Eligibility Step 1: The Four Categories of Statutory Subject Matter

I.

THE FOUR

CATEGORIES

35 U.S.C. 101

enumerates four

categories of subject matter that Congress deemed to be appropriate subject matter

for a patent: processes, machines, manufactures and compositions of matter. As

explained by the courts, these “four categories together describe the exclusive reach

of patentable subject matter. If a claim covers material not found in any of the four

statutory categories, that claim falls outside the plainly expressed scope of

§

101

even if the subject matter is otherwise new and useful.”

In re Nuijten,

500 F.3d 1346, 1354, 84 USPQ2d 1495, 1500 (Fed.

Cir. 2007).

A process defines “actions”,

i.e.,

an invention that is claimed as an act or step, or a series of acts or steps. As

explained by the Supreme Court, a “process” is “a mode of treatment of certain

materials to produce a given result. It is an

act, or a series of

acts,

performed upon the subject-matter to be transformed and reduced to

a different state or thing.”

Gottschalk v. Benson,

409 U.S. 63,

70, 175 USPQ 673, 676 (1972) (italics added) (quoting

Cochrane v.

Deener,

94 U.S. 780, 788, 24 L. Ed. 139, 141 (1876)). See also

Nuijten,

500 F.3d at 1355, 84 USPQ2d at 1501 (“The Supreme

Court and this court have consistently interpreted the statutory term ‘process’ to

require action”);

NTP, Inc. v. Research in Motion, Ltd.,

418 F.3d

1282, 1316, 75 USPQ2d 1763, 1791 (Fed. Cir. 2005) (“[A] process is a series of

acts.”) (quoting

Minton v. Natl. Ass’n. of Securities Dealers,

336

F.3d 1373, 1378, 67 USPQ2d 1614, 1681 (Fed. Cir. 2003)). As defined in

35 U.S.C.

100(b)

, the term “process” is synonymous with “method.”

The other three categories (machines, manufactures

and compositions of matter) define the types of physical or tangible “things” or

“products” that Congress deemed appropriate to patent.

Digitech Image Techs.

v. Electronics for Imaging,

758 F.3d 1344, 1348, 111 USPQ2d 1717, 1719

(Fed. Cir. 2014) (“For all categories except process claims, the eligible subject

matter must exist in some physical or tangible form.”)

categories (machines, manufactures

and compositions of matter) define the types of physical or tangible “things” or

“products” that Congress deemed appropriate to patent.

Digitech Image Techs.

v. Electronics for Imaging,

758 F.3d 1344, 1348, 111 USPQ2d 1717, 1719

(Fed. Cir. 2014) (“For all categories except process claims, the eligible subject

matter must exist in some physical or tangible form.”). Thus, when determining

whether a claimed invention falls within one of these three categories, examiners

should verify that the invention is to at least one of the following categories

and

is claimed in a physical or tangible form.

• A machine is a “concrete thing, consisting of

parts, or of certain devices and combination of devices.”

Digitech,

758 F.3d at 1348-49, 111 USPQ2d at 1719

(quoting

Burr v. Duryee,

68 U.S. 531, 570, 17 L. Ed. 650,

657 (1863)). This category “includes every mechanical device or combination of

mechanical powers and devices to perform some function and produce a certain

effect or result.”

Nuijten,

500 F.3d at 1355, 84 USPQ2d at

1501 (quoting

Corning v. Burden,

56 U.S. 252, 267, 14 L. Ed.

683, 690 (1854)).

• A manufacture is “a tangible article that is

given a new form, quality, property, or combination through man-made or

artificial means.”

Digitech,

758 F.3d at 1349, 111 USPQ2d at

1719-20 (citing

Diamond v. Chakrabarty,

447 U.S. 303, 308,

206 USPQ 193, 197 (1980)). As the courts have explained, manufactures are

articles that result from the process of manufacturing,

i.e.,

they were produced “from raw or prepared materials

by giving to these materials new forms, qualities, properties, or combinations,

whether by hand-labor or by machinery.”

Samsung Electronics Co. v.

Apple Inc.,

137 S. Ct. 429, 120 USPQ2d 1749, 1752-3 (2016)

(quoting

Diamond v. Chakrabarty,

447 U. S. 303, 308, 206

USPQ 193, 196-97 (1980));

Nuijten,

500 F.3d at 1356-57, 84

USPQ2d at 1502. Manufactures also include “the parts of a machine considered

separately from the machine itself.”

Samsung Electronics,

137 S. Ct

combinations,

whether by hand-labor or by machinery.”

Samsung Electronics Co. v.

Apple Inc.,

137 S. Ct. 429, 120 USPQ2d 1749, 1752-3 (2016)

(quoting

Diamond v. Chakrabarty,

447 U. S. 303, 308, 206

USPQ 193, 196-97 (1980));

Nuijten,

500 F.3d at 1356-57, 84

USPQ2d at 1502. Manufactures also include “the parts of a machine considered

separately from the machine itself.”

Samsung Electronics,

137 S. Ct. at 435, 120 USPQ2d at 1753 (quoting 1 W. Robinson, The Law of

Patents for Useful Inventions §183, p. 270 (1890)).

• A composition of matter is a “combination of

two or more substances and includes all composite articles.”

Digitech,

758 F.3d at 1348-49, 111 USPQ2d at 1719

(citation omitted). This category includes all compositions of two or more

substances and all composite articles, “'whether they be the results of

chemical union or of mechanical mixture, or whether they be gases, fluids,

powders or solids.'”

Chakrabarty,

447 U.S. at 308, 206 USPQ

at 197 (quoting

Shell Dev. Co. v. Watson,

149 F. Supp. 279,

280 (D.D.C. 1957);

id.

at 310 holding genetically modified

microorganism to be a manufacture or composition of matter).

It is not necessary to identify a single category into

which a claim falls, so long as it is clear that the claim falls into at least one

category. For example, because a microprocessor is generally understood to be a

manufacture, a product claim to the microprocessor or a system comprising the

microprocessor satisfies Step 1 regardless of whether the claim falls within any

other statutory category (such as a machine). It is also not necessary to identify a

“correct” category into which the claim falls, because although in many instances it

is clear within which category a claimed invention falls, a claim may satisfy the

requirements of more than one category

r or a system comprising the

microprocessor satisfies Step 1 regardless of whether the claim falls within any

other statutory category (such as a machine). It is also not necessary to identify a

“correct” category into which the claim falls, because although in many instances it

is clear within which category a claimed invention falls, a claim may satisfy the

requirements of more than one category. For example, a bicycle satisfies both the

machine and manufacture categories, because it is a tangible product that is concrete

and consists of parts such as a frame and wheels (thus satisfying the machine

category), and it is an article that was produced from raw materials such as aluminum

ore and liquid rubber by giving them a new form (thus satisfying the manufacture

category). Similarly, a genetically modified bacterium satisfies both the composition

of matter and manufacture categories, because it is a tangible product that is a

combination of two or more substances such as proteins, carbohydrates and other

chemicals (thus satisfying the composition of matter category), and it is an article

that was genetically modified by humans to have new properties such as the ability to

digest multiple types of hydrocarbons (thus satisfying the manufacture category).

Non-limiting examples of claims that are not directed

to any of the statutory categories include:

• Products that do not have a physical or

tangible form, such as information (often referred to as “data per se”) or a

computer program per se (often referred to as “software per se”) when claimed

as a product without any structural recitations;

• Transitory forms of signal transmission

(often referred to as “signals per se”), such as a propagating electrical or

electromagnetic signal or carrier wave; and

• Subject matter that the statute expressly

prohibits from being patented, such as humans per se, which are excluded under

The Leahy-Smith America Invents Act (AIA), Public Law 112-29, sec. 33, 125

Stat. 284 (September 16, 2011)

tations;

• Transitory forms of signal transmission

(often referred to as “signals per se”), such as a propagating electrical or

electromagnetic signal or carrier wave; and

• Subject matter that the statute expressly

prohibits from being patented, such as humans per se, which are excluded under

The Leahy-Smith America Invents Act (AIA), Public Law 112-29, sec. 33, 125

Stat. 284 (September 16, 2011).

As the courts' definitions of machines, manufactures

and compositions of matter indicate, a product must have a physical or tangible form

in order to fall within one of these statutory categories.

Digitech,

758 F.3d at 1348, 111 USPQ2d at 1719. Thus, the

Federal Circuit has held that a product claim to an intangible collection of

information, even if created by human effort, does not fall within any statutory

category.

Digitech,

758 F.3d at 1350, 111 USPQ2d at 1720 (claimed

“device profile” comprising two sets of data did not meet any of the categories

because it was neither a process nor a tangible product). Similarly, software

expressed as code or a set of instructions detached from any medium is an idea

without physical embodiment. See

Microsoft Corp. v. AT&T

Corp.,

550 U.S. 437, 449, 82 USPQ2d 1400, 1407 (2007); see also

Benson,

409 U.S. 67, 175 USPQ2d 675 (An "idea" is not patent

eligible). Thus, a product claim to a software program that does not also contain at

least one structural limitation (such as a “means plus function” limitation) has no

physical or tangible form, and thus does not fall within any statutory category.

Another example of an intangible product that does not fall within a statutory

category is a paradigm or business model for a marketing company.

In re

Ferguson,

558 F.3d 1359, 1364, 90 USPQ2d 1035, 1039-40 (Fed. Cir. 2009).

Even when a product has a physical or tangible form,

it may not fall within a statutory category

hysical or tangible form, and thus does not fall within any statutory category.

Another example of an intangible product that does not fall within a statutory

category is a paradigm or business model for a marketing company.

In re

Ferguson,

558 F.3d 1359, 1364, 90 USPQ2d 1035, 1039-40 (Fed. Cir. 2009).

Even when a product has a physical or tangible form,

it may not fall within a statutory category. For instance, a transitory signal, while

physical and real, does not possess concrete structure that would qualify as a device

or part under the definition of a machine, is not a tangible article or commodity

under the definition of a manufacture (even though it is man-made and physical in

that it exists in the real world and has tangible causes and effects), and is not

composed of matter such that it would qualify as a composition of matter.

Nuijten,

500 F.3d at 1356-1357, 84 USPQ2d at 1501-03. As such,

a transitory, propagating signal does not fall within any statutory category.

Mentor Graphics Corp. v. EVE-USA, Inc.,

851 F.3d 1275, 1294,

112 USPQ2d 1120, 1133 (Fed. Cir. 2017);

Nuijten,

500 F.3d at

1356-1357, 84 USPQ2d at 1501-03.

II.

ELIGIBILITY STEP 1: WHETHER A CLAIM

IS TO A STATUTORY CATEGORY

As described in

MPEP § 2106

,

subsection III, Step 1 of the eligibility analysis asks: Is the claim to a process,

machine, manufacture or composition of matter? Like the other steps in the

eligibility analysis, evaluation of this step should be made after determining what

the inventor has invented by reviewing the entire application disclosure and

construing the claims in accordance with their broadest reasonable interpretation

(BRI). See

MPEP §

2106

, subsection II, for more information about the

importance of understanding what has been invented, and

MPEP § 2111

for

more information about the BRI

ysis, evaluation of this step should be made after determining what

the inventor has invented by reviewing the entire application disclosure and

construing the claims in accordance with their broadest reasonable interpretation

(BRI). See

MPEP §

2106

, subsection II, for more information about the

importance of understanding what has been invented, and

MPEP § 2111

for

more information about the BRI.

In the context of the flowchart in

MPEP §

2106

, subsection III, Step 1 determines whether:

• The claim as a whole does not fall within any

statutory category (Step 1: NO) and thus is non-statutory, warranting a

rejection for failure to claim statutory subject matter; or

• The claim as a whole falls within one or

more statutory categories (Step 1: YES), and thus must be further analyzed to

determine whether it qualifies as eligible at Pathway A or requires further

analysis at Step 2A to determine if the claim is directed to a judicial

exception.

A claim whose BRI covers both statutory and

non-statutory embodiments embraces subject matter that is not eligible for patent

protection and therefore is directed to non-statutory subject matter. Such claims

fail the first step (Step 1: NO) and should be rejected under

35 U.S.C. 101

,

for at least this reason. In such a case, it is a best practice for the examiner to

point out the BRI and recommend an amendment, if possible, that would narrow the

claim to those embodiments that fall within a statutory category.

For example, the BRI of machine readable media can

encompass non-statutory transitory forms of signal transmission, such as a

propagating electrical or electromagnetic signal per se. See

In re

Nuijten,

500 F.3d 1346, 84 USPQ2d 1495 (Fed. Cir. 2007). When the BRI

encompasses transitory forms of signal transmission, a rejection under

35 U.S.C.

101

as failing to claim statutory subject matter would be

appropriate

the BRI of machine readable media can

encompass non-statutory transitory forms of signal transmission, such as a

propagating electrical or electromagnetic signal per se. See

In re

Nuijten,

500 F.3d 1346, 84 USPQ2d 1495 (Fed. Cir. 2007). When the BRI

encompasses transitory forms of signal transmission, a rejection under

35 U.S.C.

101

as failing to claim statutory subject matter would be

appropriate. Thus, a claim to a computer readable medium that can be a compact disc

or a carrier wave covers a non-statutory embodiment and therefore should be rejected

under

35 U.S.C.

101

as being directed to non-statutory subject matter. See,

e.g., Mentor Graphics v. EVE-USA, Inc.,

851 F.3d at 1294-95,

112 USPQ2d at 1134 (claims to a “machine-readable medium” were non-statutory, because

their scope encompassed both statutory random-access memory and non-statutory carrier

waves).

If a claim is clearly not within one of the four

categories (Step 1: NO), then a rejection under

35 U.S.C. 101

must be made

indicating that the claim is directed to non-statutory subject matter. Form

paragraphs

7.05

and

7.05.01

should be used; see

MPEP

§ 2106.07(a)(1)

. However, as shown in the flowchart in

MPEP §

2106

subsection III, when a claim fails under Step 1 (Step

1: NO), but it appears from applicant’s disclosure that the claim could be amended to

fall within a statutory category (Step 1: YES), the analysis should proceed to

determine whether such an amended claim would qualify as eligible at Pathway A, B or

C. In such a case, it is a best practice for the examiner to recommend an amendment,

if possible, that would resolve eligibility of the claim.