Enablement Commensurate in Scope With the Claims

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.