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2105    Patentable Subject Matter — Living Subject Matter [R-08.2012]

The decision of the Supreme Court in Diamond v. 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.

In view of this decision, the Office has issued these guidelines as to how 35 U.S.C. 101 will be interpreted.

The Supreme Court made the following points in the Chakrabarty opinion:

1. “Guided by these canons of construction, this Court 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’ 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, 148 USPQ459, 462-464 (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, 76 USPQ 280 (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.

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 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.

The Leahy-Smith America Invents Act (AIA), Pub. L. 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, Pub. L. 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 humanorganism, 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. Form paragraph 7.04.01 may be used; see MPEP § 706.03(a). 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.

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, 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 protections). 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).” 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.

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