, Suppressed, orConcealed It Conception Reduction to Practice Reasonable Diligence Rejections Under Pre-AIA 35 Effective Filing Date of a ClaimedInvention Under Pre-AIA 35 Determining Whether To ApplyPre-AIA 35 102(a), (b), or (e)

8 Form Paragraphs for Use inRejections Under Pre-AIA 35 [Reserved]2140 Examination Guidelines forDetermining Obviousness Under 1032141 Scope and Content of the Prior Analogous and Nonanalogous (a) Differences Between Prior Art andClaimed Level of Ordinary Skill in the Legal Concept of Prima FacieObviousness2142 Examples of Basic Requirements of aPrima Facie Case of Obviousness2143 Suggestion or Motivation To Modifythe Reasonable Expectation of SuccessIs All Claim Limitations Must Supporting a Rejection Under 35 Implicit Reliance on Scientific Reliance on Common Knowledge inthe Art or Well Known Prior Legal Precedent as Source ofSupporting Obviousness of Similar

9 AndOverlapping Ranges, Amounts, Art Recognized Equivalence for theSame Art Recognized Suitability for anIntended Obviousness of Species When PriorArt Teaches Close Structural Similarity BetweenChemical Compounds (Homologs,Analogues, Isomers) Consideration of Applicant s RebuttalArguments2145 Pre-AIA 35 103(c)2146 Prior Art Disqualification UnderPre-AIA 35 103(c) Establishing Common Ownership orJoint Research Agreement UnderPre-AIA 35 103(c) Examination Procedure With Respectto Pre-AIA 35 103(c) Provisional Rejection(Obviousness) Under 35 (a) 103 Using Provisional Prior ArtUnder Pre-AIA 35 102(e)Biotechnology Process Applications.

10 Pre-AIA 35 103(b)2147 Form Paragraphs for Use in RejectionsUnder Pre-AIA 35 1032148 [Reserved]2149 Examination Guidelines for 35 and 103 as Amended by the First2150 Inventor To File Provisions of theLeahy-Smith America Invents ActOverview of the Changes to 35 and 103 in the AIA2151 Detailed Discussion of AIA 35 (a) and (b)2152 Rev. , June 20202100-3 PATENTABILITYE ffective Filing Date of the Prior Art Under AIA 35 (a)(1) (Patented, Described in Printed Publication, or in Public Use,on Sale, or Otherwise Available to thePublic) (a) Described in a Printed (b) In Public (c) On (d) Otherwise Available to the (e) No Requirement of "By Others" (f) The Meaning of "Disclosure" Determining Whether To Apply 102(a)(1) or 102(a)(2) Overcoming a 35 102(a)(1) or102(a)(2)