MPEP 2105: Difference between revisions

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==[[MPEP 2105|2105 Patentable Subject Matter — Living Subject Matter]]==
==[[MPEP 2105|2105 Patentable Subject Matter — Living Subject Matter]]==


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The decision of the Supreme Court in Diamond v.
35 U.S.C. 101 defines Inventions which are  patentable
Chakrabarty, 447 U.S. 303, 206 USPQ 193 (1980),
held that microorganisms produced by genetic engineering
are not excluded from patent protection by
35  
U.S.C. 101. It is clear from the Supreme Court
decision and opinion that the question of whether or
not an invention embraces living matter is irrelevant
to the issue of patentability. The test set down by the
Court for patentable subject matter in this area is
whether the living matter is the result of human intervention.


According to 35 U.S.C. 101 :


In view of this decision, the Office has issued these
"Whoever invents or discovers any new and useful process,machine, manufacture, or composition of matter, or any new and useful improvement thereof may obtain a patent therefor, subject to the conditions and requirements of this title.
guidelines as to how 35 U.S.C. 101 will be interpreted.


*By using such expansive terms as "manufacture" and "composition of matter," modified by the comprehensive "any," Congress plainly contemplated that the patent laws would be given wide scope.This is not to suggest that § 101 has no limits or that it embraces every discovery. The laws of nature, physical phenomena, and abstract ideas have been held not patentable.


The Supreme Court made the following points in  
The use of the comprehensive term "any" in 35 U.S.C 101 may encompass living subject matter. The test set down for patentable subject matter in this area is whether the living matter is the result of human intervention. Therefore, the relevant distinction is not between living and inanimate things, but between products of nature, whether living or not, and human made inventions. This determination was made in the US Supreme Court Case Diamond v Chakrabarty wherein the Court held that microorganisms produced by genetic engineering are not excluded from patent protection.
the Chakrabarty opinion:


1. “Guided by these canons of construction, this Court  
The tests set forth by the Court for determining the patentability of Living Subject matter are:
has read the term ‘manufacture’ in § 101 in accordance
with its dictionary definition to mean ‘the production of  
articles for use from raw materials prepared by giving to
these materials new forms, qualities, properties, or combinations
whether by hand labor or by machinery.’”


2. “In choosing such expansive terms as ‘manufacture’
(A) “The laws of nature, physical phenomena and abstract ideas” are not patentable subject matter.
and ‘composition of matter,’ modified by the comprehensive
‘any,’ Congress plainly contemplated that the patent
laws would be given wide scope.”


3. “The Act embodied Jefferson’s philosophy that
(B) A “non-naturally occurring manufacture or composition of matter — a product of human ingenuity—having a distinctive name, character, [and] use” is patentable subject matter.
‘ingenuity should receive a liberal encouragement.’ 5
Writings of Thomas Jefferson, at 75-76. See Graham v.
John Deere Co., 383 U.S. 1, 7-10 (1966). Subsequent
patent statutes in 1836, 1870, and 1874 employed this
same broad language. In 1952, when the patent laws were
recodified, Congress replaced the word ‘art’ with ‘process,’
but otherwise left Jefferson’s language intact. The
Committee Reports accompanying the 1952 act inform us
that Congress intended statutory subject matter to ‘include
any thing under the sun that is made by man.’ S. Rep. No.
1979, 82d Cong., 2d Sess., 5 (1952).”


4. “This is not to suggest that § 101 has no limits or
(C) “[A] new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter. Likewise, Einstein could not patent his celebrated E=mc2; nor could Newton have patented the law of gravity. Such discoveries are ‘manifestations of... nature,free to all men and reserved exclusively to none.’”
that it embraces every discovery. The laws of nature,  
physical phenomena, and abstract ideas have been held
not patentable.”


5. “Thus, a new mineral discovered in the earth or a
(D) “The production of articles for use from raw materials prepared by giving to these materials new forms,qualities, properties, or combinations whether by hand labor or by machinery” [emphasis added] is a“manufacture” under 35 U.S.C. 101.
new plant found in the wild is not patentable subject matter.  
Likewise, Einstein could not patent his celebrated law
that E=mc2; nor could Newton have patented the law of
gravity.”


6. “His claim is not to a hitherto unknown natural phenomenon,
'''Patentability of Animals''':
but to a nonnaturally occurring manufacture or
composition of matter __ a product of human ingenuity
‘having a distinctive name, character [and] use.’”


7. “Congress thus recognized that the relevant distinction
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. The Commissioner of Patents and Trademarks issued a notice (Animals - Patentability, 1077 O.G. 24, April 21, 1987) that the Patent and Trademark Office would now consider non naturally occurring, nonhuman multicellular living organisms, including animals, to be patentable subject matter within the scope of 35 U.S.C. 101.
was not between living and inanimate things, but
between products of nature, whether living or not, and
human-made inventions. Here, respondent’s microorganism
is the result of human ingenuity and research.”


8. After reference to Funk Seed Co. & Kalo Co., 333
'''Patentability of Human organism:'''
U.S.127 (1948), “Here, by contrast, the patentee has produced
a new bacterium with markedly different characteristics
from any found in nature and one having the
potential for significant utility. His discovery is not
nature’s handiwork, but his own; accordingly it is patentable
subject matter under § 101.”


A review of the Court statements above as well as
The Leahy-Smith America Invents Act (AIA), Public Law112-29, sec. 33(a), 125 Stat. 284, states:
the whole Chakrabarty opinion reveals:
 
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.


(A)That the Court did not limit its decision to
The legislative history of the AIA includes the following statement, which sheds light on the meaning of this provision:
genetically engineered living organisms;


(B)The Court enunciated a very broad interpretation
"The 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."
of “manufacture” and “composition of matter” in
35 U.S.C. 101 (Note esp. quotes 1, 2, and 3 above);


(C)The Court set forth several tests for weighing
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 non-statutory 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.
whether patentable subject matter under 35 U.S.C.  
101 is present, stating (in quote 7 above) that:


The relevant distinction was not between living and inanimate
'''Patentability of Plant Subject Matter'''
things but between products of nature, whether living
or not, and human-made inventions.


The tests set forth by the Court are (note especially
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 and the Plant Variety Protection Act. The work of the plant breeder ‘in aid of nature’ is a patentable invention.
the italicized portions):


(A)“The laws of nature, physical phenomena and
<noinclude>{{MPEP Section|2103|2100|2106}}</noinclude>
abstract ideas” are not patentable subject matter.
 
(B)A “nonnaturally occurring manufacture or
composition of matter — a product of human ingenuity
—having a distinctive name, character, [and] use”
is patentable subject matter.
 
(C)“[A] new mineral discovered in the earth or a
new plant found in the wild is not patentable subject
matter. Likewise, Einstein could not patent his celebrated
E=mc2; nor could Newton have patented the
law of gravity. Such discoveries are ‘manifestations
of... nature, free to all men and reserved exclusively to
none.’”
 
(D)“[T]he production of articles for use from raw
materials prepared by giving to these materials new
forms, qualities, properties, or combinations whether
by hand labor or by machinery” [emphasis added] is
a “manufacture” under 35 U.S.C. 101.
 
In analyzing the history of the Plant Patent Act of
1930, the Court stated: “In enacting the Plant Patent
Act, Congress addressed both of these concerns [the
concern that plants, even those artificially bred, were
products of nature for purposes of the patent law and
the concern that plants were thought not amenable to
the written description]. It explained at length its
belief that the work of the plant breeder ‘in aid of
nature’ was patentable invention. S. Rep. No. 315,
71st Cong., 2d Sess., 6-8 (1930); H.R. Rep. No. 1129,
71st Cong., 2d Sess., 7-9 (1930).”
 
The Office will decide the questions as to patentable
subject matter under 35 U.S.C. 101 on a case-by-
case basis following the tests set forth in Chakrabarty,
e.g., that “a nonnaturally occurring manufacture or
composition of matter” is patentable, etc. It is inappropriate
to try to attempt to set forth here in advance
the exact parameters to be followed.
 
The standard of patentability has not and will not be
lowered. The requirements of 35 U.S.C. 102 and 103still apply. The tests outlined above simply mean that
a rational basis will be present for any 35 U.S.C. 101determination. In addition, the requirements of
35 U.S.C. 112 must also be met. In this regard, see
MPEP § 608.01(p).
 
In another case addressing the scope of 35
U.S.C. 101, 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, 122 S.Ct. 593, 605-06, 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 protec
tions). See also Ex parte Hibberd, 227 USPQ 443
(Bd. Pat. App. & Inter. 1985), wherein the Board held
that plant subject matter may be the proper subject of
a patent under 35
U.S.C. 101 even though such subject
matter may be protected under the Plant Patent
Act or the Plant Variety Protection Act. Following the
reasoning in Chakrabarty, the Board of Patent
Appeals and Interferences has also 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 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) that the Patent and
Trademark Office would now consider nonnaturally
occurring, nonhuman multicellular living organisms,
including animals, to be patentable subject matter
within the scope of 35
U.S.C. 101.
 
If the broadest reasonable interpretation of the
claimed invention as a whole encompasses a human
being, then a rejection under 35 U.S.C. 101 must be
made indicating that the claimed invention is directed
to 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.

Latest revision as of 22:45, May 31, 2020

← MPEP 2103 ↑ MPEP 2100 MPEP 2106 →


2105 Patentable Subject Matter — Living Subject Matter[edit | edit source]

35 U.S.C. 101 defines Inventions which are patentable

According to 35 U.S.C. 101 :

"Whoever invents or discovers any new and useful process,machine, manufacture, or composition of matter, or any new and useful improvement thereof may obtain a patent therefor, subject to the conditions and requirements of this title.

  • By using such expansive terms as "manufacture" and "composition of matter," modified by the comprehensive "any," Congress plainly contemplated that the patent laws would be given wide scope.This is not to suggest that § 101 has no limits or that it embraces every discovery. The laws of nature, physical phenomena, and abstract ideas have been held not patentable.

The use of the comprehensive term "any" in 35 U.S.C 101 may encompass living subject matter. The test set down for patentable subject matter in this area is whether the living matter is the result of human intervention. Therefore, the relevant distinction is not between living and inanimate things, but between products of nature, whether living or not, and human made inventions. This determination was made in the US Supreme Court Case Diamond v Chakrabarty wherein the Court held that microorganisms produced by genetic engineering are not excluded from patent protection.

The tests set forth by the Court for determining the patentability of Living Subject matter are:

(A) “The laws of nature, physical phenomena and abstract ideas” are not patentable subject matter.

(B) A “non-naturally occurring manufacture or composition of matter — a product of human ingenuity—having a distinctive name, character, [and] use” is patentable subject matter.

(C) “[A] new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter. Likewise, Einstein could not patent his celebrated E=mc2; nor could Newton have patented the law of gravity. Such discoveries are ‘manifestations of... nature,free to all men and reserved exclusively to none.’”

(D) “The production of articles for use from raw materials prepared by giving to these materials new forms,qualities, properties, or combinations whether by hand labor or by machinery” [emphasis added] is a“manufacture” under 35 U.S.C. 101.

Patentability of Animals:

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. The Commissioner of Patents and Trademarks issued a notice (Animals - Patentability, 1077 O.G. 24, April 21, 1987) that the Patent and Trademark Office would now consider non naturally occurring, nonhuman multicellular living organisms, including animals, to be patentable subject matter within the scope of 35 U.S.C. 101.

Patentability of Human organism:

The Leahy-Smith America Invents Act (AIA), Public Law112-29, 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:

"The 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."

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 non-statutory 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.

Patentability of 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 and the Plant Variety Protection Act. The work of the plant breeder ‘in aid of nature’ is a patentable invention.

← MPEP 2103 ↑ MPEP 2100 MPEP 2106 →
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