MPEP § 2164 — MPEP § 2164
Current through: 2022-07-01

2164-The Enablement Requirement 
 
 

 
 
 
 
 
 
 
 

 

 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 

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 Manual of Patent Examining Procedure 

 Chapter 2100 

 Section 2164 
 

 
 
 
 
 
 2164 The Enablement Requirement [R-11.2013]

 The enablement requirement refers to the requirement of 35 U.S.C.
 112(a) or pre-AIA 35 U.S.C. 112 , first paragraph
 that the specification describe how to make and how to use the invention. The invention
 that one skilled in the art must be enabled to make and use is that defined by the claim(s)
 of the particular application or patent.
 

 The purpose of the requirement that the specification describe the
 invention in such terms that one skilled in the art can make and use the claimed invention
 is to ensure that the invention is communicated to the interested public in a meaningful
 way. The information contained in the disclosure of an application must be sufficient to
 inform those skilled in the relevant art how to both make and use the claimed invention.
 However, to comply with 35 U.S.C. 112(a) or pre-AIA 35 U.S.C.
 112 , first paragraph, it is not necessary to “enable one of ordinary
 skill in the art to make and use a perfected, commercially viable embodiment absent a claim
 limitation to that effect.” CFMT, Inc. v. Yieldup Int’l Corp., 349 F.3d
 1333, 1338, 68 USPQ2d 1940, 1944 (Fed. Cir. 2003) (an invention directed to a general
 system to improve the cleaning process for semiconductor wafers was enabled by a disclosure
 showing improvements in the overall system). Detailed procedures for making and using the
 invention may not be necessary if the description of the invention itself is sufficient to
 permit those skilled in the art to make and use the invention. A patent claim is invalid if
 it is not supported by an enabling disclosure.
 

 The enablement requirement of 35 U.S.C.
 112(a) or pre-AIA 35 U.S.C. 112 , first paragraph,
 is separate and distinct from the written description requirement.
 Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563, 19 USPQ2d 1111, 1116-17 (Fed.
 Cir. 1991) (“the purpose of the ‘written description’ requirement is broader than to merely
 explain how to ‘make and use’”). See also MPEP § 2161 . Therefore, the fact that an
 additional limitation to a claim may lack descriptive support in the disclosure as
 originally filed does not necessarily mean that the limitation is also not enabled. In
 other words, even if a new limitation is not described in the original disclosure, the
 addition of a new limitation in and of itself may not create an enablement problem provided
 that one skilled in the art could make and use the claimed invention with the new
 limitation. Consequently, such limitations must be analyzed for both enablement and
 description using their separate and distinct criteria.
 

 Furthermore, when the limitation is not described in the specification
 portion of the application as filed but is in the claims, the limitation in and of itself
 may enable one skilled in the art to make and use the claimed invention. When claimed
 subject matter is only presented in the claims and not in the specification portion of the
 application, the specification should be objected to for lacking the requisite support for
 the claimed subject matter using form paragraph 7.44 . See MPEP § 2163.06 . This is an objection to
 the specification only and enablement issues should be treated separately.
 

 
 2164.01 Test of Enablement [R-01.2024]

 Any analysis of whether a particular claim is supported by the
 disclosure in an application requires a determination of whether that disclosure, when
 filed, contained sufficient information regarding the subject matter of the claims as to
 enable one skilled in the pertinent art to make and use the claimed invention. The
 standard for determining whether the specification meets the enablement requirement was
 cast in the Supreme Court decision of Minerals Separation Ltd. v.
 Hyde, 242 U.S. 261, 270 (1916) which postured the question: is the
 experimentation needed to practice the invention undue or unreasonable? That standard is
 still the one to be applied. See also In re Wands, 858 F.2d 731, 737,
 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). Accordingly, even though the statute does not use
 the term “undue experimentation,” it has been interpreted to require that the claimed
 invention be enabled so that any person skilled in the art can make and use the
 invention without undue experimentation. See MPEP § 2164.06 for discussion of
 quantity of experimentation, including determining reasonableness of experimentation.
 See also United States v. Telectronics, Inc., 857 F.2d 778, 785, 8
 USPQ2d 1217, 1223 (Fed. Cir. 1988) (“The test of enablement is whether one reasonably
 skilled in the art could make or use the invention from the disclosures in the patent
 coupled with information known in the art without undue experimentation.”). A patent
 need not teach, and preferably omits, what is well known in the art. In re
 Buchner, 929 F.2d 660, 661, 18 USPQ2d 1331, 1332 (Fed. Cir. 1991);
 Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367,
 1384, 231 USPQ 81, 94 (Fed. Cir. 1986), cert. denied, 480 U.S. 947
 (1987); and Lindemann Maschinenfabrik GMBH v. American Hoist & Derrick
 Co., 730 F.2d 1452, 1463, 221 USPQ 481, 489 (Fed. Cir. 1984). Any part of
 the specification can support an enabling disclosure, even a background section that
 discusses, or even disparages, the subject matter disclosed therein. Callicrate
 v. Wadsworth Mfg., Inc., 427 F.3d 1361, 77 USPQ2d 1041 (Fed. Cir.
 2005)(discussion of problems with a prior art feature does not mean that one of ordinary
 skill in the art would not know how to make and use this feature). Determining
 enablement is a question of law based on underlying factual findings. In
 re Vaeck, 947 F.2d 488, 495, 20 USPQ2d 1438, 1444 (Fed. Cir. 1991);
 Atlas Powder Co. v. E.I. du Pont de Nemours & Co., 750 F.2d 1569, 1576, 224 USPQ 409,
 413 (Fed. Cir. 1984).
 

 In Amgen Inc. et al. v. Sanofi et al., 
 598 U.S. 594, 2023 USPQ2d 602 (2023), the Supreme Court, held that claims drawn to a
 genus of monoclonal antibodies, which were functionally claimed by their ability to bind
 to a specific protein, PCSK9, were invalid due to lack of enablement. The claims at
 issue were functional, in that they defined the genus by its function (the ability to
 bind to specific residues of PCSK9) as opposed to reciting a specific structure (the
 amino acid sequence of the antibodies in the genus). The Supreme Court concluded that
 the patents at issue failed to adequately enable the full scope of the genus of
 antibodies that performed the function of binding to specific amino acid residues on
 PCSK9 and blocking the binding of PCSK9 to a particular cholesterol receptor, LDLR. 
 

 The Court clarified that the specification does not
 always need to “describe with particularity how to make and use every single embodiment
 within a claimed class.” Id. at 610-11. However, “[i]f a patent
 claims an entire class of processes, machines, manufactures, or compositions of matter,
 the patent’s specification must enable a person skilled in the art to make and use the
 entire class….The more one claims, the more one must enable.” Id. 

 The specification may require a reasonable amount of
 experimentation to make and use the invention and what is reasonable will depend on the
 nature of the invention and the underlying art. For example, “it may suffice to give an
 example (or a few examples) if the specification also discloses some general quality . .
 . running through the class that gives it a peculiar fitness for the particular purpose”
 and “disclosing that general quality may reliably enable a person skilled in the art to
 make and use all of what is claimed, not merely a subset.” Id. at 611
 (internal quotations omitted). However, the Supreme Court found that Amgen failed to
 enable all that it claimed, even if allowing for a reasonable degree of experimentation.
 Id. at 613; see also Baxalta Inc. v Genentech,
 Inc., 81 F.4th 1362, 1367, 2023 USPQ2d 1103 (Fed. Cir. 2023) (“[t]he facts
 of this case are more analogous to—and are, in fact, indistinguishable from—those in
 Amgen. We do not interpret Amgen to have disturbed our prior enablement case law,
 including Wands and its factors.”). Moreover, “[w]e see no meaningful
 difference between Wands' ‘undue experimentation’ and
 Amgen's ‘[un]reasonable experimentation’ standards.
 Id. at footnote 4. See also Guidelines for Assessing
 Enablement in Utility Applications and Patents in View of the Supreme Court Decision
 in Amgen Inc. et al. v. Sanofi et al., 89 FR 1563 (January 10, 2024), which
 explains that regardless of the technology the Wands factors should be used when
 assessing enablement.
 

 QUANTITY OF EXPERIMENTATION A specification may call for a reasonable amount of experimentation
 to make and use a patented invention. What is reasonable in any case will depend on
 the nature of the invention and the underlying art. Amgen Inc. et al. v.
 Sanofi et al., 598 U.S. 594, 2023 USPQ2d 602 (2023) (citing
 Minerals Separation Ltd. v. Hyde, 242 U.S. 261, 270-71 (1916)).
 The fact that experimentation may be complex does not necessarily make it undue, if
 the art typically engages in such experimentation. In re Certain
 Limited-Charge Cell Culture Microcarriers, 221 USPQ 1165, 1174 (Int’l
 Trade Comm'n 1983), aff’d. sub nom., Massachusetts Institute of Technology v. A.B. Fortia, 774 F.2d 1104, 227 USPQ 428 (Fed. Cir. 1985). See
 also In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404. The test of
 enablement is not whether any experimentation is necessary, but whether, if
 experimentation is necessary, it is undue. In re Angstadt, 537 F.2d 498, 504, 190 USPQ 214, 219 (CCPA 1976). See
 MPEP §
 2164.06 for further discussion of quantity of
 experimentation. 
 

 
 2164.01(a) Undue Experimentation Factors [R-01.2024]

 In order to determine compliance with the enablement requirement of
 35 U.S.C.
 112(a) , the Federal Circuit developed a framework of factors in
 In re Wands , 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir.
 1988), referred to as the Wands factors to assess whether any
 necessary experimentation required by the specification is “reasonable” or is
 “undue.” Consistent with Amgen Inc. et al. v. Sanofi et al., 598
 U.S. 594, 2023 USPQ2d 602 (2023), the Wands factors continue to
 provide a framework for assessing enablement in a utility application or patent,
 regardless of technology area. See Guidelines for Assessing Enablement in
 Utility Applications and Patents in View of the Supreme Court Decision in Amgen
 Inc. et al. v. Sanofi et al., 89 FR 1563 (January 10, 2024). These
 factors include, but are not limited to: 
 

 
 (A) The breadth of the claims; 

 (B) The nature of the invention;

 (C) The state of the prior art;

 (D) The level of one of ordinary skill;

 (E) The level of predictability in the art;

 (F) The amount of direction provided by the inventor;

 (G) The existence of working examples; and 

 (H) The quantity of experimentation needed to make or use the
 invention based on the content of the disclosure. 
 

 
 In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir.
 1988) (reversing the PTO’s determination that claims directed to methods for
 detection of hepatitis B surface antigens did not satisfy the enablement
 requirement). In Wands, the court noted that there was no
 disagreement as to the facts, but merely a disagreement as to the interpretation of
 the data and the conclusion to be made from the facts. In re Wands,
 858 F.2d at 736-40, 8 USPQ2d at 1403-07. The court held that the
 specification was enabling with respect to the claims at issue and found that “there
 was considerable direction and guidance” in the specification; there was “a high
 level of skill in the art at the time the application was filed;” and “all of the
 methods needed to practice the invention were well known.” 858 F.2d at 740, 8 USPQ2d
 at 1406. After considering all the factors related to the enablement issue, the court
 concluded that “it would not require undue experimentation to obtain antibodies
 needed to practice the claimed invention.” Id., 8 USPQ2d at
 1407.
 

 It is improper to conclude that a disclosure is not enabling based
 on an analysis of only one of the above factors while ignoring one or more of the
 others. The examiner’s analysis must consider all the evidence related to each of
 these factors, and any conclusion of nonenablement must be based on the evidence as a
 whole. 858 F.2d at 737, 740, 8 USPQ2d at 1404, 1407.
 

 A conclusion of lack of enablement means that, based on the evidence
 regarding each of the above factors, the specification, at the time the application
 was filed, would not have taught one skilled in the art how to make and/or use the
 full scope of the claimed invention without undue experimentation. In re
 Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).
 

 The Wands factors are probative of the essential
 inquiry in determining whether one must engage in more than a reasonable amount of
 experimentation. The determination that “undue experimentation” would have been
 needed to make and use the claimed invention is not a single, simple factual
 determination. Rather, it is a conclusion reached by weighing all the above noted
 factual considerations. In re Wands, 858 F.2d at 737, 8 USPQ2d at
 1404. These factual considerations are discussed more fully in MPEP § 2164.08 
 (scope or breadth of the claims), § 2164.05(a) (nature of the
 invention and state of the prior art), § 2164.05(b) (level of one of
 ordinary skill), §
 2164.03 (level of predictability in the art and amount of
 direction provided by the inventor), § 2164.02 (the existence of working
 examples) and § 2164.06 (quantity of experimentation needed to make or
 use the invention based on the content of the disclosure).
 

 The specification may require a reasonable amount of
 experimentation to make and use the invention and what is reasonable will depend on
 the nature of the invention and the underlying art. Amgen Inc. et al. v.
 Sanofi et al., 598 U.S. 594, 596, 2023 USPQ2d 602 (2023). For example,
 “it may suffice to give an example (or a few examples) if the specification also
 discloses some general quality . . . running through the class that gives it a
 peculiar fitness for the particular purpose” and “disclosing that general quality may
 reliably enable a person skilled in the art to make and use all of what is claimed,
 not merely a subset.” Id. at 611 (internal quotations omitted).
 However, while the specification in Amgen identified 26 exemplary
 antibodies that performed the claimed function by their amino acid sequences, the
 claims at issue were directed to a class which included “a ‘vast’ number of
 additional antibodies” that Amgen had not described by their amino acid sequences.
 Id. at 613. The Court found that Amgen sought to monopolize an
 entire class by their function, even though that class was much broader than the 26
 exemplary antibodies disclosed by their amino acid structure. Id. 
 at 613.
 

 In Amgen Inc. v. Sanofi, Aventisub
 LLC, 987 F.3d 1080 (Fed. Cir. 2021), which the Supreme Court affirmed,
 the Federal Circuit explicitly applied the Wands factors to assess
 whether the specification of Amgen’s patent provided sufficient enablement, for
 purposes of 35
 U.S.C. 112(a) , to make and use the full scope of the claimed
 invention. The court relied on evidence showing that the scope of the claims
 encompassed millions of antibodies and that it was necessary to screen each candidate
 antibody in order to determine whether it met the functional limitations of the
 claim. Id. at 1088. Consequently, the Federal Circuit concluded
 that there was a lack of enablement. See also the following cases across various
 technology areas: McRO, Inc. v. Bandai Namco Games Am. Inc., 959
 F.3d 1091, 2020 USPQ2d 10550 (Fed. Cir. 2020); Wyeth & Cordis Corp. v.
 Abbott Laboratories, 720 F.3d 1380, 107 USPQ2d 1273 (Fed. Cir. 2013);
 Enzo Life Sciences, Inc. v. Roche Molecular Systems, Inc., 928
 F.3d 1340 (Fed. Cir. 2019); and Idenix Pharmaceuticals LLC v. Gilead
 Sciences Inc., 941 F.3d 1149, 2019 USPQ2d 415844 (Fed. Cir. 2019).
 

 

 
 2164.01(b) How to Make the Claimed Invention [R-08.2012]

 As long as the specification discloses at least one method for
 making and using the claimed invention that bears a reasonable correlation to the
 entire scope of the claim, then the enablement requirement of 35 U.S.C. 112 
 is satisfied. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24
 (CCPA 1970). Failure to disclose other methods by which the claimed invention may be
 made does not render a claim invalid under 35 U.S.C. 112 .
 Spectra-Physics, Inc. v. Coherent, Inc ., 827 F.2d 1524, 1533, 3
 USPQ2d 1737, 1743 (Fed. Cir. 1987), cert. denied, 484 U.S. 954
 (1987).
 

 Naturally, for unstable and transitory chemical intermediates, the
 “how to make” requirement does not require that the applicant teach how to make the
 claimed product in stable, permanent or isolatable form. In re
 Breslow, 616 F.2d 516, 521, 205 USPQ 221, 226 (CCPA 1980).
 

 A key issue that can arise when determining whether the
 specification is enabling is whether the starting materials or apparatus necessary to
 make the invention are available. In the biotechnical area, this is often true when
 the product or process requires a particular strain of microorganism and when the
 microorganism is available only after extensive screening.
 

 The court in In re Ghiron, 442 F.2d 985, 991, 169
 USPQ 723, 727 (CCPA 1971), made clear that if the practice of a method requires a
 particular apparatus, the application must provide a sufficient disclosure of the
 apparatus if the apparatus is not readily available. The same can be said if certain
 chemicals are required to make a compound or practice a chemical process. In
 re Howarth, 654 F.2d 103, 105, 210 USPQ 689, 691 (CCPA 1981).
 

 

 
 2164.01(c) How to Use the Claimed Invention [R-08.2017]

 If a statement of utility in the specification contains within it a
 connotation of how to use, and/or the art recognizes that standard modes of
 administration are known and contemplated, 35 U.S.C. 112 is satisfied.
 In re Johnson, 282 F.2d 370, 373, 127 USPQ 216, 219 (CCPA
 1960); In re Hitchings, 342 F.2d 80, 87, 144 USPQ 637, 643 (CCPA
 1965); see also In re Brana, 51 F.3d 1560, 1566, 34 USPQ2d 1436,
 1441 (Fed. Cir. 1995).
 

 For example, it is not necessary to specify the dosage or method of
 use if it is known to one skilled in the art that such information could be obtained
 without undue experimentation. If one skilled in the art, based on knowledge of
 compounds having similar physiological or biological activity, would be able to
 discern an appropriate dosage or method of use without undue experimentation, this
 would be sufficient to satisfy 35 U.S.C. 112(a) or
 pre-AIA 35
 U.S.C. 112 , first paragraph. The applicant need not demonstrate
 that the invention is completely safe. See also MPEP §§ 2107.01 
 and 2107.03 .
 

 When a compound or composition claim is limited by a particular use,
 enablement of that claim should be evaluated based on that limitation. See
 In re Vaeck, 947 F.2d 488, 495, 20 USPQ2d 1438, 1444 (Fed. Cir.
 1991) (claiming a chimeric gene capable of being expressed in any cyanobacterium and
 thus defining the claimed gene by its use).
 

 In contrast, when a compound or composition claim is not limited by
 a recited use, any enabled use that would reasonably correlate with the entire scope
 of that claim is sufficient to preclude a rejection for nonenablement based on how to
 use. If multiple uses for claimed compounds or compositions are disclosed in the
 application, then an enablement rejection must include an explanation, sufficiently
 supported by the evidence, why the specification fails to enable each disclosed use.
 In other words, if any use is enabled when multiple uses are disclosed, the
 application is enabling for the claimed invention.
 

 

 

 
 2164.02 Working and Prophetic Examples [R-01.2024]

 Compliance with the enablement requirement of 35 U.S.C.
 112(a) or pre-AIA 35 U.S.C. 112 , first
 paragraph, does not turn on whether an example is disclosed. An example may be “working”
 or “prophetic.” A working example is based on work actually performed. A prophetic
 example describes an embodiment of the invention based on predicted results rather than
 work actually conducted or results actually achieved. The claims should be drafted in a
 manner that assists readers in differentiating between actual working examples and
 prophetic examples (i.e., prophetic examples should not be described using the past
 tense, but rather in future or present tense). 
 

 An applicant need not have actually reduced the invention to practice
 prior to filing. In Gould v. Quigg, 822 F.2d 1074, 1078, 3 USPQ 2d 1302, 1304 (Fed. Cir. 1987),
 as of Gould’s filing date, no person had built a light amplifier or measured a
 population inversion in a gas discharge. The court held that “The mere fact that
 something has not previously been done clearly is not, in itself, a sufficient basis for
 rejecting all applications purporting to disclose how to do it.” 822 F.2d at 1078, 3
 USPQ2d at 1304 (quoting In re Chilowsky, 229 F.2d 457, 461, 108 USPQ
 321, 325 (CCPA 1956)). 
 

 The specification need not contain an example if the invention is
 otherwise disclosed in such manner that one skilled in the art will be able to practice
 it without an undue amount of experimentation. In re Borkowski, 422 F.2d 904, 908, 164 USPQ 642, 645 (CCPA 1970).
 Allergan, Inc. v. Sandoz Inc., 796 F.3d 1293, 1310, 115 USPQ2d
 2012, 2023 (Fed. Cir. 2015) ( “Only a sufficient description enabling a person of
 ordinary skill in the art to carry out an invention is needed.”). Lack of a working
 example, however, is a factor to be considered, especially in a case involving an
 unpredictable and undeveloped art. But because only an enabling disclosure is required,
 applicant need not describe all actual embodiments. 
 

 The courts have further cautioned that the presence of
 prophetic examples alone should not be the basis for asserting that a specification is
 not enabling; rather, a lack of operative embodiments and undue experimentation should
 be determinative. Atlas Powder Co. v. E.I. du Pont De Nemours &
 Co., 750 F.2d 1569, 1577, 224 USPQ 409, 414 (Fed. Cir. 1984).
 

 I. NONE OR ONE WORKING EXAMPLE When considering the factors relating to a determination of
 non-enablement, if all the other factors point toward enablement, then the absence of
 working examples will not by itself render the invention non-enabled. In other words,
 lack of working examples or lack of evidence that the claimed invention works as
 described should never be the sole reason for rejecting the claimed invention on the
 grounds of lack of enablement. A single working example in the specification for a
 claimed invention is enough to preclude a rejection which states that nothing is
 enabled since at least that embodiment would be enabled. However, a rejection stating
 that enablement is limited to a particular scope may be appropriate.
 

 The presence of only one working example should never be the sole
 reason for rejecting claims as being broader than the enabling disclosure, even
 though it is a factor to be considered along with all the other factors. In some
 instances, “it may suffice to give an example (or a few examples) if the
 specification also discloses ‘some general quality . . . running through” the class
 that gives it ‘a peculiar fitness for the particular purpose.” Amgen Inc. et
 al. v. Sanofi et al., 598 U.S. 594, 611, 2023 USPQ2d 602 (2023) (citing
 Incandescent Lamp, 159 U. S. 465, 475, 16 S. Ct. 75, 40 L. Ed.
 221 (1895)). However, it should be noted that that “[t]he more one claims, the more
 one must enable.” Id. at 610. To make a valid rejection, the
 examiner must evaluate all the facts and evidence and state why one would not expect
 to be able to extrapolate that one example across the entire scope of the claims.
 

 II. CORRELATION: IN VITRO / IN VIVO The issue of “correlation” is related to the issue of the presence
 or absence of working examples. “Correlation” as used herein refers to the
 relationship between in vitro or in vivo animal
 model assays and a disclosed or a claimed method of use. An in
 vitro or in vivo animal model example in the
 specification, in effect, constitutes a “working example” if that example
 “correlates” with a disclosed or claimed method invention. If there is no
 correlation, then the examples do not constitute “working examples.” In this regard,
 the issue of “correlation” is also dependent on the state of the prior art. In other
 words, if the art is such that a particular model is recognized as correlating to a
 specific condition, then it should be accepted as correlating unless the examiner has
 evidence that the model does not correlate. Even with such evidence, the examiner
 must weigh the evidence for and against correlation and decide whether one skilled in
 the art would accept the model as reasonably correlating to the condition.
 In re Brana, 51 F.3d 1560, 1566, 34 USPQ2d 1436, 1441 (Fed.
 Cir. 1995) (reversing a USPTO decision based on finding that in
 vitro data did not support in vivo applications).
 

 Since the initial burden is on the examiner to give reasons for the
 lack of enablement, the examiner must also give reasons for a conclusion of lack of
 correlation for an in vitro or in vivo animal
 model example. However, a rigorous or an invariable exact correlation is not
 required, as stated in Cross v. Iizuka, 753 F.2d 1040, 1050, 224
 USPQ 739, 747 (Fed. Cir. 1985):
 

 
 [B]ased upon the relevant evidence as a whole, there is a
 reasonable correlation between the disclosed in vitro utility
 and an in vivo activity, and therefore a rigorous correlation
 is not necessary where the disclosure of pharmacological activity is reasonable
 based upon the probative evidence. (Citations omitted.)
 

 III. WORKING EXAMPLES AND A CLAIMED GENUS For a claimed genus, representative examples together with a
 statement applicable to the genus as a whole will ordinarily be sufficient if one
 skilled in the art (in view of level of skill, state of the art and the information
 in the specification) would expect the claimed genus could be used in that manner
 without undue experimentation. Proof of enablement will be required for other members
 of the claimed genus only where adequate reasons are advanced by the examiner to
 establish that a person skilled in the art could not use the genus as a whole without
 undue experimentation. In some instances “it may suffice to give an example (or a few
 examples) if the specification also discloses ‘some general quality . . . running
 through’ the class that gives it ‘a peculiar fitness for the particular purpose.’”
 Amgen Inc. et al. v. Sanofi et al., 598 U.S. 594, 611, 2023
 USPQ2d 602 (2023) (citing Incandescent Lamp, 159 U. S., at 475, 16
 S. Ct. 75, 40 L. Ed. 221, 1895 Dec. Comm'r Pat. 675).
 

 IV. PROPHETIC EXAMPLES When prophetic examples are described in a manner
 that is ambiguous or that implies that the results are actual, the adequacy and
 accuracy of the disclosure may come into question. If the characterization of the
 results, when taken in light of the disclosure as a whole, reasonably raises any
 questions as to whether the results from the examples are actual, the examiner should
 determine whether to reject the appropriate claims based on an insufficient
 disclosure under the enablement and/or written description requirements of
 35
 U.S.C. 112(a) following the guidance in MPEP §§ 2164 and
 
 2163 , respectively. When such a rejection(s) is made, the
 applicant should reply with the results of an actual test or example that has been
 conducted, or by providing relevant arguments and/or declaration evidence that there
 is strong reason to believe that the result would be as predicted, being careful not
 to introduce new matter into the application. See Hoffmann-La Roche, Inc. v.
 Promega Corp., 323 F.3d. 1354, 1367, 66 USPQ2d 1385, 1394 (Fed. Cir.
 2003) (improperly identifying a prophetic example in the past tense validly raises an
 inequitable conduct issue based on the intent of the inventors in drafting the
 example in the past tense, when the example, in fact, is prophetic); and
 Apotex Inc. v. UCB, Inc., 763 F.3d 1354, 1362, 112 USPQ2d 1081,
 1087 (Fed. Cir. 2014) (the inventor “admitted that he never performed the experiments
 described in the . . . patent, and yet he drafted the examples in the specification
 entirely in past-tense language.”). No results should be represented as actual
 results unless they have actually been achieved. See MPEP § 2004 , item
 8. 
 

 

 
 2164.03 Relationship of Predictability of the Art and the Enablement
 Requirement [R-07.2022]
 

 The amount of guidance or direction needed to enable the invention is
 inversely related to the amount of knowledge in the state of the art as well as the
 predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ
 18, 24 (CCPA 1970). The “amount of guidance or direction” refers to that information in
 the application, as originally filed, that teaches exactly how to make or use the
 invention. The more that is known in the prior art about the nature of the invention,
 how to make, and how to use the invention, and the more predictable the art is, the less
 information needs to be explicitly stated in the specification. In contrast, if little
 is known in the prior art about the nature of the invention and the art is
 unpredictable, the specification would need more detail as to how to make and use the
 invention in order to be enabling. See, e.g., Chiron Corp. v. Genentech
 Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1326 (Fed. Cir. 2004) (“Nascent
 technology, however, must be enabled with a ‘specific and useful teaching.’ The law
 requires an enabling disclosure for nascent technology because a person of ordinary
 skill in the art has little or no knowledge independent from the patentee’s instruction.
 Thus, the public’s end of the bargain struck by the patent system is a full enabling
 disclosure of the claimed technology.” (citations omitted)).
 

 The “predictability or lack thereof” in the art refers to the ability
 of one skilled in the art to extrapolate the disclosed or known results to the claimed
 invention. If one skilled in the art can readily anticipate the effect of a change
 within the subject matter to which the claimed invention pertains, then there is
 predictability in the art. On the other hand, if one skilled in the art cannot readily
 anticipate the effect of a change within the subject matter to which that claimed
 invention pertains, then there is lack of predictability in the art. Accordingly, what
 is known in the art provides evidence as to the question of predictability. In
 particular, the court in In re Marzocchi, 439 F.2d 220, 223-24, 169
 USPQ 367, 369-70 (CCPA 1971), stated: 
 

 
 [I]n the field of chemistry generally, there may be times when the
 well-known unpredictability of chemical reactions will alone be enough to create a
 reasonable doubt as to the accuracy of a particular broad statement put forward as
 enabling support for a claim. This will especially be the case where the statement
 is, on its face, contrary to generally accepted scientific principles. Most often,
 additional factors, such as the teachings in pertinent references, will be available
 to substantiate any doubts that the asserted scope of objective enablement is in fact
 commensurate with the scope of protection sought and to support any demands based
 thereon for proof. [Footnote omitted.]
 

 
 The scope of the required enablement varies inversely with the degree
 of predictability involved, but even in unpredictable arts, a disclosure of every
 operable species is not required. A single embodiment may provide broad enablement in
 cases involving predictable factors, such as mechanical or electrical elements.
 In re Vickers, 141 F.2d 522, 526-27, 61 USPQ 122, 127 (CCPA 1944);
 In re Cook, 439 F.2d 730, 734, 169 USPQ 298, 301 (CCPA 1971). However, in
 applications directed to inventions in arts where the results are unpredictable, the
 disclosure of a single species usually does not provide an adequate basis to support
 generic claims. In re Soll, 97 F.2d 623, 624, 38 USPQ 189, 191 (CCPA 1938). In cases
 involving unpredictable factors, such as most chemical reactions and physiological
 activity, more may be required. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) (contrasting
 mechanical and electrical elements with chemical reactions and physiological activity).
 See also In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993);
 In re Vaeck, 947 F.2d 488, 496, 20 USPQ2d 1438, 1445 (Fed. Cir. 1991). This
 is because in art areas having a high degree of uncertainty (i.e. the unpredictable
 arts) it is not reasonably predictable from the disclosure of one species, what other
 species will work. 
 

 

 
 2164.04 Burden on the Examiner Under the Enablement
 Requirement [R-08.2017]
 

 Before any analysis of enablement can occur, it is necessary for the
 examiner to construe the claims. For terms that are not well-known in the art, or for
 terms that could have more than one meaning, it is necessary that the examiner select
 the definition that the examiner intends to use when examining the application, based on
 their understanding of what applicant intends it to mean, and explicitly set forth the
 meaning of the term and the scope of the claim when writing an Office action. See
 Genentech v. Wellcome Foundation, 29 F.3d 1555, 1563-64, 31 USPQ2d
 1161, 1167-68 (Fed. Cir. 1994).
 

 In order to make a rejection, the examiner has the initial burden to
 establish a reasonable basis to question the enablement provided for the claimed
 invention. In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)
 (examiner must provide a reasonable explanation as to why the scope of protection
 provided by a claim is not adequately enabled by the disclosure). A specification
 disclosure which contains a teaching of the manner and process of making and using an
 invention in terms which correspond in scope to those used in describing and defining
 the subject matter sought to be patented must be taken as being in compliance with the
 enablement requirement of 35 U.S.C. 112(a) or
 pre-AIA 35 U.S.C.
 112 , first paragraph, unless there is a reason to doubt the
 objective truth of the statements contained therein which must be relied on for enabling
 support. Assuming that sufficient reason for such doubt exists, a rejection for failure
 to teach how to make and/or use will be proper on that basis. In re Marzocchi, 439 F.2d 220, 224, 169 USPQ 367, 370 (CCPA 1971). As
 stated by the court, “it is incumbent upon the Patent Office, whenever a rejection on
 this basis is made, to explain why it doubts the truth or accuracy of
 any statement in a supporting disclosure and to back up assertions of its own with
 acceptable evidence or reasoning which is inconsistent with the contested statement.
 Otherwise, there would be no need for the applicant to go to the trouble and expense of
 supporting his presumptively accurate disclosure.” 439 F.2d at 224, 169 USPQ at 370
 (emphasis in original).
 

 According to In re Bowen, 492 F.2d 859, 862-63, 181 USPQ 48, 51 (CCPA 1974), the minimal
 requirement is for the examiner to give reasons explaining the uncertainty of the
 enablement. This standard is applicable even when there is no evidence in the record of
 operability without undue experimentation beyond the disclosed embodiments. See also
 In re Brana, 51 F.3d 1560, 1566, 34 USPQ2d 1436, 1441 (Fed. Cir. 1995)
 (citing In re Bundy, 642 F.2d 430, 433, 209 USPQ 48, 51 (CCPA 1981)) (discussed in
 MPEP §
 2164.07 regarding the relationship of the enablement
 requirement to the utility requirement of 35 U.S.C. 101 ). 
 

 While the analysis and conclusion of a lack of enablement are based on
 the factors discussed in MPEP § 2164.01(a) and the evidence as a whole, it is not
 necessary to discuss each factor in the enablement rejection. However, it is improper to
 conclude that a disclosure is not enabling based on an analysis of only one of the above
 factors while ignoring one or more of the others. The examiner’s analysis must consider
 all the evidence related to each of these factors, and any conclusion of nonenablement
 must be based on the evidence as a whole. In re Wands, 858 F.2d 731,
 737, 740, 8 USPQ2d 1400, 1404, 1407 (Fed. Cir. 1988). The explanation of the rejection
 should focus on those factors, reasons, and evidence that lead the examiner to conclude
 e.g., that the specification fails to teach how to make and use 
 the claimed invention without undue experimentation , or that the
 scope of any enablement provided to one skilled in the art is not commensurate with the
 scope of protection sought by the claims. This can be done by making specific findings
 of fact, supported by the evidence, and then drawing conclusions based on these findings
 of fact. For example, doubt may arise about enablement because information is missing
 about one or more essential parts or relationships between parts which one skilled in
 the art could not develop without undue experimentation. In such a case, the examiner
 should specifically identify what information is missing and why one skilled in the art
 could not supply the information without undue experimentation. See
 MPEP
 § 2164.06(a) . References should be supplied if possible to
 support a prima facie case of lack of enablement, but are not always
 required. In re Marzocchi, 439 F.2d 220, 224, 169 USPQ 367, 370 (CCPA
 1971). However, specific technical reasons are always required.
 

 In accordance with the principles of compact prosecution, if an
 enablement rejection is appropriate, the first Office action on the merits should
 present the best case with all the relevant reasons, issues, and evidence so that all
 such rejections can be withdrawn if applicant provides appropriate convincing arguments
 and/or evidence in rebuttal. Providing the best rejection in the first Office action
 will also allow the second Office action to be made final should applicant fail to
 provide appropriate convincing arguments and/or evidence. Citing new references and/or
 expanding arguments in a second Office action could prevent that Office action from
 being made final. The principles of compact prosecution also dictate that if an
 enablement rejection is appropriate and the examiner recognizes limitations that would
 render the claims enabled, the examiner should note such limitations to applicant as
 early in the prosecution as possible. 
 

 In other words, the examiner should always look for enabled,
 allowable subject matter and communicate to applicant what that subject
 matter is at the earliest point possible in the prosecution of the application.
 

 

 
 2164.05 Determination of Enablement Based on Evidence as a
 Whole [R-07.2022]
 

 Once the examiner has weighed all the evidence and established a
 reasonable basis to question the enablement provided for the claimed invention, the
 burden falls on applicant to present persuasive arguments, supported by suitable proofs
 where necessary, that one skilled in the art would be able to make and use the claimed
 invention using the application as a guide. In re Brandstadter, 484 F.2d 1395, 1406-07, 179 USPQ 286, 294 (CCPA 1973).
 The evidence provided by applicant need not be absolute but
 merely convincing to one skilled in the art, based on a
 preponderance of the evidence standard. 
 

 Applicant may submit factual affidavits under 37 CFR 1.132 or
 cite references to show what one skilled in the art knew at the time of filing the
 application. A declaration or affidavit is, itself, evidence that must be
 considered . The weight to give a declaration or affidavit will depend
 upon the amount of factual evidence the declaration or affidavit contains to support the
 conclusion of enablement. In re Buchner, 929 F.2d 660, 661, 18 USPQ2d
 1331, 1332 (Fed. Cir. 1991) (Stating that an “expert’s opinion on [an] ultimate legal
 conclusion must be supported by something more than a conclusory statement”);
 cf. In re Alton, 76 F.3d 1168, 1174, 37 USPQ2d 1578, 1583 (Fed. Cir.
 1996) (declarations relating to the written description requirement should have been
 considered).
 

 Applicant should be encouraged to provide evidence demonstrating that
 the disclosure enables the claimed invention. In chemical and biotechnical applications,
 evidence actually submitted to the FDA to obtain approval for clinical trials may be
 submitted, but is not required. Considerations made by the FDA for approving clinical
 trials are different from those made by the USPTO in determining whether a claim is
 enabled. See Scott v. Finney, 34 F.3d 1058, 1063, 32 USPQ2d 1115,
 1120 (Fed. Cir. 1994) (“Testing for full safety and effectiveness of a prosthetic device
 is more properly left to the [FDA].”). Once that evidence is submitted, it must be
 weighed with all other evidence according to the standards set forth above so as to
 reach a determination as to whether the disclosure enables the claimed invention. 
 

 To overcome a prima facie case of lack of
 enablement, applicant must present argument and/or evidence that the disclosure would
 have enabled one of ordinary skill in the art to make and use the claimed invention at
 the time of filing. This does not preclude applicant from providing a declaration after
 the filing date which demonstrates that the claimed invention works. However, the
 examiner should carefully compare the steps, materials, and conditions used in the
 experiments of the declaration with those disclosed in the application to make sure that
 they are commensurate in scope; i.e., that the experiments used the guidance in the
 specification as filed and what was well known to one of skill in the art at the time of
 filing. Such a showing also must be commensurate with the scope of the claimed
 invention, i.e., must reasonably enable the full scope of the claimed invention. See
 Pac. Biosciences of Cal., Inc. v. Oxford Nanopore Techs., Inc., 
 996 F.3d 1342, 1352, 2021 USPQ2d 519 (Fed. Cir. 2021) (The court found that undue
 experimentation was required to enable the full scope of the claims where there was
 ample evidence that relevant artisans would not know how to perform the claimed
 invention for more than a narrow range of the claimed scope of invention. Moreover,
 there was no evidence of actual reduction to practice to support patentee’s rebuttal of
 the lack of enablement determination).
 

 The examiner must then weigh all the evidence of record, including the
 specification, any new evidence supplied by applicant, and any evidence and scientific
 reasoning previously presented in the rejection and then decide whether the claimed
 invention is enabled, based on a preponderance of the evidence standard. The examiner
 should never make this determination based on personal opinion. The determination should
 always be based on the weight of all the evidence of record.
 

 
 2164.05(a) Specification Must Be Enabling as of the Filing
 Date [R-07.2022]
 

 Whether the specification would have been enabling as of the filing
 date involves consideration of the nature of the invention, the state of the prior
 art, and the level of skill in the art. The initial inquiry is into the nature of the
 invention, i.e., the subject matter to which the claimed invention pertains. The
 nature of the invention becomes the backdrop to determine the state of the art and
 the level of skill possessed by one skilled in the art. 
 

 The state of the prior art is what one skilled in the art would have
 known, at the time the application was filed, about the subject matter to which the
 claimed invention pertains. The relative skill of those in the art refers to the
 skill of those in the art in relation to the subject matter to which the claimed
 invention pertains at the time the application was filed. See MPEP § 2164.05(b) .
 See Pac. Biosciences of Cal., Inc. v. Oxford Nanopore Techs.,
 Inc., 996 F.3d 1342, 1352, 2021 USPQ2d 519 (Fed. Cir. 2021).
 

 The state of the prior art provides evidence for the degree of
 predictability in the art and is related to the amount of direction or guidance
 needed in the specification as filed to meet the enablement requirement. The state of
 the prior art is also related to the need for working examples in the specification. 
 

 The state of the art for a given technology is not static in time.
 It is entirely possible that a disclosure which would not have been enabled if filed
 on January 2, 1990 might be enabled if the same disclosure had been filed on January
 2, 1996. Therefore, the state of the prior art must be evaluated for each application
 based on its filing date .
 

 35 U.S.C.
 112(a) requires the specification to be enabling only to a
 person “skilled in the art to which it pertains, or with which it is most nearly
 connected.” In general, the pertinent art should be defined in terms of the problem
 to be solved rather than in terms of the technology area, industry, trade, etc. for
 which the invention is used. 
 

 The specification need not disclose what is well-known to those
 skilled in the art and preferably omits that which is well-known to those skilled and
 already available to the public. In re Buchner, 929 F.2d 660, 661,
 18 USPQ2d 1331, 1332 (Fed. Cir. 1991); Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1384, 231 USPQ 81,
 94 (Fed. Cir. 1986), cert. denied, 480 U.S. 947 (1987); and
 Lindemann Maschinenfabrik GMBH v. American Hoist & Derrick Co., 730 F.2d 1452, 1463, 221 USPQ
 481, 489 (Fed. Cir. 1984). 
 

 The state of the art existing at the filing date of the application
 is used to determine whether a particular disclosure is enabling as of the filing
 date. Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70
 USPQ2d 1321, 1325-26 (Fed. Cir. 2004) (Stating that “a patent document cannot enable
 technology that arises after the date of application.”). Information published for
 the first time after the filing date generally cannot be used to show what was known
 at the time of filing. In re Gunn, 537 F.2d 1123, 1128, 190 USPQ 402,405-06 (CCPA 1976);
 In re Budnick, 537 F.2d 535, 538, 190 USPQ 422, 424 (CCPA 1976)
 (In general, if an applicant seeks to use a patent to prove the state of the art for
 the purpose of the enablement requirement, the patent must have an issue date earlier
 than the effective filing date of the application.). While a later dated publication
 cannot supplement an insufficient disclosure in a prior dated application to make it
 enabling, an applicant can offer the testimony of an expert based on the publication
 as evidence of the level of skill in the art at the time the application was filed.
 Gould v. Quigg, 822 F.2d 1074, 1077, 3 USPQ2d 1302, 1304 (Fed. Cir. 1987). 
 

 In general, the examiner should not use post-filing date references
 to demonstrate that a patent is not enabled. Exceptions to this rule could occur if a
 later-dated reference provides evidence of what one skilled in the art would have
 known on or before the effective filing date of the patent application. In
 re Hogan, 559 F.2d 595, 605, 194 USPQ 527, 537 (CCPA 1977). If a
 publication demonstrates that those of ordinary skill in the art would find that a
 particular invention was not enabled years after the filing date, the publication
 would be evidence that the claimed invention was not possible at the time of filing.
 See In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513-14
 (Fed. Cir. 1993) (The court found that an article published 5 years after the filing
 date of the application adequately supported the examiner’s position that the
 physiological activity of certain viruses was sufficiently unpredictable so that a
 person skilled in the art would not have believed that the success with one virus and
 one animal could be extrapolated successfully to all viruses with all living
 organisms. Accordingly, the court held that the applicant’s earlier-filed claims not
 limited to the specific virus or the specific animal were nonenabled). 
 

 

 
 2164.05(b) Specification Must Be Enabling to Persons Skilled in the
 Art [R-01.2024]
 

 The relative skill of those in the art refers to the skill level of
 those in the art in the technological field to which the claimed invention pertains.
 See United Therapeutics Corp. v Liquidia Techs., Inc., 74 F.4th
 1360, 1370, 2023 USPQ2d 862 (Fed. Cir. 2023) (The court found that the claims
 directed to administration of treprostinil to treat all five types of pulmonary
 hypertension, which were construed to not require safety and efficacy, were
 adequately enabled by the specification which described administration,
 concentrations and dosages as well as an open label study despite potential safety
 concerns associated with one type of pulmonary hypotension. The record included
 evidence that ”a skilled artisan would understand that the claimed administration of
 treprostinil would vasodilate the pulmonary vasculature, improve hemodynamics, and in
 this way for a single dose, treat a patient’s elevated pulmonary blood pressure
 independent of the type (i.e., group) of pulmonary hypertension patient.”). 
 

 Where different arts are involved in the invention,
 the specification is enabling if it enables persons skilled in each art to carry out
 the aspect of the invention applicable to their specialty. In re Naquin, 398 F.2d 863, 866, 158 USPQ 317, 319 (CCPA 1968). See
 Pac. Biosciences of Cal., Inc. v. Oxford Nanopore Techs., Inc., 
 996 F.3d 1342, 1352, 2021 USPQ2d 519 (Fed. Cir. 2021) (The court found that undue
 experimentation was required to enable the full scope of the claims where there was
 ample evidence that relevant artisans would not know how to perform the claimed
 invention for more than a narrow range of the claimed scope of invention).
 

 When an invention, in its different aspects, involves distinct arts,
 the specification is enabling if it enables those skilled in each art, to carry out
 the aspect proper to their specialty. “If two distinct technologies are relevant to
 an invention, then the disclosure will be adequate if a person of ordinary skill in
 each of the two technologies could practice the invention from the disclosures.”
 Technicon Instruments Corp. v. Alpkem Corp., 664 F. Supp. 1558, 1578, 2 USPQ2d 1729, 1742 (D.
 Ore. 1986), aff’d in part, vacated in part, rev’d in part, 837 F. 2d 1097 (Fed. Cir.
 1987) (unpublished opinion), appeal after remand, 866 F. 2d 417, 9 USPQ 2d 1540 (Fed.
 Cir. 1989). In Ex parte Zechnall, 194 USPQ 461 (Bd. Pat. App. & Int. 1973), the Board
 stated “appellants’ disclosure must be held sufficient if it would enable a person
 skilled in the electronic computer art, in cooperation with a person skilled in the
 fuel injection art, to make and use appellants’ invention.” 194 USPQ at 461.
 

 

 

 
 2164.06 Quantity of Experimentation [R-01.2024]

 “A specification may call for a reasonable amount of
 experimentation to make and use a claimed invention, and reasonableness in any case will
 depend on the nature of the invention and the underlying art.” Amgen Inc. et
 al. v. Sanofi et al., 598 U.S. 594, 596, 2023 USPQ2d 602 (2023).
 

 The quantity of experimentation needed to be performed by one skilled
 in the art is only one factor involved in determining whether “undue experimentation” is
 required to make and use the invention. “[A]n extended period of experimentation may not
 be undue if the skilled artisan is given sufficient direction or guidance.” In
 re Colianni, 561 F.2d 220, 224, 195 USPQ 150, 153 (CCPA 1977). “‘The test
 is not merely quantitative, since a considerable amount of experimentation is
 permissible, if it is merely routine, or if the specification in question provides a
 reasonable amount of guidance with respect to the direction in which the experimentation
 should proceed.’” In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404
 (Fed. Cir. 1988) (citing In re Angstadt, 537 F.2d 498, 502-04, 190
 USPQ 214, 217-19 (CCPA 1976)). Time and expense are merely factors in this consideration
 and are not the controlling factors. United States v. Telectronics
 Inc., 857 F.2d 778, 785, 8 USPQ2d 1217, 1223 (Fed. Cir. 1988),
 cert. denied, 490 U.S. 1046 (1989).
 

 In the chemical arts, the guidance and ease in carrying out an assay to
 achieve the claimed objectives may be an issue to be considered in determining the
 quantity of experimentation needed. For example, if a very difficult and time consuming
 assay is needed to identify a compound within the scope of a claim, then this great
 quantity of experimentation should be considered in the overall analysis. Time and
 difficulty of experiments are not determinative if they are merely routine. Quantity of
 examples is only one factor that must be considered before reaching the final conclusion
 that undue experimentation would be required. In re Wands, 858 F.2d
 at 737, 8 USPQ2d at 1404. 
 

 I. EXAMPLE OF REASONABLE EXPERIMENTATION In United States v. Telectronics, Inc., 857 F.2d
 778, 8 USPQ2d 1217 (Fed. Cir. 1988), cert. denied, 490 U.S. 1046
 (1989), the court reversed the findings of the district court for lack of clear and
 convincing proof that undue experimentation was needed. The court ruled that since
 one embodiment (stainless steel electrodes) and the method to determine dose/response
 was set forth in the specification, the specification was enabling. The question of
 time and expense of such studies, approximately $50,000 and 6-12 months standing
 alone, failed to show undue experimentation.
 

 II. EXAMPLE OF UNREASONABLE EXPERIMENTATION In Amgen Inc. v. Sanofi, Aventisub
 LLC, 987 F.3d 1080 (Fed. Cir. 2021), which the Supreme Court affirmed,
 the Federal Circuit relied on evidence showing that the scope of the claims
 encompassed millions of antibodies and that it was necessary to screen each candidate
 antibody in order to determine whether it met the functional limitations of the
 claim. Id. at 1088. Consequently, the Federal Circuit concluded
 that there was a lack of enablement.
 

 In In re Ghiron, 442 F.2d 985, 991-92, 169 USPQ
 723, 727-28 (CCPA 1971), functional “block diagrams” were insufficient to enable a
 person skilled in the art to practice the claimed invention with only a reasonable
 degree of experimentation because the claimed invention required a “modification to
 prior art overlap computers,” and because “many of the components which appellants
 illustrate as rectangles in their drawing necessarily are themselves complex
 assemblages . . . . It is common knowledge that many months or years elapse from the
 announcement of a new computer by a manufacturer before the first prototype is
 available. This does not bespeak of a routine operation but of extensive
 experimentation and development work. . . .” See Pac. Biosciences of Cal.,
 Inc. v. Oxford Nanopore Techs., Inc., 996 F.3d 1342, 1352, 2021 USPQ2d
 519 (Fed. Cir. 2021) (The court found that undue experimentation was required to
 enable the full scope of the claims where there was ample evidence that relevant
 artisans would not know how to perform the claimed invention for more than a narrow
 range of the claimed scope of invention).
 

 
 2164.06(a) Examples of Enablement Issues-Missing Information [R-08.2017]

 It is common that doubt arises about enablement because information
 is missing about one or more essential claim elements or relationships between
 elements which one skilled in the art could not develop without undue
 experimentation. In such a case, the examiner should specifically identify what
 information is missing and why the missing information is needed to provide
 enablement.
 

 I. ELECTRICAL AND MECHANICAL DEVICES OR PROCESSES Enablement serves the dual function of ensuring
 adequate disclosure of the claimed invention and of preventing claims broader than
 the disclosed invention. Broad claim language is used at the peril of losing any
 claim that cannot be enabled across its full scope. For example, in
 MagSil Corp. v. Hitachi Global Storage Technologies, Inc., 
 687 F.3d 1377, 103 USPQ2d 1769 (Fed. Cir. 2012), the claim recited a change in
 resistance by at least 10% at room temperature, but the specification contained no
 showing that the knowledge of a person of ordinary skill in the art at the time of
 filing would have been able to achieve resistive changes in values that greatly
 exceed 10% without undue experimentation (noting that it took nearly 12 years of
 experimentation to achieve modern values above 600%). Similarly in Auto.
 Techs. Int'l, Inc. v. BMW of N. Am., Inc., 501 F.3d 1274, 1283, 84
 USPQ2d 1108, 1115 (Fed. Cir. 2007), a claim limitation means responsive to the
 motion of a mass was construed to include both mechanical and electronic side
 impact sensors for performing the function of initiating an occupant protection
 apparatus. The specification did not disclose any details or circuitry for
 electronic side impact sensors, and thus, failed to apprise one of ordinary skill
 how to make and use the electronic sensor.
 

 A disclosure of an electrical circuit apparatus, depicted in the
 drawings by block diagrams with functional labels, was held to be nonenabling in
 In re Gunn, 537 F.2d 1123, 1129, 190 USPQ 402, 406 (CCPA 1976), where
 there was no indication in the specification as to whether the parts represented
 by boxes were “off the shelf” or must be specifically constructed or modified for
 applicant’s system. Also there were no details in the specification of how the
 parts should be interconnected, timed and controlled so as to obtain the specific
 operations desired by the applicant. In In re Donohue, 550 F.2d 1269, 193 USPQ 136 (CCPA 1977), the lack of
 enablement was caused by lack of information in the specification about a single
 block labeled “LOGIC” in the drawings. See also Union Pac. Res. Co. v.
 Chesapeake Energy Corp., 236 F.3d 684, 57 USPQ2d 1293 (Fed. Cir.
 2001) (Claims directed to a method of determining the location of a horizontal
 borehole in the earth failed to comply with enablement requirement of
 35 U.S.C.
 112 because certain computer programming details used to
 perform claimed method were not disclosed in the specification, and the record
 showed that a person of skill in art would not understand how to “compare” or
 “rescale” data as recited in the claims in order to perform the claimed
 method.).
 

 In re Ghiron, 442 F.2d 985, 169 USPQ 723 (CCPA 1971), involved a
 method of facilitating transfers from one subset of program instructions to
 another which required modification of prior art “overlap mode” computers. The
 Board rejected the claims on the basis that, inter alia, the
 disclosure was insufficient to satisfy the requirements of 35 U.S.C.
 112 , first paragraph and was affirmed. The Board focused on
 the fact that the drawings were “block diagrams, i.e., a group of rectangles
 representing the elements of the system, functionally labeled and interconnected
 by lines.” 442 F.2d at 991, 169 USPQ at 727. The specification did not
 particularly identify each of the elements represented by the blocks or the
 relationship therebetween, nor did it specify particular apparatus intended to
 carry out each function. The Board further questioned whether the selection and
 assembly of the required components could be carried out routinely by persons of
 ordinary skill in the art.
 

 An adequate disclosure of a device may require details of how
 complex components are constructed and perform the desired function. The claim
 before the court in In re Scarbrough, 500 F.2d 560, 182 USPQ 298 (CCPA 1974), was
 directed to a system which comprised several component parts (e.g., computer,
 timing and control mechanism, A/D converter, etc.) only by generic name and
 overall ultimate function. The court concluded that there was not an enabling
 disclosure because the specification did not describe how “complex elements known
 to perform broadly recited functions in different systems would be adaptable for
 use in Appellant’s particular system with only a reasonable amount of
 experimentation” and that “an unreasonable amount of work would be required to
 arrive at the detailed relationships appellant says that he has solved.” 500 F.2d
 at 566, 182 USPQ at 302.
 

 II. MICROORGANISMS Patent applications involving living biological products, such as
 microorganisms, as critical elements in the process of making the invention,
 present a unique question with regard to availability. For example, in In
 re Argoudelis, 434 F.2d 1390, 168 USPQ 99 (CCPA 1970), the court
 considered the enablement of claims drawn to a fermentative method of producing
 two novel antibiotics using a specific microorganism and claims to the novel
 antibiotics so produced. As stated by the court, “a unique aspect of using
 microorganisms as starting materials is that a sufficient description of how to
 obtain the microorganism from nature cannot be given.” 434 F.2d at 1392, 168 USPQ
 at 102. It was determined by the court that availability of the biological product
 via a public depository provided an acceptable means of meeting the written
 description and the enablement requirements of 35 U.S.C. 112 , first
 paragraph.
 

 To satisfy the enablement requirement a deposit must be made
 “prior to issue” but need not be made prior to filing the application. In
 re Lundak, 773 F.2d 1216, 1223, 227 USPQ 90, 95 (Fed. Cir.
 1985).
 

 The availability requirement of enablement must also be
 considered in light of the scope or breadth of the claim limitations. The Board
 considered this issue in an application which claimed a fermentative method using
 microorganisms belonging to a species. Applicants had identified three novel
 individual strains of microorganisms that were related in such a way as to
 establish a new species of microorganism, a species being a broader classification
 than a strain. The three specific strains had been appropriately deposited. The
 issue before the Board focused on whether the specification enabled one skilled in
 the art to make any member of the species other than the three strains which had
 been deposited. The Board concluded that the verbal description of the species was
 inadequate to allow a skilled artisan to make any and all members of the claimed
 species. Ex parte Jackson, 217 USPQ 804, 806 (Bd. Pat. App. & Int. 1982). 
 

 See MPEP § 2402 -
 §
 2411.03 for a detailed discussion of the deposit rules.
 See MPEP §
 2411.01 for rejections under 35 U.S.C.
 112 based on deposit issues.
 

 III. DRUG CASES See MPEP § 2107 -
 §
 2107.03 for a discussion of the utility requirement
 under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112 , first
 paragraph, in drug cases.
 

 

 
 2164.06(b) Examples of Enablement Issues — Biological and Chemical
 Cases [R-10.2019]
 

 The following summaries should not be relied on to support a case of
 lack of enablement without carefully reading the case.
 

 I. SEVERAL DECISIONS RULING THAT THE DISCLOSURE WAS NONENABLING 
 (A) In Enzo Biochem, Inc. v. Calgene, Inc., 
 188 F.3d 1362, 52 USPQ2d 1129 (Fed. Cir. 1999), the court held that two
 patents with claims directed to genetic antisense technology (which aims to
 control gene expression in a particular organism), were invalid because the
 breadth of enablement was not commensurate in scope with the claims. Both
 specifications disclosed applying antisense technology in regulating three
 E. coli genes. Despite the limited disclosures, the
 specifications asserted that the “[t]he practices of this invention are
 generally applicable with respect to any organism containing genetic
 material which is capable of being expressed … such as bacteria, yeast, and
 other cellular organisms.” Thus, the court construed the claims to encompass
 the application of antisense methodology in a broad range of organisms.
 Ultimately, the court relied on the fact that (1) the amount of direction
 presented and the number of working examples provided in the specification
 were very narrow compared to the wide breadth of the claims at issue, (2)
 antisense gene technology was highly unpredictable, and (3) the amount of
 experimentation required to adapt the practice of creating antisense DNA
 from E. coli to other types of cells was quite high, especially in light of
 the record, which included notable examples of the inventor’s own failures
 to control the expression of other genes in E. coli and other types of cells. Thus, the teachings set forth in the
 specification provided no more than a “plan” or “invitation” for those of
 skill in the art to experiment using the technology in other types of cells.
 
 

 (B) In In re Wright, 999 F.2d 1557, 27
 USPQ2d 1510 (Fed. Cir. 1993), Wright's 1983 application disclosed a vaccine
 against the RNA tumor virus known as Prague Avian Sarcoma Virus, a member of
 the Rous Associated Virus family. Wright claimed a vaccine “comprising an
 immunologically effective amount” of a viral expression product using
 functional language. Id. at 1559, 27 USPQ2d at 1511. The
 examiner rejected Wright's claims covering all RNA viruses as well as all
 avian RNA viruses. The examiner provided a teaching that, in 1988, a vaccine
 for another retrovirus (i.e., HIV) remained an intractable problem. This
 evidence, along with evidence that the RNA viruses were a diverse and
 complicated genus, convinced the Federal Circuit that the invention was not
 enabled for either all retroviruses or even for avian retroviruses.
 

 (C) In In re Goodman, 11 F.3d 1046, 29
 USPQ2d 2010 (Fed. Cir. 1993), Goodman's 1985 application functionally
 claimed a method of producing protein in plant cells by expressing a foreign
 gene. The court stated that “[n]aturally, the specification must teach those
 of skill in the art ‘how to make and use the invention as broadly as it is
 claimed.’” Id. at 1050, 29 USPQ2d at 2013. Although
 protein expression in dicotyledonous plant cells was enabled, the claims
 covered protein expression in any plant cell. The examiner provided evidence
 that even as late as 1987, use of the claimed method in monocot plant cells
 was not enabled. Id. at 1051, 29 USPQ2d at 2014.
 

 (D) In In re Vaeck, 947 F.2d 488, 495,
 20 USPQ2d 1438, 1444 (Fed. Cir. 1991), the court found that several claims
 to a chimeric gene capable of being expressed in Cyanobacteria cells were
 not supported by an enabling disclosure. The court determined that claims at
 issue were not limited to any particular genus or species of cyanobacteria
 and the specification mentioned nine genera and the working examples
 employed one species of cyanobacteria. The court then reasoned that the
 claims were not enabled after “[t]aking into account the relatively
 incomplete understanding of the biology of cyanobacteria as of appellants’
 filing date, as well as the limited disclosure by appellants of the
 particular cyanobacterial genera operative in the claimed invention....”
 

 (E) In In re Colianni, 561 F.2d 220, 222-23,
 195 USPQ 150, 152 (CCPA 1977), the court affirmed a rejection under
 35
 U.S.C. 112 , first paragraph, because the claims were
 directed to a method of mending a fractured bone by applying “sufficient”
 ultrasonic energy to the bone, but applicant’s specification did not define
 what constituted a “sufficient” dosage or teach one of ordinary skill how to
 select the appropriate intensity, frequency, or duration of the ultrasonic
 energy. 
 

 II. SEVERAL DECISIONS RULING THAT THE DISCLOSURE WAS ENABLING 
 (A) In PPG Indus. v. Guardian Indus., 75
 F.3d 1558, 1564, 37 USPQ2d 1618, 1623 (Fed. Cir. 1996), the court found
 PPG’s claims to a UV-absorbing, ceramide-free glass enabled, even though
 PPG’s specification included several examples in which faulty UV
 transmittance data made it appear as though the production of a cerium
 oxide-free glass satisfying the UV transmittance limitation would be
 difficult, because the specification indicated that such glass could be
 made. The specification was also found to indicate how to minimize the
 cerium content while maintaining low UV transmittance. 
 

 (B) In In re Wands, 858 F.2d 731, 8 USPQ2d
 1400 (Fed. Cir. 1988), the court reversed the rejection for lack of
 enablement under 35 U.S.C. 112 , first
 paragraph, concluding that undue experimentation would not be required to
 practice the claimed immunoassay using monoclonal antibodies to detect
 hepatitis B-surface antigen (HBsAg). The court found that the nature of
 monoclonal antibody technology was such that experiments first involve the
 entire attempt to make monoclonal hybridomas to determine which ones secrete
 antibody with the desired characteristics. The court found that the
 specification also provided considerable direction and guidance on how to
 practice the claimed invention and presented working examples, that all of
 the methods needed to practice the invention were well known, and that there
 was a high level of skill in the art at the time the application was filed.
 Furthermore, the applicant carried out the entire procedure for making a
 monoclonal antibody against HBsAg three times and each time was successful
 in producing at least one antibody which fell within the scope of the
 claims.
 

 (C) In In re Bundy, 642 F.2d 430, 434, 209
 USPQ 48, 51-52 (CCPA 1981), the court ruled that appellant’s disclosure was
 sufficient to enable one skilled in the art to use the claimed analogs of
 naturally occurring prostaglandins even though the specification lacked any
 examples of specific dosages, because the specification taught that the
 novel prostaglandins had certain pharmacological properties and possessed
 activity similar to known E-type prostaglandins.
 

 
 

 
 2164.06(c) Examples of Enablement Issues – Computer Programming
 Cases [R-10.2019]
 

 To establish a reasonable basis for questioning the adequacy of a
 disclosure, the examiner must present a factual analysis of a disclosure to show that
 a person skilled in the art would not be able to make and use the claimed invention
 without resorting to undue experimentation.
 

 In computer applications, it is not unusual for the claimed
 invention to involve two areas of prior art or more than one technology, e.g., an
 appropriately programmed computer and an area of application of said computer. White Consol. Indus. v. Vega Servo-Control, Inc., 214 USPQ 796,
 821 (S.D.Mich. 1982) . In regard to the “skilled in the art” standard, in
 cases involving both the art of computer programming, and another technology, the
 examiner must recognize that the knowledge of persons skilled in both technologies is
 the appropriate criteria for determining sufficiency. See In re
 Naquin, 398 F.2d 863, 158 USPQ 317 (CCPA 1968); In re
 Brown, 477 F.2d 946, 177 USPQ 691 (CCPA 1973); White Consol.
 Indus., 214 USPQ at 822, aff’d on related grounds,
 713 F.2d 788, 218 USPQ 961 (Fed. Cir. 1983).
 

 In a typical computer application, system components are often
 represented in a “block diagram” format, i.e., a group of hollow rectangles
 representing the elements of the system, functionally labeled, and interconnected by
 lines. Such block diagram computer cases may be categorized into (A) systems that
 include but are more comprehensive than a computer and (B) systems wherein the block
 elements are totally within the confines of a computer. For instances where a
 computer invention is claimed using functional language, that is not limited to a
 specific structure, see MPEP § 2161.01 or
 MPEP §
 2181 , subsection II.B.2(a).
 

 I. BLOCK ELEMENTS MORE COMPREHENSIVE THAN A COMPUTER The first category of such block diagram cases involves systems
 which include a computer as well as other system hardware and/or software
 components. In order to meet the burden of establishing a reasonable basis for
 questioning the adequacy of such disclosure, the examiner should initiate a
 factual analysis of the system by focusing on each of the individual block element
 components. More specifically, such an inquiry should focus on the diverse
 functions attributed to each block element as well as the teachings in the
 specification as to how such a component could be implemented. If based on such an
 analysis, the examiner can reasonably contend that more than routine
 experimentation would be required by one of ordinary skill in the art to implement
 such a component or components, then enablement of the component or components
 should specifically be challenged by the examiner as part of a 35 U.S.C.
 112(a) or pre-AIA 35 U.S.C. 112 , first
 paragraph, rejection. Additionally, the examiner should determine whether certain
 of the hardware or software components depicted as block elements are themselves
 complex assemblages which have widely differing characteristics and which must be
 precisely coordinated with other complex assemblages. Under such circumstances, a
 reasonable basis may exist for challenging such a functional block diagram form of
 disclosure. See In re Ghiron, 442 F.2d 985, 169 USPQ 723 (CCPA
 1971) and In re Brown, supra. Even if the applicant has cited
 prior art patents or publications to demonstrate that particular block diagram
 hardware or software components are old, it should not always be considered as
 self-evident how such components are to be interconnected to function in a
 disclosed complex manner. See In re Scarbrough, 500 F.2d 560,
 566, 182 USPQ 298, 301 (CCPA 1974) and In re Forman, 463 F.2d
 1125, 1129, 175 USPQ 12, 16 (CCPA 1972).
 

 For example, where the specification provides in a block diagram
 disclosure of a complex system that includes a microprocessor and other system
 components controlled by the microprocessor, a mere reference to a commercially
 available microprocessor, without any description of the precise operations to be
 performed by the microprocessor, fails to disclose how such a microprocessor would
 be properly programmed to (1) either perform any required calculations or (2)
 coordinate the other system components in the proper timed sequence to perform the
 functions disclosed and claimed. If a particular program is disclosed in such a
 system, the program should be carefully reviewed to ensure that its scope is
 commensurate with the scope of the functions attributed to such a program in the
 claims. In re Brown, 477 F.2d at 951, 177 USPQ at 695. If (1)
 the disclosure fails to disclose any program and (2) more than routine
 experimentation would be required of one skilled in the art to generate such a
 program, the examiner clearly would have a reasonable basis for challenging the
 sufficiency of such a disclosure. The amount of experimentation that is considered
 routine will vary depending on the facts and circumstances of individual cases and
 should be reviewed on a case-by-case basis. No exact numerical standard has been
 fixed by the courts, but the “amount of required experimentation must, however, be
 reasonable.” White Consol. Indus., 713 F.2d at 791, 218 USPQ at
 963. One court apparently found that the amount of experimentation involved was
 reasonable where a skilled programmer was able to write a general computer
 program, implementing an embodiment form, within four hours. Hirschfield
 v. Banner, 462 F. Supp. 135, 142, 200 USPQ 276, 279 (D.D.C. 1978),
 aff’d, 615 F.2d 1368 (D.C. Cir. 1986),
 cert. denied, 450 U.S. 994 (1981). Another court found that, where
 the required period of experimentation for skilled programmers to develop a
 particular program would run to one to two man years, this would be “a clearly
 unreasonable requirement” (White Consol. Indus., 713 F.2d at
 791, 218 USPQ at 963).
 

 II. BLOCK ELEMENTS WITHIN A COMPUTER The second category of block diagram cases occurs most frequently
 in pure data processing applications where the combination of block elements is
 totally within the confines of a computer, where there is no interfacing with
 external apparatus other than normal input/output devices. In some instances, it
 has been found that particular kinds of block diagram disclosures were sufficient
 to meet the enabling requirement of 35 U.S.C. 112(a) or
 pre-AIA 35
 U.S.C. 112 , first paragraph. See In re
 Knowlton, 481 F.2d 1357, 178 USPQ 486 (CCPA 1973), In re
 Comstock, 481 F.2d 905, 178 USPQ 616 (CCPA 1973). The
 Comstock and Knowlton decisions turned on
 the appellants’ disclosure of (1) a reference to and reliance on an identified
 prior art computer system, and (2) an operative computer program for the
 referenced prior art computer system. In Knowlton, the
 disclosure was presented in such a detailed fashion that the individual program's
 steps were specifically interrelated with the operative structural elements in the
 referenced prior art computer system. The court in Knowlton 
 indicated that the disclosure did not merely consist of a cursory explanation of
 flow diagrams or a bare group of program listings together with a reference to a
 proprietary computer in which they might be run. The disclosure was characterized
 as going into considerable detail in explaining the interrelationships between the
 disclosed hardware and software elements. Under such circumstances, the court
 considered the disclosure to be concise as well as full, clear, and exact to a
 sufficient degree to satisfy the literal language of 35 U.S.C.
 112 , first paragraph. It must be emphasized that because of
 the significance of the program listing and the reference to and reliance on an
 identified prior art computer system, absent either of these items, a block
 element disclosure within the confines of a computer should be scrutinized in
 precisely the same manner as the first category of block diagram cases discussed
 above.
 

 Regardless of whether a disclosure involves block elements more
 comprehensive than a computer or block elements totally within the confines of a
 computer, USPTO personnel, when analyzing method claims, must recognize that the
 specification must be adequate to teach how to practice the claimed method. If
 such practice requires a particular apparatus, then the application must provide a
 sufficient disclosure of that apparatus if such is not already available. See
 In re Ghiron, 442 F.2d 985, 991, 169 USPQ 723, 727 (CCPA
 1971) and In re Gunn, 537 F.2d 1123, 1128, 190 USPQ 402, 406
 (CCPA 1976). When USPTO personnel question the adequacy of computer system or
 computer programming disclosures, the reasons for finding the specification to be
 nonenabling should be supported by the record as a whole. In this regard, it is
 also essential for USPTO personnel to reasonably challenge evidence submitted by
 the applicant. For example, in In re Naquin, supra, an
 affiant’s statement that the average computer programmer was familiar with the
 subroutine necessary for performing the claimed process, was held to be
 a statement of fact as it was unchallenged by USPTO personnel. In other words,
 unless USPTO personnel present a reasonable basis for challenging the disclosure
 in view of the record as a whole, a 35 U.S.C. 112(a) or
 pre-AIA 35
 U.S.C. 112 , first paragraph, rejection in a computer system
 or computer programming application may not be sustained on appeal. See
 In re Naquin, supra, and In re Morehouse,
 545 F.2d 162, 165-66, 192 USPQ 29, 32 (CCPA 1976).
 

 While no specific universally applicable rule exists for
 recognizing an insufficiently disclosed application involving computer programs,
 an examining guideline to generally follow is to challenge the sufficiency of
 disclosures that fail to include the programmed steps, algorithms or procedures
 that the computer performs necessary to produce the claimed function. These can be
 described in any way that would be understood by one of ordinary skill in the art,
 such as with a reasonably detailed flowchart which delineates the sequence of
 operations the program must perform. In programming applications where the
 software disclosure only includes a flowchart, as the complexity of functions and
 the generality of the individual components of the flowchart increase, the basis
 for challenging the sufficiency of such a flowchart becomes more reasonable
 because the likelihood of more than routine experimentation being required to
 generate a working program from such a flowchart also increases.
 

 As stated earlier, once USPTO personnel have advanced a
 reasonable basis or presented evidence to question the adequacy of a computer
 system or computer programming disclosure, the applicant must show that the
 specification would enable one of ordinary skill in the art to make and use the
 claimed invention without resorting to undue experimentation. In most cases,
 efforts to meet this burden involve submitting affidavits, referencing prior art
 patents or technical publications, presenting arguments of counsel, or
 combinations of these approaches.
 

 III. AFFIDAVIT PRACTICE (37 CFR 1.132) In computer cases, affidavits must be critically analyzed.
 Affidavit practice at the outset usually involves analyzing the skill level and/or
 qualifications of the affiant, which should be of the person of ordinary skill in
 the art. When an affiant’s skill level is higher than that required by the person
 of ordinary skill in the art for a particular application, an examiner may
 challenge the affidavit as insufficient should the affiant not submit evidence
 demonstrating the amount of experimentation required by a person of ordinary skill
 in the art to implement the invention. An affiant having a skill level or
 qualifications above that of the person of ordinary skill in the art would require
 less experimentation to implement the claimed invention than that for the person
 of ordinary skill. Similarly, an affiant having a skill level or qualifications
 below that of the person of ordinary skill in the art would require more
 experimentation to implement the claimed invention than that for the person of
 ordinary skill in the art. In either situation, the standard of the person of
 ordinary skill in the art would not have been met.
 

 In computer systems or programming cases, the problems with a
 given affidavit, which relate to the sufficiency of disclosure issue, generally
 involve affiants submitting few facts to support their conclusions or opinions.
 Some affidavits may go so far as to present conclusions on the ultimate legal
 question of sufficiency. In re Brandstadter, 484 F.2d 1395,
 179 USPQ 286 (CCPA 1973), illustrates the extent of the inquiry into the factual
 basis underlying an affiant’s conclusions or opinions. In
 Brandstadter, the invention concerned a stored program
 controller (computer) programmed to control the storing, retrieving, and
 forwarding of messages in a communications system. The disclosure consisted of
 broadly defined block diagrams of the structure of the invention and no flowcharts
 or program listings of the programs of the controller. The court quoted
 extensively from the examiner’s Office actions and examiner’s answer in its
 opinion where it was apparent that the examiner consistently argued that the
 disclosure was merely a broad system diagram in the form of labeled block diagrams
 along with statements of a myriad of desired results. Various affidavits were
 presented in which the affiants stated that all or some of the system circuit
 elements in the block diagrams were either well-known in the art or “could be
 constructed” by the skilled design engineer, that the controller was “capable of
 being programmed” to perform the stated functions or results desired, and that the
 person having ordinary skill in the art “could design or construct or was able to
 program” the system. The court did consider the affiants’ statements as being some
 evidence on the ultimate legal question of enablement but concluded that the
 statements failed in their purpose since they recited conclusions or opinions with
 few facts to support or buttress these conclusions. With reference to the lack of
 a disclosed computer program or even a flowchart of the program to control the
 message switching system, the record contained no evidence as to the number of
 programmers needed, the number of man-hours and the level of skill of the
 programmers to produce the program required to practice the invention.
 

 Factual evidence directed to the amount of time and effort and
 level of knowledge required for the practice of the invention from the disclosure,
 and knowledge in the art can be expected to rebut a prima facie 
 case of nonenablement, but not opinion evidence directed to the ultimate legal
 question of enablement. See Hirschfield, 462 F. Supp. at 143,
 200 USPQ at 281. Where an affidavit shows that an inventor described the problem
 to be solved to an affiant, which then enabled the affiant to generate a computer
 program to solve the problem, such an affidavit will fail to demonstrate that the
 application alone would have taught a person of ordinary skill in the art how to
 make and use the claimed invention. See In re Brown, 477 F.2d
 at 951, 177 USPQ at 695. In Brown, the court indicated that it
 had not been factually established that the applicant had not conveyed to the
 affiant vital and additional information in their several meetings in addition to
 that set out in the application. For an affidavit to be relevant to the
 determination of enablement, it must be probative of the level of skill of the
 person of ordinary skill in the art as of the time the applicant filed his
 application. See In re Gunn, 537 F.2d 1123, 1128, 190 USPQ 402,
 406 (CCPA 1976). In that case, each of the affiants stated what was known at the
 time the affiant executed the affidavit, and not what was known at the time the
 applicant filed his application.
 

 IV. REFERENCING PRIOR ART DOCUMENTS The commercial availability of an identified prior art computer
 system is very pertinent to the issue of enablement. But in some cases, this
 approach may not be sufficient to meet the applicant’s burden. Merely citing
 excerpts from technical publications in an affidavit in order to satisfy the
 enablement requirement is not sufficient if it is not made clear that a person
 skilled in the art would know which, or what parts, of the cited circuits could be
 used to construct the claimed device or how they could be interconnected to act in
 combination to produce the required results. See In re Forman,
 463 F.2d 1125, 1129, 175 USPQ 12, 16 (CCPA 1972). This analysis would
 appear to be less critical where the circuits comprising applicant’s system are
 essentially standard components of an identified prior art computer system and a
 standard device attached thereto.
 

 Prior art patents and patent application publications are often
 relied on by applicants to show the state of the art for purposes of enablement.
 However, these documents must have a publication date earlier than the effective
 filing date of the application under consideration. See In re
 Budnick, 537 F.2d 535, 538, 190 USPQ 422, 424 (CCPA 1976). An
 analogous point was made in In re Gunn, supra, where the court
 indicated that patents issued after the filing date of the application under
 examination are not evidence of subject matter known to any person skilled in the
 art since their subject matter may have been known only to the patentees and the
 Patent and Trademark Office.
 

 Merely citing prior art patents to demonstrate that the
 challenged components are old may not be sufficient proof since, even if each of
 the enumerated devices or labeled blocks in a block diagram disclosure were old,
 per se, this would not make it self-evident how each would
 be interconnected to function in a disclosed complex combination manner.
 Therefore, the specification in effect must set forth the integration of the prior
 art; otherwise, it is likely that undue experimentation, or more than routine
 experimentation would be required to implement the claimed invention. See
 In re Scarbrough, 500 F.2d 560, 565, 182 USPQ 298, 301 (CCPA
 1974). The court also noted that any cited patents which are used by the applicant
 to demonstrate that particular box diagram hardware or software components are old
 must be analyzed as to whether such patents are germane to the instant invention
 and as to whether such patents provide better detail of disclosure as to such
 components than an applicant’s own disclosure. Also, any patent or publication
 cited to provide evidence that a particular programming technique is well-known in
 the programming art does not demonstrate that one of ordinary skill in the art
 could make and use correspondingly disclosed programming techniques unless both
 the known and disclosed programming techniques are of approximately the same
 degree of complexity. See In re Knowlton, 500 F.2d 566, 572,
 183 USPQ 33, 37 (CCPA 1974).
 

 V. ARGUMENTS OF COUNSEL Arguments of counsel may be effective in establishing that an
 examiner has not properly met the burden or has otherwise erred in the examiner's
 position. However, it must be emphasized that arguments of counsel alone cannot
 take the place of evidence in the record once an examiner has advanced a
 reasonable basis for questioning the disclosure. See In re Budnick,
 537 F.2d at 538, 190 USPQ at 424; In re Schulze, 346
 F.2d 600, 145 USPQ 716 (CCPA 1965); In re Cole, 326 F.2d 769,
 140 USPQ 230 (CCPA 1964). For example, in a case where the record consisted
 substantially of arguments and opinions of applicant’s attorney, the court
 indicated that factual affidavits could have provided important evidence on the
 issue of enablement. See In re Knowlton, 500 F.2d at 572, 183
 USPQ at 37; In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA
 1979).
 

 

 

 
 2164.07 Relationship of Enablement Requirement to Utility Requirement
 of 35 U.S.C. 101 [R-11.2013]
 

 The requirement of 35 U.S.C. 112(a) or
 pre-AIA 35 U.S.C.
 112 , first paragraph as to how to use the invention is different
 from the utility requirement of 35 U.S.C. 101 . The requirement of
 35 U.S.C.
 101 is that some specific, substantial, and credible use be set
 forth for the invention. On the other hand, 35 U.S.C.
 112(a) or pre-AIA 35 U.S.C. 112 , first
 paragraph requires an indication of how the use (required by 35 U.S.C. 101 ) can
 be carried out, i.e., how the invention can be used. 
 

 If an applicant has disclosed a specific and substantial utility for an
 invention and provided a credible basis supporting that utility, that fact alone does
 not provide a basis for concluding that the claims comply with all the requirements of
 35 U.S.C.
 112(a) or pre-AIA 35 U.S.C. 112 , first
 paragraph. For example, if an applicant has claimed a process of treating a certain
 disease condition with a certain compound and provided a credible basis for asserting
 that the compound is useful in that regard, but to actually practice the invention as
 claimed a person skilled in the relevant art would have to engage in an undue amount of
 experimentation, the claim may be defective under 35 U.S.C. 112 , but not
 35 U.S.C.
 101 . To avoid confusion during examination, any rejection under
 35 U.S.C.
 112(a) or pre-AIA 35 U.S.C. 112 , first
 paragraph, based on grounds other than “lack of utility” should be imposed separately
 from any rejection imposed due to “lack of utility” under 35 U.S.C. 101 and
 35 U.S.C.
 112(a) or pre-AIA 35 U.S.C. 112 , first
 paragraph.
 

 I. WHEN UTILITY REQUIREMENT IS NOT SATISFIED 
 

 A. Not Useful or Operative If a claim fails to meet the utility requirement of
 35 U.S.C.
 101 because it is shown to be nonuseful or inoperative, then
 it necessarily fails to meet the how-to-use aspect of the enablement requirement
 of 35
 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112 , first
 paragraph. As noted in In re Fouche, 439 F.2d 1237, 169 USPQ
 429 (CCPA 1971), if “compositions are in fact useless, appellant’s specification
 cannot have taught how to use them.” 439 F.2d at 1243, 169 USPQ at 434. The
 examiner should make both rejections (i.e., a rejection under 35 U.S.C.
 112(a) or pre-AIA 35 U.S.C. 112 , first
 paragraph and a rejection under 35 U.S.C. 101 ) where the
 subject matter of a claim has been shown to be nonuseful or inoperative.
 

 The 35 U.S.C. 112(a) or
 pre-AIA 35
 U.S.C. 112 , first paragraph, rejection should indicate that
 because the invention as claimed does not have utility, a person skilled in the
 art would not be able to use the invention as claimed, and as such, the claim is
 defective under 35 U.S.C. 112(a) or
 pre-AIA 35
 U.S.C. 112 , first paragraph. A 35 U.S.C.
 112(a) or pre-AIA 35 U.S.C. 112 , first
 paragraph, rejection should not be imposed or maintained unless an appropriate
 basis exists for imposing a rejection under 35 U.S.C. 101 . In other words,
 Office personnel should not impose a 35 U.S.C. 112(a) or
 pre-AIA 35
 U.S.C. 112 , first paragraph, rejection grounded on a “lack
 of utility” basis unless a 35 U.S.C. 101 rejection is
 proper. In particular, the factual showing needed to impose a rejection under
 35 U.S.C.
 101 must be provided if a 35 U.S.C.
 112(a) or pre-AIA 35 U.S.C. 112 , first
 paragraph, rejection is to be imposed on “lack of utility” grounds. See
 MPEP
 § 2107 - § 2107.03 for a more detailed
 discussion of the utility requirements of 35 U.S.C. 101 and
 35
 U.S.C. 112(a) or pre-AIA 112 , first
 paragraph.
 

 B. Burden on the Examiner When the examiner concludes that an application claims an
 invention that is nonuseful, inoperative, or contradicts known scientific
 principles, the burden is on the examiner to provide a reasonable basis to support
 this conclusion. Rejections based on 35 U.S.C. 112(a) or
 pre-AIA
 35 U.S.C. 112 , first paragraph, and 35 U.S.C.
 101 should be made. 
 

 Examiner Has Initial Burden To Show That One of Ordinary Skill in the Art Would
 Reasonably Doubt the Asserted Utility The examiner has the initial burden of challenging an asserted
 utility. Only after the examiner has provided evidence showing that one of ordinary
 skill in the art would reasonably doubt the asserted utility does the burden shift to
 the applicant to provide rebuttal evidence sufficient to convince one of ordinary
 skill in the art of the invention’s asserted utility. In re
 Fisher, 421 F.3d 1365, 76 USPQ2d 1225 (Fed. Cir. 2005); In re
 Swartz, 232 F.3d 862, 863, 56 USPQ2d 1703, 1704 (Fed. Cir. 2000);
 In re Brana, 51 F.3d 1560, 1566, 34 USPQ2d 1436, 1441 (Fed. Cir. 1995)
 (citing In re Bundy, 642 F.2d 430, 433, 209 USPQ 48, 51 (CCPA 1981)).
 

 C. Rebuttal by Applicant If a rejection under 35 U.S.C. 101 has been
 properly imposed, along with a corresponding rejection under 35 U.S.C.
 112(a) or pre-AIA 35 U.S.C. 112 , first
 paragraph, the burden shifts to the applicant to rebut the prima facie
 showing. In re Oetiker, 977 F.2d 1443, 1445, 24
 USPQ2d 1443, 1444 (Fed. Cir. 1992). There is no predetermined amount or character
 of evidence that must be provided by an applicant to support an asserted utility.
 Rather, the character and amount of evidence needed to support an asserted utility
 will vary depending on what is claimed (Ex parte Ferguson, 117
 USPQ 229, 231 (Bd. App. 1957)), and whether the asserted utility appears to
 contravene established scientific principles and beliefs. In re
 Gazave, 379 F.2d 973, 978, 154 USPQ 92, 96 (CCPA 1967 ); In
 re Chilowsky, 229 F.2d 457, 462, 108 USPQ 321, 325 (CCPA 1956).
 Furthermore, the applicant does not have to provide evidence sufficient to
 establish that an asserted utility is true “beyond a reasonable doubt.”
 In re Irons, 340 F.2d 974, 978, 144 USPQ 351, 354 (CCPA
 1965). Instead, evidence will be sufficient if, considered as a whole, it leads a
 person of ordinary skill in the art to conclude that the asserted utility is more
 likely than not true. See MPEP § 2107.02 for a more
 detailed discussion of consideration of a reply to a prima
 facie rejection for lack of utility and evaluation of evidence
 related to utility. 
 

 II. WHEN UTILITY REQUIREMENT IS SATISFIED In some instances, the utility of the claimed invention will be
 provided, but the skilled artisan will not know how to effect that use. In such a
 case, no rejection will be made under 35 U.S.C. 101 , but a rejection
 will be made under 35 U.S.C. 112(a) or
 pre-AIA 35
 U.S.C. 112 , first paragraph. As pointed out in
 Mowry v. Whitney, 81 U.S. (14 Wall.) 620 (1871), an invention may in fact
 have great utility, i.e., may be “a highly useful invention,” but the specification
 may still fail to “enable any person skilled in the art or science” to use the
 invention. 81 U.S. (14 Wall.) at 644. 
 

 

 
 2164.08 Enablement Commensurate in Scope With the Claims [R-01.2024]

 All questions of enablement are evaluated against the claimed subject
 matter. When considering whether claims in a utility patent application or patent are
 enabled, USPTO personnel will use the Wands factors to ascertain
 whether the amount of experimentation required to enable the full scope of the claimed
 invention is reasonable. See Guidelines for Assessing Enablement in Utility
 Applications and Patents in View of the Supreme Court Decision in Amgen Inc. et al.
 v. Sanofi et al., 89 FR 1563 (January 10, 2024). See also
 MPEP §
 2164.01(a) . The focus of the examination inquiry is whether
 everything within the scope of the claim is enabled. Accordingly, the first analytical
 step requires that the examiner determine exactly what subject matter is encompassed by
 the claims. See, e.g., AK Steel Corp. v. Sollac, 344 F.3d 1234, 1244,
 68 USPQ2d 1280, 1287 (Fed. Cir. 2003) (When a range is claimed, there must be reasonable
 enablement of the scope of the range. Here, the claims at issue encompassed amounts of
 silicon as high as 10% by weight, however the specification included statements clearly
 and strongly warning that a silicon content above 0.5% by weight in an aluminum coating
 causes coating problems. Such statements indicate that higher amounts will not work in
 the claimed invention.). The examiner should determine what each claim recites and what
 the subject matter is when the claim is considered as a whole ,
 not when its parts are analyzed individually. No claim should be overlooked. With
 respect to dependent claims, 35 U.S.C. 112(d) or
 pre-AIA 35 U.S.C.
 112 , fourth paragraph, should be followed. These paragraphs state
 “a claim in a dependent form shall be construed to incorporate by reference all the
 limitations of the claim to which it refers” and requires the dependent claim to further
 limit the subject matter claimed. 
 

 The courts have 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’” or that any experimentation must be “reasonable”. See
 Amgen Inc. et al. v. Sanofi et al., 598 U.S. 594, 2023 USPQ2d 602
 (2023); McRO, Inc. v. Bandai Namco Games Am. Inc., 959 F.3d 1091,
 2020 USPQ2d 10550 (Fed. Cir. 2020); Wyeth & Cordis Corp. v. Abbott
 Laboratories, 720 F.3d 1380, 107 USPQ2d 1273 (Fed. Cir. 2013);
 Enzo Life Sciences, Inc. v. Roche Molecular Systems, Inc., 928
 F.3d 1340 (Fed. Cir. 2019); and Idenix Pharmaceuticals LLC v. Gilead Sciences
 Inc., 941 F.3d 1149, 2019 USPQ2d 415844 (Fed. Cir. 2019). See also
 In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir.
 1993). Nevertheless, not everything necessary to practice the invention need be
 disclosed. In fact, what is well-known is best omitted. In re
 Buchner, 929 F.2d 660, 661, 18 USPQ2d 1331, 1332 (Fed. Cir. 1991). All that
 is necessary is that one skilled in the art be able to practice the claimed invention,
 given the level of knowledge and skill in the art. Further, the scope of enablement must
 only bear a “reasonable correlation” to the scope of the claims. See, e.g., In
 re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). See
 Amgen Inc. et al. v. Sanofi et al., 598 U.S. 594, 611, 2023 USPQ2d
 602 (2023) (The Court stated that “[t]he more one claims, the more one must enable.)”. 
 

 With respect to the breadth of a claim, the relevant concern is whether
 the scope of enablement provided to one skilled in the art by the disclosure is
 commensurate with the scope of protection sought by the claims. The Federal Circuit,
 citing McRO, provided guidance on the application of enablement to
 genus claims, holding that “[a]lthough a specification does not need to describe how to
 make and use every possible variant of the claimed invention, when a range is claimed,
 there must be reasonable enablement of the scope of the range.”
 Sanofi-Aventisub, 987 F.3d at 1085 (internal quotations omitted).
 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). See also
 Plant Genetic Sys., N.V. v. DeKalb Genetics Corp., 315 F.3d 1335,
 1339, 65 USPQ2d 1452, 1455 (Fed. Cir. 2003) (alleged “pioneer status” of invention
 irrelevant to enablement determination).
 

 The propriety of a rejection based upon the scope of a claim relative
 to the scope of the enablement concerns (1) how broad the claim is with respect to the
 disclosure and (2) whether one skilled in the art could make and use the entire scope of
 the claimed invention without undue experimentation. A scope of enablement rejection
 must identify the claimed subject matter for which the specification is not enabling and
 explain why the specification is not enabling, applying the factors set forth in
 In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir.
 1998). See also MPEP §§
 2164.01(a) and 2164.04 . The explanation should include
 any questions posed by the examiner which were not satisfactorily resolved and
 consequently raise doubt as to enablement.
 

 An enabling disclosure may be set forth by specific example or broad
 terminology; the exact form of disclosure is not dispositive. In re Marzocchi, 439 F.2d 220, 223-24 169 USPQ 367, 370 (CCPA 1971). A
 rejection of a claim under 35 U.S.C. 112 as broader than the
 enabling disclosure is a 35 U.S.C. 112(a) or
 pre-AIA 35 U.S.C.
 112 , first paragraph, enablement rejection and not a
 35 U.S.C.
 112(b) or pre-AIA 35 U.S.C. 112 , second
 paragraph, definiteness rejection. Claims are not rejected as broader than the enabling
 disclosure under 35 U.S.C. 112 for noninclusion of limitations dealing with
 factors which must be presumed to be within the level of ordinary skill in the art; the
 claims need not recite such factors where one of ordinary skill in the art to whom the
 specification and claims are directed would consider them obvious. In
 re Skrivan, 427 F.2d 801, 806, 166 USPQ 85, 88 (CCPA 1970). One does not
 look to the claims but to the specification to find out how to practice the claimed
 invention. W.L. Gore & Assoc., Inc. v. Garlock, Inc., 721 F.2d
 1540, 1558, 220 USPQ 303, 316-17 (Fed. Cir. 1983); In re Johnson, 558
 F.2d 1008, 1017, 194 USPQ 187, 195 (CCPA 1977). In In re Goffe, 542
 F.2d 564, 567, 191 USPQ 429, 431 (CCPA 1976), the court stated:
 

 
 [T]o provide effective incentives, claims must adequately protect
 inventors. To demand that the first to disclose shall limit his claims to what he has
 found will work or to materials which meet the guidelines specified for “preferred”
 materials in a process such as the one herein involved would not serve the
 constitutional purpose of promoting progress in the useful arts.
 

 
 When analyzing the enabled scope of a claim, the teachings of the
 specification must not be ignored because claims are to be given their broadest
 reasonable interpretation that is consistent with the specification. “That claims are
 interpreted in light of the specification does not mean that everything in the
 specification must be read into the claims.” Raytheon Co. v. Roper
 Corp., 724 F.2d 951, 957, 220 USPQ 592, 597 (Fed. Cir. 1983),
 cert. denied, 469 U.S. 835 (1984). 
 

 The record must be clear so that the public will have notice as to the
 patentee’s scope of protection when the patent issues. If a reasonable interpretation of
 the claim is broader than the description in the specification, it is necessary for the
 examiner to make sure the full scope of the claim is enabled. Limitations and examples
 in the specification do not generally limit what is covered by the claims. See also
 United Therapeutics Corp. v Liquidia Techs., Inc., 74 F.4th 1360,
 1370, 2023 USPQ2d 862 (Fed. Cir. 2023) (the court found that the claims directed to
 administration of treprostinil to treat all five types of pulmonary hypertension, which
 were construed to not require safety and efficacy, were adequately enabled by the
 specification which described administration, concentrations and dosages as well as an
 open label study despite potential safety concerns associated with one type of pulmonary
 hypotension. The record included evidence that “a skilled artisan would understand that
 the claimed administration of treprostinil would vasodilate the pulmonary vasculature,
 improve hemodynamics, and in this way for a single dose, treat a patient’s elevated
 pulmonary blood pressure independent of the type (i.e., group) of pulmonary hypertension
 patient.”).
 

 The breadth of the claims was a factor considered in Amgen
 Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991),
 cert. denied, 502 U.S. 856 (1991). In Amgen, 
 the patent claims were directed to a purified DNA sequence encoding polypeptide analogs
 of the protein erythropoietin (EPO). The court stated that:
 

 
 Amgen has not enabled preparation of DNA sequences sufficient to
 support its all-encompassing claims. . . . [D]espite extensive statements in the
 specification concerning all the analogs of the EPO gene that can be made, there is
 little enabling disclosure of particular analogs and how to make them. Details for
 preparing only a few EPO analog genes are disclosed. . . . This disclosure might well
 justify a generic claim encompassing these and similar analogs, but it represents
 inadequate support for Amgen’s desire to claim all EPO gene analogs. There may be
 many other genetic sequences that code for EPO-type products. Amgen has told how to
 make and use only a few of them and is therefore not entitled to claim all of
 them.
 

 
 927 F.2d at 1213-14, 18 USPQ2d at 1027. However, when claims are
 directed to any purified and isolated DNA sequence encoding a specifically named protein
 where the protein has a specifically identified sequence, a rejection of the claims as
 broader than the enabling disclosure is generally not appropriate because one skilled in
 the art could readily determine any one of the claimed embodiments. 
 

 See also In re Wright, 999 F.2d 1557, 1562,
 27 USPQ2d 1510, 1513 (Fed. Cir. 1993) (The evidence did not show that a skilled artisan
 would have been able to carry out the steps required to practice the full scope of
 claims which encompass “ any and all live, non-pathogenic
 vaccines, and processes for making such vaccines, which elicit immunoprotective activity
 in any animal toward any RNA virus.”
 (original emphasis)); In re Goodman, 11 F.3d 1046, 1052, 29 USPQ2d
 2010, 2015 (Fed. Cir. 1993) (The specification did not enable the broad scope of the
 claims for producing mammalian peptides in plant cells because the specification
 contained only an example of producing gamma-interferon in a dicot species, and there
 was evidence that extensive experimentation would have been required for encoding
 mammalian peptide into a monocot plant at the time of filing); In re
 Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) (Where applicant
 claimed a composition suitable for the treatment of arthritis having a potency of “at
 least” a particular value, the court held that the claim was not commensurate in scope
 with the enabling disclosure because the disclosure was not enabling for compositions
 having a slightly higher potency. Simply because applicant was the first to achieve a
 composition beyond a particular threshold potency did not justify or support a claim
 that would dominate every composition that exceeded that threshold value.); In
 re Vaeck, 947 F.2d 488, 495, 20 USPQ2d 1438, 1444 (Fed. Cir. 1991) (Given
 the relatively incomplete understanding in the biotechnological field involved, and the
 lack of a reasonable correlation between the narrow disclosure in the specification and
 the broad scope of protection sought in the claims, a rejection under 35 U.S.C.
 112(a) or pre-AIA 35 U.S.C. 112 , first
 paragraph for lack of enablement was appropriate.); Pac. Biosciences of Cal.,
 Inc. v. Oxford Nanopore Techs., Inc., 996 F.3d 1342, 1352, 2021 USPQ2d 519
 (Fed. Cir. 2021) (The court found that undue experimentation was required to enable the
 full scope of the claims where there was ample evidence that relevant artisans would not
 know how to perform the claimed invention for more than a narrow range of the claimed
 scope of invention). 
 

 If a rejection is made based on the view that the enablement is not
 commensurate in scope with the claim, the examiner should identify the subject matter
 that is considered to be enabled.
 

 
 2164.08(a) Single Means Claim [R-11.2013]

 A single means claim, i.e., where a means recitation does not appear
 in combination with another recited element of means, is subject to an enablement
 rejection under 35 U.S.C. 112(a) or
 pre-AIA 35
 U.S.C. 112 , first paragraph. In re Hyatt, 
 708 F.2d 712, 714-715, 218 USPQ 195, 197 (Fed. Cir. 1983) (A single means claim which
 covered every conceivable means for achieving the stated purpose was held nonenabling
 for the scope of the claim because the specification disclosed at most only those
 means known to the inventor.). When claims depend on a recited property, a fact
 situation comparable to Hyatt is possible, where the claim covers
 every conceivable structure (means) for achieving the stated property (result) while
 the specification discloses at most only those known to the inventor. 
 

 

 
 2164.08(b) Inoperative Subject Matter [R-08.2012]

 The presence of inoperative embodiments within the scope of a claim
 does not necessarily render a claim nonenabled. The standard is whether a skilled
 person could determine which embodiments that were conceived, but not yet made, would
 be inoperative or operative with expenditure of no more effort than is normally
 required in the art. Atlas Powder Co. v. E.I. du Pont de Nemours &
 Co., 750 F.2d 1569, 1577, 224 USPQ 409, 414 (Fed. Cir. 1984) (prophetic
 examples do not make the disclosure nonenabling).
 

 Although, typically, inoperative embodiments are excluded by
 language in a claim (e.g., preamble), the scope of the claim may still not be enabled
 where undue experimentation is involved in determining those embodiments that are
 operable. A disclosure of a large number of operable embodiments and the
 identification of a single inoperative embodiment did not render a claim broader than
 the enabled scope because undue experimentation was not involved in determining those
 embodiments that were operable. In re Angstadt, 537 F.2d 498, 502-503, 190 USPQ 214, 218 (CCPA 1976).
 However, claims reading on significant numbers of inoperative embodiments would
 render claims nonenabled when the specification does not clearly identify the
 operative embodiments and undue experimentation is involved in determining those that
 are operative. Atlas Powder Co. v. E.I. duPont de Nemours &
 Co., 750 F.2d 1569, 1577, 224 USPQ 409, 414 (Fed. Cir. 1984);
 In re Cook, 439 F.2d 730, 735, 169 USPQ 298, 302 (CCPA 1971).
 

 

 
 2164.08(c) Critical Feature Not Claimed [R-08.2012]

 A feature which is taught as critical in a specification and is not
 recited in the claims should result in a rejection of such claim under the enablement
 provision section of 35 U.S.C. 112 . See In
 re Mayhew, 527 F.2d 1229, 1233, 188 USPQ 356, 358 (CCPA 1976). In
 determining whether an unclaimed feature is critical, the entire disclosure must be
 considered. Features which are merely preferred are not to be considered critical.
 In re Goffe, 542 F.2d 564, 567, 191 USPQ 429, 431 (CCPA 1976). 
 

 Limiting an applicant to the preferred materials in the absence of
 limiting prior art would not serve the constitutional purpose of promoting the
 progress in the useful arts. Therefore, an enablement rejection based on the grounds
 that a disclosed critical limitation is missing from a claim should be made only when
 the language of the specification makes it clear that the limitation is critical for
 the invention to function as intended. Broad language in the disclosure, including
 the abstract, omitting an allegedly critical feature, tends to rebut the argument of
 criticality.
 

 

 

 [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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 03/09/2026 20:50:42