MPEP 2105: Difference between revisions

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The decision of the Supreme Court in Diamond v.
The test set down for patentable subject matter in this area is  
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.  
whether the living matter is the result of human intervention.  


 
*The term "manufacture" in [[35_U.S.C.#35_U.S.C._101_Inventions_patentable.|35 U.S.C. § 101]] in accordance with its dictionary definition means "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."
In view of this decision, the Office has issued these
*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.
guidelines as to how 35 U.S.C. 101 will be interpreted.
*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.
 
**Thus, 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 law that E=mc2; nor could Newton have patented the law of gravity.
 
*Congress recognized that the relevant distinction was not between living and inanimate things, but between products of nature, whether living or not, and human-made inventions.
The Supreme Court made the following points in
**Genetically engineered living organisms fall under human-made inventions
the Chakrabarty opinion:
**A nonnaturally occurring manufacture or composition of matter — a product of human ingenuity —having a distinctive name, character, and use is patentable subject matter.
 
*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 is a "manufacture" under 35 U.S.C. 101.
1. “Guided by these canons of construction, this Court
*Patentable subject matter under 35 U.S.C. 101 includes newly developed plant breeds.
has read the term ‘manufacture’ in § 101 in accordance  
*The Board of Patent Appeals and Interferences has also determined that animals are patentable subject matter under 35 U.S.C. 101 if all the criteria for patentability were satisfied.
with its dictionary definition to mean ‘the production of  
**The Patent and Trademark Office now considers nonnaturally occurring, nonhuman multicellular living organisms, including animals, to be patentable subject matter within the scope of 35 U.S.C. 101.
articles for use from raw materials prepared by giving to  
**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.
these materials new forms, qualities, properties, or combinations  
whether by hand labor or by machinery.’”
 
2. “In choosing 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.”
 
3. “The Act embodied Jefferson’s philosophy that
‘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  
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  
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,
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  
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
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 whole Chakrabarty opinion reveals:
 
(A)That the Court did not limit its decision to
genetically engineered living organisms;
 
(B)The Court enunciated a very broad interpretation
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
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
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 italicized portions):
 
(A)“The laws of nature, physical phenomena and
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.

Revision as of 22:15, August 2, 2007

↑ MPEP 2100 MPEP 2106 →


2105 Patentable Subject Matter — 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.

  • The term "manufacture" in 35 U.S.C. § 101 in accordance with its dictionary definition means "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."
  • 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.
    • Thus, 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 law that E=mc2; nor could Newton have patented the law of gravity.
  • Congress recognized that the relevant distinction was not between living and inanimate things, but between products of nature, whether living or not, and human-made inventions.
    • Genetically engineered living organisms fall under human-made inventions
    • A nonnaturally occurring manufacture or composition of matter — a product of human ingenuity —having a distinctive name, character, and use is patentable subject matter.
  • 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 is a "manufacture" under 35 U.S.C. 101.
  • Patentable subject matter under 35 U.S.C. 101 includes newly developed plant breeds.
  • The Board of Patent Appeals and Interferences has also determined that animals are patentable subject matter under 35 U.S.C. 101 if all the criteria for patentability were satisfied.
    • The Patent and Trademark Office now considers 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.
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