[Federal Register Volume 66, Number 4 (Friday, January 5, 2001)]
[Notices]
[Pages 1092-1099]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-322]
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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.
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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
``[email protected],'' 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 ``[email protected],'' 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, para.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,
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.
[[Page 1093]]
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, or any 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 `new' 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 claim--pure PGE2 and
PGE3--is not `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
[[Page 1094]]
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 Sec. 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 transformed 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 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 Sec. 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 Sec. 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 medical 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 molecule--is 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 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
[[Page 1095]]
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 claims 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
biomedical 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 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, para. 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, para. 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, para.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,
[[Page 1096]]
877 F.2d 1575, 1581, 11 USPQ2d 1340, 1345 (Fed. Cir. 1989).
(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 Sec. 101. The Guidelines reflect the USPTO's understanding
of Sec. 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 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
[[Page 1097]]
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 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 Sec. 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 Sec. 112, it is not severable from the utility requirement.
[S]urely Congress intended Sec. 112 to pre-suppose full
satisfaction of the requirements of Sec. 101. Necessarily,
compliance with Sec. 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 Secs. 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
[[Page 1098]]
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. 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 Sec. 101 on the grounds that the invention as
claimed lacks utility. Also reject the claims under Sec. 112, first
paragraph, on the basis that the disclosure fails to teach how to use
the invention as claimed. The Sec. 112, first paragraph, rejection
imposed in conjunction with a Sec. 101 rejection should incorporate by
reference the grounds of the corresponding Sec. 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 Sec. 101,
emphasizing that the applicant has not disclosed a specific and
substantial utility for the invention. Also impose a separate rejection
under Sec. 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 Secs. 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.
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-
established 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
[[Page 1099]]
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 Sec. 101, withdraw the Sec. 101
rejection and the corresponding rejection imposed under Sec. 112, first
paragraph.
Dated: December 29, 2000.
Q. Todd Dickinson,
Under Secretary of Commerce for Intellectual Property and Director of
the United States Patent and Trademark Office.
[FR Doc. 01-322 Filed 1-4-01; 8:45 am]
BILLING CODE 3510-16-U