MPEP 2100

Patentability

Brief Summary:

Determining whether specific subject matter is patentable is a very difficult task. Therefore, the PTO has many rules and guidelines used to help sort out this dilemma. The patentability guidelines extend to living subject matter and computer related inventions as well as basic engineering designs.

The statutes under 35 U.S.C. 101, 102 and 103 are used to reject an application’s disclosed subject matter. 35 U.S.C. 101 discusses the types of inventions that are patentable. 35 U.S.C. 102 discusses the conditions for patenting in as far as their novelty requirements and the loss of the right to patent. 35 U.S.C. 103 states the conditions for patenting in relation to non-obvious subject matter.

The requirements for the specification are outlined in the paragraphs of 35 U.S.C. 112. The general requirements for a specification can be broken down into three basic categories; the written description, the enablement and the best mode.

Key Terms:

Best ModeThe Best Mode requirement mandates that a patent application must disclose the best method known to the inventor for carrying out the invention at the time of filing.
Compositions of MatterCompositions of Matter refers to chemical compositions, including mixtures and compounds of ingredients, that can be patented if they are new, useful, and non-obvious.
Enabling DisclosureEnabling Disclosure requires that a patent application provide sufficient information for someone skilled in the relevant field to make and use the invention without undue experimentation.
ObviousnessObviousness is a criterion for patentability that assesses whether an invention is sufficiently inventive or if it would be obvious to someone with ordinary skill in the relevant field, based on prior art.
Patentable Subject MatterPatentable Subject Matter refers to the types of inventions or discoveries that can be legally protected by a patent, typically including processes, machines, manufactures, and compositions of matter, but excluding abstract ideas, natural phenomena, and laws of nature.
Written DescriptionThe “Written Description” requirement mandates that a patent application clearly describe the invention in sufficient detail to demonstrate that the inventor was in possession of the claimed invention at the time of filing.

35 USC (United States Code):

35 USC 101 – Inventions patentable.
35 USC 101 defines that any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, is eligible for patent protection in the United States.
35 USC 112 – Specification.
35 USC 112 requires a patent application to include a written specification that clearly describes the invention, enabling a person skilled in the art to make and use it, and to distinctly claim the subject matter regarded as the invention.

Quick Statistics:

Number of Pages:  524 pgs
Sections:  2101 – 2190

List of Sections:

2101 – 2102[Reserved]
2103Patent Examination Process
2104Requirements of 35 U.S.C. 101
 2104.01 Barred by Atomic Energy Act
2105Patent Eligible Subject Matter — Living Subject Matter
2106Patent 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 2A: Whether a Claim is Directed to a Judicial Exception
 2106.04(a) Abstract Ideas
 2106.04(a)(1) Examples of Claims That Do Not Recite Abstract Ideas
 2106.04(a)(2) Abstract Idea Groupings
 2106.04(a)(3) Tentative Abstract Ideas
 2106.04(b) Laws of Nature, Natural Phenomena & Products of Nature
 2106.04(c) The Markedly Different Characteristics Analysis
 2106.04(d) Integration of a Judicial Exception Into A Practical Application
 2106.04(d)(1) Evaluating Improvements in the Functioning of a Computer, or an Improvement to Any Other Technology or Technical Field in Step 2A Prong Two
 2106.04(d)(2) Particular Treatment and Prophylaxis in Step 2A Prong Two
 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(a)(1) Form Paragraphs for use in Lack of Subject Matter Eligibility Rejections
 2106.07(b) Evaluating Applicant’s Response
 2106.07(c) Clarifying the Record
2107Guidelines 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[Reserved]
2109Inventorship
 2109.01 Joint Inventorship
2110[Reserved]
2111Claim 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
2112Requirements of Rejection Based on Inherency; Burden of Proof
 2112.01 Composition, Product, and Apparatus Claims
 2112.02 Process Claims
2113Product-by-Process Claims
2114Apparatus and Article Claims — Functional Language
2115Material or Article Worked Upon by Apparatus
2116Novel, Nonobvious Starting Material or End Product
 2116.01 Novel, Nonobvious Starting Material or End Product
2117Markush Claims
2118 – 2119[Reserved]
2120Rejection on Prior Art
 2120.01 Rejections Under 35 U.S.C. 102(a)(1) and (a)(2) and Pre-AIA 35 U.S.C. 102(a), (b), or (e): Printed Publication or Patent
 2120.02 Rejections Under 35 U.S.C. 102(a)(1) or Pre-AIA 35 U.S.C. 102(a) or (b): Knowledge by Others, or Public Use, or On Sale
2121Prior 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
2122Discussion of Utility in the Prior Art
2123Rejection Over Prior Art’s Broad Disclosure Instead of Preferred Embodiments
2124Exception to the Rule That the Reference Must be Prior Art
 2124.01 Tax Strategies Deemed Within the Prior Art
2125Drawings as Prior Art
2126Availability 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”
2127Domestic 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
2129Admissions as Prior Art
2130[Reserved]
2131Anticipation — 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
2132Pre-AIA 35 U.S.C. 102(a)
 2132.01 Overcoming a Pre-AIA 35 U.S.C. 102(a) Rejection based on a Printed Publication or Patent
2133Pre-AIA 35 U.S.C. 102(b)
 2133.01 Rejections of Continuation-In-Part (CIP) Applications
 2133.02 Rejections Based on Publications and Patents
 2133.02(a) Overcoming a Pre-AIA 35 U.S.C. 102(b) Rejection Based on a Printed Publication or Patent
 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
2134Pre-AIA 35 U.S.C. 102(c)
2135Pre-AIA 35 U.S.C. 102(d)
 2135.01 The Four Requirements of Pre-AIA 35 U.S.C. 102(d)
2136Pre-AIA 35 U.S.C. 102(e)
 2136.01 Status of Unpublished or Published as Redacted U.S. Application as a Reference Under Pre-AIA 35 U.S.C. 102(e)
 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)
 2136.05(a) Antedating a Pre-AIA 35 U.S.C. 102(e) Reference
 2136.05(b) Showing The Reference Is Describing An Inventor’s Or At Least One Joint Inventor’s Own Work
2137Pre-AIA 35 U.S.C. 102(f)
 2137.01 [Reserved]
 2137.02 [Reserved]
2138Pre-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”
2139Rejections Under Pre-AIA 35 U.S.C. 102
 2139.01 Effective Filing Date of a Claimed Invention Under Pre-AIA 35 U.S.C. 102
 2139.02 Determining Whether To Apply Pre-AIA 35 U.S.C. 102(a), (b), or (e)
 2139.03 Form Paragraphs for Use in Rejections Under Pre-AIA 35 U.S.C. 102
2140[Reserved]
2141Examination 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
2142Legal Concept of Prima Facie Obviousness
2143Examples 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
2144Supporting 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)
2145Consideration of Applicant’s Rebuttal Arguments and Evidence
2146Pre-AIA 35 U.S.C. 103(c)
 2146.01 Prior Art Disqualification Under Pre-AIA 35 U.S.C. 103(c)
 2146.02 Establishing Common Ownership or Joint Research Agreement Under Pre-AIA 35 U.S.C. 103(c)
 2146.03 Examination Procedure With Respect to Pre-AIA 35 U.S.C. 103(c)
 2146.03(a) Provisional Rejection (Obviousness) Under 35 U.S.C. 103(a) Using Provisional Prior Art Under Pre-AIA 35 U.S.C. 102(e)
2147Biotechnology Process Applications; Pre-AIA 35 U.S.C. 103(b)
2148Form Paragraphs for Use in Rejections Under Pre-AIA 35 U.S.C. 103
2149[Reserved]
2150Examination 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
2151Overview of the Changes to 35 U.S.C. 102 and 103 in the AIA
2152Detailed 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”
 2152.05 Determining Whether To Apply 35 U.S.C. 102(a)(1) or 102(a)(2)
 2152.06 Overcoming a 35 U.S.C. 102(a)(1) or 102(a)(2) Rejection
 2152.07 Form Paragraphs for Use in Rejections Under AIA 35 U.S.C. 102
2153Prior 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-Originated Disclosure Exception)
 2153.01(a) Grace Period Inventor-Originated Disclosure Exception
2153.01(b) [Reserved]
 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-Originated Prior Public Disclosure Exception)
2154Provisions 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”
 2154.01(d) Provisional Rejections Under 35 U.S.C. 102(a)(2); Reference Is a Copending U.S. Patent Application
 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-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)
2155Use 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
2156Joint Research Agreements
2157Improper Naming of Inventors
2158AIA 35 U.S.C. 103
 2158.01 Form Paragraphs for Use in Rejections Under AIA 35 U.S.C. 103
2159Applicability 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]
2161Three 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
2162Policy Underlying 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, First Paragraph
2163Guidelines 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
2164The 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 and Prophetic Examples
 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 — Biological and 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
2165The 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
2166Rejections Under 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, First Paragraph
2167 – 2170[Reserved]
2171Two Separate Requirements for Claims Under 35 U.S.C. 112 (b) or Pre-AIA 35 U.S.C. 112, Second Paragraph
2172Subject Matter Which the Inventor or a Joint Inventor Regards as The Invention
 2172.01 Unclaimed Essential Subject Matter
2173Claims 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
2174Relationship Between the Requirements of 35 U.S.C. 112(a) and (b) or Pre-AIA 35 U.S.C. 112, First and Second Paragraphs
2175Form Paragraphs for Use in Rejections Under 35 U.S.C. 112(b) or Pre-AIA 35 U.S.C. 112, Second Paragraph
2176 – 2180[Reserved]
2181Identifying and Interpreting a 35 U.S.C. 112(f) or Pre-AIA 35 U.S.C. 112, Sixth Paragraph Limitation
2182Search and Identification of the Prior Art
2183Making a Prima Facie Case of Equivalence
2184Determining Whether an Applicant Has Met the Burden of Proving Nonequivalence After a Prima Facie Case Is Made
2185Related Issues Under 35 U.S.C. 112(a) or (b) and Pre-AIA 35 U.S.C. 112, First or Second Paragraphs
2186Relationship to the Doctrine of Equivalents
2187Form Paragraphs for Use Relating to 35 U.S.C. 112(f) or Pre-AIA 35 U.S.C. 112, Sixth Paragraph
2188 – 2189[Reserved]
2190Prosecution Laches and Res Judicata

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