MANUAL OF PATENT EXAMINING PROCEDURE

as Redacted U.S. Application as a 2136.01 Reference Under Pre-AIA 35 U.S.C. 102(e) 2100-2 Rev. 01.2024, November 2024 MANUAL OF PATENT EXAMINING PROCEDURE Content of the Prior Art Available Against the Claims 2136.02 Critical Reference Date 2136.03 Different Inventive Entity; Meaning of “By Another” 2136.04 Overcoming a Rejection Under Pre-AIA 35 U.S.C. 102(e) 2136.05 Antedating a Pre-AIA 35 U.S.C. 102(e) Reference 2136.05(a) Showing The Reference Is Describing An Inventor's Or At 2136.05(b) Least One Joint Inventor's Own Work Pre-AIA 35 U.S.C. 102(f) 2137 [Reserved] 2137.01 [Reserved] 2137.02 Pre-AIA 35 U.S.C. 102(g) 2138 Interference Practice 2138.01 “The Invention Was Made in This Country” 2138.02 “By Another Who Has Not Abandoned, Suppressed, or Concealed It” 2138.03 “Conception” 2138.04 “Reduction to Practice” 2138.05 “Reasonable Diligence” 2138.06 Rejections Under Pre-AIA 35 U.S.C. 102 2139 Effective Filing Date of a Claimed Invention Under Pre-AIA 35 U.S.C. 102 2139.01 Determining Whether To Apply Pre-AIA 35 U.S.C. 102(a), (b), or (e) 2139.02 Form Paragraphs for Use in Rejections Under Pre-AIA 35 U.S.C. 102 2139.03 [Reserved] 2140 Examination Guidelines for Determining Obviousness Under 35 U.S.C. 103 2141 Scope and Content of the Prior Art 2141.01 Analogous and Nonanalogous Art 2141.01(a) Differences Between Prior Art and Claimed Invention 2141.02 Level of Ordinary Skill in the Art 2141.03 Legal Concept of Prima Facie Obviousness 2142 Examples of Basic Requirements of a Prima Facie Case of Obviousness 2143 Suggestion or Motivation To Modify the References 2143.01 Reasonable Expectation of Success Is Required 2143.02 All Claim Limitations Must Be Considered 2143.03 Supporting a Rejection Under 35 U.S.C. 103 2144 Implicit Disclosure 2144.01 Reliance on Scientific Theory 2144.02 Reliance on Common Knowledge in the Art or “Well Known” Prior Art 2144.03 Legal Precedent as Source of Supporting Rationale 2144.04 Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions 2144.05 Art Recognized Equivalence for the Same Purpose 2144.06 Art Recognized Suitability for an Intended Purpose 2144.07 Obviousness of Species When Prior Art Teaches Genus 2144.08 Close Structural Similarity Between Chemical Compounds (Homologs, Analogues, Isomers) 2144.09 Consideration of Applicant’s Rebuttal Arguments and Evidence 2145 Pre-AIA 35 U.S.C. 103(c) 2146 Prior Art Disqualification Under Pre-AIA 35 U.S.C. 103(c) 2146.01 Establishing Common Ownership or Joint Research Agreement Under Pre-AIA 35 U.S.C. 103(c) 2146.02 Examination Procedure With Respect to Pre-AIA 35 U.S.C. 103(c) 2146.03 Provisional Rejection (Obviousness) Under 35 U.S.C. 2146.03(a) 103(a) Using Provisional Prior Art Under Pre-AIA 35 U.S.C. 102(e) Biotechnology Process Applications; Pre-AIA 35 U.S.C. 103(b) 2147 Form Paragraphs for Use in Rejections Under Pre-AIA 35 U.S.C. 103 2148 [Reserved] 2149 Examination Guidelines for 35 U.S.C. 102 and 103 as Amended by the First 2150 Inventor To File Provisions of the Leahy-Smith America Invents Act Overview of the Changes to 35 U.S.C. 102 and 103 in the AIA 2151 Rev. 01.2024, November 2024 2100-3 PATENTABILITY Detailed Discussion of AIA 35 U.S.C. 102(a) and (b) 2152 Effective Filing Date of the Claimed Invention 2152.01 Prior Art Under AIA 35 U.S.C. 102(a)(1) (Patented, Described in a 2152.02 Printed Publication, or in Public Use, on Sale, or Otherwise Available to the Public) Patented 2152.02(a) Described in a Printed Publication 2152.02(b) In Public Use 2152.02(c) On Sale 2152.02(d) Otherwise Available to the Public 2152.02(e) No Requirement of “By Others” 2152.02(f) Admissions 2152.03 The Meaning of “Disclosure” 2152.04 Determining Whether To Apply 35 U.S.C. 102(a)(1) or 102(a)(2) 2152.05 Overcoming a 35 U.S.C. 102(a)(1) or 102(a)(2) Rejection 2152.06 Form Paragraphs for Use in Rejections Under AIA 35 U.S.C. 102 2152.07 Prior Art Exceptions Under 35 U.S.C. 102(b)(1) to AIA 35 U.S.C. 102(a)(1) 2153 Prior Art Exception Under AIA 35 U.S.C. 102(b)(1)(A) To AIA 35 2153.01 U.S.C. 102(a)(1) (Grace Period Inventor-Originated Disclosure Exception) Grace Period Inventor-Originated Disclosure Exception 2153.01(a) [Reserved] 2153.01(b) Prior Art Exception Under AIA 35 U.S.C. 102(b)(1)(B) to AIA 35 U.S.C. 2153.02 102(a)(1) (Inventor-Originated Prior Public Disclosure Exception) Provisions Pertaining to Subject Matter in a U.S. Patent or Application 2154 Effectively Filed Before the Effective Filing Date of the Claimed Invention Prior Art Under AIA 35 U.S.C. 102(a)(2) “U.S. Patent Documents” 2154.01 WIPO Published Applications 2154.01(a) Determining When Subject Matter Was Effectively Filed Under AIA 35 U.S.C. 102(d) 2154.01(b) Requirement Of “Names Another Inventor” 2154.01(c) Provisional Rejections Under 35 U.S.C. 102(a)(2); Reference Is a 2154.01(d) Copending U.S. Patent Application Prior Art Exceptions Under 35 U.S.C. 102(b)(2) to AIA 35 U.S.C. 102(a)(2) 2154.02 Prior Art Exception Under AIA 35 U.S.C. 102(b)(2)(A) to AIA 2154.02(a) 35 U.S.C. 102(a)(2) (Inventor-Originated Disclosure Exception) Prior Art Exception Under AIA 35 U.S.C. 102(b)(2)(B) to AIA 2154.02(b) 35 U.S.C. 102(a)(2) (Inventor-Originated Prior Public Disclosure Exception) Prior Art Exception Under AIA 35 U.S.C. 102(b)(2)(C) to AIA 2154.02(c) 35 U.S.C. 102(a)(2) (Common Ownership or Obligation of Assignment) Use of Affidavits or Declarations Under 37 CFR 1.130 To Overcome Prior Art Rejections 2155 Showing That the Disclosure Was Made by the Inventor or a Joint Inventor 2155.01 Showing That the Subject Matter Disclosed Had Been Previously 2155.02 Publicly Disclosed by the Inventor or a Joint Inventor Showing That the Disclosure was Made, or That Subject Matter had 2155.03 Been Previously Publicly Disclosed, by Another Who Obtained the Subject Matter Disclosed Directly or Indirectly From the Inventor or a Joint Inventor Enablement 2155.04 Who May File an Affidavit or Declaration Under 37 CFR 1.130 2155.05 Situations in Which an Affidavit or Declaration Is Not Available 2155.06 Joint Research Agreements 2156 Improper Naming of Inventors 2157 AIA 35 U.S.C. 103 2158 Form Paragraphs for Use in Rejections Under AIA 35 U.S.C. 103 2158.01 Applicability Date Provisions and Determining Whether an Application 2159 Is Subject to the First Inventor To File Provisions of the AIA 2100-4 Rev. 01.2024, November 2024 MANUAL OF PATENT EXAMINING PROCEDURE Applications Filed Before March 16, 2013 2159.01 Applications Filed on or After March 16, 2013 2159.02 Applications Subject to the AIA but Also Containing a Claimed Invention 2159.03 Having an Effective Filing Date Before March 16, 2013 Applicant Statement in Transition Applications Containing a Claimed 2159.04 Invention Having an Effective Filing Date on or After March 16, 2013 [Reserved] 2160 Three Separate Requirements for Specification Under 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, First Paragraph 2161 Computer Programming, Computer Implemented Inventions, and 35 2161.01 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, First Paragraph Policy Underlying 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, First Paragraph 2162 Guidelines for the Examination of Patent Applications Under the 35 2163 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, first paragraph, “Written Description” Requirement Support for the Claimed Subject Matter in Disclosure 2163.01 Standard for Determining Compliance With the Written Description Requirement 2163.02 Typical Circumstances Where Adequate Written Description Issue Arises 2163.03 Burden on the Examiner with Regard to the Written Description Requirement 2163.04 Changes to the Scope of Claims 2163.05 Relationship of Written Description Requirement to New Matter 2163.06 Amendments to Application Which Are Supported in the Original Description 2163.07 Inherent Function, Theory, or Advantage 2163.07(a) Incorporation by Reference 2163.07(b) The Enablement Requirement 2164 Test of Enablement 2164.01 Undue Experimentation Factors 2164.01(a) How to Make the Claimed Invention 2164.01(b) How to Use the Claimed Invention 2164.01(c) Working and Prophetic Examples 2164.02 Relationship of Predictability of the Art and the Enablement Requirement 2164.03 Burden on the Examiner Under the Enablement Requirement 2164.04 Determination of Enablement Based on Evidence as a Whole 2164.05 Specification Must Be Enabling as of the Filing Date 2164.05(a) Specification Must Be Enabling to Persons Skilled in the Art 2164.05(b) Quantity of Experimentation 2164.06 Examples of Enablement Issues-Missing Information 2164.06(a) Examples of Enablement Issues — Biological and Chemical Cases 2164.06(b) Examples of Enablement Issues – Computer Programming Cases 2164.06(c) Relationship of Enablement Requirement to Utility Requirement of 35 U.S.C. 101 2164.07 Enablement Commensurate in Scope With the Claims 2164.08 Single Means Claim 2164.08(a) Inoperative Subject Matter 2164.08(b) Critical Feature Not Claimed 2164.08(c) The Best Mode Requirement 2165 Considerations Relevant to Best Mode 2165.01 Best Mode Requirement Compared to Enablement Requirement 2165.02 Requirements for Rejection for Lack of Best Mode 2165.03 Examples of Evidence of Concealment 2165.04 Rejections Under 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, First Paragraph 2166 [Reserved] 2167 -2170 Two Separate Requirements for Claims Under 35 U.S.C. 112(b) or Pre-AIA 35 U.S.C. 112, Second Paragraph 2171 Subject Matter Which the Inventor or a Joint Inventor Regards as The Invention 2172 Unclaimed Essential Subject Matter 2172.01 Rev. 01.2024, November 2024 2100-5 PATENTABILITY Claims Must Particularly Point Out and Distinctly Claim the Invention 2173 Interpreting the Claims 2173.01 Determining Whether Claim Language is Definite 2173.02 Correspondence Between Specification and Claims 2173.03 Breadth Is Not Indefiniteness 2173.04 Specific Topics Related to Issues Under 35 U.S.C. 112(b) or Pre-AIA 35 U.S.C. 112, Second Paragraph 2173.05 New Terminology 2173.05(a) Relative Terminology 2173.05(b) Numerical Ranges and Amounts Limitations 2173.05(c) Exemplary Claim Language (“for example,” “such as”) 2173.05(d) Lack of Antecedent Basis 2173.05(e) Reference to Limitations in Another Claim 2173.05(f) Functional Limitations 2173.05(g) Alternative Limitations 2173.05(h) Negative Limitations 2173.05(i) Old Combination 2173.05(j) Aggregation 2173.05(k) [Reserved] 2173.05(l) Prolix 2173.05(m) Multiplicity 2173.05(n) Double Inclusion 2173.05(o) Claim Directed to Product-By- Process or Product and Process 2173.05(p) “Use” Claims 2173.05(q) Omnibus Claim 2173.05(r) Reference to Figures or Tables 2173.05(s) Chemical Formula 2173.05(t) Trademarks or Trade Names in a Claim 2173.05(u) Mere Function of Machine 2173.05(v) Practice Compact Prosecution 2173.06 Relationship Between the Requirements of 35 U.S.C. 112(a) and (b) or Pre-AIA 2174 35 U.S.C. 112, First and Second Paragraphs Form Paragraphs for Use in Rejections Under 35 U.S.C. 112(b) or Pre-AIA 35 U.S.C. 112, Second Paragraph 2175 [Reserved] 2176 -2180 Identifying and Interpreting a 35 U.S.C. 112(f) or Pre-AIA 35 U.S.C. 112, Sixth Paragraph Limitation 2181 Search and Identification of the Prior Art 2182 Making a Prima Facie Case of Equivalence 2183 Determining Whether an Applicant Has Met the Burden of Proving 2184 Nonequivalence After a Prima Facie Case Is Made Related Issues Under 35 U.S.C. 112(a) or (b) and Pre-AIA 35 U.S.C. 112, First or Second Paragraphs 2185 Relationship to the Doctrine of Equivalents 2186 Form Paragraphs for Use Relating to 35 U.S.C. 112(f) or Pre-AIA 35 U.S.C. 112, Sixth Paragraph 2187 [Reserved] 2188 -2189 Prosecution Laches and Res Judicata 2190 2101-2102 [Reserved] 2103 Patent Examination Process [R-07.2022] I. DETERMINE WHAT INVENTION IS SOUGHT TO BE PATENTED It is essential that patent applicants obtain a prompt yet complete examination of their applications. Under the principles of compact prosecution, each claim should be reviewed for compliance with every statutory requirement for patentability in the initial review of the application, even if one or more claims are found to be deficient with respect to some statutory requirement. Thus, examiners should state all reasons and bases for rejecting claims in the first Office action. Deficiencies should be explained clearly, particularly when they serve as a basis for a rejection. Whenever practicable, examiners and patent reexamination specialists should indicate how rejections may be overcome and how problems may be resolved. Where a rejection not based on prior art is proper (lack of adequate written description, enablement, or utility, etc.) such rejection should be stated with a full development of the reasons rather than by a mere conclusion. A failure to follow this approach can lead to unnecessary delays in the prosecution of the application. 2100-6 Rev. 01.2024, November 2024 MANUAL OF PATENT EXAMINING PROCEDURE § 2101 -2102 The examination of reissue applications is covered in MPEP Chapter 1400, reexamination proceedings are covered in MPEP Chapters 2200 (ex parte) and 2600 (inter partes), and supplemental examination is covered in MPEP Chapter 2800. Prior to focusing on specific statutory requirements, examiners must begin examination by determining what, precisely, the inventor or joint inventor has invented and is seeking to patent, and how the claims relate to and define that invention. Examiners will review the complete specification, including the detailed description of the invention, any specific embodiments that have been disclosed, the claims and any specific, substantial, and credible utilities that have been asserted for the invention. After obtaining an understanding of the invention, the examiner will conduct a search of the prior art and determine whether the invention as claimed complies with all statutory requirements. A. Identify and Understand Any Utility for the Invention The claimed invention as a whole must be useful. The purpose of this requirement is to limit patent protection to inventions that possess a certain level of “real world” value, as opposed to subject matter that represents nothing more than an idea or concept, or is simply a starting point for future investigation or research (Brenner v. Manson, 383 U.S. 519, 528-36, 148 USPQ 689, 693-96 (1966); In re Fisher, 421 F.3d 1365, 76 USPQ2d 1225 (Fed. Cir. 2005); In re Ziegler, 992 F.2d 1197, 1200-03, 26 USPQ2d 1600, 1603-06 (Fed. Cir. 1993)). Examiners should review the application to identify any asserted utility. The applicant or the inventor is in the best position to explain why an invention is useful. Accordingly, a complete disclosure should contain some indication of the practical application for the claimed invention, i.e., why the applicant asserts the claimed invention is useful. Such a statement will usually explain the purpose of the invention or how the invention may be used (e.g., a compound is believed to be useful in the treatment of a particular disorder). Note that the concept of a “practical application” in the evaluation of utility is different from the concept of whether a judicial exception is integrated into a “practical application” in the evaluation of subject matter eligibility. Regardless of the form of statement of utility, it must enable one ordinarily skilled in the art to understand why the applicant asserts the claimed invention is useful. See MPEP § 2106 for subject matter eligibility guidelines and MPEP § 2107 for utility examination guidelines. The application may describe more than one utility and practical application, but only one is necessary. Alternatively, an applicant may rely on the contemporaneous art to provide that the claimed invention has a well-established utility. B. Review the Detailed Disclosure and Specific Embodiments of the Invention To Understand What the Applicant Has Asserted as the Invention The written description will provide the clearest explanation of the invention, by exemplifying the invention, explaining how it relates to the prior art and explaining the relative significance of various features of the invention. Accordingly, examiners should continue their evaluation by: (A) determining the function of the invention, that is, what the invention does when used as disclosed (e.g., the functionality of a programmed computer); and (B) determining the features necessary to accomplish at least one asserted practical application. Patent applicants can assist the USPTO by preparing applications that clearly set forth these aspects of an invention. C. Review the Claims The claims define the property rights provided by a patent, and thus require careful scrutiny. The goal of claim analysis is to identify the boundaries of the protection sought by the applicant and to understand how the claims relate to and define what the applicant has indicated is the invention. Examiners must first determine the scope of a claim by thoroughly analyzing the language of the claim before determining if the claim complies with each statutory requirement for patentability. See In re Hiniker Co., 150 F.3d 1362, 1369, 47 USPQ2d 1523, Rev. 01.2024, November 2024 2100-7 § 2103 PATENTABILITY 1529 (Fed. Cir. 1998) (“[T]he name of the game is the claim.”). Examiners should begin claim analysis by identifying and evaluating each claim limitation. For processes, the claim limitations will define steps or acts to be performed. For products, the claim limitations will define discrete physical structures or materials. Product claims are claims that are directed to either machines, manufactures or compositions of matter. Examiners should then correlate each claim limitation to all portions of the disclosure that describe the claim limitation. This is to be done in all cases, regardless of whether the claimed invention is defined using means- (or step-) plus- function language. The correlation step will ensure that examiners correctly interpret each claim limitation in light of the specification. The subject matter of a properly construed claim is defined by the terms that limit the scope of the claim when given their broadest reasonable interpretation. It is this subject matter that must be examined. As a general matter, grammar and the plain meaning of terms as understood by one having ordinary skill in the art used in a claim will dictate whether, and to what extent, the language limits the claim scope. See MPEP § 2111.01 for more information on the plain meaning of claim language. Language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation. The following types of claim language may raise a question as to its limiting effect: (A) statements of intended use or field of use, including statements of purpose or intended use in the preamble, (B) “adapted to” or “adapted for” clauses, (C) "wherein" or "whereby" clauses, (D) contingent limitations, (E) printed matter, or (F) terms with associated functional language. This list of examples is not intended to be exhaustive. The determination of whether particular language is a limitation in a claim depends on the specific facts of the case. See, e.g., Griffin v. Bertina, 285 F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002)(finding that a “wherein” clause limited a process claim where the clause gave “meaning and purpose to the manipulative steps”). For more information about these types of claim language and how to determine whether they have a limiting effect on claim scope, see MPEP §§ 2111.02 through 2111.05. Examiners are to give claims their broadest reasonable interpretation in light of the supporting disclosure. See MPEP § 2111. Disclosure may be express, implicit, or inherent. Examiners are to give claimed means- (or step-) plus- function limitations their broadest reasonable interpretation consistent with all corresponding structures (or materials or acts) described in the specification and their equivalents. See In re Aoyama, 656 F.3d 1293, 1297, 99 USPQ2d 1936, 1939 (Fed. Cir. 2011). Further guidance in interpreting the scope of equivalents is provided in MPEP §§ 2181 through 2186. While it is appropriate to use the specification to determine what applicant intends a term to mean, a positive limitation from the specification cannot be read into a claim that does not itself impose that limitation. See MPEP § 2111.01, subsection II. As explained in MPEP § 2111, giving a claim its broadest reasonable interpretation during prosecution will reduce the possibility that the claim, when issued, will be interpreted more broadly than is justified. Finally, when evaluating the scope of a claim, every limitation in the claim must be considered. Examiners may not dissect a claimed invention into discrete elements and then evaluate the elements in isolation. Instead, the claim as a whole must be considered. See, e.g., Diamond v. Diehr, 450 U.S. 175, 188-89, 209 USPQ 1, 9 (1981) (“In determining the eligibility of respondents’ claimed process for patent protection under § 101, their claims must be considered as a whole. It is inappropriate to dissect the claims into old and new elements and then to ignore the presence of the old elements in the analysis. This is particularly true in a process claim because a new combination of steps in a process may be patentable even though all the constituents of the 2100-8 Rev. 01.2024, November 2024 MANUAL OF PATENT EXAMINING PROCEDURE § 2103 combination were well known and in common use before the combination was made.”). II. CONDUCT A THOROUGH SEARCH OF THE PRIOR ART Prior to evaluating the claimed invention for patentability, examiners are expected to conduct a thorough search of the prior art. See MPEP §§ 904 through 904.03 for more information about how to conduct a search. In many cases, the result of such a search will contribute to examiners' understanding of the invention. Both claimed and unclaimed aspects of the invention described in the specification should be searched if there is a reasonable expectation that the unclaimed aspects may be later claimed. A search must take into account any structure or material described in the specification and its equivalents which correspond to the claimed means- (or step-) plus- function limitation, in accordance with 35 U.S.C. 112(f) and MPEP § 2181 through MPEP § 2186. III. DETERMINE WHETHER THE CLAIMED INVENTION COMPLIES WITH 35 U.S.C. 101 A. Consider the Breadth of 35 U.S.C. 101 Under Controlling Law Section 101 of title 35, United States Code, provides: 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: (i) only one patent may be obtained for an invention; (ii) the inventor(s) must be identified in an application filed on or after September 16, 2012 or must be the applicant in applications filed before September 16, 2012; (iii) the claimed invention must be eligible for patenting; and (iv) the claimed invention must be useful (have utility). See MPEP § 2104 for a discussion of the four requirements, MPEP § 2106 for a discussion of eligibility, and MPEP § 2107 for the utility examination guidelines. The patent eligibility inquiry under 35 U.S.C. 101 is a threshold inquiry. Even if a claimed invention qualifies as eligible subject matter under 35 U.S.C. 101, it must also satisfy the other conditions and requirements of the patent laws, including the requirements for novelty (35 U.S.C. 102), nonobviousness (35 U.S.C. 103), and adequate description and definite claiming (35 U.S.C. 112). Bilski v. Kappos, 561 U.S. 593, 602, 95 USPQ2d 1001, 1006 (2010). Therefore, examiners should avoid focusing on only issues of patent-eligibility under 35 U.S.C. 101 to the detriment of considering an application for compliance with the requirements of 35 U.S.C. 102, 35 U.S.C. 103, and 35 U.S.C. 112, and should avoid treating an application solely on the basis of patent-eligibility under 35 U.S.C. 101 except in the most extreme cases. IV. EVALUATE APPLICATION FOR COMPLIANCE WITH 35 U.S.C. 112 A. Determine Whether the Claimed Invention Complies with 35 U.S.C. 112(b) or Pre-AIA 35 U.S.C. 112, Second Paragraph Requirements 35 U.S.C. 112(b) contains two separate and distinct requirements: (A) that the claim(s) set forth the subject matter the inventor or a joint inventor regards as the invention, and (B) that the claim(s) particularly point out and distinctly claim the invention. An application will be deficient under the first requirement of 35 U.S.C. 112(b) when evidence outside the application as filed, e.g., admissions, shows that the inventor or a joint inventor regards the invention to be different from what is claimed (see MPEP § 2171 - MPEP § 2172.01). An application fails to comply with the second requirement of 35 U.S.C. 112(b) when the claims do not set out and define the invention with a reasonable degree of precision and particularity. In this regard, the definiteness of the language must be analyzed, not in a vacuum, but always in light of the teachings of the disclosure as it would be interpreted by one of ordinary skill in the art. Applicant’s claims, interpreted in light of the disclosure, must reasonably Rev. 01.2024, November 2024 2100-9 § 2103 PATENTABILITY apprise a person of ordinary skill in the art of the invention. The scope of a limitation that invokes 35 U.S.C. 112(f) is defined as the corresponding structure or material set forth in the written description and equivalents thereof that perform the claimed function. See MPEP § 2181 through MPEP § 2186. See MPEP § 2173 et seq. for a discussion of a variety of issues pertaining to the 35 U.S.C. 112(b) requirement that the claims particularly point out and distinctly claim the invention. B. Determine Whether the Claimed Invention Complies with 35 U.S.C. 112(a) or 35 U.S.C. 112, First Paragraph Requirements 35 U.S.C. 112(a) contains three separate and distinct requirements: (A) adequate written description, (B) enablement, and (C) best mode. 1. Adequate Written Description For the written description requirement, an applicant’s specification must reasonably convey to those skilled in the art that the inventor was in possession of the claimed invention as of the date of invention. See MPEP § 2163 for further guidance with respect to the evaluation of a patent application for compliance with the written description requirement. 2. Enabling Disclosure An applicant’s specification must enable a person skilled in the art to make and use the claimed invention without undue experimentation. The fact that experimentation is complex, however, will not make it undue if a person of skill in the art routinely engages in such experimentation. See MPEP § 2164 et seq. for detailed guidance with regard to the enablement requirement of 35 U.S.C. 112(a). 3. Best Mode Determining compliance with the best mode requirement requires a two-prong inquiry: (1) at the time the application was filed, did the inventor possess a best mode for practicing the invention; and (2) if the inventor did possess a best mode, does the written description disclose the best mode in such a manner that a person of ordinary skill in the art could practice the best mode. See MPEP § 2165 et seq. for additional guidance. Deficiencies related to disclosure of the best mode for carrying out the claimed invention are not usually encountered during examination of an application because evidence to support such a deficiency is seldom in the record. Fonar Corp. v. General Elec. Co., 107 F.3d 1543, 1548-49, 41 USPQ2d 1801, 1804-05 (Fed. Cir. 1997). V. DETERMINE WHETHER THE CLAIMED INVENTION COMPLIES WITH 35 U.S.C. 102 AND 103 Reviewing a claimed invention for compliance with 35 U.S.C. 102 and 35 U.S.C.103 begins with a comparison of the claimed subject matter to what is known in the prior art. See MPEP §§ 2131 - 2146 and MPEP §§ 2150 - 2159 for specific guidance on patentability determinations under 35 U.S.C. 102 and 35 U.S.C. 103. If no differences are found between the claimed invention and the prior art, then the claimed invention lacks novelty and is to be rejected by USPTO personnel under 35 U.S.C. 102. Once differences are identified between the claimed invention and the prior art, those differences must be assessed and resolved in light of the knowledge possessed by a person of ordinary skill in the art. Against this backdrop, one must determine whether the invention would have been obvious to one of ordinary skill in the art. If not, the claimed invention satisfies 35 U.S.C. 103. VI. CLEARLY COMMUNICATE FINDINGS, CONCLUSIONS AND THEIR BASES Once examiners have completed the above analyses of the claimed invention under all the statutory 2100-10 Rev. 01.2024, November 2024 MANUAL OF PATENT EXAMINING PROCEDURE § 2103 provisions, including 35 U.S.C. 101, 35 U.S.C. 112, 35 U.S.C. 102, and 35 U.S.C. 103, they should review all the proposed rejections and their bases to confirm that a prima facie case of unpatentability exists. Only then should any rejection be imposed in an Office action. The Office action should clearly communicate the findings, conclusions and reasons which support them. EXAMINERS SHOULD USE THE APPLICABLE FORM PARAGRAPHS IN OFFICE ACTIONS TO STATE THE BASIS FOR ANY OBJECTIONS OR REJECTIONS TO REDUCE THE CHANCE OF A MISUNDERSTANDING AS TO THE GROUNDS OF OBJECTION OR REJECTION. 2104 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 PROHIBITED 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. 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 INVENTOR 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. 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 ELIGIBILITY 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., Rev. 01.2024, November 2024 2100-11 § 2104 PATENTABILITY 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. UTILITY A 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. 2104.01 Barred by Atomic Energy Act [R-07.2022] A limitation on what can be patented is imposed by the Atomic Energy Act of 1954. Section 151(a) (42 U.S.C. 2181(a)) thereof reads in part as follows: No patent shall hereafter be granted for any invention or discovery which is useful solely in the utilization of special nuclear material or atomic energy in an atomic weapon. The terms “atomic energy” and “special nuclear material” are defined in Section 11 of the Act (42 U.S.C. 2014). Sections 151(c) and 151(d) (42 U.S.C. 2181(c) and (d)) set up categories of pending applications relating to atomic energy that must be brought to the attention of the Department of Energy. Under 37 CFR 1.14(d), applications for patents which disclose or which appear to disclose, or which purport to disclose, inventions or discoveries relating to atomic energy are reported to the Department of Energy and the Department will be given access to such applications, but such reporting does not constitute a determination that the subject matter of each application so reported is in fact useful or an invention or discovery or that such application in 2100-12 Rev. 01.2024, November 2024 MANUAL OF PATENT EXAMINING PROCEDURE § 2104.01 fact discloses subject matter in categories specified by the Atomic Energy Act. All applications received in the U.S. Patent and Trademark Office are screened by Licensing and Review personnel, under 37 CFR 1.14(d), in order for the Director to fulfill his or her responsibilities under section 151(d) (42 U.S.C. 2181(d)) of the Atomic Energy Act. Papers subsequently added must be inspected promptly by the examiner when received to determine whether the application has been amended to relate to atomic energy and those so related must be promptly forwarded to Licensing and Review. All rejections based upon sections 151(a) (42 U.S.C. 2181(a)), 152 (42 U.S.C. 2182), and 155 (42 U.S.C. 2185) of the Atomic Energy Act must be made only by Licensing and Review personnel. 2105 Patent Eligible Subject Matter — Living Subject Matter [R-10.2019] I. INTRODUCTION Prior to 1980, it was widely believed that living subject matter was not eligible for patenting, either because such subject matter did not fall within a statutory category, or because it was a judicial exception to patent eligibility. However, the decision of the Supreme Court in Diamond v. Chakrabarty, 447 U.S. 303, 206 USPQ 193 (1980), made it clear that the question of whether an invention embraces living matter is irrelevant to the issue of patent eligibility. Note, however, that Congress has excluded claims directed to or encompassing a human organism from eligibility. See The Leahy-Smith America Invents Act (AIA), Pub. L. 112-29, sec. 33(a), 125 Stat. 284 (September 16, 2011). II. LIVING SUBJECT MATTER MAY BE PATENT ELIGIBLE A. Living Subject Matter May Be Directed To A Statutory Category In Chakrabarty, the Supreme Court held that a claim to a genetically engineered bacterium was directed to at least one of the four statutory categories, because the bacterium was a “manufacture” and/or a “composition of matter.” In its opinion, the Court stated that “Congress plainly contemplated that the patent laws would be given wide scope” because it chose to draft 35 U.S.C. 101 using “such expansive terms as ‘manufacture’ and ‘composition of matter,’ modified by the comprehensive ‘any.’” 447 U.S. at 308, 206 USPQ at 197. The Court also determined that the distinction between living and inanimate things was not relevant for subject matter eligibility. 447 U.S. at 313, 206 USPQ at 199. Thus, the Court held that living subject matter with markedly different characteristics from any found in nature, such as the claimed bacterium produced by genetic engineering, is not excluded from patent protection by 35 U.S.C. 101. 447 U.S. at 310, 206 USPQ at 197. Following the reasoning in Chakrabarty, the Board of Patent Appeals and Interferences determined that animals are patentable subject matter under 35 U.S.C. 101. In Ex parte Allen, 2 USPQ2d 1425 (Bd. Pat. App. & Inter. 1987), the Board decided that a non-naturally occurring polyploid Pacific coast oyster could have been the proper subject of a patent under 35 U.S.C. 101 if all the criteria for patentability were satisfied. Shortly after the Allen decision, the Commissioner of Patents and Trademarks issued a notice (Animals - Patentability, 1077 O.G. 24, April 21, 1987) stating that the Patent and Trademark Office “now considers nonnaturally occurring, non-human multicellular living organisms, including animals, to be patentable subject matter within the scope of 35 U.S.C. 101.” With respect to plant subject matter, the Supreme Court held that patentable subject matter under 35 U.S.C. 101 includes newly developed plant breeds, even though plant protection is also available under the Plant Patent Act (35 U.S.C. 161 - 164) and the Plant Variety Protection Act (7 U.S.C. 2321 et. seq.). J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred Int’ l, Inc., 534 U.S. 124, 143-46, 60 USPQ2d 1865, 1874 (2001) (The scope of coverage of 35 U.S.C. 101 is not limited by the Plant Patent Act or the Plant Variety Protection Act; each statute can be regarded as effective because of its different requirements and protections). Rev. 01.2024, November 2024 2100-13 § 2105 PATENTABILITY See MPEP § 2106.03 for a discussion of the categories of statutory subject matter. B. Living Subject Matter May Be Eligible for Patent Protection The Supreme Court in Chakrabarty held a claim to a genetically engineered bacterium eligible, because the claimed bacterium was not a “product of nature” exception. As the Court explained, the modified bacterium was patentable because the patent claim was not to a “hitherto unknown natural phenomenon,” but instead had “markedly different characteristics from any found in nature,” due to the additional plasmids and resultant capacity for degrading oil. 447 U.S. at 309-10, 206 USPQ at 197. Subsequent judicial decisions have made clear that the Supreme Court’s decision in Chakrabarty is “central” to the eligibility inquiry with respect to nature-based products. See, e.g., Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 590, 106 USPQ2d 1972, 1979 (2013). For example, the Federal Circuit has indicated that “discoveries that possess ‘markedly different characteristics from any found in nature,’ … are eligible for patent protection.” In re Roslin Institute (Edinburgh), 750 F.3d 1333, 1336, 110 USPQ2d 1668, 1671 (Fed. Cir. 2014) (quoting Chakrabarty, 447 U.S. at 310, 206 USPQ2d at 197). In Roslin, the claimed invention was a live-born clone of a pre-existing, non-embryonic, donor mammal selected from cattle, sheep, pigs, and goats. An embodiment of the claimed invention was the famous Dolly the Sheep, which the court stated was “the first mammal ever cloned from an adult somatic cell.” Despite acknowledging that the method used to create the claimed clones “constituted a breakthrough in scientific discovery”, the court relied on Chakrabarty in holding the claims ineligible because “Dolly herself is an exact genetic replica of another sheep and does not possess ‘markedly different characteristics from any [farm animals] found in nature.’” Roslin, 750 F.3d at 1337, 110 USPQ2d at 1671. See MPEP § 2106.04 for a discussion of the judicial exceptions in general, MPEP § 2106.04(b), subsection II, for a discussion of products of nature, and MPEP § 2106.04(c) for a discussion of the markedly different characteristics analysis that examiners should use to determine whether a nature-based product such as living subject matter is eligible for patent protection. III. HUMAN ORGANISMS ARE NONSTATUTORY SUBJECT MATTER Congress has excluded claims directed to or encompassing a human organism from patentability. The Leahy-Smith America Invents Act (AIA), Public Law 112-29, sec. 33(a), 125 Stat. 284, states: Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism. The legislative history of the AIA includes the following statement, which sheds light on the meaning of this provision: [T]he U.S. Patent Office has already issued patents on genes, stems cells, animals with human genes, and a host of non-biologic products used by humans, but it has not issued patents on claims directed to human organisms, including human embryos and fetuses. My amendment would not affect the former, but would simply affirm the latter. 157 Cong. Rec. E1177-04 (testimony of Representative Dave Weldon previously presented in connection with the Consolidated Appropriations Act, 2004, Public Law 108-199, 634, 118 Stat. 3, 101, and later resubmitted with regard to the AIA; see 149 Cong. Rec. E2417-01). Thus, section 33(a) of the AIA codifies existing Office policy that human organisms are not patent-eligible subject matter. If the broadest reasonable interpretation of the claimed invention as a whole encompasses a human organism, then a rejection under 35 U.S.C. 101 and AIA sec. 33(a) must be made indicating that the claimed invention is directed to a human organism and is therefore nonstatutory subject matter. Furthermore, the claimed invention must be examined with regard to all issues pertinent to patentability, and any applicable rejections under 35 U.S.C. 102, 103, or 112 must also be made. 2100-14 Rev. 01.2024, November 2024 MANUAL OF PATENT EXAMINING PROCEDURE § 2105 Use form paragraph 7.04.03 to reject a claim under 35 U.S.C. 101 and AIA sec. 33(a). ¶ 7.04.03 Human Organism Section 33(a) of the America Invents Act reads as follows Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism. Claim [1] rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). [2] Examiner Note: 1. This paragraph must be preceded by form paragraph 7.04.01 which quotes 35 U.S.C. 101. 2. In bracket 1, pluralize “Claim” if necessary, insert claim number(s), and insert “is” or “are” as appropriate. 3. In bracket 2, explain why the claim is interpreted to read on a human organism. 2106 Patent Subject Matter Eligibility [R-10.2019] I. TWO CRITERIA FOR SUBJECT MATTER ELIGIBILITY First, the claimed invention must be to one of the four statutory categories. 35 U.S.C. 101 defines the four categories of invention that Congress deemed to be the appropriate subject matter of a patent: processes, machines, manufactures and compositions of matter. The latter three categories define “things” or “products” while the first category defines “actions” (i.e., inventions that consist of a series of steps or acts to be performed). See 35 U.S.C. 100(b) (“The term ‘process’ means process, art, or method, and includes a new use of a known process, machine, manufacture, composition of matter, or material.”). See MPEP § 2106.03 for detailed information on the four categories. Second, the claimed invention also must qualify as patent-eligible subject matter, i.e., the claim must not be directed to a judicial exception unless the claim as a whole includes additional limitations amounting to significantly more than the exception. The judicial exceptions (also called “judicially recognized exceptions” or simply “exceptions”) are subject matter that the 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 Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 589, 106 USPQ2d 1972, 1979 (2013). See MPEP § 2106.04 for detailed information on the judicial exceptions. Because abstract ideas, laws of nature, and natural phenomenon "are the basic tools of scientific and technological work", the Supreme Court has expressed concern that monopolizing these tools by granting patent rights may impede innovation rather than promote it. See Alice Corp., 573 U.S. at 216, 110 USPQ2d at 1980; Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 (2012). However, the Court has also emphasized that an invention is not considered to be ineligible for patenting simply because it involves a judicial exception. Alice Corp., 573 U.S. at 217, 110 USPQ2d at 1980-81 (citing Diamond v. Diehr, 450 U.S. 175, 187, 209 USPQ 1, 8 (1981)). See also Thales Visionix Inc. v. United States, 850 F.3d. 1343, 1349, 121 USPQ2d 1898, 1902 (Fed. Cir. 2017) (“That a mathematical equation is required to complete the claimed method and system does not doom the claims to abstraction.”). Accordingly, the Court has said that integration of an abstract idea, law of nature or natural phenomenon into a practical application may be eligible for patent protection. See, e.g., Alice, 573 U.S. at 217, 110 USPQ2d at 1981 (explaining that “in applying the §101 exception, we must distinguish between patents that claim the ‘buildin[g] block[s]’ of human ingenuity and those that integrate the building blocks into something more” (quoting Mayo, 566 U.S. at 89, 110 USPQ2d at 1971) and stating that Mayo “set forth a framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts”); Mayo, 566 U.S. at 80, 84, 101 USPQ2d at 1969, 1971 (noting that the Court in Diamond v. Diehr found “the overall process patent eligible because of the way the additional steps of the process integrated the equation into the process as a whole,” Rev. 01.2024, November 2024 2100-15 § 2106 PATENTABILITY but the Court in Gottschalk v. Benson “held that simply implementing a mathematical principle on a physical machine, namely a computer, was not a patentable application of that principle”); Bilski v. Kappos, 561 U.S. 593, 611, 95 USPQ2d 1001, 1010 (2010) (“ Diehr explained that while an abstract idea, law of nature, or mathematical formula could not be patented, ‘an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection.’” (quoting Diamond v. Diehr, 450 U.S. 175, 187, 209 USPQ 1, 8 (1981)) (emphasis in original)); Diehr, 450 U.S. at 187, 192 n.14, 209 USPQ at 10 n.14 (explaining that the process in Parker v. Flook was ineligible not because it contained a mathematical formula, but because it did not provide an application of the formula). See Diamond v. Diehr, 450 U.S. 175, 209 USPQ 1 (1981); Gottschalk v. Benson, 409 U.S. 63, 175 USPQ 673 (1972); Parker v. Flook, 437 U.S. 584, 198 USPQ 193 (1978). The Supreme Court in Mayo laid out a framework for determining whether an applicant is seeking to patent a judicial exception itself, or a patent-eligible application of the judicial exception. See Alice Corp., 573 U.S. at 217-18, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. 66, 101 USPQ2d 1961). This framework, which is referred to as the Mayo test or the Alice/Mayo test, is discussed in further detail in subsection III, below. The first part of the Mayo test is to determine whether the claims are directed to an abstract idea, a law of nature or a natural phenomenon (i.e., a judicial exception). Id. If the claims are directed to a judicial exception, the second part of the Mayo test is to determine whether the claim recites additional elements that amount to significantly more than the judicial exception. Id. citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966). The Supreme Court has described the second part of the test as the "search for an 'inventive concept'". Alice Corp., 573 U.S. at 217-18, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966). The Alice/Mayo two-part test is the only test that should be used to evaluate the eligibility of claims u n d e r e x a m i n a t i o n . W h i l e t h e machine-or-transformation test is an important clue to eligibility, it should not be used as a separate test for eligibility. Instead it should be considered as part of the "integration" determination or "significantly more" determination articulated in the Alice/Mayo test. Bilski v. Kappos, 561 U.S. 593, 605, 95 USPQ2d 1001, 1007 (2010). See MPEP § 2106.04(d) for more information about evaluating whether a claim reciting a judicial exception is integrated into a practical application and MPEP § 2106.05(b) and MPEP § 2106.05(c) for more information about how the machine-or-transformation test fits into the Alice/Mayo two-part framework. Likewise, eligibility should not be evaluated based on whether the claim recites a "useful, concrete, and tangible result," State Street Bank, 149 F.3d 1368, 1374, 47 USPQ2d 1596, 1602 (Fed. Cir. 1998) (quoting In re Alappat, 33 F.3d 1526, 1544, 31 USPQ2d 1545, 1557 (Fed. Cir. 1994)), as this test has been superseded. In re Bilski, 545 F.3d 943, 959-60, 88 USPQ2d 1385, 1394-95 (Fed. Cir. 2008) (en banc), aff'd by Bilski v. Kappos, 561 U.S. 593, 95 USPQ2d 1001 (2010). See also TLI Communications LLC v. AV Automotive LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (“It is well-settled that mere recitation of concrete, tangible components is insufficient to confer patent eligibility to an otherwise abstract idea”). The programmed computer or “special purpose computer” test of In re Alappat, 33 F.3d 1526, 31 USPQ2d 1545 (Fed. Cir. 1994) (i.e., the rationale that an otherwise ineligible algorithm or software could be made patent-eligible by merely adding a generic computer to the claim for the “special purpose” of executing the algorithm or software) was also superseded by the Supreme Court’s Bilski and Alice Corp. decisions. Eon Corp. IP Holdings LLC v. AT&T Mobility LLC, 785 F.3d 616, 623, 114 USPQ2d 1711, 1715 (Fed. Cir. 2015) (“[W]e note that Alappat has been superseded by Bilski, 561 U.S. at 605–06, and Alice Corp. v. CLS Bank Int’l, 573 U.S. 208, 110 USPQ2d 1976 (2014)”); Intellectual Ventures I LLC v. Capital One Bank (USA), N.A., 792 F.3d 1363, 1366, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015) (“An abstract idea does not become nonabstract by limiting the invention to a particular field of use or technological environment, such as the Internet [or] a computer”). Lastly, eligibility should not be evaluated based on whether the claimed invention has utility, because “[u]tility is not the test for patent-eligible subject matter.” Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1380, 118 USPQ2d 1541, 1548 (Fed. Cir. 2016). 2100-16 Rev. 01.2024, November 2024 MANUAL OF PATENT EXAMINING PROCEDURE § 2106 Examiners are reminded that 35 U.S.C. 101 is not the sole tool for determining patentability; 35 U.S.C. 112 , 35 U.S.C. 102, and 35 U.S.C. 103 will provide additional tools for ensuring that the claim meets the conditions for patentability. As the Supreme Court made clear in Bilski, 561 U.S. at 602, 95 USPQ2d at 1006: The § 101 patent-eligibility inquiry is only a threshold test. Even if an invention qualifies as a process, machine, manufacture, or composition of matter, in order to receive the Patent Act’s protection the claimed invention must also satisfy ‘‘the conditions and requirements of this title.’’ § 101. Those requirements include that the invention be novel, see § 102, nonobvious, see § 103, and fully and particularly described, see § 112. II. ESTABLISH BROADEST REASONABLE INTERPRETATION OF CLAIM AS A WHOLE It is essential that the broadest reasonable interpretation (BRI) of the claim be established prior to examining a claim for eligibility. The BRI sets the boundaries of the coverage sought by the claim and will influence whether the claim seeks to cover subject matter that is beyond the four statutory categories or encompasses subject matter that falls within the exceptions. See MyMail, Ltd. v. ooVoo, LLC, 934 F.3d 1373, 1379, 2019 USPQ2d 305789 (Fed. Cir. 2019) (“Determining patent eligibility requires a full understanding of the basic character of the claimed subject matter”), citing Bancorp Servs., LLC v. Sun Life Assurance Co. of Can. (U.S.), 687 F.3d 1266, 1273-74, 103 USPQ2d 1425, 1430 (Fed. Cir. 2012); In re Bilski, 545 F.3d 943, 951, 88 USPQ2d 1385, 1388 (Fed. Cir. 2008) (en banc ), aff'd by Bilski v. Kappos, 561 U.S. 593, 95 USPQ2d 1001 (2010) (“claim construction … is an important first step in a § 101 analysis”). Evaluating eligibility based on the BRI also ensures that patent eligibility under 35 U.S.C. 101 does not depend simply on the draftsman’s art. Alice, 573 U.S. 208, 224, 110 USPQ2d at 1984, 1985 (citing Parker v. Flook, 437 U.S. 584, 593, 198 USPQ 193, 198 (1978) and Mayo, 566 U.S. at 72, 101 USPQ2d at 1966). See MPEP § 2111 for more information about determining the BRI. Claim interpretation affects the evaluation of both criteria for eligibility. For example, in Mentor Graphics v. EVE-USA, Inc., 851 F.3d 1275, 112 USPQ2d 1120 (Fed. Cir. 2017), claim interpretation was crucial to the court’s determination that claims to a “machine-readable medium” were not to a statutory category. In Mentor Graphics, the court interpreted the claims in light of the specification, which expressly defined the medium as encompassing “any data storage device” including random-access memory and carrier waves. Although random-access memory and magnetic tape are statutory media, carrier waves are not because they are signals similar to the transitory, propagating signals held to be non-statutory in Nuijten. 851 F.3d at 1294, 112 USPQ2d at 1133 (citing In re Nuijten, 500 F.3d 1346, 84 USPQ2d 1495 (Fed. Cir. 2007)). Accordingly, because the BRI of the claims covered both subject matter that falls within a statutory category (the random-access memory), as well as subject matter that does not (the carrier waves), the claims as a whole were not to a statutory category and thus failed the first criterion for eligibility. With regard to the second criterion for eligibility, the Alice/Mayo test, claim interpretation can affect the first part of the test (whether the claims are directed to a judicial exception). For example, the patentee in Synopsys argued that the claimed methods of logic circuit design were intended to be used in conjunction with computer-based design tools, and were thus not mental processes. Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1147-49, 120 USPQ2d 1473, 1480-81 (Fed. Cir. 2016). The court disagreed, because it interpreted the claims as encompassing nothing other than pure mental steps (and thus falling within an abstract idea grouping) because the claims did not include any limitations requiring computer implementation. In contrast, the patentee in Enfish argued that its claimed self-referential table for a computer database was an improvement in an existing technology and thus not directed to an abstract idea. Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1336-37, 118 USPQ2d 1684, 1689-90 (Fed. Cir. 2016). The court agreed with the patentee, based on its interpretation of the claimed “means for configuring” under 35 U.S.C. 112(f) as requiring a four-step algorithm that achieved the improvements, as opposed to merely any form of storing tabular data. See also McRO, Rev. 01.2024, November 2024 2100-17 § 2106 PATENTABILITY Inc. v. Bandai Namco Games America, Inc. 837 F.3d 1299, 1314, 120 USPQ2d 1091, 1102 (Fed. Cir. 2016) (the claim’s construction incorporated rules of a particular type that improved an existing technological process). Claim interpretation can also affect the second part of the Alice/Mayo test (whether the claim recites additional elements that amount to significantly more than the judicial exception). For example, in Amdocs (Israel) Ltd. v. Openet Telecom, Inc., where the court relied on the construction of the term “enhance” (to require application of a number of field enhancements in a distributed fashion) to determine that the claim entails an unconventional technical solution to a technological problem. 841 F.3d 1288, 1300-01, 120 USPQ2d 1527, 1537 (Fed. Cir. 2016). III. SUMMARY OF ANALYSIS AND FLOWCHART Examiners should determine whether a claim satisfies the criteria for subject matter eligibility by evaluating the claim in accordance with the following flowchart. The flowchart illustrates the steps of the subject matter eligibility analysis for products and processes that are to be used during examination for evaluating whether a claim is drawn to patent-eligible subject matter. It is recognized that under the controlling legal precedent there may be variations in the precise contours of the analysis for subject matter eligibility that will still achieve the same end result. The analysis set forth herein promotes examination efficiency and consistency across all technologies. As shown in the flowchart, Step 1 relates to the statutory categories and ensures that the first criterion is met by confirming that the claim falls within one of the four statutory categories of invention. See MPEP § 2106.03 for more information on Step 1. Step 2, which is the Supreme Court’s Alice/Mayo test, is a two-part test to identify claims that are directed to a judicial exception (Step 2A) and to then evaluate if additional elements of the claim provide an inventive concept (Step 2B) (also called "significantly more" than the recited judicial exception). See MPEP § 2106.04 for more information on Step 2A and MPEP § 2106.05 for more information on Step 2B. The flowchart also shows three pathways (A, B, and C) to eligibility: Pathway A: Claims taken as a whole that fall within a statutory category (Step 1: YES) and, which may or may not recite a judicial exception, but whose eligibility is self-evident can be found eligible at Pathway A using a streamlined analysis. See MPEP § 2106.06 for more information on this pathway and on self-evident eligibility. Pathway B: Claims taken as a whole that fall within a statutory category (Step 1: YES) and are not directed to a judicial exception (Step 2A: NO) are eligible at Pathway B. These claims do not need to go to Step 2B. See MPEP § 2106.04 for more information about this pathway and Step 2A. Pathway C: Claims taken as a whole that fall within a statutory category (Step 1: YES), are directed to a judicial exception (Step 2A: YES), and recite additional elements either individually or in an ordered combination that amount to significantly more than the judicial exception (Step 2B: YES) are eligible at Pathway C. See MPEP § 2106.05 for more information about this pathway and Step 2B. Claims that could have been found eligible at Pathway A (streamlined analysis), but are subjected to further analysis at Steps 2A or Step 2B, will ultimately be found eligible at Pathways B or C. Thus, if the examiner is uncertain about whether a streamlined analysis is appropriate, the examiner is encouraged to conduct a full eligibility analysis. However, if the claim is not found eligible at any of Pathways A, B or C, the claim is patent ineligible and should be rejected under 35 U.S.C. 101. Regardless of whether a rejection under 35 U.S.C. 101 is made, a complete examination should be made for every claim under each of the other patentability requirements: 35 U.S.C. 102, 103, 112, and 101 (utility, inventorship and double patenting) and non-statutory double patenting. MPEP § 2103. 2100-18 Rev. 01.2024, November 2024 MANUAL OF PATENT EXAMINING PROCEDURE § 2106 Rev. 01.2024, November 2024 2100-19 § 2106 PATENTABILITY 2106.01 [Reserved] 2106.02 [Reserved] 2106.03 Eligibility Step 1: The Four Categories of Statutory Subject Matter [R-07.2022] I. THE FOUR CATEGORIES 35 U.S.C. 101 enumerates four categories of subject matter that Congress deemed to be appropriate subject matter for a patent: processes, machines, manufactures and compositions of matter. As explained by the courts, these “four categories together describe the exclusive reach of patentable subject matter. If a claim covers material not found in any of the four statutory categories, that claim falls outside the plainly expressed scope of § 101 even if the subject matter is otherwise new and useful.” In re Nuijten, 500 F.3d 1346, 1354, 84 USPQ2d 1495, 1500 (Fed. Cir. 2007). A process defines “actions”, i.e., an invention that is claimed as an act or step, or a series of acts or steps. As explained by the Supreme Court, a “process” is “a mode of treatment of certain materials to produce a given result. It is an act, or a series of acts, performed upon the subject-matter to be transformed and reduced to a different state or thing.” Gottschalk v. Benson, 409 U.S. 63, 70, 175 USPQ 673, 676 (1972) (italics added) (quoting Cochrane v. Deener, 94 U.S. 780, 788, 24 L. Ed. 139, 141 (1876)). See also Nuijten, 500 F.3d at 1355, 84 USPQ2d at 1501 (“The Supreme Court and this court have consistently interpreted the statutory term ‘process’ to require action”); NTP, Inc. v. Research in Motion, Ltd., 418 F.3d 1282, 1316, 75 USPQ2d 1763, 1791 (Fed. Cir. 2005) (“[A] process is a series of acts.”) (quoting Minton v. Natl. Ass’n. of Securities Dealers, 336 F.3d 1373, 1378, 67 USPQ2d 1614, 1681 (Fed. Cir. 2003)). As defined in 35 U.S.C. 100(b), the term “process” is synonymous with “method.” The other three categories (machines, manufactures and compositions of matter) define the types of physical or tangible “things” or “products” that Congress deemed appropriate to patent. Digitech Image Techs. v. Electronics for Imaging, 758 F.3d 1344, 1348, 111 USPQ2d 1717, 1719 (Fed. Cir. 2014) (“For all categories except process claims, the eligible subject matter must exist in some physical or tangible form.”). Thus, when determining whether a claimed invention falls within one of these three categories, examiners should verify that the invention is to at least one of the following categories and is claimed in a physical or tangible form. • A machine is a “concrete thing, consisting of parts, or of certain devices and combination of devices.” Digitech, 758 F.3d at 1348-49, 111 USPQ2d at 1719 (quoting Burr v. Duryee, 68 U.S. 531, 570, 17 L. Ed. 650, 657 (1863)). This category “includes every mechanical device or combination of mechanical powers and devices to perform some function and produce a certain effect or result.” Nuijten, 500 F.3d at 1355, 84 USPQ2d at 1501 (quoting Corning v. Burden, 56 U.S. 252, 267, 14 L. Ed. 683, 690 (1854)). • A manufacture is “a tangible article that is given a new form, quality, property, or combination through man-made or artificial means.” Digitech, 758 F.3d at 1349, 111 USPQ2d at 1719-20 (citing Diamond v. Chakrabarty, 447 U.S. 303, 308, 206 USPQ 193, 197 (1980)). As the courts have explained, manufactures are articles that result from the process of manufacturing, i.e., they were produced “from raw or prepared materials by giving to these materials new forms, qualities, properties, or combinations, whether by hand-labor or by machinery.” Samsung Electronics Co. v. Apple Inc., 137 S. Ct. 429, 120 USPQ2d 1749, 1752-3 (2016) (quoting Diamond v. Chakrabarty, 447 U. S. 303, 308, 206 USPQ 193, 196-97 (1980)); Nuijten, 500 F.3d at 1356-57, 84 USPQ2d at 1502. Manufactures also include “the parts of a machine considered separately from the machine itself.” Samsung Electronics, 137 S. Ct. at 435, 120 USPQ2d at 1753 (quoting 1 W. Robinson, The Law of Patents for Useful Inventions §183, p. 270 (1890)). • A composition of matter is a “combination of two or more substances and includes all composite articles.” Digitech, 758 F.3d at 1348-49, 111 USPQ2d at 1719 (citation omitted). This category includes all compositions of two or more substances and all composite articles, “'whether they be the results of chemical union or of mechanical mixture, or whether they be gases, fluids, powders or solids.'” 2100-20 Rev. 01.2024, November 2024 MANUAL OF PATENT EXAMINING PROCEDURE § 2106.01 Chakrabarty, 447 U.S. at 308, 206 USPQ at 197 (quoting Shell Dev. Co. v. Watson, 149 F. Supp. 279, 280 (D.D.C. 1957); id. at 310 holding genetically modified microorganism to be a manufacture or composition of matter). It is not necessary to identify a single category into which a claim falls, so long as it is clear that the claim falls into at least one category. For example, because a microprocessor is generally understood to be a manufacture, a product claim to the microprocessor or a system comprising the microprocessor satisfies Step 1 regardless of whether the claim falls within any other statutory category (such as a machine). It is also not necessary to identify a “correct” category into which the claim falls, because although in many instances it is clear within which category a claimed invention falls, a claim may satisfy the requirements of more than one category. For example, a bicycle satisfies both the machine and manufacture categories, because it is a tangible product that is concrete and consists of parts such as a frame and wheels (thus satisfying the machine category), and it is an article that was produced from raw materials such as aluminum ore and liquid rubber by giving them a new form (thus satisfying the manufacture category). Similarly, a genetically modified bacterium satisfies both the composition of matter and manufacture categories, because it is a tangible product that is a combination of two or more substances such as proteins, carbohydrates and other chemicals (thus satisfying the composition of matter category), and it is an article that was genetically modified by humans to have new properties such as the ability to digest multiple types of hydrocarbons (thus satisfying the manufacture category). Non-limiting examples of claims that are not directed to any of the statutory categories include: • Products that do not have a physical or tangible form, such as information (often referred to as “data per se”) or a computer program per se (often referred to as “software per se”) when claimed as a product without any structural recitations; • Transitory forms of signal transmission (often referred to as “signals per se”), such as a propagating electrical or electromagnetic signal or carrier wave; and • Subject matter that the statute expressly prohibits from being patented, such as humans per se, which are excluded under The Leahy-Smith America Invents Act (AIA), Public Law 112-29, sec. 33, 125 Stat. 284 (September 16, 2011). As the courts' definitions of machines, manufactures and compositions of matter indicate, a product must have a physical or tangible form in order to fall within one of these statutory categories. Digitech, 758 F.3d at 1348, 111 USPQ2d at 1719. Thus, the Federal Circuit has held that a product claim to an intangible collection of information, even if created by human effort, does not fall within any statutory category. Digitech, 758 F.3d at 1350, 111 USPQ2d at 1720 (claimed “device profile” comprising two sets of data did not meet any of the categories because it was neither a process nor a tangible product). Similarly, software expressed as code or a set of instructions detached from any medium is an idea without physical embodiment. See Microsoft Corp. v. AT&T Corp., 550 U.S. 437, 449, 82 USPQ2d 1400, 1407 (2007); see also Benson, 409 U.S. 67, 175 USPQ2d 675 (An "idea" is not patent eligible). Thus, a product claim to a software program that does not also contain at least one structural limitation (such as a “means plus function” limitation) has no physical or tangible form, and thus does not fall within any statutory category. Another example of an intangible product that does not fall within a statutory category is a paradigm or business model for a marketing company. In re Ferguson, 558 F.3d 1359, 1364, 90 USPQ2d 1035, 1039-40 (Fed. Cir. 2009). Even when a product has a physical or tangible form, it may not fall within a statutory category. For instance, a transitory signal, while physical and real, does not possess concrete structure that would qualify as a device or part under the definition of a machine, is not a tangible article or commodity under the definition of a manufacture (even though it is man-made and physical in that it exists in the real world and has tangible causes and effects), and is not composed of matter such that it would qualify as a composition of matter. Nuijten, 500 F.3d at 1356-1357, 84 USPQ2d at 1501-03. As such, a transitory, propagating signal does not fall within any statutory category. Mentor Graphics Corp. v. EVE-USA, Inc., 851 F.3d 1275, 1294, 112 USPQ2d Rev. 01.2024, November 2024 2100-21 § 2106.03 PATENTABILITY 1120, 1133 (Fed. Cir. 2017); Nuijten, 500 F.3d at 1356-1357, 84 USPQ2d at 1501-03. II. ELIGIBILITY STEP 1: WHETHER A CLAIM IS TO A STATUTORY CATEGORY As described in MPEP § 2106, subsection III, Step 1 of the eligibility analysis asks: Is the claim to a process, machine, manufacture or composition of matter? Like the other steps in the eligibility analysis, evaluation of this step should be made after determining what the inventor has invented by reviewing the entire application disclosure and construing the claims in accordance with their broadest reasonable interpretation (BRI). See MPEP § 2106, subsection II, for more information about the importance of understanding what has been invented, and MPEP § 2111 for more information about the BRI. In the context of the flowchart in MPEP § 2106, subsection III, Step 1 determines whether: • The claim as a whole does not fall within any statutory category (Step 1: NO) and thus is non-statutory, warranting a rejection for failure to claim statutory subject matter; or • The claim as a whole falls within one or more statutory categories (Step 1: YES), and thus must be further analyzed to determine whether it qualifies as eligible at Pathway A or requires further analysis at Step 2A to determine if the claim is directed to a judicial exception. A claim whose BRI covers both statutory and non-statutory embodiments embraces subject matter that is not eligible for patent protection and therefore is directed to non-statutory subject matter. Such claims fail the first step (Step 1: NO) and should be rejected under 35 U.S.C. 101, for at least this reason. In such a case, it is a best practice for the examiner to point out the BRI and recommend an amendment, if possible, that would narrow the claim to those embodiments that fall within a statutory category. For example, the BRI of machine readable media can encompass non-statutory transitory forms of signal transmission, such as a propagating electrical or electromagnetic signal per se. See In re Nuijten, 500 F.3d 1346, 84 USPQ2d 1495 (Fed. Cir. 2007). When the BRI encompasses transitory forms of signal transmission, a rejection under 35 U.S.C. 101 as failing to claim statutory subject matter would be appropriate. Thus, a claim to a computer readable medium that can be a compact disc or a carrier wave covers a non-statutory embodiment and therefore should be rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter. See, e.g., Mentor Graphics v. EVE-USA, Inc., 851 F.3d at 1294-95, 112 USPQ2d at 1134 (claims to a “machine-readable medium” were non-statutory, because their scope encompassed both statutory random-access memory and non-statutory carrier waves). If a claim is clearly not within one of the four categories (Step 1: NO), then a rejection under 35 U.S.C. 101 must be made indicating that the claim is directed to non-statutory subject matter. Form paragraphs 7.05 and 7.05.01 should be used; see MPEP § 2106.07(a)(1). However, as shown in the flowchart in MPEP § 2106 subsection III, when a claim fails under Step 1 (Step 1: NO), but it appears from applicant’s disclosure that the claim could be amended to fall within a statutory category (Step 1: YES), the analysis should proceed to determine whether such an amended claim would qualify as eligible at Pathway A, B or C. In such a case, it is a best practice for the examiner to recommend an amendment, if possible, that would resolve eligibility of the claim. 2106.04 Eligibility Step 2A: Whether a Claim is Directed to a Judicial Exception [R-07.2022] I. JUDICIAL EXCEPTIONS Determining that a claim falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter) in Step 1 does not end the eligibility analysis, because claims directed to nothing more than abstract ideas (such as a mathematical formula or equation), natural phenomena, and laws of nature are not eligible for patent protection. Diamond v. Diehr, 450 U.S. 175, 185, 209 USPQ 1, 7 (1981). Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 216, 110 USPQ2d 1976, 1980 (2014) (citing Association for Molecular 2100-22 Rev. 01.2024, November 2024 MANUAL OF PATENT EXAMINING PROCEDURE § 2106.04 Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 589, 106 USPQ2d 1972, 1979 (2013)); Diamond v. Chakrabarty, 447 U.S. 303, 309, 206 USPQ 193, 197 (1980); Parker v. Flook, 437 U.S. 584, 589, 198 USPQ 193, 197 (1978); Gottschalk v. Benson, 409 U.S. 63, 67-68, 175 USPQ 673, 675 (1972). See also Bilski v. Kappos, 561 U.S. 593, 601, 95 USPQ2d 1001, 1005-06 (2010) (“The Court’s precedents provide three specific exceptions to § 101's broad patent-eligibility principles: ‘laws of nature, physical phenomena, and abstract ideas’”) (quoting Chakrabarty, 447 U.S. at 309, 206 USPQ at 197 (1980)). In addition to the terms “laws of nature,” “natural phenomena,” and “abstract ideas,” judicially recognized exceptions have been described using various other terms, including “physical phenomena,” “products of nature,” “scientific principles,” “systems that depend on human intelligence alone,” “disembodied concepts,” “mental processes,” and “disembodied mathematical algorithms and formulas.” It should be noted that there are no bright lines between the types of exceptions, and that many of the concepts identified by the courts as exceptions can fall under several exceptions. For example, mathematical formulas are considered to be a judicial exception as they express a scientific truth, but have been labelled by the courts as both abstract ideas and laws of nature. Likewise, “products of nature” are considered to be an exception because they tie up the use of naturally occurring things, but have been labelled as both laws of nature and natural phenomena. Thus, it is sufficient for this analysis for the examiner to identify that the claimed concept (the specific claim limitation(s) that the examiner believes may recite an exception) aligns with at least one judicial exception. The Supreme Court has explained that the judicial exceptions reflect the Court’s view that abstract ideas, laws of nature, and natural phenomena are “the basic tools of scientific and technological work”, and are thus excluded from patentability because “monopolization of those tools through the grant of a patent might tend to impede innovation more than it would tend to promote it.” Alice Corp., 573 U.S. at 216, 110 USPQ2d at 1980 (quoting Myriad, 569 U.S. at 589, 106 USPQ2d at 1978 and Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 (2012)). The Supreme Court’s concern that drives this “exclusionary principle” is pre-emption. Alice Corp., 573 U.S. at 216, 110 USPQ2d at 1980. The Court has held that a claim may not preempt abstract ideas, laws of nature, or natural phenomena, even if the judicial exception is narrow (e.g., a particular mathematical formula such as the Arrhenius equation). See, e.g., Mayo, 566 U.S. at 79-80, 86-87, 101 USPQ2d at 1968-69, 1971 (claims directed to “narrow laws that may have limited applications” held ineligible); Flook, 437 U.S. at 589-90, 198 USPQ at 197 (claims that did not “wholly preempt the mathematical formula” held ineligible). This is because such a patent would “in practical effect [] be a patent on the [abstract idea, law of nature or natural phenomenon] itself.” Benson, 409 U.S. at 71- 72, 175 USPQ at 676. The concern over preemption was expressed as early as 1852. See Le Roy v. Tatham, 55 U.S. (14 How.) 156, 175 (1852) (“A principle, in the abstract, is a fundamental truth; an original cause; a motive; these cannot be patented, as no one can claim in either of them an exclusive right.”). While preemption is the concern underlying the judicial exceptions, it is not a standalone test for determining eligibility. Rapid Litig. Mgmt. v. CellzDirect, Inc., 827 F.3d 1042, 1052, 119 USPQ2d 1370, 1376 (Fed. Cir. 2016). Instead, questions of preemption are inherent in and resolved by the two-part framework from Alice Corp. and Mayo (the Alice/Mayo test referred to by the Office as Steps 2A and 2B). Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1150, 120 USPQ2d 1473, 1483 (Fed. Cir. 2016); Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1379, 115 USPQ2d 1152, 1158 (Fed. Cir. 2015). It is necessary to evaluate eligibility using the Alice/Mayo test, because while a preemptive claim may be ineligible, the absence of complete preemption does not demonstrate that a claim is eligible. Diamond v. Diehr, 450 U.S. 175, 191-92 n.14, 209 USPQ 1, 10-11 n.14 (1981) (“We rejected in Flook the argument that because all possible uses of the mathematical formula were not pre-empted, the claim should be eligible for patent protection”). See also Synopsys v. Mentor Graphics, 839 F.3d at 1150, 120 USPQ2d at 1483; FairWarning IP, LLC v. Iatric Rev. 01.2024, November 2024 2100-23 § 2106.04 PATENTABILITY Sys., Inc., 839 F.3d 1089, 1098, 120 USPQ2d 1293, 1299 (Fed. Cir. 2016); Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1320-21, 120 USPQ2d 1353, 1362 (Fed. Cir. 2016); Sequenom, 788 F.3d at 1379, 115 USPQ2d at 1158. Several Federal Circuit decisions, however, have noted the absence of preemption when finding claims eligible under the Alice/Mayo test. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1315, 120 USPQ2d 1091, 1102-03 (Fed. Cir. 2016); Rapid Litig. Mgmt. v. CellzDirect, Inc., 827 F.3d 1042, 1052, 119 USPQ2d 1370, 1376 (Fed. Cir. 2016); BASCOM Global Internet v. AT&T Mobility, LLC, 827 F.3d 1341, 1350-52, 119 USPQ2d 1236, 1243-44 (Fed. Cir. 2016). The Supreme Court’s decisions make it clear that judicial exceptions need not be old or long-prevalent, and that even newly discovered or novel judicial exceptions are still exceptions. For example, the mathematical formula in Flook, the laws of nature in Mayo, and the isolated DNA in Myriad were all novel or newly discovered, but nonetheless were considered by the Supreme Court to be judicial exceptions because they were “‘basic tools of scientific and technological work’ that lie beyond the domain of patent protection.” Myriad, 569 U.S. 576, 589, 106 USPQ2d at 1976, 1978 (noting that Myriad discovered the BRCA1 and BRCA1 genes and quoting Mayo, 566 U.S. 71, 101 USPQ2d at 1965); Flook, 437 U.S. at 591-92, 198 USPQ2d at 198 (“the novelty of the mathematical algorithm is not a determining factor at all”); Mayo, 566 U.S. 73-74, 78, 101 USPQ2d 1966, 1968 (noting that the claims embody the researcher's discoveries of laws of nature). The Supreme Court’s cited rationale for considering even “just discovered” judicial exceptions as exceptions stems from the concern that “without this exception, there would be considerable danger that the grant of patents would ‘tie up’ the use of such tools and thereby ‘inhibit future innovation premised upon them.’” Myriad, 569 U.S. at 589, 106 USPQ2d at 1978-79 (quoting Mayo, 566 U.S. at 86, 101 USPQ2d at 1971). See also Myriad, 569 U.S. at 591, 106 USPQ2d at 1979 (“Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry.”). The Federal Circuit has also applied this principle, for example, when holding a concept of using advertising as an exchange or currency to be an abstract idea, despite the patentee’s arguments that the concept was “new”. Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 714-15, 112 USPQ2d 1750, 1753-54 (Fed. Cir. 2014). Cf. Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1151, 120 USPQ2d 1473, 1483 (Fed. Cir. 2016) (“a new abstract idea is still an abstract idea”) (emphasis in original). For a detailed discussion of abstract ideas, see MPEP § 2106.04(a); for a detailed discussion of laws of nature, natural phenomena and products of nature, see MPEP § 2106.04(b). II. ELIGIBILITY STEP 2A: WHETHER A CLAIM IS DIRECTED TO A JUDICIAL EXCEPTION As described in MPEP § 2106, subsection III, Step 2A of the Office’s eligibility analysis is the first part of the Alice/Mayo test, i.e., the Supreme Court’s “framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts.” Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 217-18, 110 USPQ2d 1976, 1981 (2014) (citing Mayo, 566 U.S. at 77-78, 101 USPQ2d at 1967-68). Like the other steps in the eligibility analysis, evaluation of this step should be made after determining what the inventor has invented by reviewing the entire application disclosure and construing the claims in accordance with their broadest reasonable interpretation. See MPEP § 2106, subsection II for more information about the importance of understanding what has been invented, and MPEP § 2111 for more information about the broadest reasonable interpretation. Step 2A asks: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or an abstract idea? In the context of the flowchart in MPEP § 2106, subsection III, Step 2A determines whether: • The claim as a whole is not directed to a judicial exception (Step 2A: NO) and thus is eligible at Pathway B, thereby concluding the eligibility analysis; or • The claim as a whole is directed to a judicial exception (Step 2A: YES) and thus requires further analysis at Step 2B to determine if the claim as a 2100-24 Rev. 01.2024, November 2024 MANUAL OF PATENT EXAMINING PROCEDURE § 2106.04 whole amounts to significantly more than the exception itself. A. Step 2A Is a Two-Prong Inquiry Step 2A is a two-prong inquiry, in which examiners determine in Prong One whether a claim recites a judicial exception, and if so, then determine in Prong Two if the recited judicial exception is integrated into a practical application of that exception. Together, these prongs represent the first part of the Alice/Mayo test, which determines whether a claim is directed to a judicial exception. The flowchart below depicts the two-prong analysis that is performed in order to answer the Step 2A inquiry. 1. Prong One Prong One asks does the claim recite an abstract idea, law of nature, or natural phenomenon? In Prong One examiners evaluate whether the claim recites a judicial exception, i.e. whether a law of nature, natural phenomenon, or abstract idea is set forth or described in the claim. While the terms "set forth" and "described" are thus both equated with "recite", their different language is intended to indicate that there are two ways in which an exception can be recited in a claim. For instance, the claims in Diehr, Rev. 01.2024, November 2024 2100-25 § 2106.04 PATENTABILITY 450 U.S. at 178 n. 2, 179 n.5, 191-92, 209 USPQ at 4-5 (1981), clearly stated a mathematical equation in the repetitively calculating step, and the claims in Mayo, 566 U.S. 66, 75-77, 101 USPQ2d 1961, 1967-68 (2012), clearly stated laws of nature in the wherein clause, such that the claims “set forth” an identifiable judicial exception. Alternatively, the claims in Alice Corp., 573 U.S. at 218, 110 USPQ2d at 1982, described the concept of intermediated settlement without ever explicitly using the words “intermediated” or “settlement.” The Supreme Court has held that Section 101 contains an implicit exception for ‘‘[l]aws of nature, natural phenomena, and abstract ideas,’’ which are ‘‘the basic tools of scientific and technological work.’’ Alice Corp., 573 U.S. at 216, 110 USPQ2d at 1980 (citing Mayo, 566 US at 71, 101 USPQ2d at 1965). Yet, the Court has explained that ‘‘[a]t some level, all inventions embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas,’’ and has cautioned ‘‘to tread carefully in construing this exclusionary principle lest it swallow all of patent law.’’ Id. See also Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335, 118 USPQ2d 1684, 1688 (Fed. Cir. 2016) (“The ‘directed to’ inquiry, therefore, cannot simply ask whether the claims involve a patent-ineligible concept, because essentially every routinely patent-eligible claim involving physical products and actions involves a law of nature and/or natural phenomenon”). Examiners should accordingly be careful to distinguish claims that recite an exception (which require further eligibility analysis) and claims that merely involve an exception (which are eligible and do not require further eligibility analysis). An example of a claim that recites a judicial exception is “A machine comprising elements that operate in accordance with F=ma.” This claim sets forth the principle that force equals mass times acceleration (F=ma) and therefore recites a law of nature exception. Because F=ma represents a mathematical formula, the claim could alternatively be considered as reciting an abstract idea. Because this claim recites a judicial exception, it requires further analysis in Prong Two in order to answer the Step 2A inquiry. An example of a claim that merely involves, or is based on, an exception is a claim to “A teeter-totter comprising an elongated member pivotably attached to a base member, having seats and handles attached at opposing sides of the elongated member.” This claim is based on the concept of a lever pivoting on a fulcrum, which involves the natural principles of mechanical advantage and the law of the lever. However, this claim does not recite these natural principles and therefore is not directed to a judicial exception (Step 2A: NO). Thus, the claim is eligible at Pathway B without further analysis. If the claim recites a judicial exception (i.e., an abstract idea enumerated in MPEP § 2106.04(a), a law of nature, or a natural phenomenon), the claim requires further analysis in Prong Two. If the claim does not recite a judicial exception (a law of nature, natural phenomenon, or abstract idea), then the claim cannot be directed to a judicial exception (Step 2A: NO), and thus the claim is eligible at Pathway B without further analysis. For more information how to determine if a claim recites an abstract idea, see MPEP § 2106.04(a). For more information on how to determine if a claim recites a law of nature or natural phenomenon, see MPEP § 2106.04(b). For more information on how to determine if a claim recites a product of nature, see MPEP § 2106.04(c). 2. Prong Two Prong Two asks does the claim recite additional elements that integrate the judicial exception into a practical application? In Prong Two, examiners evaluate whether the claim as a whole integrates the exception into a practical application of that exception. If the additional elements in the claim integrate the recited exception into a practical application of the exception, then the claim is not directed to the judicial exception (Step 2A: NO) and thus is eligible at Pathway B. This concludes the eligibility analysis. If, however, the additional elements do not integrate the exception into a practical application, then the claim is directed to the recited judicial exception (Step 2A: YES), and requires further analysis under Step 2B (where it may still be eligible if it amounts to an ‘‘inventive concept’’). For more information on how to evaluate whether a judicial exception is integrated into a practical application, see MPEP § 2106.04(d)(2). 2100-26 Rev. 01.2024, November 2024 MANUAL OF PATENT EXAMINING PROCEDURE § 2106.04 The mere inclusion of a judicial exception such as a mathematical formula (which is one of the mathematical concepts identified as an abstract idea in MPEP § 2106.04(a)) in a claim means that the claim “recites” a judicial exception under Step 2A Prong One. However, mere recitation of a judicial exception does not mean that the claim is “directed to” that judicial exception under Step 2A Prong Two. Instead, under Prong Two, a claim that recites a judicial exception is not directed to that judicial exception, if the claim as a whole integrates the recited judicial exception into a practical application of that exception. Prong Two thus distinguishes claims that are “directed to” the recited judicial exception from claims that are not “directed to” the recited judicial exception. Because a judicial exception is not eligible subject matter, Bilski, 561 U.S. at 601, 95 USPQ2d at 1005-06 (quoting Chakrabarty, 447 U.S. at 309, 206 USPQ at 197 (1980)), if there are no additional claim elements besides the judicial exception, or if the additional claim elements merely recite another judicial exception, that is insufficient to integrate the judicial exception into a practical application. See, e.g., RecogniCorp, LLC v. Nintendo Co., 855