MPEP § 2161 — MPEP § 2161
Current through: 2022-07-01

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

 
 
 
 
 
 
 
 

 

 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 

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 Manual of Patent Examining Procedure 

 Chapter 2100 

 Section 2161 
 

 
 
 
 
 
 2161 Three Separate Requirements for Specification Under 35 U.S.C.
 112(a) or Pre-AIA 35 U.S.C. 112, First Paragraph [R-07.2015]
 
 I. THE SPECIFICATION MUST INCLUDE A WRITTEN DESCRIPTION OF THE INVENTION,
 ENABLEMENT, AND BEST MODE OF CARRYING OUT THE CLAIMED INVENTION 
 

 35 U.S.C. 112(a) (applicable to applications
 filed on or after September 16, 2012) provides:
 
 (a) IN GENERAL.—The specification shall contain a
 written description of the invention, and of the manner and process of making and
 using it, in such full, clear, concise, and exact terms as to enable any person
 skilled in the art to which it pertains, or with which it is most nearly
 connected, to make and use the same, and shall set forth the best mode
 contemplated by the inventor or joint inventor of carrying out the invention. 
 

 
 The first paragraph of pre-AIA 35 U.S.C. 112 (applicable to
 applications filed before September 16, 2012) provides:
 

 
 The specification shall contain a written
 description of the invention, and of the manner and process of making
 and using it, in such full, clear, concise, and exact terms as to
 enable any person skilled in the art to which it pertains,
 or with which it is most nearly connected, to make and use the same, and shall set
 forth the best mode contemplated by the inventor of carrying
 out his invention. [emphasis added].
 

 
 35 U.S.C.
 112(a) and pre-AIA 35 U.S.C. 112 , first
 paragraph require that the specification include the following:
 

 
 (A) A written description of the invention;

 (B) The manner and process of making and using the invention (the
 enablement requirement); and
 

 (C) The best mode contemplated by the inventor of carrying out his
 invention.
 

 II. THE THREE REQUIREMENTS ARE SEPARATE AND DISTINCT FROM EACH OTHER The written description requirement is separate and distinct from the
 enablement requirement. Ariad Pharm., Inc. v. Eli Lilly and Co., 598
 F.3d 1336, 1341, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010) (en banc) (If
 Congress had intended enablement to be the sole description requirement of
 §
 112 , first paragraph, the statute would have been written
 differently.) Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562, 19 USPQ2d 1111, 1115 (Fed. Cir. 1991)
 (While acknowledging that some of its cases concerning the written description
 requirement and the enablement requirement are confusing, the Federal Circuit reaffirmed
 that under 35 U.S.C.
 112 , first paragraph, the written description requirement is
 separate and distinct from the enablement requirement and gave an example thereof.);
 In re Barker, 559 F.2d 588, 194 USPQ 470 (CCPA 1977), cert.
 denied, 434 U.S. 1064 (1978). See also, e.g., Vasudevan Software, Inc. v.
 MicroStrategy, Inc., 782 F.3d 671, 681-685, 114 USPQ2d 1349, 1356, 1357
 (Fed. Cir. 2015) (reversing and remanding the district court's grant of summary judgment
 of invalidity for lack of an adequate written description and lack of enablement because
 there were genuine issues of material fact regarding 1) whether the claims had
 sufficient written description support (“[t]he fact that . . . the specification do[es]
 not speak in haec verba of accessing ‘disparate databases’ does not eliminate as a
 genuine issue of material fact that the existence of at least some discussion, and
 therefore, possession, of the accessing of disparate databases, as claimed”); and 2)
 whether the claims were enabled (“the effort it took the inventor to reduce the
 invention to practice does not conclusively show lack of enablement”). An invention may
 be described without the disclosure being enabling (e.g., a chemical compound for which
 there is no disclosed or apparent method of making), and a disclosure could be enabling
 without describing the invention (e.g., a specification describing a method of making
 and using a paint composition made of functionally defined ingredients within broad
 ranges would be enabling for formulations falling within the description but would not
 describe any specific formulation). See In re Armbruster, 512 F.2d 676, 677, 185 USPQ 152, 153 (CCPA 1975) (“[A]
 specification which ‘describes’ does not necessarily also ‘enable’ one skilled in the
 art to make or use the claimed invention.”). Best mode is a separate and distinct
 requirement from the enablement requirement. In re Newton, 414 F.2d 1400, 163 USPQ 34 (CCPA 1969).
 

 
 2161.01 Computer Programming, Computer Implemented Inventions, and 35
 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, First Paragraph [R-07.2022]
 

 The statutory requirements for computer-implemented
 inventions are the same as for all inventions, such as the subject matter eligibility
 and utility requirements under 35 U.S.C. 101 (see
 MPEP §§
 2106 and 2107 , respectively), the novelty
 requirement of 35
 U.S.C. 102 , the nonobviousness requirement of 35 U.S.C. 103 , the
 definiteness requirement of 35 U.S.C. 112(b) or
 pre-AIA 35 U.S.C.
 112 , second paragraph, and the three separate and distinct
 requirements of 35 U.S.C. 112(a) or
 pre-AIA 35 U.S.C.
 112 , first paragraph. In addition, claims with
 computer-implemented functional claim limitations may invoke 35 U.S.C.
 112(f) or pre-AIA 35 U.S.C. 112 , sixth
 paragraph. See MPEP §
 2181 , subsection II.B, and § 2181 , subsection
 IV. for information regarding means- (or step-) plus- function limitations.
 

 Even if a claim is not construed as a means-plus-
 function limitation under 35 U.S.C. 112(f) ,
 computer-implemented functional claim language must still be evaluated for sufficient
 disclosure under the written description and enablement requirements of
 35 U.S.C.
 112(a) .
 

 I. DETERMINING WHETHER THERE IS ADEQUATE WRITTEN DESCRIPTION FOR A
 COMPUTER-IMPLEMENTED FUNCTIONAL CLAIM LIMITATION The 35 U.S.C. 112(a) or first
 paragraph of pre-AIA 35 U.S.C. 112 contains a written description
 requirement that is separate and distinct from the enablement requirement.
 Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340,
 94 USPQ2d 1161, 1167 (Fed. Cir. 2010) (en banc) . To satisfy the
 written description requirement, the specification must describe the claimed
 invention in sufficient detail that one skilled in the art can reasonably conclude
 that the inventor had possession of the claimed invention at the time of filing.
 Reiffin v. Microsoft Corp., 214 F.3d 1342, 1345, 54 USPQ2d
 1915, 1917 (Fed. Cir. 2000) (“The purpose of [the written description requirement] is
 to ensure that the scope of the right to exclude, as set forth in the claims, does
 not overreach the scope of the inventor’s contribution to the field of art as
 described in the patent specification”); LizardTech Inc. v. Earth Resource
 Mapping Inc., 424 F.3d 1336, 1345, 76 USPQ2d 1724, 1732 (Fed. Cir. 2005)
 (“Whether the flaw in the specification is regarded as a failure to demonstrate that
 the patentee [inventor] possessed the full scope of the invention recited in [the
 claim] or a failure to enable the full breadth of that claim, the specification
 provides inadequate support for the claim under [ §
 112(a) ]”); cf. id. (“A claim will not be
 invalidated on [§] 112 grounds simply because
 the embodiments of the specification do not contain examples explicitly covering the
 full scope of the claim language.”). While “[t]here is no special rule for supporting
 a genus by the disclosure of a species,” the Federal Circuit has stated that
 “[w]hether the genus is supported vel non depends upon the state of the art and the
 nature and breadth of the genus.” Hynix Semiconductor Inc. v. Rambus
 Inc., 645 F.3d 1336, 1352, 98 USPQ2d 1711, 1724 (Fed. Cir. 2011);
 id. (further explaining that “so long as disclosure of the
 species is sufficient to convey to one skilled in the art that the inventor possessed
 the subject matter of the genus, the genus will be supported by an adequate written
 description.”). See also Rivera v. Int’l Trade Comm’n, 857 F.3d
 1315, 1319-21, 123 USPQ2d 1059, 1061-62 (Fed. Cir. 2017) (affirming the Commission’s
 findings that “the specification did not provide the necessary written description
 support for the full breadth of the asserted claims,” where the claims were broadly
 drawn to a “container . . . adapted to hold brewing material” while the specification
 disclosed only a “pod adapter assembly” or “receptacle” designed to hold a “pod”). 
 

 Specifically, the specification must describe the
 claimed invention in a manner understandable to a person of ordinary skill in the art
 in a way that shows that the inventor actually invented the claimed invention at the
 time of filing. Id.; Ariad, 598 F.3d at 1351, 94 USPQ2d at 1172. The function of the
 written description requirement is to ensure that the inventor had possession of the
 specific subject matter later claimed as of the filing date of the application relied
 on; how the specification accomplishes this is not material. In re
 Herschler, 591 F.2d 693, 700-01, 200 USPQ 711, 717 (CCPA 1979), further
 reiterated in In re Kaslow, 707 F.2d 1366, 217 USPQ 1089 (Fed.
 Cir. 1983); see also MPEP §§ 2163 - 2163.04 . 
 

 The written description requirement of
 35
 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112 , first
 paragraph, applies to all claims including original claims that are part of the
 disclosure as filed. Ariad, 598 F.3d at 1349, 94 USPQ2d at 1170.
 As stated by the Federal Circuit, “[a]lthough many original claims will satisfy the
 written description requirement, certain claims may not.” Id. at
 1349, 94 USPQ2d at 1170-71; see also LizardTech, Inc. v. Earth Res. Mapping,
 Inc., 424 F.3d 1336, 1343-46, 76 USPQ2d 1724, 1730-33 (Fed. Cir. 2005);
 Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d
 1559, 1568, 43 USPQ2d 1398, 1405-06 (Fed. Cir. 1997)(“The description requirement of
 the patent statute requires a description of an invention, not an indication of a
 result that one might achieve if one made that invention.”). Problems satisfying the
 written description requirement for original claims often occur when claim language
 is generic or functional, or both. Ariad, 593 F.3d at 1349, 94
 USPQ2d at 1171 (“The problem is especially acute with genus claims that use
 functional language to define the boundaries of a claimed genus. In such a case, the
 functional claim may simply claim a desired result, and may do so without describing
 species that achieve that result. But the specification must demonstrate that the
 applicant [inventor] has made a generic invention that achieves the claimed result
 and do so by showing that the applicant [inventor] has invented species sufficient to
 support a claim to the functionally-defined genus.”).
 

 For instance, generic claim language in the original
 disclosure does not satisfy the written description requirement if it fails to
 support the scope of the genus claimed. Ariad, 598 F.3d at
 1349-50, 94 USPQ2d at 1171 (“[A]n adequate written description of a claimed genus
 requires more than a generic statement of an invention’s boundaries.”) (citing
 Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1405-06);
 Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63
 USPQ2d 1609, 1616 (Fed. Cir. 2002) (holding that generic claim language appearing in
 ipsis verbis in the original specification did not satisfy the
 written description requirement because it failed to support the scope of the genus
 claimed); Fiers v. Revel, 984 F.2d 1164, 1170, 25 USPQ2d 1601,
 1606 (Fed. Cir. 1993) (rejecting the argument that “only similar language in the
 specification or original claims is necessary to satisfy the written description
 requirement”).
 

 The Federal Circuit has explained that a
 specification cannot always support expansive claim language and satisfy the
 requirements of 35 U.S.C. 112 “merely by clearly describing one embodiment of the
 thing claimed.” LizardTech v. Earth Resource Mapping, Inc., 424
 F.3d 1336, 1346, 76 USPQ2d 1731, 1733 (Fed. Cir. 2005). The issue is whether a person
 skilled in the art would understand the inventor to have invented, and been in
 possession of, the invention as broadly claimed. In LizardTech, 
 claims to a generic method of making a seamless discrete wavelet transformation (DWT)
 were held invalid under 35 U.S.C. 112, first paragraph, because the specification
 taught only one particular method for making a seamless DWT and there was no evidence
 that the specification contemplated a more generic method. “[T]he description of one
 method for creating a seamless DWT does not entitle the inventor . . . to claim any
 and all means for achieving that objective.” LizardTech, 424 F.3d
 at 1346, 76 USPQ2d at 1733. 
 

 Similarly, original claims may lack written
 description when the claims define the invention in functional language specifying a
 desired result but the specification does not sufficiently describe how the function
 is performed or the result is achieved. For software, this can occur when the
 algorithm or steps/procedure for performing the computer function are not explained
 at all or are not explained in sufficient detail (simply restating the function
 recited in the claim is not necessarily sufficient). In other words, the algorithm or
 steps/procedure taken to perform the function must be described with sufficient
 detail so that one of ordinary skill in the art would understand
 how the inventor intended the function to be performed. See
 MPEP §§
 2163.02 and 2181 , subsection IV.
 
 

 The level of detail required to satisfy the written
 description requirement varies depending on the nature and scope of the claims and on
 the complexity and predictability of the relevant technology.
 Ariad, 598 F.3d at 1351, 94 USPQ2d at 1172; Capon v.
 Eshhar, 418 F.3d 1349, 1357-58, 76 USPQ2d 1078, 1083-84 (Fed. Cir.
 2005). Computer-implemented inventions are often disclosed and claimed in terms of
 their functionality. For computer-implemented inventions, the determination of the
 sufficiency of disclosure will require an inquiry into the sufficiency of both the
 disclosed hardware and the disclosed software due to the interrelationship and
 interdependence of computer hardware and software. The critical inquiry is whether
 the disclosure of the application relied upon reasonably conveys to those skilled in
 the art that the inventor had possession of the claimed subject matter as of the
 filing date. Vasudevan Software, Inc. v. MicroStrategy, Inc., 782
 F.3d 671, 682. 114 USPQ2d 1349, 1356 (citing Ariad Pharm., Inc. V. Eli Lilly
 & Co, 598 F.3d 1336, 1351, 94 USPQ2d 1161, 1172 (Fed. Cir. 2010) in
 the context of determining possession of a claimed means of accessing disparate
 databases). 
 

 When examining computer-implemented functional claims,
 examiners should determine whether the specification discloses the computer and the
 algorithm (e.g., the necessary steps and/or flowcharts) that perform the claimed
 function in sufficient detail such that one of ordinary skill in the art can
 reasonably conclude that the inventor possessed the claimed subject matter at the
 time of filing. An algorithm is defined, for example, as “a finite sequence of steps
 for solving a logical or mathematical problem or performing a task.” Microsoft
 Computer Dictionary (5th ed., 2002). Applicant may “express that algorithm in any
 understandable terms including as a mathematical formula, in prose, or as a flow
 chart, or in any other manner that provides sufficient structure.” Finisar
 Corp. v. DirecTV Grp., Inc., 523 F.3d 1323, 1340, 86 USPQ2d 1609, 1623
 (Fed. Cir. 2008) (internal citation omitted). It is not enough that one skilled in
 the art could write a program to achieve the claimed function because the
 specification must explain how the inventor intends to achieve the claimed function
 to satisfy the written description requirement. See, e.g., Vasudevan
 Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-683, 114 USPQ2d
 1349, 1356, 1357 (Fed. Cir. 2015) (reversing and remanding the district court’s grant
 of summary judgment of invalidity for lack of adequate written description where
 there were genuine issues of material fact regarding “whether the specification
 show[ed] possession by the inventor of how accessing disparate databases is
 achieved”). If the specification does not provide a disclosure of the computer and
 algorithm in sufficient detail to demonstrate to one of ordinary skill in the art
 that the inventor possessed the invention a rejection under 35 U.S.C.
 112(a) or pre-AIA 35 U.S.C. 112 , first
 paragraph, for lack of written description must be made. For more information
 regarding the written description requirement, see MPEP § 2162 -
 §
 2163.07(b) . If the specification does not provide a
 disclosure of sufficient corresponding structure, materials, or acts that perform the
 entire claimed function of a means- (or step-) plus- function limitation in a claim
 under 35
 U.S.C. 112(f) or the sixth paragraph of pre-AIA 35 U.S.C.
 112 , "the applicant has in effect failed to particularly point
 out and distinctly claim the invention" as required by the 35 U.S.C.
 112(b) [or the second paragraph of pre-AIA 35 U.S.C.
 112 ]. In re Donaldson Co., 16 F.3d 1189,
 1195, 29 USPQ2d 1845, 1850 (Fed. Cir. 1994) ( en banc ). A rejection
 under 35
 U.S.C. 112(b) or the second paragraph of pre-AIA 35 U.S.C.
 112 must be made in addition to the written description
 rejection. See also MPEP § 2181 , subsection II.B.2(a).
 

 II. BEST MODE The purpose of the best mode requirement is to “restrain inventors
 from applying for patents while at the same time concealing from the public the
 preferred embodiments of their inventions which they have in fact conceived.”
 In re Gay, 309 F.2d 769, 772, 135 USPQ 311, 315 (CCPA 1962).
 Only evidence of concealment, “whether accidental or intentional,” is considered in
 judging the adequacy of the disclosure for compliance with the best mode requirement.
 Spectra-Physics, Inc. v. Coherent, Inc., 827 F.2d 1524, 1535, 3
 USPQ2d 1737, 1745 (Fed. Cir. 1987). “That evidence, in order to result in affirmance
 of a best mode rejection, must tend to show that the quality of an
 [inventor's] best mode disclosure is so poor as to effectively result in
 concealment.” In re Sherwood, 613 F.2d 809, 816, 204 USPQ 537, 544
 (CCPA 1980)(emphasis omitted); White Consol. Indus. v. Vega Servo-Control
 Inc., 214 USPQ 796, 824 (S.D. Mich. 1982), aff’d on related
 grounds, 713 F.2d 788, 218 USPQ 961 (Fed. Cir. 1983); see also
 MPEP §§
 2165 - 2165.04 .
 

 There are two factual inquiries to be made in determining whether a
 specification satisfies the best mode requirement. First, there must be a subjective
 determination as to whether the inventor knew of a best mode of practicing the
 invention at the time the application was filed. Second, if the inventor had a best
 mode of practicing the invention in mind, there must be an objective determination as
 to whether that best mode was disclosed in sufficient detail to allow one skilled in
 the art to practice it. Fonar Corp. v. Gen. Elect. Co., 107 F.3d
 1543, 41 USPQ2d 1801, 1804 (Fed. Cir. 1997); Chemcast Corp. v. Arco
 Indus., 913 F.2d 923, 927-28, 16 USPQ2d 1033, 1036 (Fed. Cir. 1990). “As
 a general rule, where software constitutes part of a best mode of carrying out an
 invention, description of such a best mode is satisfied by a disclosure of the
 functions of the software. This is because, normally, writing code for such software
 is within the skill of the art, not requiring undue experimentation, once its
 functions have been disclosed. . . . [F]low charts or source code listings are not a
 requirement for adequately disclosing the functions of software.” Fonar
 Corp., 107 F.3d at 1549, 41 USPQ2d at 1805 (citations omitted).
 

 III. DETERMINING WHETHER THE FULL SCOPE OF A COMPUTER-IMPLEMENTED FUNCTIONAL CLAIM
 LIMITATION IS ENABLED To satisfy the enablement requirement of
 35
 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112 , first
 paragraph, the specification must teach those skilled in the art how to make and use
 the full scope of the claimed invention without “undue experimentation.” See, e.g.,
 In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed.
 Cir. 1993); In re Wands, 858 F.2d 731, 736-37, 8 USPQ2d 1400, 1402
 (Fed. Cir. 1988). In In re Wands, the court set forth the
 following factors to consider when determining whether undue experimentation is
 needed: (1) the breadth of the claims; (2) the nature of the invention; (3) the state
 of the prior art; (4) the level of one of ordinary skill; (5) the level of
 predictability in the art; (6) the amount of direction provided by the inventor; (7)
 the existence of working examples; and (8) the quantity of experimentation needed to
 make or use the invention based on the content of the disclosure. 
 Wands, 858 F.2d at 737, 8 USPQ2d 1404. The undue experimentation
 determination is not a single factual determination; rather, it is a conclusion
 reached by weighing all the factual considerations. Id. 

 All questions of enablement under 35 U.S.C.
 112(a) are evaluated against the claimed subject matter with
 the focus of the examination inquiry being whether everything within the scope of the
 claim is enabled. Accordingly, examiners should determine what each claim recites and
 what subject matter is encompassed by the claim when the claim is considered as a
 whole and not analyze the claim elements individually.
 

 When basing a rejection on the failure of the applicant’s disclosure
 to meet the enablement provisions of 35 U.S.C. 112(a) or the first
 paragraph of pre-AIA 35 U.S.C. 112 , USPTO personnel must establish on the
 record a reasonable basis for questioning the adequacy of the
 disclosure to enable a person of ordinary skill in the art to make and use the
 claimed invention without resorting to undue experimentation . See
 In re Brown, 477 F.2d 946, 177 USPQ 691 (CCPA 1973);
 In re Ghiron, 442 F.2d 985, 169 USPQ 723 (CCPA 1971). Once
 USPTO personnel have advanced a reasonable basis for questioning the adequacy of the
 disclosure, it becomes incumbent on the applicant to rebut that challenge and
 factually demonstrate that the application disclosure is sufficient. See In
 re Doyle, 482 F.2d 1385, 1392, 179 USPQ 227, 232 (CCPA 1973);
 In re Scarbrough, 500 F.2d 560, 566, 182 USPQ 298, 302 (CCPA
 1974); In re Ghiron, supra ; see also MPEP §§ 2164 -
 2164.08(c) .
 

 When a claim is not limited to any particular
 structure for performing a recited function and does not invoke 35 U.S.C.
 112(f) , any claim language reciting the ability to perform a
 function per se would typically be construed broadly to cover any and all embodiments
 that perform the recited function. Because such a claim encompasses all devices or
 structures that perform the recited function, there is a concern regarding whether
 the applicant's disclosure sufficiently enables the full scope of protection sought
 by the claim. In re Swinehart, 439 F.2d 210, 213, 169 USPQ 226,
 229 (CCPA 1971); AK Steel Corp. v. Sollac, 344 F.3d 1234, 1244, 68
 USPQ2d 1280, 1287 (Fed. Cir. 2003); In re Moore, 439 F.2d 1232,
 1236, 169 USPQ 236, 239 (CCPA 1971). Applicants who present broad claim language must
 ensure the claims are fully enabled. Specifically, the scope of the claims must be
 less than or equal to the scope of the enablement provided by the specification.
 Sitrick v. Dreamworks, LLC, 516 F.3d 993, 999, 85 USPQ2d 1826,
 1830 (Fed. Cir. 2008) (“The scope of the claims must be less than or equal to the
 scope of the enablement to ensure that the public knowledge is enriched by the patent
 specification to a degree at least commensurate with the scope of the claims.”
 (quotation omitted)). 
 

 For example, the claims in Sitrick 
 were directed to “integrating” or “substituting” a user’s audio signal or visual
 image into a pre-existing video game or movie. While the claims covered both video
 games and movies, the specification only taught the skilled artisan how to substitute
 and integrate user images into video games. The Federal Circuit held that the
 specification failed to enable the full scope of the claims because the skilled
 artisan could not substitute a user image for a preexisting character image in movies
 without undue experimentation. Specifically, the court recognized that one skilled in
 the art could not apply the teachings of the specification regarding video games to
 movies, because movies, unlike video games, do not have easily separable character
 functions. Because the specification did not teach how the substitution and
 integration of character functions for a user image would be accomplished in movies,
 the claims were not enabled. Sitrick, 516 F.3d at 999-1001, 85
 USPQ2d at 1830-32. 
 

 In MagSil Corp. v. Hitachi Global Storage
 Techs., Inc. 687 F.3d 1377, 103 USPQ2d 1769 (Fed. Cir. 2012), the
 Federal Circuit stated that “a patentee chooses broad claim language at the peril of
 losing any claim that cannot be enabled across its full scope of coverage,” finding
 “one skilled in the art could not have taken the disclosure in the specification
 regarding ‘change in the resistance by at least 10% at room temperature’ and achieved
 a change in resistance in the full scope of that term without undue experimentation.”
 687 F.3d at 1381-82, 103 USPQ2d at 1771. “Thus, the specification enabled a marginal
 advance over the prior art, but did not enable at the time of filing a tunnel
 junction of resistive changes reaching even up to 20%, let alone the more recent
 achievements above 600%.” The court held that the “claims [were] invalid for lack of
 enablement because their broad scope [was] not reasonably supported by the scope of
 enablement in the specification.” 687 F.3d at 1381-1382, 1384, 103 USPQ2d at 1771,
 1772, 1774 (“MagSil did not fully enable its broad claim scope. Therefore, it cannot
 claim an exclusive right to exclude later tri-layer tunnel junctions that greatly
 exceed a 10% resistive change.”). See also Convolve, Inc. v. Compaq Computer
 Corp., 527 Fed. App'x 910, 931 (Fed. Cir. 2013) (non-precedential),
 quoting MagSil Corp. )(affirming grant of summary judgment of
 invalidity due to lack of enablement where the patentee “[b]y choosing such broad
 claim language, ... put itself ‘at the peril of losing any claim that cannot be
 enabled across its full scope of coverage.’”). 
 

 The specification need not teach what is well known in
 the art. However, applicant cannot rely on the knowledge of one skilled in the art to
 supply information that is required to enable the novel aspect of the claimed
 invention when the enabling knowledge is in fact not known in the art. ALZA
 Corp. v. Andrx Pharms., LLC, 603 F.3d 935, 941, 94 USPQ2d 1823, 1827
 (Fed. Cir. 2010) (“ALZA was required to provide an adequate enabling disclosure in
 the specification; it cannot simply rely on the knowledge of a person of ordinary
 skill to serve as a substitute for the missing information in the specification.”);
 Auto. Techs. Int’l, Inc. v. BMW of N. Am., Inc., 501 F.3d 1274,
 1283, 84 USPQ2d 1108, 1114-15 (Fed. Cir. 2007) (“Although the knowledge of one
 skilled in the art is indeed relevant, the novel aspect of an invention must be
 enabled in the patent.”). The Federal Circuit has stated that “‘[i]t is the
 specification, not the knowledge of one skilled in the art, that must supply the
 novel aspects of an invention in order to constitute adequate enablement.’”
 Auto. Technologies, 501 F.3d at 1283, 84 USPQ2d at 1115
 (quoting Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1366,
 42 USPQ2d 1001, 1005 (Fed. Cir. 1997)). See also Idenix Pharms. LLC v.
 Gilead Scis. Inc., 941 F.3d 1149, 1159-61, 2019 USPQ 2d 415844 (Fed.
 Cir. 2019). The rule that a specification need not disclose what is well known in the
 art is “merely a rule of supplementation, not a substitute for a basic enabling
 disclosure.” Genentech, 108 F.3d at 1366, 42 USPQ2d 1005; see also
 ALZA Corp., 603 F.3d at 940-41, 94 USPQ2d at 1827. Therefore,
 the specification must contain the information necessary to enable the novel aspects
 of the claimed invention. Id. at 941, 94 USPQ2d at 1827;
 Auto. Technologies, 501 F.3d at 1283-84, 84 USPQ2d at 1115
 (“[T]he ‘omission of minor details does not cause a specification to fail to meet the
 enablement requirement. However, when there is no disclosure of any specific starting
 material or of any of the conditions under which a process can be carried out, undue
 experimentation is required.’”) (quoting Genentech, 108 F.3d at
 1366, 42 USPQ2d at 1005). For instance, in Auto. Technologies, the
 claim limitation “means responsive to the motion of said mass” was construed to
 include both mechanical side impact sensors and electronic side impact sensors for
 performing the function of initiating an occupant protection apparatus.
 Auto. Technologies, 501 F.3d at 1282, 84 USPQ2d at 1114. The
 specification did not include any discussion of the details or circuitry involved in
 the electronic side impact sensor and thus, failed to apprise one of ordinary skill
 how to make and use the electronic sensor. Because the novel aspect of the invention
 was side impact sensors, the patentee could not rely on the knowledge of one skilled
 in the art to supply the missing information. Auto. Technologies, 
 501 F.3d at 1283, 84 USPQ2d at 1114.
 

 Not everything necessary to practice the invention
 need be disclosed. Trs. of Bos. Univ. v. Everlight Elecs. Co.,
 LTD., 896 F.3d 1357, 1364, 127 USPQ2d 1609, 1614 (Fed. Cir. 2018)
 (explaining that while “the specification must enable the full scope of the claimed
 invention[,]” “[t]his is not to say that the specification must expressly spell out
 every possible iteration of every claim.”). For instance, “‘a specification need not
 disclose what is well known in the art.’” Id. (quoting
 Genentech, Inc.v. Novo Nordisk A/S, 108 F.3d 1361, 1366, 42
 USPQ2d 1001, 1005 (Fed. Cir. 1997)); see also AK Steel Corp. v. Sollac &
 Ugine, 344 F.3d 1234, 1244, 68 USPQ2d 1280, 1287 (Fed. Cir. 2003). This
 is of particular importance with respect to computer-implemented inventions due to
 the high level of skill in the art and the similarly high level of predictability in
 generating programs to achieve an intended result without undue experimentation. See
 MPEP §
 2164.08 .
 

 The Federal Circuit has repeatedly held that the
 specification must teach those skilled in the art how to make and use the full scope
 of the claimed invention without undue experimentation. See Trs. of Bos.
 Univ., 896 F.3d at 1364 (“‘The scope of enablement . . . is that which
 is disclosed in the specification plus the scope of what would be known to one of
 ordinary skill in the art without undue experimentation.’” (quoting Nat’l
 Recovery Techs., Inc. v. Magnetic Separation Sys., Inc., 166 F.3d 1190,
 1196, 49 USPQ2d 1671, 1676 (Fed. Cir. 1999))). For example, in Sitrick v.
 Dreamworks, LLC, 516 F.3d 993, 85 USPQ2d 1826 (Fed. Cir. 2008), the
 claims at issue were directed to “integrating” or “substituting” a user’s audio
 signal or visual image into a pre-existing video game or movie.
 Id. at 995-97. While the claims covered both video games and
 movies, the specification only taught the skilled artisan how to substitute and
 integrate user images into video games. Id. at 1000. The Federal
 Circuit held that the specification “did not enable the full scope of the asserted
 claims” because “one skilled in the art could not take the disclosure in the
 specification with respect to substitution or integration of user images in video
 games and substitute a user image for a pre- existing character image in movies
 without undue experimentation.” Id. 

 A rejection under 35 U.S.C.
 112(a) or pre-AIA 35 U.S.C. 112 , first
 paragraph for lack of enablement must be made when the specification does not enable
 the full scope of the claim. USPTO personnel should establish a reasonable basis to
 question the enablement provided for the claimed invention and provide reasons for
 the uncertainty of the enablement. For more information regarding the enablement
 requirement, see MPEP
 §§ 2164.01(a) - 2164.08(c) , especially,
 MPEP §
 2164.06(c) for examples of computer programming cases. See
 also MPEP §
 2181 , subsection IV.
 

 

 [top] 

 

 

 
 

 
 

 

 

 

 
 
 
 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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