[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