9 Chisum on Patents A.
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`Chisum on Patents > Part II. Appendices and Bibliography > APPENDIX 24 Policy Statement on
`Patentability of Animals > Policy Statement on Patentability of Animals
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`A. Animals - Patentability
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`in Ex parte Allen,
`Interferences
`the Board of Patent Appeals and
`A decision by
`______________________ USPQ ______________________ (Bd. App. & Int. April 3, 1987), held that
`claimed polyploid oysters are nonnaturally occurring manufactures or compositions of matter within the
`meaning of 35 U.S.C. 101. The Board relied upon the opinion of the Supreme Court in Diamond v.
`Chakrabarty, 447 U.S. 303, 206 USPQ 193 (1980) as it had done in Ex parte Hibberd, 227 USPQ 443
`(Bd. App. & Int., 1985), as controlling authority that Congress intended statutory subject matter to
`“include anything under the sun that is made by man.” 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.
`The Board’s decision does not affect the principle and practice that products found in nature will not be
`considered to be patentable subject matter under 35 U.S.C. 101 and/or 102. An article of manufacture
`or composition of matter occurring in nature will not be considered patentable unless given a new form,
`quality, properties or combination not present in the original article existing in nature in accordance with
`existing law. See e.g. Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 76 USPQ 280 (1948);
`American Fruit Growers v. Brogdex, 283 U.S. 1, 8 USPQ 131 (1931); Ex parte Grayson, 51 USPQ 413
`(Bd. App. 1941).
`A claim directed to or including within its scope a human being will not be considered to be patentable
`subject matter under 35 U.S.C. 101. The grant of a limited, but exclusive property right in a human
`being is prohibited by the Constitution. Accordingly, it is suggested that any claim directed to a non-
`plant multicellular organism which would include a human being within its scope include the limitation
`“non-human” to avoid this ground of rejection. The use of a negative limitation to define the metes and
`bounds of the claimed subject matter is a permissible form of expression. In re Wakefield, 422 F.2d
`897, 164 USPQ 636 (CCPA 1970).
`Accordingly, the Patent and Trademark Office is now examining claims directed to multicellular living
`organisms, including animals. To the extent that the claimed subject matter is directed to a non-human
`“nonnaturally occurring manufacture or composition of matter—a product of human ingenuity”
`(Diamond v. Chakrabarty ), such claims will not be rejected under 35 U.S.C. 101 as being directed to
`nonstatutory subject matter.
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`Background Paper on OG Notice
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`Exhibit 1008
`Select Sires, et al. v. ABS Global
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`9 Chisum on Patents A.
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`Animals - Patentability
`The April 3, 1987 decision by the Board of Patent Appeals and Interferences (Ex Parte Allen ) held that
`the claimed polyploid oysters are manufactures or compositions of matter within the scope of 35 USC
`101. This reverses a long-standing policy of the PTO that multicellular animals per se did not constitute
`patentable subject matter under the general patent law.
`The Allen application contained claims to a method of producing polyploidy in oysters which results in
`increased growth. The examiner determined that the process was patentable. The application also
`contained claims directed to a polyploid Pacific oyster produced by the method defined in the
`patentable process claims. The examiner had rejected these claims on two separate grounds of
`rejection: (1) 35 USC 101—the claimed oysters were non patentable subject matter; and (2) 35 USC
`103—the claimed oysters were obvious over a printed publication that taught that it was known to
`chemically treat an American oyster to induce polyploidy as a way to increase growth. The Board
`reversed the first rejection, but agreed that the claimed oyster was not patentably different from the
`polyploid oysters taught in the prior art. The only reported case in the United States on the patentability
`of an animal per se prior to the Allen decision was another Board of Appeals decisions in 1974 that
`held that a claim to a dwarf hen (i.e. a chicken of subnormal size) did not constitute patentable subject
`matter under 35 USC 101. This decision was reversed on other grounds by the CCPA (now the Court
`of Appeals for the Federal Circuit—CAFC). In re Merat, 519 F.2d 1390, 186 USPQ 471 (CCPA 1975).
`Up until the 1980 Supreme Court decision in Diamond v. Chakrabarty, the PTO had taken the position
`that any life form, even a single cell organism was not patentable subject matter within the meaning of
`35 USC 101 and that special laws had been created to protect plant life forms depending on whether
`they were asexually reproduced (Plant Patent Act) or sexually reproduced (Plant Variety Protection
`Art). In deciding that a genetically engineered microorganism qualified as patentable subject matter, the
`Supreme Court noted that the use of expansive terms “manufacture” and “composition of matter”
`modified by the comprehensive “any” in 35 USC 101 indicated that Congress “plainly contemplated that
`the patent laws would be given wide scope.” The Court also noted that the legislative history of Section
`101 supports a broad construction and concluded from the Committee Reports accompanying the 1952
`Act that Congress intended statutory subject matter to “include anything under the sun that is made by
`man.” The Board has twice relied on this broad interpretation used by the Supreme Court to hold that
`subject matter is patentable under 35 USC 101—plants (Ex Parte Hibberd ) and now multicellular
`animals (Ex Parte Allen ). In each case, there was no evidence that these higher life forms claimed in
`these applications occur naturally without the intervention of man. Therefore, this latest decision does
`not affect the principle and practice that products found in nature will not be considered to be
`patentable subject matter under 35 USC 101 and/or 102.
`Although the PTO now considers nonnaturally occurring multicellular living organisms, including
`animals, to be patentable subject matter within the scope of35 USC 101, the issue will arise as to
`whether a claim directed to or including within its scope a genetically modified human being will be
`considered to be patentable subject matter. The position of the PTO is that the grant of a limited, but
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`Exhibit 1008
`Select Sires, et al. v. ABS Global
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`exclusive property right in a human being is prohibited by the Constitution. While the precise
`Constitutional basis has not been defined, an argument could be based on the 13th Amendment which
`prohibits involuntary servitude, or perhaps the 4th amendment which includes the right to be protected
`against unreasonable search and seizure. While there may be other ways to exclude a human being
`from the scope of a broad claim directed to mammals, for example, one clearly appropriate mechanism
`would be to use the negative limitation “non-human” to exclude a human being from the scope of a
`claim and avoid a rejection under 35 USC 101.
`PTO now has an estimated 15 applications pending with claims directed to animals per se. To the
`extent that such claims are directed to non-human nonnaturally occurring manufactures or
`compositions of matter—a product of human ingenuity—such claims will not be rejected under 35 USC
`101 as being directed to non-statutory subject matter.
`Patents claiming new animals will be classified in class 800—Multicellular Living Organisms and
`Unmodified Parts Thereof.
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`Chisum on Patents
`Copyright 2021, Matthew Bender & Company, Inc., a member of the LexisNexis Group.
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`End of Document
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`Exhibit 1008
`Select Sires, et al. v. ABS Global
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