Patent Eligible Subject Matter — Living Subject Matter

I.

INTRODUCTION

Prior to 1980, it was widely believed that living subject matter was

not eligible for patenting, either because such subject matter did not fall within a

statutory category, or because it was a judicial exception to patent eligibility.

However, the decision of the Supreme Court in

Diamond v. Chakrabarty,

447 U.S. 303, 206 USPQ 193 (1980), made it clear that the question of whether an

invention embraces living matter is irrelevant to the issue of patent eligibility. Note,

however, that Congress has excluded claims directed to or encompassing a human organism

from eligibility. See The Leahy-Smith America Invents Act (AIA), Pub. L. 112-29, sec.

33(a), 125 Stat. 284 (September 16, 2011).

II.

LIVING SUBJECT MATTER MAY BE PATENT ELIGIBLE

A.

Living Subject Matter May Be Directed To A Statutory Category

In

Chakrabarty,

the Supreme Court held that a

claim to a genetically engineered bacterium was directed to at least one of the four

statutory categories, because the bacterium was a “manufacture” and/or a “composition

of matter.” In its opinion, the Court stated that “Congress plainly contemplated that

the patent laws would be given wide scope” because it chose to draft

35 U.S.C.

101

using “such expansive terms as ‘manufacture’ and

‘composition of matter,’ modified by the comprehensive ‘any.’” 447 U.S. at 308, 206

USPQ at 197. The Court also determined that the distinction between living and

inanimate things was not relevant for subject matter eligibility. 447 U.S. at 313,

206 USPQ at 199. Thus, the Court held that living subject matter with markedly

different characteristics from any found in nature, such as the claimed bacterium

produced by genetic engineering, is not excluded from patent protection by

35 U.S.C.

101

. 447 U.S. at 310, 206 USPQ at 197.

Following the reasoning in

Chakrabarty,

the Board of Patent Appeals and Interferences

determined that animals are patentable subject matter under

35 U.S.C. 101

.

In

Ex parte Allen,

2 USPQ2d 1425 (Bd. Pat. App. & Inter

s from any found in nature, such as the claimed bacterium

produced by genetic engineering, is not excluded from patent protection by

35 U.S.C.

101

. 447 U.S. at 310, 206 USPQ at 197.

Following the reasoning in

Chakrabarty,

the Board of Patent Appeals and Interferences

determined that animals are patentable subject matter under

35 U.S.C. 101

.

In

Ex parte Allen,

2 USPQ2d 1425 (Bd. Pat. App. & Inter.

1987), the Board decided that a non-naturally occurring polyploid Pacific coast

oyster could have been the proper subject of a patent under

35 U.S.C. 101

if all the criteria for patentability were satisfied. Shortly after the

Allen

decision, the Commissioner of Patents and Trademarks

issued a notice (Animals - Patentability, 1077 O.G. 24, April 21, 1987) stating that

the Patent and Trademark Office “now considers nonnaturally occurring, non-human

multicellular living organisms, including animals, to be patentable subject matter

within the scope of

35 U.S.C. 101

.”

With respect to plant subject matter, the Supreme

Court held that patentable subject matter under

35 U.S.C. 101

includes newly

developed plant breeds, even though plant protection is also available under the

Plant Patent Act (

35 U.S.C. 161

-

164

) and the Plant Variety

Protection Act (7 U.S.C. 2321

et. seq.

).

J.E.M. Ag

Supply, Inc. v. Pioneer Hi-Bred Int’ l, Inc.,

534 U.S. 124, 143-46, 60

USPQ2d 1865, 1874 (2001) (The scope of coverage of

35 U.S.C. 101

is not limited by the Plant Patent Act or the Plant Variety Protection Act; each

statute can be regarded as effective because of its different requirements and

protections).

See

MPEP §

2106.03

for a discussion of the categories of statutory

subject matter.

B.

Living Subject Matter May Be Eligible for Patent Protection

The Supreme Court in

Chakrabarty

held a claim to a genetically engineered bacterium eligible, because the claimed

bacterium was not a “product of nature” exception

atute can be regarded as effective because of its different requirements and

protections).

See

MPEP §

2106.03

for a discussion of the categories of statutory

subject matter.

B.

Living Subject Matter May Be Eligible for Patent Protection

The Supreme Court in

Chakrabarty

held a claim to a genetically engineered bacterium eligible, because the claimed

bacterium was not a “product of nature” exception. As the Court explained, the

modified bacterium was patentable because the patent claim was not to a “hitherto

unknown natural phenomenon,” but instead had “markedly different characteristics from

any found in nature,” due to the additional plasmids and resultant capacity for

degrading oil. 447 U.S. at 309-10, 206 USPQ at 197.

Subsequent judicial decisions have made clear that the Supreme

Court’s decision in

Chakrabarty

is “central” to the eligibility

inquiry with respect to nature-based products. See,

e.g., Association for

Molecular Pathology v. Myriad Genetics, Inc.,

569 U.S. 576, 590, 106

USPQ2d 1972, 1979 (2013). For example, the Federal Circuit has indicated that

“discoveries that possess ‘markedly different characteristics from any found in

nature,’ … are eligible for patent protection.”

In re Roslin Institute

(Edinburgh),

750 F.3d 1333, 1336, 110 USPQ2d 1668, 1671 (Fed. Cir. 2014)

(quoting

Chakrabarty,

447 U.S. at 310, 206 USPQ2d at 197). In

Roslin,

the claimed invention was a live-born clone of a

pre-existing, non-embryonic, donor mammal selected from cattle, sheep, pigs, and

goats

rkedly different characteristics from any found in

nature,’ … are eligible for patent protection.”

In re Roslin Institute

(Edinburgh),

750 F.3d 1333, 1336, 110 USPQ2d 1668, 1671 (Fed. Cir. 2014)

(quoting

Chakrabarty,

447 U.S. at 310, 206 USPQ2d at 197). In

Roslin,

the claimed invention was a live-born clone of a

pre-existing, non-embryonic, donor mammal selected from cattle, sheep, pigs, and

goats. An embodiment of the claimed invention was the famous Dolly the Sheep, which

the court stated was “the first mammal ever cloned from an adult somatic cell.”

Despite acknowledging that the method used to create the claimed clones “constituted

a breakthrough in scientific discovery”, the court relied on

Chakrabarty

in holding the claims ineligible because “Dolly

herself is an exact genetic replica of another sheep and does not possess ‘markedly

different characteristics from any [farm animals] found in nature.’”

Roslin,

750 F.3d at 1337, 110 USPQ2d at 1671.

See

MPEP §

2106.04

for a discussion of the judicial exceptions in

general,

MPEP § 2106.04(b)

, subsection II, for a discussion of

products of nature, and

MPEP § 2106.04(c)

for a discussion

of the markedly different characteristics analysis that examiners should use to

determine whether a nature-based product such as living subject matter is eligible

for patent protection.

III.

HUMAN ORGANISMS ARE NONSTATUTORY SUBJECT MATTER

Congress has excluded claims directed to or encompassing

a human organism from patentability. The Leahy-Smith America Invents Act (AIA), Public

Law 112-29,

sec. 33(a)

, 125 Stat. 284,

states:

Notwithstanding any other provision of law, no patent

may issue on a claim directed to or encompassing a human organism.

The legislative history of the AIA includes the following

statement, which sheds light on the meaning of this provision:

[T]he U.S

encompassing

a human organism from patentability. The Leahy-Smith America Invents Act (AIA), Public

Law 112-29,

sec. 33(a)

, 125 Stat. 284,

states:

Notwithstanding any other provision of law, no patent

may issue on a claim directed to or encompassing a human organism.

The legislative history of the AIA includes the following

statement, which sheds light on the meaning of this provision:

[T]he U.S. Patent Office has already issued patents on

genes, stems cells, animals with human genes, and a host of non-biologic products

used by humans, but it has not issued patents on claims directed to human organisms,

including human embryos and fetuses. My amendment would not affect the former, but

would simply affirm the latter.

157 Cong. Rec. E1177-04 (testimony of Representative Dave

Weldon previously presented in connection with the Consolidated Appropriations Act,

2004, Public Law 108-199, 634, 118 Stat. 3, 101, and later resubmitted with regard to

the AIA; see 149 Cong. Rec. E2417-01). Thus,

section 33(a) of the

AIA

codifies existing Office policy that human organisms are not

patent-eligible subject matter.

If the broadest reasonable interpretation of the claimed invention as a

whole encompasses a human organism, then a rejection under

35 U.S.C. 101

and

AIA

sec. 33(a)

must be made indicating that the claimed invention is

directed to a human organism and is therefore nonstatutory subject matter. Furthermore,

the claimed invention must be examined with regard to all issues pertinent to

patentability, and any applicable rejections under

35 U.S.C. 102

,

103

, or

112

must also be made.

Use form paragraph

7.04.03

to reject a claim under

35 U.S.C.

101

and

AIA sec. 33(a)

.