1092 Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Notices

DEPARTMENT OF COMMERCE

National Oceanic and Atmospheric

Administration

Fair Market Value Analysis for a Fiber

Optic Cable Permit in National Marine

Sanctuaries

AGENCY: Office of National Marine

Sanctuaries (ONMS), National Ocean

Service (NOS), National Oceanic and

Atmospheric Administration (NOAA),

Department of Commerce (DOC).

ACTION: Notice of availability.

SUMMARY: Notice is hereby given that

NOAA is requesting comments on the

report ‘‘Fair Market Value Analysis for

a Fiber Optic Cable Permit in National

Marine Sanctuaries’’ and two peer

reviews of this report. The report and

peer reviews are available for download

at http://www.sanctuaries.nos.noaa.gov/

news/newsbboard/newsbboard.html or

by requesting an electronic or hard

copy. Requests can be made by sending

an email to submarine.cables@noaa.gov

(subject line ‘‘Request for Fair Market

Value Analysis’’) or by calling Matt

Brookhart at (301) 713–3125 x140.

DATES: Comments on this notice must be

received by January 18, 2001.

ADDRESSES: Address all comments

regarding this notice to Matt Brookhart,

Conservation Policy and Planning

Branch, Office of National Marine

Sanctuaries, 1305 East-West Highway,

11th Floor, Silver Spring, MD 20910,

Attention: Fair Market Value Analysis.

Comments may also be submitted by

email to: submarine.cables@noaa.gov,

subject line ‘‘Fair Market Value

Analysis.’’

FOR FURTHER INFORMATION CONTACT:

Helen Golde, (301) 713–3125 x152.

SUPPLEMENTARY INFORMATION: The Office

of National Marine Sanctuaries has

issued several special-use permits to

companies seeking to install fiber optic

cables in National Marine Sanctuaries.

The Sanctuary statute allows ONMS to

permit the presence of cables on the

sanctuaries’ seafloor should it decide to

do so. If an application is approved,

ONMS may collect certain

administrative and monitoring fees. In

addition, ONMS is entitled to receive

fair market value for the permitted use

of sanctuary resources.

The report ‘‘Fair Market Value

Analysis for a Fiber Optic Cable Permit

in National Marine Sanctuaries’’

presents an assessment of fair market

value for the use of National Marine

Sanctuary resources for a fiber optic

cable. Proper stewardship of sanctuary

resources and open and equitable

relations with telecommunication

industry interests require a clear and

consistent policy in this matter. The

content of this report is based on dozens

of industry and government sources and

draws on the collaboration and review

of numerous experts in the business,

legal and technical arenas.

Once finalized, the fee structure

proposed in this report will be used to

assess fees (as stated in their respective

special use permits) for cables already

installed in the Olympic Coast and

Stellwagen Bank National Marine

Sanctuaries. In addition, this structure

will provide the basis for future fair

market value assessment of submarine

cable permit applications in National

Marine Sanctuaries. Comments on the

report and peer reviews should focus on

the methodology employed and the

conclusions that it reached.

Dated: December 29, 2000.

John Oliver,

Chief Financial Officer, National Ocean

Service.

[FR Doc. 01–387 Filed 1–4–01; 8:45 am]

BILLING CODE 3510–08–P

DEPARTMENT OF COMMERCE

United States Patent and Trademark

Office

[Docket No. 991027289–0263–02]

RIN 0651–AB09

Utility Examination Guidelines

AGENCY: United States Patent and

Trademark Office, Commerce.

ACTION: Notice.

SUMMARY: The United States Patent and

Trademark Office (USPTO) is

publishing a revised version of

guidelines to be used by Office

personnel in their review of patent

applications for compliance with the

‘‘utility’’ requirement of 35 U.S.C. 101.

This revision supersedes the Revised

Interim Utility Examination Guidelines

that were published at 64 FR 71440,

Dec. 21, 1999; 1231 O.G. 136 (2000); and

correction at 65 FR 3425, Jan. 21, 2000;

1231 O.G. 67 (2000).

DATES: The Guidelines are effective as of

January 5, 2001.

FOR FURTHER INFORMATION CONTACT:

Mark Nagumo by telephone at (703)

305–8666, by facsimile at (703) 305–

9373, by electronic mail at

‘‘mark.nagumo@uspto.gov,’’ or by mail

marked to his attention addressed to the

Office of the Solicitor, Box 8,

Washington, DC 20231; or Linda

Therkorn by telephone at (703) 305–

9323, by facsimile at (703) 305–8825, by

electronic mail at

‘‘linda.therkorn@uspto.gov,’’ or by mail

marked to her attention addressed to

Box Comments, Commissioner for

Patents, Washington, DC 20231.

SUPPLEMENTARY INFORMATION: As of the

publication date of this notice, these

Guidelines will be used by USPTO

personnel in their review of patent

applications for compliance with the

‘‘utility’’ requirement of 35 U.S.C. 101.

Because these Guidelines only govern

internal practices, they are exempt from

notice and comment rulemaking under

5 U.S.C. 553(b)(A).

I. Discussion of Public Comments

The Revised Interim Utility

Examination Guidelines published at 64

FR 71440, Dec. 21, 1999; 1231 O.G. 136,

Feb. 29, 2000, with a correction at 65 FR

3425, Jan. 21, 2000; 1231 O.G. 67, Feb.

15, 2000, requested comments from the

public. Comments were received from

35 individuals and 17 organizations.

The written comments have been

carefully considered.

Overview of Comments

The majority of comments generally

approved of the guidelines and several

expressly stated support for the three

utility criteria (specific, substantial, and

credible) set forth in the Guidelines. A

few comments addressed particular

concerns with respect to the coordinate

examiner training materials that are

available for public inspection at the

USPTO website, www.uspto.gov. The

comments on the training materials will

be taken under advisement in the

revision of the training materials.

Consequently, those comments are not

specifically addressed below because

they do not impact the content of the

Guidelines. Comments received in

response to the request for comments on

the ‘‘Revised Interim Guidelines for

Examination of Patent Applications

Under the 35 U.S.C. 112, ¶1 ‘Written

Description’ Requirement,’’ 64 FR

71427, Dec. 21, 1999; 1231 O.G. 123,

Feb. 29, 2000, which raised issues

pertinent to the utility requirement are

also addressed below.

Responses to Specific Comments

(1) Comment: Several comments state

that while inventions are patentable,

discoveries are not patentable.

According to the comments, 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.

Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Notices 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 wellestablished 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.’’ ParkeDavis & 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

1094 Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Notices

the composition for a limited time. That

is, a patent owner can stop infringing

activity by others for a limited time.

Discoveries from nature have led to

marketable inventions in the past, but

assessing the marketability of an

invention is not pertinent to

determining if an invention has a

specific, substantial, and credible use.

‘‘[D]evelopment of a product to the

extent that it is presently commercially

salable in the marketplace is not

required to establish ‘usefulness’ within

the meaning of § 101.’’ In re Langer, 503

F.2d 1380, 1393, 183 USPQ 288, 298

(CCPA 1974). Inventors are entitled to

patents when they have met the

statutory requirements for novelty,

nonobviousness and usefulness, and

their patent disclosure adequately

describes the invention and clearly

teaches others how to make and use the

invention. The utility requirement, as

explained by the courts, only requires

that the inventor disclose a practical or

real world benefit available from the

invention, i.e., a specific, substantial

and credible utility. As noted in a

response to other comments, it is a long

tradition in the United States that

discoveries from nature which are

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 § 101, it

indicated that ‘‘anything under the sun

that is made by man’’ is subject matter

for a patent. S. Rep. No. 1979, 82d

Cong., 2d Sess., 5 (1952); H.R. Rep. No.

1923, 82d Cong., 2d Sess., 6 (1952). The

Supreme Court has interpreted § 101

many times without overturning it. See,

e.g., Diamond v. Diehr, 450 U.S. 175,

209 USPQ 1 (1981) (discussing cases

construing section 101). Under United

States law, a patent applicant is entitled

to a patent when an invention meets the

patentability criteria of title 35. Thus,

ESTs which meet the criteria for utility,

novelty, and nonobviousness are

eligible for patenting when the

application teaches those of skill in the

art how to make and use the invention.

(7) Comment: Several comments state

that patents should not issue for genes

because patents on genes are delaying

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

Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Notices 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 wellestablished 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, ¶ 1, an

application must disclose the claimed

invention in sufficient detail to enable

a person of ordinary skill in the art to

make and use the claimed invention. To

satisfy the written description

requirement of 35 U.S.C. 112, ¶ 1, the

description must show that the

applicant was in possession of the

claimed invention at the time of filing.

If all the requirements under 35 U.S.C.

112, ¶1, are met, there is no statutory

basis to require disclosure of why an

invention works or how it was

developed. ‘‘[I]t is not a requirement of

patentability that an inventor correctly

set forth, or even know, how or why the

invention works.’’ Newman v. Quigg,

1096 Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Notices

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 § 101. The

Guidelines reflect the USPTO’s

understanding of § 101.

(18) Comment: Several comments

addressed specific concerns about the

examiner training materials. Response:

The comments received with respect to

the training materials will be taken

under advisement as the Office revises

the training materials. Except for

comments with regard to whether

sequence homology is sufficient to

demonstrate a specific and substantial

credible utility, specific concerns about

the training materials will not be

addressed herein as they will not impact

the language of the guidelines.

(19) Comment: Several comments

suggested that the use of computerbased 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 homologybased 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 wellestablished use. If there is a wellestablished 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

Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Notices 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 wellestablished utility for the invention.

(21) Comment: Several comments

stated that the Guidelines erroneously

burden the examiner with proving that

a person of skill in the art would not be

aware of a well-established utility. One

comment states that this requires the

examiner to prove a negative. Another

comment states that the Guidelines

should direct examiners that if a

specific utility has not been disclosed,

the applicant should be required to

identify a specific utility. Response: The

comments have been adopted in part.

The Guidelines have been revised to

indicate that where the applicant has

not asserted a specific, substantial, and

credible utility, and the examiner does

not perceive a well-established utility, a

rejection under § 101 should be entered.

That is, if a well-established utility is

not readily apparent and an invention is

not otherwise supported by an asserted

specific, substantial, and credible

utility, the burden will be shifted to

applicant to show either that the

specification discloses an adequate

utility, or to show that a wellestablished 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 wellestablished utility exists.

(23) Comment: One comment states

that the Office is using an improper

standard in assessing ‘‘specific’’ utility.

According to the comment, a distinction

between ‘‘specific’’ and ‘‘general’’

utilities is an overreaching

interpretation of the specificity

requirement in the case law because

‘‘unique’’ or ‘‘particular’’ utilities have

never been required by the law. The

comment states that the specificity

requirement concerns sufficiency of

disclosure, i.e., teaching how to make

and use a claimed invention, not the

utility requirement. The comment states

that the specificity requirement is to be

distinguished from the ‘‘substantial’’

utility requirement, and that the

Brenner v. Manson decision concerned

only a ‘‘substantial’’ utility issue, not

specificity. Response: The comment is

not adopted. The disclosure of only a

general utility rather than a particular

utility is insufficient to meet statutory

requirements. Although the specificity

requirement is relevant to § 112, it is not

severable from the utility requirement.

[S]urely Congress intended § 112 to presuppose full satisfaction of the requirements

of § 101. Necessarily, compliance with § 112

requires a description of how to use presently

useful inventions, otherwise an applicant

would anomalously be required to teach how

to use a useless invention. As this court

stated in Diederich, quoting with approval

from the decision of the board:

‘We do not believe that it was the intention

of the statutes to require the Patent Office,

the courts, or the public to play the sort of

guessing game that might be involved if an

applicant could satisfy the requirements of

the statutes by indicating the usefulness of a

claimed compound in terms of possible use

so general as to be meaningless and then,

after his research or that of his competitors

has definitely ascertained an actual use for

the compound, adducing evidence intended

to show that a particular specific use would

have been obvious to men skilled in the

particular art to which this use relates.’ As

the Supreme Court said in Brenner v.

Manson:

‘* * * a patent is not a hunting license. It

is not a reward for the search, but

compensation for its successful conclusion.’

In re Kirk, 376 F.2d 936, 942, 153

USPQ 48, 53 (CCPA 1967) (affirming

rejections under §§ 101 and 112)

(emphasis in original).

II. Guidelines for Examination of

Applications for Compliance With the

Utility Requirement

A. Introduction

The following Guidelines establish

the policies and procedures to be

followed by Office personnel in the

evaluation of any patent application for

compliance with the utility

requirements of 35 U.S.C. 101 and 112.

These Guidelines have been

promulgated to assist Office personnel

in their review of applications for

compliance with the utility

1098 Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Notices

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 wellestablished utility, reject the claim(s)

under § 101 on the grounds that the

invention as claimed lacks utility. Also

reject the claims under § 112, first

paragraph, on the basis that the

disclosure fails to teach how to use the

invention as claimed. The § 112, first

paragraph, rejection imposed in

conjunction with a § 101 rejection

should incorporate by reference the

grounds of the corresponding § 101

rejection.

(c) If the applicant has not asserted

any specific and substantial utility for

the claimed invention and it does not

have a readily apparent well-established

utility, impose a rejection under § 101,

emphasizing that the applicant has not

disclosed a specific and substantial

utility for the invention. Also impose a

separate rejection under § 112, first

paragraph, on the basis that the

applicant has not disclosed how to use

the invention due to the lack of a

specific and substantial utility. The

§§ 101 and 112 rejections shift the

burden of coming forward with

evidence to the applicant to:

(1) Explicitly identify a specific and

substantial utility for the claimed

invention; and

(2) Provide evidence that one of

ordinary skill in the art would have

recognized that the identified specific

and substantial utility was well

established at the time of filing. The

examiner should review any

subsequently submitted evidence of

utility using the criteria outlined above.

The examiner should also ensure that

there is an adequate nexus between the

evidence and the properties of the now

claimed subject matter as disclosed in

the application as filed. That is, the

applicant has the burden to establish a

probative relation between the

submitted evidence and the originally

disclosed properties of the claimed

invention.

3. Any rejection based on lack of

utility should include a detailed

explanation why the claimed invention

has no specific and substantial credible

utility. Whenever possible, the examiner

should provide documentary evidence

regardless of publication date (e.g.,

scientific or technical journals, excerpts

from treatises or books, or U.S. or

foreign patents) to support the factual

basis for the prima facie showing of no

specific and substantial credible utility.

If documentary evidence is not

available, the examiner should

specifically explain the scientific basis

for his or her factual conclusions.

(a) Where the asserted utility is not

specific or substantial, a prima facie

showing must establish that it is more

likely than not that a person of ordinary

skill in the art would not consider that

any utility asserted by the applicant

would be specific and substantial. The

prima facie showing must contain the

following elements:

(1) An explanation that clearly sets

forth the reasoning used in concluding

that the asserted utility for the claimed

invention is not both specific and

substantial nor well-established;

(2) Support for factual findings relied

upon in reaching this conclusion; and

(3) An evaluation of all relevant

evidence of record, including utilities

taught in the closest prior art.

(b) Where the asserted specific and

substantial utility is not credible, a

prima facie showing of no specific and

substantial credible utility must

establish that it is more likely than not

that a person skilled in the art would

not consider credible any specific and

substantial utility asserted by the

applicant for the claimed invention.

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 wellestablished, 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

Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Notices 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 § 101, withdraw the § 101

rejection and the corresponding

rejection imposed under § 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

DEPARTMENT OF COMMERCE

United States Patent and Trademark

Office

[Docket No. 991027288–0264–02]

RIN 0651–AB10

Guidelines for Examination of Patent

Applications Under the 35 U.S.C. 112,

¶ 1, ‘‘Written Description’’ Requirement

AGENCY: United States Patent and

Trademark Office, Commerce.

ACTION: Notice.

SUMMARY: These Guidelines will be used

by USPTO personnel in their review of

patent applications for compliance with

the ‘‘written description’’ requirement

of 35 U.S.C. 112, ¶ 1. These Guidelines

supersede the ‘‘Revised Interim

Guidelines for Examination of Patent

Applications Under the 35 U.S.C. 112,

¶ 1 ‘Written Description’ Requirement’’

that were published in the Federal

Register at 64 FR 71427, Dec. 21, 1999,

and in the Official Gazette at 1231 O.G.

123, Feb. 29, 2000. These Guidelines

reflect the current understanding of the

USPTO regarding the written

description requirement of 35 U.S.C.

112, ¶ 1, and are applicable to all

technologies.

DATES: The Guidelines are effective as of

January 5, 2001.

FOR FURTHER INFORMATION CONTACT:

Stephen Walsh by telephone at (703)

305–9035, by facsimile at (703) 305–

9373, by mail to his attention addressed

to United States Patent and Trademark

Office, Box 8, Washington, DC 20231, or

by electronic mail at

‘‘stephen.walsh@uspto.gov’’; or Linda

Therkorn by telephone at (703) 305–

8800, by facsimile at (703) 305–8825, by

mail addressed to Box Comments,

Commissioner for Patents, Washington,

DC 20231, or by electronic mail at

‘‘linda.therkorn@uspto.gov.’’

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

‘‘written description’’ requirement of 35

U.S.C. 112, ¶ 1. Because these

Guidelines only govern internal

practices, they are exempt from notice

and comment rulemaking under 5

U.S.C. 553(b)(A).

Discussion of Public Comments

Comments were received from 48

individuals and 18 organizations in

response to the request for comments on

the ‘‘Revised Interim Guidelines for

Examination of Patent Applications

Under the 35 U.S.C. 112, ¶ 1 ‘Written

Description’ Requirement’’ published in

the Federal Register at 64 FR 71427,

Dec. 21, 1999, and in the Official

Gazette at 1231 O.G. 123, Feb. 29, 2000.

The written comments have been

carefully considered.

Overview of Comments

The majority of comments favored

issuance of final written description

guidelines with minor revisions.

Comments pertaining to the written

description guidelines are addressed in

detail below. A few comments

addressed particular concerns with

respect to the associated examiner

training materials that are available for

public inspection at the USPTO web site

(www.uspto.gov). Such comments will

be taken under advisement in the

revision of the training materials;

consequently, these comments are not

specifically addressed below as they do

not impact the content of the

Guidelines. Several comments raised

issues pertaining to the patentability of

ESTs, genes, or genomic inventions with

respect to subject matter eligibility (35

U.S.C. 101), novelty (35 U.S.C. 102), or

obviousness (35 U.S.C. 103). As these

comments do not pertain to the written

description requirement under 35 U.S.C.

112, they have not been addressed.

However, the aforementioned comments

are fully addressed in the ‘‘Discussion of

Public Comments’’ in the ‘‘Utility

Examination Guidelines’’ Final Notice,

which will be published at or about the

same time as the present Guidelines.

Responses to Specific Comments

(1) Comment: One comment stated

that the Guidelines instruct the patent

examiner to determine the

correspondence between what applicant

has described as the essential

identifying characteristic features of the

invention and what applicant has

claimed, and that such analysis will

lead to error. According to the comment,

the examiner may decide what

applicant should have claimed and

reject the claim for failure to claim what

the examiner considers to be the

invention. Another comment suggested

that the Guidelines should clarify what

is meant by ‘‘essential features of the

invention.’’ Another comment suggested

that what applicant has identified as the

‘‘essential distinguishing

characteristics’’ of the invention should

be understood in terms of Fiers v. Revel,

984 F.2d 1164, 1169, 25 USPQ2d 1601,

1605 (Fed. Cir. 1993) (‘‘Conception of a

substance claimed per se without

reference to a process requires

conception of its structure, name,