# MPEP § 2164.08: Enablement Commensurate in Scope With the Claims

> Federal · Agency guidance · In force

URL: https://www.frixlaw.com/law-library/statutes/MPEP_S2164.08

## Section

- **Citation:** MPEP § 2164.08
- **Heading:** Enablement Commensurate in Scope With the Claims
- **Jurisdiction:** Federal
- **Kind:** Agency guidance
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** USPTO MPEP / Chapter 2100 - Patentability / MPEP § 2164.08

## Text

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
e 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.)”
aimed 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
d 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
o 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
t 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
ecification 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
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
gical 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.

## Nearby sections

- [MPEP § 2103 Patent Examination Process](https://www.frixlaw.com/law-library/statutes/MPEP_S2103.md)
- [MPEP § 2104 Requirements of 35 U.S.C. 101](https://www.frixlaw.com/law-library/statutes/MPEP_S2104.md)
- [MPEP § 2104.01 Barred by Atomic Energy Act](https://www.frixlaw.com/law-library/statutes/MPEP_S2104.01.md)
- [MPEP § 2105 Patent Eligible Subject Matter — Living Subject Matter](https://www.frixlaw.com/law-library/statutes/MPEP_S2105.md)
- [MPEP § 2106 Patent Subject Matter Eligibility](https://www.frixlaw.com/law-library/statutes/MPEP_S2106.md)
- [MPEP § 2106.01 [Reserved]](https://www.frixlaw.com/law-library/statutes/MPEP_S2106.01.md)
- [MPEP § 2106.02 [Reserved]](https://www.frixlaw.com/law-library/statutes/MPEP_S2106.02.md)
- [MPEP § 2106.03 Eligibility Step 1: The Four Categories of Statutory Subject Matter](https://www.frixlaw.com/law-library/statutes/MPEP_S2106.03.md)
- [MPEP § 2106.04 Eligibility Step 2A: Whether a Claim is Directed to a Judicial Exception](https://www.frixlaw.com/law-library/statutes/MPEP_S2106.04.md)
- [MPEP § 2106.04(a) Abstract Ideas](https://www.frixlaw.com/law-library/statutes/MPEP_S2106.04(a).md)
- [MPEP § 2106.04(a)(1) Examples of Claims That Do Not Recite Abstract Ideas](https://www.frixlaw.com/law-library/statutes/MPEP_S2106.04(a)(1).md)
- [MPEP § 2106.04(a)(2) Abstract Idea Groupings](https://www.frixlaw.com/law-library/statutes/MPEP_S2106.04(a)(2).md)
- [MPEP § 2106.04(a)(3) Tentative Abstract Ideas](https://www.frixlaw.com/law-library/statutes/MPEP_S2106.04(a)(3).md)
- [MPEP § 2106.04(b) Laws of Nature, Natural Phenomena & Products of Nature](https://www.frixlaw.com/law-library/statutes/MPEP_S2106.04(b).md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/MPEP_S2164.08. Check the current official text before relying on it. Not legal advice.