| CREATE Act, Examination Instructions and Guidelines |
Referenced Items (171, 172, 173, 174, 175, 176, 177, 178, 179, 180, 181, 182, 183) |
(177) DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
[Docket No. 991027289-0263-02]
RIN 0651-AB09
Utility Examination Guidelines
AGENCY: United States Patent and Trademark Office, Commerce.
ACTION: Notice.
SUMMARY: The United States Patent and Trademark Office (USPTO) is
publishing a revised version of guidelines to be used by Office personnel
in their review of patent applications for compliance with the `utility'
requirement of 35 U.S.C. 101. This revision supersedes the Revised Interim
Utility Examination Guidelines that were published at 64 FR 71440, Dec. 21,
1999; 1231 O.G. 136 (2000); and correction at 65 FR 3425, Jan. 21, 2000;
1231 O.G. 67 (2000).
DATES: The Guidelines are effective as of January 5, 2001.
FOR FURTHER INFORMATION CONTACT: Mark Nagumo by telephone at (703)
305-8666, by facsimile at (703) 305-9373, by electronic mail at
`mark.nagumo@uspto.gov,' or by mail marked to his attention addressed to
the Office of the Solicitor, Box 8, Washington, DC 20231; or Linda Therkorn
by telephone at (703) 305-9323, by facsimile at (703) 305-8825, by
electronic mail at `linda.therkorn@uspto.gov,' or by mail marked to her
attention addressed to Box Comments, Commissioner for Patents, Washington,
DC 20231.
SUPPLEMENTARY INFORMATION: As of the publication date of this notice,
these Guidelines will be used by USPTO personnel in their review of patent
applications for compliance with the `utility' requirement of 35 U.S.C.
101. Because these Guidelines only govern internal practices, they are
exempt from notice and comment rulemaking under 5 U.S.C. 553(b)(A).
I. Discussion of Public Comments
The Revised Interim Utility Examination Guidelines published at 64 FR
71440, Dec. 21, 1999; 1231 O.G. 136, Feb. 29, 2000, with a correction at 65
FR 3425, Jan. 21, 2000; 1231 O.G. 67, Feb. 15, 2000, requested comments
from the public. Comments were received from 35 individuals and 17
organizations. The written comments have been carefully considered.
Overview of Comments
The majority of comments generally approved of the guidelines and
several expressly stated support for the three utility criteria (specific,
substantial, and credible) set forth in the Guidelines. A few comments
addressed particular concerns with respect to the coordinate examiner
training materials that are available for public inspection at the USPTO
website, www.uspto.gov. The comments on the training materials will be
taken under advisement in the revision of the training materials.
Consequently, those comments are not specifically addressed below because
they do not impact the content of the Guidelines. Comments received in
response to the request for comments on the `Revised Interim Guidelines for
Examination of Patent Applications Under the 35 U.S.C. 112, ¶ 1 `Written
Description' Requirement,' 64 FR 71427, Dec. 21, 1999; 1231 O.G. 123, Feb.
29, 2000, which raised issues pertinent to the utility requirement are also
addressed below.
Responses to Specific Comments
(1) Comment: Several comments state that while inventions are
patentable, discoveries are not patentable. According to the comments,
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genes are discoveries rather than inventions. These comments urge the USPTO
not to issue patents for genes on the ground that genes are not inventions.
Response: The suggestion is not adopted. An inventor can patent a discovery
when the patent application satisfies the statutory requirements. The U.S.
Constitution uses the word `discoveries' where it authorizes Congress to
promote progress made by inventors. The pertinent part of the Constitution
is Article 1, section 8, clause 8, which reads: `The Congress shall have
power * * * To promote the Progress of Science and useful Arts, by
securing for limited Times to Authors and Inventors the exclusive Right
to their respective Writings and Discoveries.'
When Congress enacted the patent statutes, it specifically authorized
issuing a patent to a person who `invents or discovers' a new and useful
composition of matter, among other things. The pertinent statute is 35
U.S.C. 101, which reads: `Whoever invents or discovers any new and useful
process, machine, manufacture, or composition of matter, orany new and
useful improvement thereof, may obtain a patent therefor, subject to the
conditions and requirements of this title.' Thus, an inventor's discovery
of a gene can be the basis for a patent on the genetic composition isolated
from its natural state and processed through purifying steps that separate
the gene from other molecules naturally associated with it.
If a patent application discloses only nucleic acid molecular structure
for a newly discovered gene, and no utility for the claimed isolated gene,
the claimed invention is not patentable. But when the inventor also
discloses how to use the purified gene isolated from its natural state, the
application satisfies the `utility' requirement. That is, where the
application discloses a specific, substantial, and credible utility for the
claimed isolated and purified gene, the isolated and purified gene
composition may be patentable.
(2) Comment: Several comments state that a gene is not a new composition
of matter because it exists in nature, and/or that an inventor who isolates
a gene does not actually invent or discover a patentable composition
because the gene exists in nature. These comments urge the USPTO not to
issue patents for genes on the ground that genes are products of nature.
Others state that naturally occurring DNAs are part of our heritage and are
not inventions. Another comment expressed concern that a person whose body
includes a patented gene could be guilty of patent infringement. Response:
The comments are not adopted. A patent claim directed to an isolated and
purified DNA molecule could cover, e.g., a gene excised from a natural
chromosome or a synthesized DNA molecule. An isolated and purified DNA
molecule that has the same sequence as a naturally occurring gene is
eligible for a patent because (1) an excised gene is eligible for a patent
as a composition of matter or as an article of manufacture because that DNA
molecule does not occur in that isolated form in nature, or (2) synthetic
DNA preparations are eligible for patents because their purified state is
different from the naturally occurring compound. Patenting compositions or
compounds isolated from nature follows well-established principles, and is
not a new practice. For example, Louis Pasteur received U.S. Patent 141,072
in 1873, claiming `[y]east, free from organic germs of disease, as an
article of manufacture.' Another example is an early patent for adrenaline.
In a decision finding the patent valid, the court explained that compounds
isolated from nature are patentable: `even if it were merely an extracted
product without change, there is no rule that such products are not
patentable. Takamine was the first to make it [adrenaline] available for
any use by removing it from the other gland-tissue in which it was found,
and, while it is of course possible logically to call this a purification
of the principle, it became for every practical purpose a new thing
commercially and therapeutically. That was a good ground for a patent.'
Parke-Davis & Co. v. H. K. Mulford Co., 189 F. 95, 103 (S.D.N.Y. 1911) (J.
Learned Hand).
In a more recent case dealing with the prostaglandins PGE2 and PGE3,
extracted from human or animal prostate glands, a patent examiner had
rejected the claims, reasoning that `inasmuch as the `claimed compounds are
naturally occurring' * * * they therefore `are not 1new' within the
connotation of the patent statute.'' In re Bergstrom, 427 F.2d 1394, 1397,
166 USPQ 256, 259 (CCPA 1970). The Court reversed the Patent Office and
explained the error: `what appellants claimMpure PGE2 and PGE3Mis not
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`naturally occurring.' Those compounds, as far as the record establishes,
do not exist in nature in pure form, and appellants have neither merely
discovered, nor claimed sufficiently broadly to encompass, what has
previously existed in fact in nature's storehouse, albeit unknown, or what
has previously been known to exist.' Id. at 1401, 166 USPQ at 261-62. Like
other chemical compounds, DNA molecules are eligible for patents when
isolated from their natural state and purified or when synthesized in a
laboratory from chemical starting materials.
A patent on a gene covers the isolated and purified gene but does not
cover the gene as it occurs in nature. Thus, the concern that a person
whose body `includes' a patented gene could infringe the patent is
misfounded. The body does not contain the patented, isolated and purified
gene because genes in the body are not in the patented, isolated and
purified form. When the patent issued for purified adrenaline about one
hundred years ago, people did not infringe the patent merely because their
bodies naturally included unpurified adrenaline.
(3) Comment: Several comments suggested that the USPTO should seek
guidance from Congress as to whether naturally occurring genetic sequences
are patentable subject matter. Response: The suggestion is not adopted.
Congress adopted the current statute defining patentable subject matter (35
U.S.C. 101) in 1952. The legislative history indicates that Congress
intended `anything under the sun that is made by man' to be eligible for
patenting. S. Rep. No. 1979, 82d Cong., 2d Sess., 5 (1952); H.R. Rep. No.
1923, 82d Cong., 2d Sess., 6 (1952). The Supreme Court interprets the
statute to cover a `nonnaturally occurring manufacture or composition of
matter-a product of human ingenuity.' Diamond v. Chakrabarty, 447 U.S. 303,
309, 206 USPQ 193, 197 (1980). Thus, the intent of Congress with regard to
patent eligibility for chemical compounds has already been determined: DNA
compounds having naturally occurring sequences are eligible for patenting
when isolated from their natural state and purified, and when the
application meets the statutory criteria for patentability. The genetic
sequence data represented by strings of the letters A, T, C and G alone is
raw, fundamental sequence data, i.e., nonfunctional descriptive
information. While descriptive sequence information alone is not patentable
subject matter, a new and useful purified and isolated DNA compound
described by the sequence is eligible for patenting, subject to satisfying
the other criteria for patentability.
(4) Comment: Several comments state that patents should not issue for
genes because the sequence of the human genome is at the core of what it
means to be human and no person should be able to own/control something so
basic. Other comments stated that patents should be for marketable
inventions and not for discoveries in nature. Response: The comments are
not adopted. Patents do not confer ownership of genes, genetic information,
or sequences. The patent system promotes progress by securing a complete
disclosure of an invention to the public, in exchange for the inventor's
legal right to exclude other people from making, using, offering for sale,
selling, or importing the composition for a limited time. That is, a patent
owner can stop infringing activity by others for a limited time.
Discoveries from nature have led to marketable inventions in the past,
but assessing the marketability of an invention is not pertinent to
determining if an invention has a specific, substantial, and credible use.
`[D]evelopment of a product to the extent that it is presently commercially
salable in the marketplace is not required to establish `usefulness' within
the meaning of § 101.' In re Langer, 503 F.2d 1380, 1393, 183 USPQ 288, 298
(CCPA 1974). Inventors are entitled to patents when they have met the
statutory requirements for novelty, nonobviousness and usefulness, and
their patent disclosure adequately describes the invention and clearly
teaches others how to make and use the invention. The utility requirement,
as explained by the courts, only requires that the inventor disclose a
practical or real world benefit available from the invention, i.e., a
specific, substantial and credible utility. As noted in a response to other
comments, it is a long tradition in the United States that discoveries from
nature which are transfor into new and useful products are eligible for
patents.
(5) Comment: Several comments state that the Guidelines mean that anyone
who discovers a gene will be allowed a broad patent covering any number of
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possible applications even though those uses may be unattainable and
unproven. Therefore, according to these comments, gene patents should not
be issued. Response: The comment is not adopted. When a patent claiming a
new chemical compound issues, the patentee has the right to exclude others
from making, using, offering for sale, selling, or importing the compound
for a limited time. The patentee is required to disclose only one utility,
that is, teach others how to use the invention in at least one way. The
patentee is not required to disclose all possible uses, but promoting the
subsequent discovery of other uses is one of the benefits of the patent
system. When patents for genes are treated the same as for other chemicals,
progress is promoted because the original inventor has the possibility to
recoup research costs, because others are motivated to invent around the
original patent, and because a new chemical is made available as a basis
for future research. Other inventors who develop new and nonobvious methods
of using the patented compound have the opportunity to patent those
methods.
(6) Comment: One comment suggests that the USPTO should not allow the
patenting of ESTs because it is contrary to indigenous law, because the
Supreme Court's Diamond v. Chakrabarty decision was a bare 5-to-4 decision,
because it would violate the Thirteenth Amendment of the U.S. Constitution,
because it violates the novelty requirement of the patent laws, because it
will exacerbate tensions between indigenous peoples and western academic/
research communities and because it will undermine indigenous peoples' own
research and academic institutions. The comment urges the USPTO to
institute a moratorium on patenting of life forms and natural processes.
Response: The comments are not adopted. Patents on chemical compounds such
as ESTs do not implicate the Thirteenth Amendment. The USPTO must
administer the patent statutes as the Supreme Court interprets them. When
Congress enacted 101, it indicated that `anything under the sun that is
made by man' is subject matter for a patent. S. Rep. No. 1979, 82d Cong.,
2d Sess., 5 (1952); H.R. Rep. No. 1923, 82d Cong., 2d Sess., 6 (1952). The
Supreme Court has interpreted 101 many times without overturning it. See,
e.g., Diamond v. Diehr, 450 U.S. 175, 209 USPQ 1 (1981) (discussing cases
construing section 101). Under United States law, a patent applicant is
entitled to a patent when an invention meets the patentability criteria of
title 35. Thus, ESTs which meet the criteria for utility, novelty, and
nonobviousness are eligible for patenting when the application teaches
those of skill in the art how to make and use the invention.
(7) Comment: Several comments state that patents should not issue for
genes because patents on genes are delaying ical research and thus there is
no societal benefit associated with gene patents. Others state that
granting patents on genes at any stage of research deprives others of
incentives and the ability to continue exploratory research and
development. Some comment that patentees will deny access to genes and our
property (our genes) will be owned by others. Response: The comments are
not adopted. The incentive to make discoveries and inventions is generally
spurred, not inhibited, by patents. The disclosure of genetic inventions
provides new opportunities for further development. The patent statutes
provide that a patent must be granted when at least one specific,
substantial and credible utility has been disclosed, and the application
satisfies the other statutory requirements. As long as one specific,
substantial and credible use is disclosed and the statutory requirements
are met, the USPTO is not authorized to withhold the patent until another,
or better, use is discovered. Other researchers may discover higher,
better or more practical uses, but they are advantaged by the starting
point that the original disclosure provides. A patent grants exclusionary
rights over a patented composition but does not grant ownership of the
composition. Patents are not issued on compositions in the natural
environment but rather on isolated and purified compositions.
(8) Comment: Several comments stated that DNA should be
considered unpatentable because a DNA sequence by itself has little
utility. Response: A DNA sequence-i.e., the sequence of base pairs making
up a DNA moleculeMis simply one of the properties of a DNA molecule. Like
any descriptive property, a DNA sequence itself is not patentable. A
purified DNA molecule isolated from its natural environment, on the other
hand, is a chemical compound and is patentable if all the statutory
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requirements are met. An isolated and purified DNA molecule may meet the
statutory utility requirement if, e.g., it can be used to produce a useful
protein or it hybridizes near and serves as a marker for a disease gene.
Therefore, a DNA molecule is not per se unpatentable for lack of utility,
and each application claim must be examined on its own facts.
(9) Comment: One comment states that the disclosure of a DNA sequence
has inherent value and that possible uses for the DNA appear endless, even
if no single use has been worked out. According to the comment, the `basic
social contract of the patent deal' requires that such a discovery should
be patentable, and that patenting should be `value-blind.' Response: The
comment is not adopted. The Supreme Court did not find a similar argument
persuasive in Brenner v. Manson, 383 U.S. 519 (1966). The courts interpret
the statutory term `useful' to require disclosure of at least one available
practical benefit to the public. The Guidelines reflect this determination
by requiring the disclosure of at least one specific, substantial, and
credible utility. If no such utility is disclosed or readily apparent from
an application, the Office should reject the claim. The applicant may rebut
the Office position by showing that the invention does have a specific,
substantial, and credible utility that would have been recognized by one of
skill in the art at the time the application was filed.
(10) Comment: Several comments stated that the scope of patent claims
directed to DNA should be limited to applications or methods of using DNA,
and should not be allowed to encompass the DNA itself. Response: The
comment is not adopted. Patentable subject matter includes both
`process[es]' and `composition[s] of matter.' 35 U.S.C. 101. Patent law
provides no basis for treating DNA differently from other chemical
compounds that are compositions of matter. If a patent application claims a
composition of matter comprising DNA, and the claims meet all the statutory
requirements of patentability, there is no legal basis for rejecting the
application.
(11) Comment: Several comments stated that DNA patent claim scope should
be limited to uses that are disclosed in the patent application and that
allowing patent claims that encompass DNA itself would enable the inventor
to assert claimedms to `speculative' uses of the DNA that were not foreseen
at the time the patent application was filed. Response: The comment is not
adopted. A patent on a composition gives exclusive rights to the
composition for a limited time, even if the inventor disclosed only a
single use for the composition. Thus, a patent granted on an isolated and
purified DNA composition confers the right to exclude others from any
method of using that DNA composition, for up to 20 years from the filing
date. This result flows from the language of the statute itself. When the
utility requirement and other requirements are satisfied by the
application, a patent granted provides a patentee with the right to
exclude others from, inter alia, `using' the patented composition of
matter. See 35 U.S.C. 154. Where a new use is discovered for a patented DNA
composition, that new use may qualify for its own process patent,
notwithstanding that the DNA composition itself is patented.
By statute, a patent is required to disclose one practical utility. If
a well-established utility is readily apparent, the disclosure is deemed to
be implicit. If an application fails to disclose one specific,
substantial, and credible utility, and the examiner discerns no well-
established utility, the examiner will reject the claim under section 101.
The rejection shifts the burden to the applicant to show that the examiner
erred, or that a well-established utility would have been readily apparent
to one of skill in the art. The applicant cannot rebut the rejection by
relying on a utility that would not have been readily apparent at the time
the application was filed. See, e.g., In re Wright, 999 F.2d 1557, 1562-63,
27 USPQ2d 1510, 1514 (Fed. Cir. 1993) (`developments occurring after the
filing date of an application are of no significance regarding what one
skilled in the art believed as of the filing date').
(12) Comment: Several comments stated that DNA should be freely
available for research. Some of these comments suggested that patents are
not necessary to encourage additional discovery and sequencing of genes.
Some comments suggested that patenting of DNA inhibits bioical research by
allowing a single person or company to control use of the claimed DNA.
Another comment expressed concern that patenting ESTs will impede complete
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characterization of genes and delay or restrict exploration of genetic
materials for the public good. Response: The scope of subject matter that
is eligible for a patent, the requirements that must be met in order to be
granted a patent, and the legal rights that are conveyed by an issued
patent, are all controlled by statutes which the USPTO must administer.
`Whoever invents or discovers any new and useful * * * composition of
matter * * * may obtain a patent therefor.' 35 U.S.C. 101. Congress creates
the law and the Federal judiciary interprets the law. The USPTO must
administer the laws as Congress has enacted them and as the Federal
courts have interpreted them. Current law provides that when the statutory
patentability requirements are met, there is no basis to deny patent
applications claiming DNA compositions, or to limit a patent's scope in
order to allow free access to the use of the invention during the patent
term.
(13) Comment: Several comments suggested that DNA sequences should be
considered unpatentable because sequencing DNA has become so routine that
determining the sequence of a DNA molecule is not inventive. Response:
The comments are not adopted. A DNA sequence is not patentable because a
sequence is merely descriptive information about a molecule. An isolated
and purified DNA molecule may be patentable because a molecule is a
`composition of matter,' one of the four classes of invention authorized by
35 U.S.C. 101. A DNA molecule must be nonobvious in order to be patentable.
Obviousness does not depend on the amount of work required to characterize
the DNA molecule. See 35 U.S.C. 103(a) (`Patentability shall not be
negatived by the manner in which the invention was made.'). As the
nonobviousness requirement has been interpreted by the U.S. Court of
Appeals for the Federal Circuit, whether a claimed DNA molecule would have
been obvious depends on whether a molecule having the particular structure
of the DNA would have been obvious to one of ordinary skill in the art at
the time the invention was made. See, e.g., In re Deuel, 51 F.3d 1552,
1559, 34 USPQ2d 1210, 1215 (Fed. Cir. 1995) (`[T]he existence of a general
method of isolating cDNA or DNA molecules is essentially irrelevant to the
question whether the specific molecules themselves would have been
obvious.'); see also, In re Bell, 991 F.2d 781, 26 USPQ2d 1529 (Fed. Cir.
1993).
(14) Comment: One comment suggested that genes ought to be patentable
only when the complete sequence of the gene is disclosed and a function for
the gene product has been determined. Response: The suggestion is not
adopted. To obtain a patent on a chemical compound such as DNA, a patent
applicant must adequately describe the compound and must disclose how to
make and use the compound. 35 U.S.C. 101, 112. `An adequate written
description of a DNA * * * requires a precise definition, such as by
structure, formula, chemical name, or physical properties.' Univ. of
California v. Eli Lilly & Co., 119 F.3d 1559, 1556, 43 USPQ2d 1398, 1404
(Fed. Cir. 1997) (emphasis added, internal quote omitted). Thus, describing
the complete chemical structure, i.e., the DNA sequence, is one method of
describing a DNA molecule but it is not the only method. In addition, the
utility of a claimed DNA does not necessarily depend on the function of the
encoded gene product. A claimed DNA may have a specific and substantial
utility because, e.g., it hybridizes near a disease-associated gene or it
has a gene- regulating activity.
(15) Comment: One comment stated that the specification should `disclose
the invention,' including why the invention works and how it was developed.
Response: The comment is not adopted. The comment is directed more to the
requirements imposed by 35 U.S.C. 112 than to those of 35 U.S.C. 101. To
satisfy the enablement requirement of 35 U.S.C. 112, ¶ 1, an application
must disclose the claimed invention in sufficient detail to enable a person
of ordinary skill in the art to make and use the claimed invention. To
satisfy the written description requirement of 35 U.S.C. 112, ¶ 1, the
description must show that the applicant was in possession of the claimed
invention at the time of filing. If all the requirements under 35 U.S.C.
112, ¶ 1, are met, there is no statutory basis to require disclosure of why
an invention works or how it was developed. `[I]t is not a requirement
of patentability that an inventor correctly set forth, or even know,
how or why the invention works.' Newman v. Quigg, 877 F.2d 1575, 1581, 11
USPQ2d 1340, 1345 (Fed. Cir. 1989).
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(16) Comment: One comment suggested that patents should `allow for
others to learn from and improve the invention.' The comment suggested that
claims to patented plant varieties should not prohibit others from using
the patented plants to develop improved varieties. The comment also stated
that uses of plants in speculative manners should not be permitted.
Response: By statute, a patent provides the patentee with the right to
exclude others from, inter alia, making and using the claimed invention,
although a limited research exemption exists. See 35 U.S.C. 163,
271(a), (e). These statutory provisions are not subject to revision by
the USPTO and are not affected by these Guidelines. Where a plant is
claimed in a utility patent application, compliance with the statutory
requirements for utility under 35 U.S.C. § 101 only requires that a claimed
invention be supported by at least one specific, substantial and credible
utility. It is somewhat rare for academic researchers to be sued by
commercial patent owners for patent infringement. Most inventions are made
available to academic researchers on very favorable licensing terms, which
enable them to continue their research.
(17) Comment: Two comments suggested that although the USPTO has made a
step in the right direction in raising the bar in the Utility Guidelines,
there is still a need to apply stricter standards for utility. Response:
The USPTO is bound by 35 U.S.C. § 101 and the case law interpreting § 101.
The Guidelines reflect the USPTO's understanding of § 101.
(18) Comment: Several comments addressed specific concerns
about the examiner training materials. Response: The comments received with
respect to the training materials will be taken under advisement as the
Office revises the training materials. Except for comments with regard to
whether sequence homology is sufficient to demonstrate a specific and
substantial credible utility, specific concerns about the training
materials will not be addressed herein as they will not impact the language
of the guidelines.
(19) Comment: Several comments suggested that the use of computer-based
analysis of nucleic acids to assign a function to a given nucleic acid
based upon homology to prior art nucleic acids found in databases is highly
unpredictable and cannot form a basis for an assignment of function to a
putatively encoded protein. These comments also indicate that even in
instances where a general functional assignment may be reasonable, the
assignment does not provide information regarding the actual biological
activity of an encoded protein and therefore patent claims drawn to such
nucleic acids should be limited to method of use claims that are explicitly
supported by the as-filed specification(s). These comments also state that
if homology-based utilities are acceptable, then the nucleic acids, and
proteins encoded thereby, should be considered as obvious over the prior
art nucleic acids. On the other hand, one comment stated that homology is
a standard, art- accepted basis for predicting utility, while another
comment stated that any level of homology to a protein with known utility
should be accepted as indicative of utility. Response: The suggestions to
adopt a per se rule rejecting homology-based assertions of utility are not
adopted. An applicant is entitled to a patent to the subject matter claimed
unless statutory requirements are not met (35 U.S.C. § 101, 102, 103, 112).
When the USPTO denies a patent, the Office must set forth at least a
prima facie case as to why an applicant has not met the statutory
requirements. The inquiries involved in assessing utility are fact
dependent, and the determinations must be made on the basis of scientific
evidence. Reliance on the commenters' per se rule, rather than a fact
dependent inquiry, is impermissible because the commenters provide no
scientific evidence that homology-based assertions of utility are
inherently unbelievable or involve implausible scientific principles. See,
e.g., In re Brana, 51 F.3d 1560, 1566, 34 USPQ2d 1436, 1441 (Fed. Cir.
1995) (rejection of claims improper where claims did `not suggest an
inherently unbelievable undertaking or involve implausible scientific
principles' and where `prior art * * * discloses structurally similar
compounds to those claimed by the applicants which have been proven * * *
to be effective').
A patent examiner must accept a utility asserted by an applicant unless
the Office has evidence or sound scientific reasoning to rebut the
assertion. The examiner's decision must be supported by a preponderance of
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all the evidence of record. In re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d
1443, 1444 (Fed. Cir. 1992). More specifically, when a patent application
claiming a nucleic acid asserts a specific, substantial, and credible
utility, and bases the assertion upon homology to existing nucleic acids or
proteins having an accepted utility, the asserted utility must be accepted
by the examiner unless the Office has sufficient evidence or sound
scientific reasoning to rebut such an assertion. `[A] `rigorous
correlation' need not be shown in order to establish practical utility;
`reasonable correlation' is sufficient.' Fujikawa v. Wattanasin, 93
F.3d 1559, 1565, 39 USPQ2d 1895, 1900 (Fed. Cir. 1996). The Office will
take into account both the nature and degree of the homology.
When a class of proteins is defined such that the members share a
specific, substantial, and credible utility, the reasonable assignment
of a new protein to the class of sufficiently conserved proteins would
impute the same specific, substantial, and credible utility to the
assigned protein. If the preponderance of the evidence of record, or of
sound scientific reasoning, casts doubt upon such an asserted utility,
the examiner should reject the claim for lack of utility under 35
U.S.C. § 101. For example, where a class of proteins is defined by common
structural features, but evidence shows that the members of the class
do not share a specific, substantial functional attribute or utility,
despite having structural features in common, membership in the class
may not impute a specific, substantial, and credible utility to a new
member of the class. When there is a reason to doubt the functional
protein assignment, the utility examination may turn to whether or not
the asserted protein encoded by a claimed nucleic acid has a well-
established use. If there is a well-established utility for the protein
and the claimed nucleic acid, the claim would meet the requirements for
utility under 35 U.S.C. § 101. If not, the burden shifts to the applicant
to provide evidence supporting a well-established utility. There is no
per se rule regarding homology, and each application must be
judged on its own merits.
The comment indicating that if a homology-based utility could meet the
requirements set forth under 35 U.S.C. § 101, then the invention would
have been obvious, is not adopted. Assessing nonobviousness under 35
U.S.C. 103 is separate from analyzing the utility requirements under 35
U.S.C. § 101. When a claim to a nucleic acid supported by a homology-based
utility meets the utility requirement of section § 101, it does not follow
that the claimed nucleic acid would have been prima facie obvious over the
nucleic acids to which it is homologous. `[S]ection 103 requires a fact-
intensive comparison of the [claim] with the prior art rather than the
mechanical application of one or another per se rule.' In re Ochiai,
71 F.3d 1565, 1571, 37 USPQ2d 1127, 1132 (Fed. Cir. 1995). Nonobviousness
must be determined according to the analysis in Graham v. John Deere, 383
U.S. 1, 148 USPQ 459 (1966). See also, In re Dillon, 919 F.2d 688, 692, 16
USPQ2d 1897, 1901 (Fed. Cir. 1990) (in banc) (`structural similarity
between claimed and prior art subject matter, * * * where the prior art
gives reason or motivation to make the claimed compositions, creates a
prima facie case of obviousness') (emphasis added). Where `the prior art
teaches a specific, structurally-definable compound [] the question becomes
whether the prior art would have suggested making the specific molecular
modifications necessary to achieve the claimed invention.' In re Deuel, 51
F.3d 1552, 1558, 34 USPQ2d 1210, 1214 (Fed. Cir. 1995).
(20) Comment: Several comments indicated that in situations
where a well-established utility is relied upon for compliance with 35
U.S.C. § 101, the record should reflect what that utility is. One comment
stated that the record should reflect whether the examiner accepted an
asserted utility or relied upon a well-established utility after
dismissing all asserted utilities. Another comment stated that when the
examiner relies on a well-established utility not explicitly asserted
by the applicant, the written record should clearly identify this
utility and the rationale for considering it specific and substantial.
Response: The comments are not adopted. Only one specific,
substantial and credible utility is required to satisfy the statutory
requirement. Where one or more well-established utilities would have
been readily apparent to those of skill in the art at the time of the
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invention, an applicant may rely on any one of those utilities without
prejudice. The record of any issued patent typically reflects
consideration of a number of references in the prior art that the
applicant or the examiner considered material to the claimed invention.
These references often indicate uses for related inventions, and any
patents listed typically disclose utilities for related inventions.
Thus, even when the examiner does not identify a well-established
utility, the record as a whole will likely disclose readily apparent
utilities. Just as the examiner without comment may accept a properly
asserted utility, there is no need for an examiner to comment on the
existence of a well-established utility. However, the Guidelines have
been revised to clarify that a well-established utility is a specific,
substantial, and credible utility that must be readily apparent to one
skilled in the art. Most often, the closest prior art cited and applied
in the course of examining the application will demonstrate a well-
established utility for the invention.
(21) Comment: Several comments stated that the Guidelines erroneously
burden the examiner with proving that a person of skill in the art would
not be aware of a well-established utility. One comment states that this
requires the examiner to prove a negative. Another comment states that the
Guidelines should direct examiners that if a specific utility has not been
disclosed, the applicant should be required to identify a specific utility.
Response: The comments have been adopted in part. The Guidelines have been
revised to indicate that where the applicant has not asserted a specific,
substantial, and credible utility, and the examiner does not perceive a
well-established utility, a rejection under §101 should be entered.
That is, if a well-established utility is not readily apparent and an
invention is not otherwise supported by an asserted specific, substantial,
and credible utility, the burden will be shifted to applicant to show
either that the specification discloses an adequate utility, or to show
that a well-established utility exists for the claimed invention. Again,
most often the search of the closest prior art will reveal whether there is
a well-established utility for the claimed invention.
(22) Comment: Several comments suggested that further clarification was
required with regard to the examiner's determination that there is an
adequate nexus between a showing supporting a well-established utility and
the application as filed. The comments indicated that the meaning of this
`nexus' was unclear. Response: The Guidelines have been modified to reflect
that evidence provided by an applicant is to be analyzed with regard to a
concordance between the showing and the full scope and content of the
claimed invention as disclosed in the application as filed. In situations
where the showing provides adequate evidence that the claim is supported by
at least one asserted specific, substantial, and credible or well-
established utility, the rejections under 35 U.S.C. § 101 and 112, first
paragraph, will be withdrawn. However, the examiner is instructed to
consider whether or not the specification, in light of applicant's showing,
is enabled for the use of the full scope of the claimed invention. Many
times prior patents and printed publications provided by applicant will
clearly demonstrate that a well-established utility exists.
(23) Comment: One comment states that the Office is using an improper
standard in assessing `specific' utility. According to the comment, a
distinction between `specific' and `general' utilities is an overreaching
interpretation of the specificity requirement in the case law because
`unique' or `particular' utilities have never been required by the law. The
comment states that the specificity requirement concerns sufficiency of
disclosure, i.e., teaching how to make and use a claimed invention, not
the utility requirement. The comment states that the specificity
requirement is to be distinguished from the `substantial' utility
requirement, and that the Brenner v. Manson decision concerned only a
`substantial' utility issue, not specificity. Response: The comment is not
adopted. The disclosure of only a general utility rather than a particular
utility is insufficient to meet statutory requirements. Although the
specificity requirement is relevant to § 112, it is not severable from the
utility requirement.
[S]urely Congress intended § 112 to pre-suppose full satisfaction of the
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requirements of § 101. Necessarily, compliance with § 112 requires a
description of how to use presently useful inventions, otherwise an
applicant would anomalously be required to teach how to use a useless
invention. As this court stated in Diederich, quoting with approval from
the decision of the board:
`We do not believe that it was the intention of the statutes to require
the Patent Office, the courts, or the public to play the sort of guessing
game that might be involved if an applicant could satisfy the requirements
of the statutes by indicating the usefulness of a claimed compound in terms
of possible use so general as to be meaningless and then, after his
research or that of his competitors has definitely ascertained an actual
use for the compound, adducing evidence intended to show that a particular
specific use would have been obvious to men skilled in the particular art
to which this use relates.' As the Supreme Court said in Brenner v. Manson:
`* * * a patent is not a hunting license. It is not a reward for the
search, but compensation for its successful conclusion.'
In re Kirk, 376 F.2d 936, 942, 153 USPQ 48, 53 (CCPA 1967) (affirming
rejections under § 101 and 112) (emphasis in original).
II. Guidelines for Examination of Applications for Compliance With the
Utility Requirement
A. Introduction
The following Guidelines establish the policies and procedures to be
followed by Office personnel in the evaluation of any patent application
for compliance with the utility requirements of 35 U.S.C. § 101 and 112.
These Guidelines have been promulgated to assist Office personnel in their
review of applications for compliance with the utility requirement. The
Guidelines do not alter the substantive requirements of 35 U.S.C. § 101 and
112, nor are they designed to obviate the examiner's review of applications
for compliance with all other statutory requirements for patentability. The
Guidelines do not constitute substantive rulemaking and hence do not have
the force and effect of law. Rejections will be based upon the substantive
law, and it is these rejections which are appealable. Consequently, any
perceived failure by Office personnel to follow these Guidelines is neither
appealable nor petitionable.
B. Examination Guidelines for the Utility Requirement
Office personnel are to adhere to the following procedures when
reviewing patent applications for compliance with the `useful invention'
(`utility') requirement of 35 U.S.C. § 101 and 112, first paragraph.
1. Read the claims and the supporting written description.
(a) Determine what the applicant has claimed, noting any specific
embodiments of the invention.
(b) Ensure that the claims define statutory subject matter (i.e., a
process, machine, manufacture, composition of matter, or improvement
thereof).
(c) If at any time during the examination, it becomes readily apparent
that the claimed invention has a well-established utility, do not impose a
rejection based on lack of utility. An invention has a well-established
utility (1) if a person of ordinary skill in the art would immediately
appreciate why the invention is useful based on the characteristics of the
invention (e.g., properties or applications of a product or process), and
(2) the utility is specific, substantial, and credible.
2. Review the claims and the supporting written description to
determine if the applicant has asserted for the claimed invention any
specific and substantial utility that is credible:
(a) If the applicant has asserted that the claimed invention is useful
for any particular practical purpose (i.e., it has a ``specific and
substantial utility') and the assertion would be considered credible by a
person of ordinary skill in the art, do not impose a rejection based on
lack of utility.
(1) A claimed invention must have a specific and substantial utility.
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This requirement excludes `throw-away,' `insubstantial,' or `nonspecific'
utilities, such as the use of a complex invention as landfill, as a way of
satisfying the utility requirement of 35 U.S.C. § 101.
(2) Credibility is assessed from the perspective of one of ordinary
skill in the art in view of the disclosure and any other evidence of
record (e.g., test data, affidavits or declarations from
experts in the art, patents or printed publications) that is probative
of the applicant's assertions. An applicant need only provide one
credible assertion of specific and substantial utility for each claimed
invention to satisfy the utility requirement.
(b) If no assertion of specific and substantial utility for the claimed
invention made by the applicant is credible, and the claimed invention
does not have a readily apparent well-established utility, reject the
claim(s) under § 101 on the grounds that the invention as claimed
lacks utility. Also reject the claims under § 112, first paragraph, on
the basis that the disclosure fails to teach how to use the invention
as claimed. The s 112, first paragraph, rejection imposed in
conjunction with a § 101 rejection should incorporate by reference the
grounds of the corresponding §101 rejection.
(c) If the applicant has not asserted any specific and substantial
utility for the claimed invention and it does not have a readily apparent
well-established utility, impose a rejection under § 101, emphasizing that
the applicant has not disclosed a specific and substantial utility for the
invention. Also impose a separate rejection under § 112, first paragraph,
on the basis that the applicant has not disclosed how to use the invention
due to the lack of a specific and substantial utility. The § 101 and 112
rejections shift the burden of coming forward with evidence to the
applicant to:
(1) Explicitly identify a specific and substantial utility for the
claimed invention; and
(2) Provide evidence that one of ordinary skill in the art would have
recognized that the identified specific and substantial utility was
well established at the time of filing. The examiner should review any
subsequently submitted evidence of utility using the criteria outlined
above. The examiner should also ensure that there is an adequate nexus
between the evidence and the properties of the now claimed subject
matter as disclosed in the application as filed. That is, the applicant
has the burden to establish a probative relation between the submitted
evidence and the originally disclosed properties of the claimed
invention.
3. Any rejection based on lack of utility should include a detailed
explanation why the claimed invention has no specific and substantial
credible utility. Whenever possible, the examiner should provide
documentary evidence regardless of publication date (e.g., scientific or
technical journals, excerpts from treatises or books, or U.S. or foreign
patents) to support the factual basis for the prima facie showing of no
specific and substantial credible utility. If documentary evidence is not
available, the examiner should specifically explain the scientific basis
for his or her factual conclusions.
(a) Where the asserted utility is not specific or substantial, a
prima facie showing must establish that it is more likely than not that a
person of ordinary skill in the art would not consider that any utility
asserted by the applicant would be specific and substantial. The prima
facie showing must contain the following elements:
(1) An explanation that clearly sets forth the reasoning used in
concluding that the asserted utility for the claimed invention is not
both specific and substantial nor well-established;
(2) Support for factual findings relied upon in reaching this
conclusion; and
(3) An evaluation of all relevant evidence of record, including
utilities taught in the closest prior art.
(b) Where the asserted specific and substantial utility is not
credible, a prima facie showing of no specific and substantial credible
utility must establish that it is more likely than not that a person
skilled in the art would not consider credible any specific and substantial
utility asserted by the applicant for the claimed invention.
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The prima facie showing must contain the following elements:
(1) An explanation that clearly sets forth the reasoning used in
concluding that the asserted specific and substantial utility is not
credible;
(2) Support for factual findings relied upon in reaching this
conclusion; and
(3) An evaluation of all relevant evidence of record, including
utilities taught in the closest prior art.
(c) Where no specific and substantial utility is disclosed or is
well-established, a prima facie showing of no specific and substantial
utility need only establish that applicant has not asserted a utility and
that, on the record before the examiner, there is no known well- stablished
utility.
4. A rejection based on lack of utility should not be maintained if an
asserted utility for the claimed invention would be considered
specific, substantial, and credible by a person of ordinary skill in
the art in view of all evidence of record. Office personnel are
reminded that they must treat as true a statement of fact made by an
applicant in relation to an asserted utility, unless countervailing
evidence can be provided that shows that one of ordinary skill in the
art would have a legitimate basis to doubt the credibility of such a
statement. Similarly, Office personnel must accept an opinion from a
qualified expert that is based upon relevant facts whose accuracy is
not being questioned; it is improper to disregard the opinion solely
because of a disagreement over the significance or meaning of the facts
offered.
Once a prima facie showing of no specific and substantial credible
utility has been properly established, the applicant bears the burden of
rebutting it. The applicant can do this by amending the claims, by
providing reasoning or arguments, or by providing evidence in the form of
a declaration under 37 CFR 1.132 or a patent or a printed publication that
rebuts the basis or logic of the prima facie showing. If the applicant
responds to the prima facie rejection, the Office personnel should review
the original disclosure, any evidence relied upon in establishing the prima
facie showing, any claim amendments, and any new reasoning or evidence
provided by the applicant in support of an asserted specific and
substantial credible utility. It is essential for Office personnel
to recognize, fully consider and respond to each substantive element of
any response to a rejection based on lack of utility. Only where the
totality of the record continues to show that the asserted utility is
not specific, substantial, and credible should a rejection based on
lack of utility be maintained.
If the applicant satisfactorily rebuts a prima facie rejection based on
lack of utility under § 101, withdraw the § 101 rejection and the
corresponding rejection imposed under § 112, first paragraph.
December 29, 2000 Q. TODD DICKINSON
Under Secretary of Commerce for Intellectual
Property and Director of the United States
Patent and Trademark Office
[1242 OG 162]