MPEP § 2121 — MPEP § 2121
Current through: 2022-07-01

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

 
 
 
 
 
 
 
 

 

 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 

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 Chapter 2100 

 Section 2121 
 

 
 
 
 
 
 2121 Prior Art; General Level of Operability Required to Make a
 Prima Facie Case [R-01.2024]
 
 I. PRIOR ART IS PRESUMED TO BE OPERABLE/ENABLING When the reference relied on expressly anticipates or makes obvious all
 of the elements of the claimed invention, the reference is presumed to be operable. Once
 such a reference is found, the burden is on applicant to rebut the presumption of
 operability. In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA 1980). See
 also MPEP
 § 716.07 . See also In re Antor Media Corp., 
 689 F.3d 1282, 103 USPQ2d 1555 (Fed. Cir. 2012). Specifically, in In re Antor
 Media Corp., the court stated:
 

 
 
 “Consistent with the statutory framework and our
 precedent, we therefore hold that, during patent prosecution, an examiner is
 entitled to reject claims as anticipated by a prior art publication or patent
 without conducting an inquiry into whether or not that prior art reference is
 enabling. As long as an examiner makes a proper prima facie case of anticipation
 by giving adequate notice under § 132 , the burden shifts to
 the applicant to submit rebuttal evidence of nonenablement.” 
 

 
 

 In re Antor Media Corp., 689 F.3d at
 1289, 103 USPQ2d at 1559.
 

 Where a reference appears to not be enabling on its
 face, however, an applicant may successfully challenge the cited prior art for lack of
 enablement by argument without supporting evidence. In re Morsa, 713
 F.3d 104, 110, 106 USPQ2d 1327, 1332 (Fed. Cir. 2013).
 

 See also MPEP § 716.07 .
 

 II. WHAT CONSTITUTES AN “ENABLING DISCLOSURE” DOES NOT DEPEND ON THE TYPE OF PRIOR
 ART THE DISCLOSURE IS CONTAINED IN The level of disclosure required within a reference to make it an
 “enabling disclosure” is the same no matter what type of prior art is at issue. It does
 not matter whether the prior art reference is a U.S. patent, foreign patent, a printed
 publication or other. There is no basis in the statute ( 35 U.S.C. 102 or
 103 ) for discriminating either in favor of or against prior art
 references on the basis of nationality. In re Moreton, 288 F.2d 708,
 129 USPQ 227 (CCPA 1961).
 

 III. EFFICACY IS NOT A REQUIREMENT FOR PRIOR ART ENABLEMENT A prior art reference provides an enabling disclosure and thus
 anticipates a claimed invention if the reference describes the claimed invention in
 sufficient detail to enable a person of ordinary skill in the art to carry out the
 claimed invention; “proof of efficacy is not required for a prior art reference to be
 enabling for purposes of anticipation.” Impax Labs. Inc. v. Aventis
 Pharm. Inc., 468 F.3d 1366, 1383, 81 USPQ2d 1001, 1013 (Fed. Cir. 2006)
 (citing Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318, 1326,
 75 USPQ2d 1297, 1302 (Fed. Cir. 2005)). See also MPEP § 2122 . 
 

 
 2121.01 Use of Prior Art in Rejections Where Operability is in
 Question [R-07.2022]
 

 “In determining that quantum of prior art disclosure which is necessary
 to declare an ... invention ‘not novel’ or ‘anticipated’ within section
 102 , the stated test is whether a reference contains an ‘enabling
 disclosure’... .” In re Hoeksema, 399 F.2d 269, 158 USPQ 596 (CCPA 1968). The disclosure in
 an assertedly anticipating reference must provide an enabling disclosure of the desired
 subject matter; mere naming or description of the subject matter is insufficient, if it
 cannot be produced without undue experimentation. Elan Pharm., Inc. v. Mayo
 Found. For Med. Educ. & Research, 346 F.3d 1051, 1054, 68 USPQ2d 1373,
 1376 (Fed. Cir. 2003) (At issue was whether a prior art reference enabled one of
 ordinary skill in the art to produce Elan’s claimed transgenic mouse without undue
 experimentation. Without a disclosure enabling one skilled in the art to produce a
 transgenic mouse without undue experimentation, the reference would not be applicable as
 prior art.). A reference contains an “enabling disclosure” if the public was in
 possession of the claimed invention before the effective filing date of the claimed
 invention for applications or patents subject to the first inventor to file provisions
 of the AIA or at the time the invention was made for applications or patents subject to
 pre-AIA law. “Such possession is effected if one of ordinary skill in the art could have
 combined the publication’s description of the invention with his [or her] own knowledge
 to make the claimed invention.” In re Donohue, 766 F.2d 531, 226 USPQ
 619 (Fed. Cir. 1985).
 

 I. 35 U.S.C. 102 REJECTIONS AND ADDITION OF EVIDENCE SHOWING REFERENCE IS
 OPERABLE It is possible to make a 35 U.S.C. 102 rejection even if
 the reference does not itself teach one of ordinary skill how to practice the
 invention, i.e., how to make the article disclosed or use the method disclosed. If
 the reference teaches every claimed element of the article or every claimed step of
 the method, secondary evidence, such as other patents or publications, can be cited
 to show public possession of the method of making the article or using the method.
 In re Donohue, 766 F.2d at 533, 226 USPQ at 621. See
 MPEP §
 2131.01 for more information on 35 U.S.C. 102 
 rejections using secondary references to show that the primary reference contains an
 “enabling disclosure.” 
 

 II. 35 U.S.C. 103 REJECTIONS AND USE OF INOPERATIVE PRIOR ART “Even if a reference discloses an inoperative device, it is prior
 art for all that it teaches.” Beckman Instruments v. LKB Produkter AB, 892 F.2d 1547, 1551, 13 USPQ2d 1301, 1304 (Fed.
 Cir. 1989). Therefore, “a non-enabling reference may qualify as prior art for the
 purpose of determining obviousness under 35 U.S.C. 103 .” Symbol
 Techs. Inc. v. Opticon Inc., 935 F.2d 1569, 1578, 19 USPQ2d 1241, 1247
 (Fed. Cir. 1991).
 

 

 
 2121.02 Compounds and Compositions — What Constitutes Enabling Prior
 Art [R-01.2024]
 

 [Editor Note: This MPEP section is applicable regardless of whether an
 application is examined under the AIA or under pre-AIA law. For applications subject
 to the first inventor to file (FITF) provisions of the AIA, the relevant time is
 "before the effective filing date of the claimed invention". For applications subject
 to pre-AIA 35
 U.S.C. 102 , the relevant time is "at the time of the
 invention". See MPEP § 2150 et seq. Many of the
 court decisions discussed in this section involved applications or patents subject to
 pre-AIA 35
 U.S.C. 102 . These court decisions may be applicable to
 applications and patents subject to AIA 35 U.S.C. 102 but the
 relevant time is before the effective filing date of the claimed invention and not at
 the time of the invention.] 

 I. ONE OF ORDINARY SKILL IN THE ART MUST BE ABLE TO MAKE OR SYNTHESIZE Where a process for making the compound is not developed until after
 the date of invention, the mere naming of a compound in a reference, without more,
 cannot constitute a description of the compound. In re Hoeksema, 
 399 F.2d 269, 158 USPQ 596 (CCPA 1968). Note, however, that a reference is presumed
 operable until applicant provides facts rebutting the presumption of operability.
 In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA 1980). Therefore,
 applicant must provide evidence showing that a process for making was not known at
 the relevant time. See the following subsection for the evidentiary standard to be
 applied. 
 

 II. A REFERENCE DOES NOT CONTAIN AN “ENABLING DISCLOSURE” IF ATTEMPTS AT MAKING
 THE COMPOUND OR COMPOSITION WERE UNSUCCESSFUL BEFORE THE RELEVANT TIME When a prior art reference merely discloses the structure of the
 claimed compound, evidence showing that attempts to prepare that compound were
 unsuccessful before the relevant time will be adequate to show inoperability.
 In re Wiggins, 488 F.2d 538, 179 USPQ 421 (CCPA 1973). However,
 the fact that an author of a publication did not attempt to make the compound
 disclosed, without more, will not overcome a rejection based on that publication.
 In re Donohue, 766 F.2d 531, 226 USPQ 619 (Fed. Cir. 1985) (In
 this case, the examiner had made a rejection under pre-AIA 35 U.S.C.
 102(b) over a publication, which disclosed the claimed
 compound, in combination with two patents teaching a general process of making the
 particular class of compounds. The applicant submitted an affidavit stating that the
 authors of the publication had not actually synthesized the compound. The court held
 that the fact that the publication’s author did not synthesize the disclosed compound
 was immaterial to the question of reference operability. The patents were evidence
 that synthesis methods were well known. The court distinguished
 Wiggins, in which a very similar rejection was reversed. In
 Wiggins, attempts to make the compounds using the prior art
 methods were all unsuccessful.). Compare In re Hoeksema, 399 F.2d
 269, 158 USPQ 596 (CCPA 1968) (A claim to a compound was rejected over a patent to
 De Boer which disclosed compounds similar in structure to those
 claimed (obvious homologs) and a process of making these compounds. Applicant
 responded with an affidavit by an expert named Wiley which stated that there was no
 indication in the De Boer patent that the process disclosed in
 De Boer could be used to produce the claimed compound and that
 he did not believe that the process disclosed in De Boer could be
 adapted to the production of the claimed compound. The court held that the facts
 stated in this affidavit were legally sufficient to overcome the rejection and that
 applicant need not show that all known processes are incapable of producing the
 claimed compound for this showing would be practically impossible.). 
 

 

 
 2121.03 Plant Genetics — What Constitutes Enabling Prior
 Art [R-01.2024]
 
 THOSE OF ORDINARY SKILL MUST BE ABLE TO GROW AND CULTIVATE THE PLANT When the claims are drawn to plants, the reference, combined with
 knowledge in the prior art, must enable one of ordinary skill in the art to reproduce
 the plant. In re LeGrice, 301 F.2d 929, 133 USPQ 365 (CCPA 1962) (National Rose
 Society Annual of England and various other catalogues showed color pictures of the
 claimed roses and disclosed that applicant had raised the roses. The publications
 were published more than 1 year before applicant's filing date. The court held that
 the publications did not place the rose in the public domain. Information on the
 grafting process required to reproduce the rose was not included in the publications
 and such information was necessary for those of ordinary skill in the art (plant
 breeders) to reproduce the rose.). Compare Ex parte Thomson, 24 USPQ2d 1618 (Bd. Pat. App. & Inter. 1992) (Seeds
 were commercially available more than 1 year prior to applicant’s filing date. One of
 ordinary skill in the art could grow the claimed cotton cultivar from the
 commercially available seeds. Thus, the publications describing the cotton cultivar
 had “enabled disclosures.” The Board distinguished In re LeGrice 
 by finding that the catalogue picture of the rose of In re LeGrice 
 was the only evidence in that case. There was no evidence of commercial availability
 in enabling form since the asexually reproduced rose could not be reproduced from
 seed. Therefore, the public would not have possession of the rose by its picture
 alone, but the public would have possession of the cotton cultivar based on the
 publications and the availability of the seeds.). In In re Elsner, 
 381 F.3d 1125, 1126, 72 USPQ2d 1038, 1040 (Fed. Cir. 2004), prior to the critical
 date of a plant patent application, the plant had been sold in Germany and a foreign
 Plant Breeder’s Rights (PBR) application for the same plant had been published in the
 Community Plant Variety Office Official Gazette . The court held
 that when (i) a publication identifies the plant, (ii) a foreign sale occurs that
 puts one of ordinary skill in the art in possession of the plant itself, and (iii)
 such possession permits asexual reproduction of the plant without undue
 experimentation by one of ordinary skill in the art, then that combination of facts
 and events directly conveys the essential knowledge of the invention and constitutes
 a pre-AIA 35 U.S.C.
 102(b) statutory bar. Id. at 1129, 72 USPQ2d
 at 1041. Although the court agreed with the Board that foreign sales may enable an
 otherwise non-enabling printed publication, the case was remanded for additional
 fact-finding in order to determine if the foreign sales of the plant were known to be
 accessible to the skilled artisan and if the skilled artisan could have reproduced
 the plant asexually after obtaining it without undue experimentation.
 Id. at 1131, 72 USPQ2d at 1043. See MPEP §
 2152.02(d) for information on foreign sales being prior art
 for applications subject to the first inventor to file provisions of the AIA. 
 

 

 
 2121.04 Apparatus and Articles — What Constitutes Enabling Prior
 Art [R-10.2019]
 
 PICTURES MAY CONSTITUTE AN “ENABLING DISCLOSURE” Pictures and drawings may be sufficiently enabling to put the public
 in the possession of the article pictured. Therefore, such an enabling picture may
 be used to reject claims to the article. However, the picture must show all the
 claimed structural features and how they are put together. In re
 Bager, 47 F.2d 951, 953, 8 USPQ 484, 486 (CCPA 1931) (“Description for
 the purposes of anticipation can be by drawings alone as well as by words.”) (citing
 Jockmus v. Leviton, 28 F.2d 812 (2d Cir. 1928)). See also
 MPEP §
 2125 for a discussion of drawings as prior art. 
 

 

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 2101-2102-[Reserved] 

 2103-Patent Examination Process 

 2104-Requirements of 35 U.S.C. 101 
 2104.01-Barred by Atomic Energy Act 

 
 

 2105-Patent Eligible Subject Matter — Living Subject Matter 

 2106-Patent Subject Matter Eligibility 
 2106.01-[Reserved] 

 2106.02-[Reserved] 

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

 2106.04-Eligibility Step 2A: Whether a Claim is Directed to a Judicial Exception 
 2106.04(a)-Abstract Ideas 
 2106.04(a)(1)-Examples of Claims That Do Not Recite Abstract Ideas 

 2106.04(a)(2)-Abstract Idea Groupings 

 2106.04(a)(3)-Tentative Abstract Ideas 

 
 

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

 2106.04(c)-The Markedly Different Characteristics Analysis 

 2106.04(d)-Integration of a Judicial Exception Into A Practical Application 
 2106.04(d)(1)-Evaluating Improvements in the Functioning of a Computer, or an Improvement to Any Other Technology or Technical Field in
 Step 2A Prong Two 

 2106.04(d)(2)-Particular Treatment and Prophylaxis in Step 2A Prong Two 

 
 

 
 

 2106.05-Eligibility Step 2B: Whether a Claim Amounts to Significantly More 
 2106.05(a)-Improvements to the Functioning of a Computer or To Any Other Technology or Technical Field 

 2106.05(b)-Particular Machine 

 2106.05(c)-Particular Transformation 

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

 2106.05(e)-Other Meaningful Limitations 

 2106.05(f)-Mere Instructions To Apply An Exception 

 2106.05(g)-Insignificant Extra-Solution Activity 

 2106.05(h)-Field of Use and Technological Environment 

 
 

 2106.06-Streamlined Analysis 
 2106.06(a)-Eligibility is Self Evident 

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

 
 

 2106.07-Formulating and Supporting Rejections For Lack Of Subject Matter Eligibility 
 2106.07(a)-Formulating a Rejection For Lack of Subject Matter Eligibility 
 2106.07(a)(1)-Form Paragraphs for use in Lack of Subject Matter Eligibility Rejections 

 
 

 2106.07(b)-Evaluating Applicant’s Response 

 2106.07(c)-Clarifying the Record 

 
 

 
 

 2107-Guidelines for Examination of Applications for Compliance with the Utility Requirement 
 2107.01-General Principles Governing Utility Rejections 

 2107.02-Procedural Considerations Related to Rejections for Lack of Utility 

 2107.03-Special Considerations for Asserted Therapeutic or Pharmacological Utilities 

 
 

 2108-[Reserved] 

 2109-Inventorship 

 2109.01-Joint Inventorship 

 2110-[Reserved] 

 2111-Claim Interpretation; Broadest Reasonable Interpretation 
 2111.01-Plain Meaning 

 2111.02-Effect of Preamble 

 2111.03-Transitional Phrases 

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

 2111.05-Functional and Nonfunctional Descriptive Material 

 
 

 2112-Requirements of Rejection Based on Inherency; Burden of Proof 
 2112.01-Composition, Product, and Apparatus Claims 

 2112.02-Process Claims 

 
 

 2113-Product-by-Process Claims 

 2114-Apparatus and Article Claims — Functional Language 

 2115-Material or Article Worked Upon by Apparatus 

 2116-Novel, Nonobvious Starting Material or End Product 
 2116.01-Novel, Nonobvious Starting Material or End Product 

 
 

 2117-Markush Claims 

 2118-2119-[Reserved] 

 2120-Rejection on Prior Art 
 2120.01-Rejections Under 35 U.S.C. 102(a)(1) and (a)(2) and Pre-AIA 35 U.S.C. 102(a), (b), or (e): Printed Publication or Patent 

 2120.02-Rejections Under 35 U.S.C. 102(a)(1) or Pre-AIA 35 U.S.C. 102(a) or (b): Knowledge by Others, or Public Use, or On Sale 

 
 

 2121-Prior Art; General Level of Operability Required to Make a Prima Facie Case 
 2121.01-Use of Prior Art in Rejections Where Operability is in Question 

 2121.02-Compounds and Compositions — What Constitutes Enabling Prior Art 

 2121.03-Plant Genetics — What Constitutes Enabling Prior Art 

 2121.04-Apparatus and Articles — What Constitutes Enabling Prior Art 

 
 

 2122-Discussion of Utility in the Prior Art 

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

 2124-Exception to the Rule That the Reference Must be Prior Art 
 2124.01-Tax Strategies Deemed Within the Prior Art 

 
 

 2125-Drawings as Prior Art 

 2126-Availability of a Document as a “Patent” for Purposes of Rejection Under 35 U.S.C. 102(a) or Pre-AIA 35 U.S.C. 102(a), (b),
 and (d) 
 2126.01-Date of Availability of a Patent as a Reference 

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

 
 

 2127-Domestic and Foreign Patent Applications as Prior Art 

 2128-“Printed Publications” as Prior Art 
 2128.01-Level of Public Accessibility Required 

 2128.02-Date Publication Is Available as a Reference 

 
 

 2129-Admissions as Prior Art 

 2130-[Reserved] 

 2131-Anticipation — Application of 35 U.S.C. 102 
 2131.01-Multiple Reference 35 U.S.C. 102 Rejections 

 2131.02-Genus-Species Situations 

 2131.03-Anticipation of Ranges 

 2131.04-Secondary Considerations 

 2131.05-Nonanalogous or Disparaging Prior Art 

 
 

 2132-Pre-AIA 35 U.S.C. 102(a) 
 2132.01-Overcoming a Pre-AIA 35 U.S.C. 102(a) Rejection based on a Printed Publication or Patent 

 
 

 2133-Pre-AIA 35 U.S.C. 102(b) 
 2133.01-Rejections of Continuation-In-Part (CIP) Applications 

 2133.02-Rejections Based on Publications and Patents 
 2133.02(a)-Overcoming a Pre-AIA 35 U.S.C. 102(b) Rejection Based on a Printed Publication or Patent 

 
 

 2133.03-Rejections Based on “Public Use” or “On Sale” 
 2133.03(a)-“Public Use” 

 2133.03(b)-“On Sale” 

 2133.03(c)-The “Invention” 

 2133.03(d)-“In This Country” 

 2133.03(e)-Permitted Activity; Experimental Use 
 2133.03(e)(1)-Commercial Exploitation 

 2133.03(e)(2)-Intent 

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

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

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

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

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

 
 

 
 

 
 

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

 2135-Pre-AIA 35 U.S.C. 102(d) 
 2135.01-The Four Requirements of Pre-AIA 35 U.S.C. 102(d) 

 
 

 2136-Pre-AIA 35 U.S.C. 102(e) 
 2136.01-Status of Unpublished or Published as Redacted U.S. Application as a Reference Under Pre-AIA 35 U.S.C. 102(e) 

 2136.02-Content of the Prior Art Available Against the Claims 

 2136.03-Critical Reference Date 

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

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

 2136.05(b)-Showing The Reference Is Describing An Inventor's Or At Least One Joint Inventor's Own Work 

 
 

 
 

 2137-Pre-AIA 35 U.S.C. 102(f) 
 2137.01-[Reserved] 

 2137.02-[Reserved] 

 
 

 2138-Pre-AIA 35 U.S.C. 102(g) 
 2138.01-Interference Practice 

 2138.02-“The Invention Was Made in This Country” 

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

 2138.04-“Conception” 

 2138.05-“Reduction to Practice” 

 2138.06-“Reasonable Diligence” 

 
 

 2139-Rejections Under Pre-AIA 35 U.S.C. 102 
 2139.01-Effective Filing Date of a Claimed Invention Under Pre-AIA 35 U.S.C. 102 

 2139.02-Determining Whether To Apply Pre-AIA 35 U.S.C. 102(a), (b), or (e) 

 2139.03-Form Paragraphs for Use in Rejections Under Pre-AIA 35 U.S.C. 102 

 
 

 2140-[Reserved] 

 2141-Examination Guidelines for Determining Obviousness Under 35 U.S.C. 103 
 2141.01-Scope and Content of the Prior Art 
 2141.01(a)-Analogous and Nonanalogous Art 

 
 

 2141.02-Differences Between Prior Art and Claimed Invention 

 2141.03-Level of Ordinary Skill in the Art 

 
 

 2142-Legal Concept of Prima Facie Obviousness 

 2143-Examples of Basic Requirements of a Prima Facie Case of Obviousness 
 2143.01-Suggestion or Motivation To Modify the References 

 2143.02-Reasonable Expectation of Success Is Required 

 2143.03-All Claim Limitations Must Be Considered 

 
 

 2144-Supporting a Rejection Under 35 U.S.C. 103 
 2144.01-Implicit Disclosure 

 2144.02-Reliance on Scientific Theory 

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

 2144.04-Legal Precedent as Source of Supporting Rationale 

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

 2144.06-Art Recognized Equivalence for the Same Purpose 

 2144.07-Art Recognized Suitability for an Intended Purpose 

 2144.08-Obviousness of Species When Prior Art Teaches Genus 

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

 
 

 2145-Consideration of Applicant’s Rebuttal Arguments and Evidence 

 2146-Pre-AIA 35 U.S.C. 103(c) 
 2146.01-Prior Art Disqualification Under Pre-AIA 35 U.S.C. 103(c) 

 2146.02-Establishing Common Ownership or Joint Research Agreement Under Pre-AIA 35 U.S.C. 103(c) 

 2146.03-Examination Procedure With Respect to Pre-AIA 35 U.S.C. 103(c) 
 2146.03(a)-Provisional Rejection (Obviousness) Under 35 U.S.C. 103(a) Using Provisional Prior Art Under Pre-AIA 35 U.S.C. 102(e) 

 
 

 
 

 2147-Biotechnology Process Applications; Pre-AIA 35 U.S.C. 103(b) 

 2148-Form Paragraphs for Use in Rejections Under Pre-AIA 35 U.S.C. 103 

 2149-[Reserved] 

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

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

 2152-Detailed Discussion of AIA 35 U.S.C. 102(a) and (b) 
 2152.01-Effective Filing Date of the Claimed Invention 

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

 2152.02(b)-Described in a Printed Publication 

 2152.02(c)-In Public Use 

 2152.02(d)-On Sale 

 2152.02(e)-Otherwise Available to the Public 

 2152.02(f)-No Requirement of “By Others” 

 
 

 2152.03-Admissions 

 2152.04-The Meaning of “Disclosure” 

 2152.05-Determining Whether To Apply 35 U.S.C. 102(a)(1) or 102(a)(2) 

 2152.06-Overcoming a 35 U.S.C. 102(a)(1) or 102(a)(2) Rejection 

 2152.07-Form Paragraphs for Use in Rejections Under AIA 35 U.S.C. 102 

 
 

 2153-Prior Art Exceptions Under 35 U.S.C. 102(b)(1) to AIA 35 U.S.C. 102(a)(1) 
 2153.01-Prior Art Exception Under AIA 35 U.S.C. 102(b)(1)(A) To AIA 35 U.S.C. 102(a)(1) (Grace Period Inventor-Originated Disclosure
 Exception) 
 2153.01(a)-Grace Period Inventor-Originated Disclosure Exception 

 2153.01(b)-[Reserved] 

 
 

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

 
 

 2154-Provisions Pertaining to Subject Matter in a U.S. Patent or Application Effectively Filed Before the Effective Filing Date
 of the Claimed Invention 
 2154.01-Prior Art Under AIA 35 U.S.C. 102(a)(2) “U.S. Patent Documents” 
 2154.01(a)-WIPO Published Applications 

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

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

 2154.01(d)-Provisional Rejections Under 35 U.S.C. 102(a)(2); Reference Is a Copending U.S. Patent Application 

 
 

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

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

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

 
 

 
 

 2155-Use of Affidavits or Declarations Under 37 CFR 1.130 To Overcome Prior Art Rejections 
 2155.01-Showing That the Disclosure Was Made by the Inventor or a Joint Inventor 

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

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

 2155.04-Enablement 

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

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

 
 

 2156-Joint Research Agreements 

 2157-Improper Naming of Inventors 

 2158-AIA 35 U.S.C. 103 
 2158.01-Form Paragraphs for Use in Rejections Under AIA 35 U.S.C. 103 

 
 

 2159-Applicability Date Provisions and Determining Whether an Application Is Subject to the First Inventor To File Provisions of
 the AIA 
 2159.01-Applications Filed Before March 16, 2013 

 2159.02-Applications Filed on or After March 16, 2013 

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

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

 
 

 2160-[Reserved] 

 2161-Three Separate Requirements for Specification Under 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, First Paragraph 
 2161.01-Computer Programming, Computer Implemented Inventions, and 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, First Paragraph 

 
 

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

 2163-Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, first paragraph,
 “Written Description” Requirement 
 2163.01-Support for the Claimed Subject Matter in Disclosure 

 2163.02-Standard for Determining Compliance With the Written Description Requirement 

 2163.03-Typical Circumstances Where Adequate Written Description Issue Arises 

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

 2163.05-Changes to the Scope of Claims 

 2163.06-Relationship of Written Description Requirement to New Matter 

 2163.07-Amendments to Application Which Are Supported in the Original Description 
 2163.07(a)-Inherent Function, Theory, or Advantage 

 2163.07(b)-Incorporation by Reference 

 
 

 
 

 2164-The Enablement Requirement 
 2164.01-Test of Enablement 
 2164.01(a)-Undue Experimentation Factors 

 2164.01(b)-How to Make the Claimed Invention 

 2164.01(c)-How to Use the Claimed Invention 

 
 

 2164.02-Working and Prophetic Examples 

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

 2164.04-Burden on the Examiner Under the Enablement Requirement 

 2164.05-Determination of Enablement Based on Evidence as a Whole 
 2164.05(a)-Specification Must Be Enabling as of the Filing Date 

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

 
 

 2164.06-Quantity of Experimentation 
 2164.06(a)-Examples of Enablement Issues-Missing Information 

 2164.06(b)-Examples of Enablement Issues — Biological and Chemical Cases 

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

 
 

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

 2164.08-Enablement Commensurate in Scope With the Claims 
 2164.08(a)-Single Means Claim 

 2164.08(b)-Inoperative Subject Matter 

 2164.08(c)-Critical Feature Not Claimed 

 
 

 
 

 2165-The Best Mode Requirement 
 2165.01-Considerations Relevant to Best Mode 

 2165.02-Best Mode Requirement Compared to Enablement Requirement 

 2165.03-Requirements for Rejection for Lack of Best Mode 

 2165.04-Examples of Evidence of Concealment 

 
 

 2166-Rejections Under 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, First Paragraph 

 2167-2170-[Reserved] 

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

 2172-Subject Matter Which the Inventor or a Joint Inventor Regards as The Invention 
 2172.01-Unclaimed Essential Subject Matter 

 
 

 2173-Claims Must Particularly Point Out and Distinctly Claim the Invention 
 2173.01-Interpreting the Claims 

 2173.02-Determining Whether Claim Language is Definite 

 2173.03-Correspondence Between Specification and Claims 

 2173.04-Breadth Is Not Indefiniteness 

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

 2173.05(b)-Relative Terminology 

 2173.05(c)-Numerical Ranges and Amounts Limitations 

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

 2173.05(e)-Lack of Antecedent Basis 

 2173.05(f)-Reference to Limitations in Another Claim 

 2173.05(g)-Functional Limitations 

 2173.05(h)-Alternative Limitations 

 2173.05(i)-Negative Limitations 

 2173.05(j)-Old Combination 

 2173.05(k)-Aggregation 

 2173.05(l)-[Reserved] 

 2173.05(m)-Prolix 

 2173.05(n)-Multiplicity 

 2173.05(o)-Double Inclusion 

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

 2173.05(q)-“Use” Claims 

 2173.05(r)-Omnibus Claim 

 2173.05(s)-Reference to Figures or Tables 

 2173.05(t)-Chemical Formula 

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

 2173.05(v)-Mere Function of Machine 

 
 

 2173.06-Practice Compact Prosecution 

 
 

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

 2175-Form Paragraphs for Use in Rejections Under 35 U.S.C. 112(b) or Pre-AIA 35 U.S.C. 112, Second Paragraph 

 2176-2180-[Reserved] 

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

 2182-Search and Identification of the Prior Art 

 2183-Making a Prima Facie Case of Equivalence 

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

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

 2186-Relationship to the Doctrine of Equivalents 

 2187-Form Paragraphs for Use Relating to 35 U.S.C. 112(f) or Pre-AIA 35 U.S.C. 112, Sixth Paragraph 

 2188-2189-[Reserved] 

 2190-Prosecution Laches and Res Judicata 

 

 

 
 

 
 
 

 
 

 

 
 
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