29620 Federal Register / Vol. 63, No. 104 / Monday, June 1, 1998 /Rules and Regulations

(1) Examination will begin after the

earliest of:

(i) Receipt of the amendment;

(ii) Receipt of applicant’s statement

that no amendment will be made; or

(iii) Expiration of the time period set

in the notification.

(2) No international preliminary

examination report will be established

prior to issuance of an international

search report.

* * * * *

17. Section 1.485 is amended by

revising paragraph (a) to read as follows:

§ 1.485 Amendment by applicant during

international preliminary examination.

(a) The applicant may make

amendments at the time of filing the

Demand. The applicant may also make

amendments within the time limit set

by the International Preliminary

Examining Authority for reply to any

notification under § 1.484(b) or to any

written opinion. Any such amendments

must:

(1) Be made by submitting a

replacement sheet in compliance with

PCT Rules 10 and 11.1 to 11.13 for every

sheet of the application which differs

from the sheet it replaces unless an

entire sheet is cancelled; and

(2) Include a description of how the

replacement sheet differs from the

replaced sheet. Amendments that do not

comply with PCT Rules 10 and 11.1 to

11.13 may not be entered.

* * * * *

18. Section 1.494 is amended by

revising paragraph (c) to read as follows:

§ 1.494 Entering the national stage in the

United States of America as a Designated

Office.

* * * * *

(c) If applicant complies with

paragraph (b) of this section before

expiration of 20 months from the

priority date but omits:

(1) A translation of the international

application, as filed, into the English

language, if it was originally filed in

another language (35 U.S.C. 371(c)(2))

and/or

(2) The oath or declaration of the

inventor (35 U.S.C. 371(c)(4); see

§ 1.497), applicant will be so notified

and given a period of time within which

to file the translation and/or oath or

declaration in order to prevent

abandonment of the application. The

payment of the processing fee set forth

in § 1.492(f) is required for acceptance

of an English translation later than the

expiration of 20 months after the

priority date. The payment of the

surcharge set forth in § 1.492(e) is

required for acceptance of the oath or

declaration of the inventor later than the

expiration of 20 months after the

priority date. A ‘‘Sequence Listing’’

need not be translated if the ‘‘Sequence

Listing’’ complies with PCT Rule 12.1(d)

and the description complies with PCT

Rule 5.2(b).

* * * * *

19. Section 1.495 is amended by

revising paragraph (c) to read as follows:

§ 1.495 Entering the national stage in the

United States of America as an Elected

Office.

* * * * *

(c) If applicant complies with

paragraph (b) of this section before

expiration of 30 months from the

priority date but omits:

(1) A translation of the international

application, as filed, into the English

language, if it was originally filed in

another language (35 U.S.C. 371(c)(2))

and/or

(2) The oath or declaration of the

inventor (35 U.S.C. 371(c)(4); see

§ 1.497), applicant will be so notified

and given a period of time within which

to file the translation and/or oath or

declaration in order to prevent

abandonment of the application. The

payment of the processing fee set forth

in § 1.492(f) is required for acceptance

of an English translation later than the

expiration of 30 months after the

priority date. The payment of the

surcharge set forth in § 1.492(e) is

required for acceptance of the oath or

declaration of the inventor later than the

expiration of 30 months after the

priority date.

A ‘‘Sequence Listing’’ need not be

translated if the ‘‘Sequence Listing’’

complies with PCT Rule 12.1(d) and the

description complies with PCT Rule

5.2(b).

* * * * *

Dated: May 22, 1998.

Bruce A. Lehman,

Assistant Secretary of Commerce and

Commissioner of Patents and Trademarks.

[FR Doc. 98–14195 Filed 5–29–98; 8:45 am]

BILLING CODE 3510–16–P

DEPARTMENT OF COMMERCE

Patent and Trademark Office

37 CFR Part 1

[Docket No: 960828235–8109–02]

RIN: 0651–AA88

Requirements for Patent Applications

Containing Nucleotide Sequence and/

or Amino Acid Disclosures

AGENCY: Patent and Trademark Office,

Commerce.

ACTION: Final rule.

SUMMARY: The Patent and Trademark

Office (PTO) is amending the rules for

submitting nucleotide or amino acid

sequences in computer readable form

(CRF) for patent applications. These

amendments simplify the requirements

of the rules, rearrange portions of the

rules for better understanding and

establish consistent rules to permit a

single internationally acceptable

computer readable form. Sequence

Listings will be presented in an

international, language neutral format

using numeric identifiers rather than the

current subject headings. The Paper

Sequence Listing will preferably be a

separately numbered section of the

patent application. Sequences which

contain fewer than four specifically

identified nucleotides or amino acids

will no longer be required to be

submitted in computer readable form.

DATES: Effective date: July 1, 1998. The

incorporation by reference of certain

publications listed in the regulations is

approved by the Director of the Federal

Register as of July 1, 1998.

Applicability date: Sections 1.821

through 1.825 as amended apply to

applications filed on or after July 1,

1998, except for: (1) applications that

claim the benefit of a prior application

under 35 U.S.C. 120 filed before July 1,

1998, and which do not add subject

matter involving a sequence listing

subject to §§ 1.821 through 1.825; and

(2) reissue applications in which the

application for the patent sought to be

reissued was filed before July 1, 1998.

Sections 1.821 through 1.825 apply

during a reexamination proceeding if

the application for the patent sought to

be reexamined was filed on or after July

1, 1998.

FOR FURTHER INFORMATION CONTACT:

Esther M. Kepplinger, by telephone at

(703) 308–1495; by mail addressed to:

Box Comments—Patents, Assistant

Commissioner for Patents, Washington,

DC 20231 marked to her attention; by

facsimile to (703) 305–3935; or by

electronic mail at

esther.kepplinger@uspto.gov.

SUPPLEMENTARY INFORMATION: Sections

1.821 through 1.825 of title 37 provide

a standardized format for the

description of nucleotide and amino

acid sequence data in patent

applications and require the submission

of such sequences in computer readable

form (CRF). Sections 1.821 through

1.825 provide the following benefits to

the PTO: (1) Improved search

capabilities; (2) improved interference

detection; (3) more efficient

examination; (4) cost savings for the

input of the sequence data; (5) more
Federal Register / Vol. 63, No. 104 / Monday, June 1, 1998 /Rules and Regulations 29621

efficient and accurate printing of

sequences in patents; (6) exchange of

the sequence data with other patent

offices electronically; and (7) improved

public access to the sequences

electronically.

Reasons for the Changes

In response to the needs of our

customers, the procedural requirements

found in former §§ 1.821 through 1.825

have been reduced. Sections 1.821

through 1.825 are being amended to be

consistent with World Intellectual

Property Organization (WIPO) Standard

ST.25 (signed in 1998 and effective July

1, 1998). ST.25 replaces WIPO

Standards ST.23 and ST.24 which deal

with paper and electronic submissions

of sequence listings.

A Meeting of International Authorities

(MIA) under the Patent Cooperation

Treaty (PCT) was held in November of

1994 to discuss simplification of

sequence listing submission

requirements. Under the previous PCT

Regulations, each International

Searching Authority, each International

Preliminary Examining Authority and

each designated/elected office was free

to set the requirements for submission

of sequence listings in paper and

electronic form. This imposed a burden

on applicants by requiring them to

prepare sequence listings in many

different formats. In addition, sequence

listings were required to be translated

for consideration in the national stage at

considerable cost to applicants and at

the risk that the information could be

inaccurately translated.

After the November 1994 MIA, the

PTO, the European Patent Office (EPO)

and the Japanese Patent Office (JPO)

worked together with WIPO to create a

new international standard which forms

the basis of WIPO Standard ST.25

(1998). Sections 1.821 through 1.825 of

37 CFR, as amended herein, are

consistent with WIPO Standard ST.25

(1998) and the PCT sequence listing

requirements. Sequence listings

prepared in accordance with §§ 1.821

through 1.825 as amended generally

will be acceptable in all countries which

adhere to WIPO Standard ST.25 (1998).

In addition, a sequence listing prepared

in accordance with the §§ 1.821 through

1.825 as amended will be acceptable for

the national stage in all PCT member

countries which require the submission

of a sequence listing. As a result of this

rule change, applicants will experience

a reduction in cost since only one

sequence listing in paper and electronic

form will need to be prepared and

translations of this listing will not be

needed.

All necessary changes to the text of

§§ 1.821 through 1.825 to reflect the

new WIPO Standard ST.25 (1998), have

been made. Each change is described

below.

Overview of the Changes

The changes in this Final Rule

include:

(1) Use of numeric identifiers to

replace the language subject headings

within the submission;

(2) Elimination of unnecessary and

confusing data elements;

(3) Movement of the paper Sequence

Listing to the end of the application,

preferably with separately numbered

pages;

(4) Elimination of the requirement to

provide a submission for sequences

with fewer than four specifically

defined nucleotides or amino acids;

(5) Use of lower-case one-letter codes

for nucleotide bases;

(6) Rearrangement of portions of the

rules to improve their context;

(7) Clarification and simplification of

the rules to aid in understanding; and

(8) Minor changes to accomplish

harmonization with WIPO Standard

ST.25 (1998) as well as the EPO and the

JPO standards.

Amended §§ 1.821 through 1.825 are

not mandatory for: (1) applications that

claim the benefit of a prior application

under 35 U.S.C. 120 filed before July 1,

1998, and which do not add subject

matter involving a sequence listing

subject to §§ 1.821 through 1.825; (2)

reissue applications in which the

application for the patent sought to be

reissued was filed before July 1, 1998;

and (3) reexamination proceedings if the

application for the patent sought to be

reexamined was filed before July 1,

1998. The PTO will accept and

encourages the submission of sequence

listings in compliance with amended

§§ 1.821 through 1.825 for any

application or reexamination

proceeding. All sequence listings

(including the entire computer readable

form) must be submitted in compliance

with either §§ 1.821 through 1.825 as

amended in this Final Rule or (when

permitted) former §§ 1.821 through

1.825.

If the CRF for a new application

would be identical to a compliant CRF

already on file in the PTO, the applicant

may make reference to the other

application and the CRF in lieu of filing

a duplicate CRF in the new application

by following the procedures set forth in

§ 1.821(e). If exceptional circumstances

do arise and certain applicants

experience specific hardships in

attempting to comply with amended

§§ 1.821 through 1.825, the PTO will

consider a petition under § 1.183 to

waive certain requirements of §§ 1.821

through 1.825.

A Notice of Proposed Rulemaking

entitled ‘‘Changes Implementing

Nucleotide and/or Amino Acid

Sequence Listings’’ (Notice of Proposed

Rulemaking) was published in the

Federal Register at 61 FR 51855

(October 4, 1996), and in the Official

Gazette of the Patent and Trademark

Office, at 1191 Off. Gaz. Pat. Office 168

(October 29, 1996). Sections 1.821

through 1.825 as adopted contain

several changes from these sections.

This Final Rule provides a discussion of

the content of the specific rules being

amended, description of the changes in

the text of the proposed rules, and

explanation of the reasons supporting

the changes. In addition, comments

received in response to the Notice of

Proposed Rulemaking are analyzed.

Discussion of Specific Rules and

Changes from the Proposed Rules:

Title 37 of the Code of Federal

Regulations, Part 1, is amended as

follows.

Section 1.77

The proposed change to 37 CFR 1.77

was previously adopted. See

Miscellaneous Changes to Patent

Practice; Final Rule, 61 FR 42790

(August 19, 1996), 1190 Off. Gaz. Pat.

Office 67 (September 17, 1996).

Section 1.821

Section 1.821 incorporates by

reference the World Intellectual

Property Organization (WIPO)

Handbook on Industrial Property

Information and Documentation,

Standard ST.25 (1998), including Tables

1 through 6 of Appendix 2, in

accordance with 5 U.S.C. 552(a) and 1

CFR part 51. Copies may be obtained

from the World Intellectual Property

Organization; 34 chemin des

Colombettes; 1211 Geneva 20

Switzerland. Copies may be inspected at

the Patent Search Room; Crystal Plaza 3,

Lobby Level; 2021 South Clark Place;

Arlington, VA 22202. Copies may also

be inspected at the Office of the Federal

Register, 800 North Capitol Street, NW,

Suite 700, Washington, DC 20408. These

Tables are reproduced below.

WIPO Standard ST.25 (1998),

Appendix 2, Table 1, provides that the

bases of a nucleotide sequence should

be represented using the following oneletter code for nucleotide sequence

characters:
29622 Federal Register / Vol. 63, No. 104 / Monday, June 1, 1998 /Rules and Regulations

TABLE 1.—ONE LETTER CODES FOR NUCLEOTIDE SEQUENCES

Symbol Meaning Origin of designation

a ................................................................................. a ................................................................................. adenine.

g ................................................................................. g ................................................................................. guanine.

c ................................................................................. c ................................................................................. cytosine.

t .................................................................................. t .................................................................................. thymine.

u ................................................................................. u ................................................................................. uracil.

r .................................................................................. g or a ......................................................................... purine.

y ................................................................................. t/u or c ....................................................................... pyrimidine.

m ................................................................................ a or c ......................................................................... amino.

k ................................................................................. g or t/u ....................................................................... keto.

s ................................................................................. g or c ......................................................................... strong interactions 3 H-bonds.

w ................................................................................. a or t/u ....................................................................... weak interactions 2 H-bonds.

b ................................................................................. g or c or t/u ................................................................ not a.

d ................................................................................. a or g or t/u ................................................................ not c.

h ................................................................................. a or c or t/u ................................................................ not g.

v ................................................................................. a or g or c .................................................................. not t, not u.

n ................................................................................. (a or g or c or t/u) or (unknown or other) .................. any

WIPO Standard ST.25 (1998), Appendix 2, Table 2, provides that modified bases may be represented as the corresponding unmodified bases in the sequence itself, if the modified base is one of those listed below and the modification

is further described in the Feature section of the Sequence Listing. The codes from the list below may be used in

the description (i.e., the specification and drawings, or in the Sequence Listing) but these codes may not be used

in the sequence itself.

TABLE 2.—MODIFIED BASES

Symbol Meaning

ac4c ..................................................................... 4-acetylcytidine.

chm5u ................................................................. 5-(carboxyhydroxylmethyl)uridine.

cm ....................................................................... 2-O-methylcytidine.

cmnm5s2u ........................................................... 5-carboxymethylaminomethyl-2-thiouridine.

cmnm5u .............................................................. 5-carboxymethylaminomethyluridine.

d .......................................................................... dihydrouridine.

fm ........................................................................ 2-O-methylpseudouridine.

gal q .................................................................... beta, D-galactosylqueuosine.

gm ....................................................................... 2-O-methylguanosine.

I ........................................................................... inosine.

i6a ....................................................................... N6-isopentenyladenosine.

m1a ..................................................................... 1-methyladenosine.

m1f ...................................................................... 1-methylpseudouridine.

m1g ..................................................................... 1-methylguanosine.

m1i ...................................................................... 1-methylinosine.

m22g ................................................................... 2,2-dimethylguanosine.

m2a ..................................................................... 2-methyladenosine.

m2g ..................................................................... 2-methylguanosine.

m3c ..................................................................... 3-methylcytidine.

m5c ..................................................................... 5-methylcytidine.

m6a ..................................................................... N6-methyladenosine.

m7g ..................................................................... 7-methylguanosine.

mam5u ................................................................ 5-methylaminomethyluridine.

mam5s2u ............................................................ 5-methoxyaminomethyl-2-thiouridine.

man q .................................................................. beta, D-mannosylqueuosine.

mcm5s2u ............................................................. 5-methoxycarbonylmethyl-2-thiouridine.

mcm5u ................................................................ 5-methoxycarbonylmethyluridine.

mo5u ................................................................... 5-methoxyuridine.

ms2i6a ................................................................. 2-methylthio-N6-isopentenyladenosine.

ms2t6a ................................................................ N-((9-beta-D-ribofuranosyl-2-methylthiopurine-6-yl) carbamoyl) threonine.

mt6a .................................................................... N-((9-beta-D-ribofuranosylpurine-6-yl)N-methylcarbamoyl) threonine.

mv ....................................................................... uridine-5-oxyacetic acid-methylester.

o5u ...................................................................... uridine-5-oxyacetic acid.

osyw .................................................................... wybutoxosine.

p .......................................................................... pseudouridine.

q .......................................................................... queuosine.

s2c ....................................................................... 2-thiocytidine.

s2t ....................................................................... 5-methyl-2-thiouridine.

s2u ...................................................................... 2-thiouridine.

s4u ...................................................................... 4-thiouridine.

t ........................................................................... 5-methyluridine.

t6a ....................................................................... N-((9-beta-D-ribofuranosylpurine-6-yl)-carbamoyl)threonine.

tm ........................................................................ 2-O-methyl-5-methyluridine.

um ....................................................................... 2-O-methyluridine.
Federal Register / Vol. 63, No. 104 / Monday, June 1, 1998 /Rules and Regulations 29623

TABLE 2.—MODIFIED BASES—Continued

Symbol Meaning

yw ........................................................................ wybutosine.

x .......................................................................... 3-(3-amino-3-carboxy-propyl)uridine, (acp3)u.

WIPO Standard ST.25 (1998),

Appendix 2, Table 3, provides that the

amino acids should be represented

using the following three-letter code

with the first letter as a capital.

TABLE 3.—AMINO ACID THREE-LETTER

CODES

Symbol Meaning

Ala ............................. Alanine.

Cys ............................ Cysteine.

Asp ............................ Aspartic Acid.

Glu ............................. Glutamic Acid.

Phe ............................ Phenylalanine.

Gly ............................. Glycine.

His ............................. Histidine.

Ile ............................... Isoleucine.

Lys ............................. Lysine.

TABLE 3.—AMINO ACID THREE-LETTER

CODES—Continued

Symbol Meaning

Leu ............................ Leucine.

Met ............................ Methionine.

Asn ............................ Asparagine.

Pro ............................. Proline.

Gln ............................. Glutamine.

Arg ............................. Arginine.

Ser ............................. Serine.

Thr ............................. Threonine.

Val ............................. Valine.

Trp ............................. Tryptophan.

Tyr ............................. Tyrosine.

Asx ............................ Asp or Asn.

Glx ............................. Glu or Gln.

Xaa ............................ Unknown or other.

WIPO Standard ST.25 (1998),

Appendix 2, Table 4, provides that

modified and unusual amino acids may

be represented as the corresponding

unmodified amino acids in the sequence

itself if the modified or unusual amino

acid is one of those listed below and the

modification is further described in the

Feature section of the Sequence Listing.

The codes from the list below may be

used in the description (i.e., the

specification and drawings, or in the

Sequence Listing) but these codes may

not be used in the sequence itself.

TABLE 4.—MODIFIED AND UNUSUAL AMINO ACID CODES

Symbol Meaning

Aad ....................................................................................................................................................... 2-Aminoadipic acid.

bAad ..................................................................................................................................................... 3-aminoadipic acid.

bAla ...................................................................................................................................................... beta-Alanine, beta-Aminopropionic acid.

Abu ....................................................................................................................................................... 2-Aminobutyric acid.

4Abu ..................................................................................................................................................... 4-Aminobutyric acid, piperidinic acid.

Acp ....................................................................................................................................................... 6-Aminocaproic acid.

Ahe ....................................................................................................................................................... 2-Aminoheptanoic acid.

Aib ........................................................................................................................................................ 2-Aminoisobutyric acid.

bAib ...................................................................................................................................................... 3-Aminoisobutyric acid.

Apm ...................................................................................................................................................... 2-Aminopimelic acid.

Dbu ....................................................................................................................................................... 2,4-Diaminobutyric acid.

Des ....................................................................................................................................................... Desmosine.

Dpm ...................................................................................................................................................... 2,2-Diaminopimelic acid.

Dpr ....................................................................................................................................................... 2,3-Diaminopropionic acid.

EtGly .................................................................................................................................................... N-Ethylglycine.

EtAsn .................................................................................................................................................... N-Ethylasparagine.

Hyl ........................................................................................................................................................ Hydroxylysine.

aHyl ...................................................................................................................................................... allo-Hydroxylysine.

3Hyp ..................................................................................................................................................... 3-Hydroxyproline.

4Hyp ..................................................................................................................................................... 4-Hydroxyproline.

Ide ........................................................................................................................................................ Isodesmosine.

aIle ....................................................................................................................................................... allo-Isoleucine.

MeGly ................................................................................................................................................... N-Methylglycine, sarcosine.

MeIle .................................................................................................................................................... N-Methylisoleucine.

MeLys ................................................................................................................................................... 6-N-Methyllysine.

MeVal ................................................................................................................................................... N-Methylvaline.

Nva ....................................................................................................................................................... Norvaline.

Nle ........................................................................................................................................................ Norleucine.

Orn ....................................................................................................................................................... Ornithine.

WIPO Standard ST.25 (1998),

Appendix 2, Table 5 provides for feature

keys related to DNA sequences.

BILLING CODE 3510–16–P
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29626 Federal Register / Vol. 63, No. 104 / Monday, June 1, 1998 /Rules and Regulations
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29628 Federal Register / Vol. 63, No. 104 / Monday, June 1, 1998 /Rules and Regulations
Federal Register / Vol. 63, No. 104 / Monday, June 1, 1998 /Rules and Regulations 29629

BILLING CODE 3510–16–C

Further in paragraph (a) of § 1.821,

both occurrences of ‘‘Copies of ST.23’’

have been changed to ‘‘Copies of WIPO

Standard ST.25 (1998).’’ This change is

necessary to reflect the new standard

number.

In paragraph (a)(1) of § 1.821, ‘‘ST.23

(April 1994), paragraph 8’’ has been

changed to ‘‘ST.25 (1998), Appendix 2,

Table 1.’’ This change reflects the

correct information with regard to the

incorporated WIPO standard and the list

of symbols to be used for nucleotide

sequence characters.

Further in paragraph (a)(1) of § 1.821,

‘‘ST.23 (April 1994), paragraph 9’’ has

been changed to ‘‘ST.25 (1998),

Appendix 2, Table 2.’’ This change

reflects the correct information with

regard to the incorporated WIPO

standard and the list of modified bases

which can be presented as unmodified

nucleotide sequence characters.

In paragraph (a)(2) of § 1.821, all three

occurrences of ‘‘ST.23 (April 1994),

paragraph 11’’ have been changed to

‘‘ST.25 (1998), Appendix 2, Table 3.’’

This change reflects the correct

information with regard to the

incorporated WIPO standard and the list

of symbols to be used for amino acid

sequence characters.

Further in paragraph (a)(2) of § 1.821,

‘‘ST.23 (April 1994), paragraph 12’’ has

been changed to ‘‘ST.25 (1998),

Appendix 2, Table 4.’’ This change

reflects the correct information with

regard to the incorporated WIPO

standard and the list of modified or

unusual amino acids which can be

presented as unmodified amino acid

sequence characters.

In paragraph (c) of § 1.821, each of the

three occurrences of the words ‘‘integer

identifier’’ or ‘‘integer identifiers’’ has

been changed to ‘‘sequence identifier’’

or ‘‘sequence identifiers’’ as appropriate.

WIPO Standard ST.25 (1998), uses the

term ‘‘sequence identifier’’ rather than

‘‘integer identifier.’’ Thus, this change is

necessary to achieve harmonization

with the international standard.

In the last sentence of paragraph (c) of

§ 1.821, the phrase ‘‘The sequence

omitted shall appear following the

integer identifier’’ of the proposed rule

has been replaced by ‘‘the code ‘000’

shall be used in place of the sequence.’’

The response for the numeric identifier

<160> shall include the total number of

SEQ ID NOs, whether followed by a

sequence or by the code ‘‘000’’. The

code ‘‘000’’ should be put into <400>.

This change permits flexibility in the

preparation and amendment of

Sequence Listings. It also makes the rule

language-neutral and is consistent with

WIPO Standard ST.25 (1998).

In paragraph (d) of § 1.821, the words

‘‘integer identifier’’ have been changed

to ‘‘sequence identifier.’’ WIPO

Standard ST.25 (1998) uses the term

‘‘sequence identifier’’ rather than

‘‘integer identifier.’’ Thus, this change is

necessary to achieve harmonization

with the international standard.

In paragraphs (f), (g) and (h) of

§ 1.821, the sentence ‘‘Such a statement

must be a verified statement if made by

a person not registered to practice before

the Office’’ has been deleted. The

separate verification requirements in

§ 1.821 have been eliminated in view of

the recent amendment to §§ 1.4(d) and

10.18. See Changes to Patent Practice

and Procedure; Final Rule, 62 FR. 53131

(October 10, 1997), 1203 Off. Gaz. Pat.

Office 63 (October 21, 1997). Paragraph

(g) of § 1.821 has also been amended to

provide that the Office will provide a

‘‘period of time’’ (rather than one

month) within which the applicant

must comply with the requirements of

§ 1.821(b) through (f) in order to avoid

abandonment.

Further in paragraph (f) of § 1.821, the

following has been added at the end of

the first sentence, ’’, e.g., the

information recorded in computer

readable form is identical to the written

sequence listing.’’ WIPO Standard ST.25

(1998), paragraph 39, requires the

language which has been added as an

acceptable example for phrasing the

required statement that the computer

readable form and the written sequence

listing are the same.

Section 1.822

In paragraph (b) of § 1.822, both

references to WIPO Standard ST.23

(April 1994), paragraphs 8 and 11, as

proposed have been changed to ‘‘WIPO

Standard ST.25 (1998), Appendix 2,

Tables 1 and 3.’’ These changes reflect

the correct information with regard to

the incorporated WIPO standard and the

lists of symbols for nucleotide and

amino acid sequence characters.

Further in paragraph (b) of § 1.822,

‘‘WIPO Standard ST.23 (April 1994),

paragraphs 9 and 12’’ as proposed has

been changed to ‘‘WIPO Standard ST.25

(1998), Appendix 2, Tables 2 and 4.’’
29630 Federal Register / Vol. 63, No. 104 / Monday, June 1, 1998 /Rules and Regulations

This change reflects the correct

information with regard to the

incorporated WIPO standard and the

lists of modified bases and modified or

unusual amino acids which can be

depicted in the Sequence Listing via the

symbols for a corresponding unmodified

base or amino acid.

Further in paragraph (b) of § 1.822,

the symbol designating an unknown

nucleotide base or a nucleotide base

other than those listed in the WIPO

standard was proposed as an upper case

letter ‘‘N.’’ This symbol has been

changed to a lower case letter ‘‘n.’’ This

change is consistent with the use of

lower case letters for the symbols

representing the nucleotide bases.

Further in paragraph (b) of § 1.822,

the language has been clarified to

specifically state that each ‘‘n’’ or ‘‘Xaa’’

represents only a single residue. Thus,

for example, a single ‘‘Xaa’’ may not be

used to designate a string of four amino

acids, each of which is unknown. This

represents a codification of existing

practice.

Further in paragraph (b) of § 1.822,

the information required in the Feature

section to explain the use of ‘‘n’’ or

‘‘Xaa’’ in a given sequence is referred to

‘‘as appropriate.’’ Additional instruction

is added at the end of paragraph (b) of

§ 1.822 following ‘‘the Feature section’’

indicating’’, preferably by including one

or more feature keys listed in WIPO

Standard ST.25 (1998), Appendix 2,

Tables 5 and 6.’’ This change specifies

the preference for using the feature keys

listed in the WIPO standard in order to

aid applicants in filing a CRF which

will comply with WIPO Standard ST.25

(1998). These feature keys are controlled

vocabulary and are considered language

neutral. Their use is required in a PCT

patent application or a patent

application in a foreign country which

has adopted WIPO Standard ST.25

(1998).

In paragraph (c)(1) of § 1.822, ‘‘WIPO

Standard ST.23 (April 1994), paragraph

8’’ as proposed has been changed to

‘‘WIPO Standard ST.25 (1998),

Appendix 2, Table 1.’’ This change

reflects the correct information with

regard to the incorporated WIPO

standard and the list of symbols to be

used for nucleotide sequence characters.

In paragraph (d)(1) of § 1.822, ‘‘WIPO

Standard ST.23 (April 1994), paragraph

11, as proposed has been changed to

‘‘WIPO Standard ST.25 (1998),

Appendix 2, Table 3.’’ This change

reflects the correct information with

regard to the incorporated WIPO

standard and the list of symbols to be

used for amino acid sequence

characters.

In paragraph (d)(4) of § 1.822, the

section notes that enumeration

requirements are applicable to amino

acid sequences that are circular in

configuration. The following language

has been added to the end of the

paragraph ’’, with the exception that the

designation of the first amino acid of the

sequence may be made at the option of

the applicant.’’ This change is necessary

to provide consistency with its

counterpart of circular nucleotide

sequences as provided in paragraph

(c)(7) of § 1.822. This change is also

consistent with WIPO Standard ST.25

(1998), paragraph 21.

In paragraph (e) of § 1.822, the words

‘‘integer identifiers’’ have been changed

to ‘‘sequence identifiers .’’ WIPO

Standard ST.25 (1998) uses the term

‘‘sequence identifier’’ rather than

‘‘integer identifier.’’ Thus, this change is

necessary to achieve harmonization

with the international standard.

Section 1.823

In paragraph (a) of § 1.823, the entire

second sentence which read ‘‘On a

separate page of the application

specification, immediately prior to the

claims, there shall be a reference to the

presence of the ‘Sequence Listing’ in a

‘Sequence Listing Annex.’’’ has been

eliminated. The designation of the

Sequence Listing as an annex to the

specification was initially proposed in

an early version of the international

standard. This terminology is not used

in WIPO Standard ST.25 (1998),

however, and so it has also been

eliminated from paragraph (a) of § 1.823,

as proposed. Simplification results as

well by the elimination of the

requirement that the Sequence Listing

must be designated as an annex to the

specification.

In paragraph (a) of § 1.823, the third

sentence has been modified by deleting

the words ‘‘shall appear in the

‘Sequence Listing Annex,’ which is.’’ As

explained above, the current version of

the international standard does not

require designating the Sequence Listing

as an annex to the specification.

In paragraph (a) of § 1.823, the words

‘‘preferably should be’’ have been added

to the third sentence, before ‘‘numbered

independently of the numbering of the

remainder of the application’’ to

describe the independent page

numbering of the Sequence Listing in

paper copy form. The term ‘‘preferably’’

was added for purposes of

harmonization with WIPO Standard

ST.25 (1998).

In paragraph (a) of § 1.823, the last

clause of the third sentence ‘‘and shall

be placed in the application file’’ has

been deleted as unnecessary and

potentially confusing now that the

reference to a ‘‘Sequence Listing

Annex’’ has been removed from this

paragraph.

In paragraph (a) of § 1.823, the fourth

sentence has been eliminated in its

entirety. As explained above, the

current version of the international

standard does not require designating

the Sequence Listing as an annex to the

specification.

In paragraph (a) of § 1.823, in both

occurrences in the fifth sentence and in

the single occurrence in the sixth

sentence, the word ‘‘shall’’ has been

changed to ‘‘should.’’ These changes are

necessary for purposes of achieving

consistency with WIPO Standard ST.25

(1998).

In paragraph (b) of § 1.823, the first

sentence has been modified by the

deletion of the words ‘‘in addition to

and immediately preceding.’’ This

change is consistent with WIPO

Standard ST.25 (1998).

In paragraph (b) of § 1.823, the fifth

sentence has been deleted, eliminating

the prohibition of any item of

information occupying more than one

line. This change is consistent with

WIPO Standard ST.25 (1998).

In paragraph (b) of § 1.823, the last

sentence has been deleted to eliminate

the ‘‘rep’’ designation for data elements

of the ‘‘Sequence Listing.’’ Certain data

elements may still be repeated within

the listing but this change was made for

harmonization of the table with WIPO

Standard ST.25 (1998).

In paragraph (b) of § 1.823, the eighth

sentence has been modified to reflect

the new numeric numbering scheme, for

harmonization with WIPO Standard

ST.25 (1998). Specifically, ‘‘<100>

through <193>’’ of the proposed rule

has been changed to ‘‘<110> through

<170>.’’

The table in paragraph (b) of § 1.823,

has been changed to reflect the revised

numbering scheme and data elements

used in WIPO Standard ST.25 (1998).

The specific changes are as follows:

Numeric identifier ‘‘<100>, General

Information,’’ has been deleted from the

proposed rules, as it is not present in

WIPO Standard ST.25 (1998).

Numeric identifier ‘‘<110>,

Applicant,’’ in the proposed rule, has

been changed to indicate that

‘‘preferably ’’ a maximum of ten names

may be indicated. This change allows

for more than ten names in the

Applicant field for those instances in

which such would be appropriate. This

change is consistent with WIPO

Standard ST.25 (1998).

Numeric identifier ‘‘<120>, Title of

Invention,’’ in the proposed rule, has

been changed to eliminate the limitation
Federal Register / Vol. 63, No. 104 / Monday, June 1, 1998 /Rules and Regulations 29631

that the title be a maximum of four

lines. This change allows applicants

more flexibility with respect to the title.

This change is consistent with WIPO

Standard ST.25 (1998).

Numeric identifier ‘‘<130>, Number

of Sequences,’’ in the proposed rule, has

been changed to reflect ‘‘<130>, File

Reference,’’ as stated in WIPO Standard

ST.25 (1998). This numeric identifier

was indicated as ‘‘<183>, File

Reference/Docket Number ’’, in the rule

as proposed. As proposed this was an

optional numeric identifier. The

numeric identifier remains optional

once the application has been assigned

an application number, e.g., a serial

number. This numeric identifier is now

MANDATORY when an application

number has not yet been assigned to the

application, such as on the day the

application is initially filed. This

change will assist in the matching of

sequence information submissions with

an application in the event that either

the paper copy or the computer readable

form were to become separated from the

remainder of the application. This

change is consistent with WIPO

Standard ST.25 (1998).

The Number of Sequences field

identified as ‘‘<130>’’ in the proposed

rule is now numbered ‘‘<160>’’ in

§ 1.823 as adopted and redefined as

‘‘Number of SEQ ID NOs.’’

The information associated with

numeric identifiers ‘‘<140>’’ through

‘‘<153>,’’ ‘‘Correspondence Address’’

through ‘‘Operating System’’ of the

proposed rule, has been eliminated to

reduce the burden on the applicant and

to harmonize with WIPO Standard

ST.25 (1998). Some of these numeric

identifiers have been used in the new

numbering scheme and have been

associated with different information as

indicated herein and in the Table of

§ 1.823.

One remaining numeric identifier

within the Computer Readable Form

section, ‘‘<154>, Software,’’ of the

proposed rule, will remain, with the

exception that it has been reassigned the

numeric identifier of ‘‘<170>’’ to reflect

the numbering scheme presented in

WIPO Standard ST.25 (1998).

The main headings ‘‘<160>, Current

Application Data’’ and ‘‘<170>, Prior

Application Data,’’ of the proposed

rules, have been eliminated to

harmonize with WIPO Standard ST.25

(1998) and reduce the number of fields

in the Sequence Listing. The

information that was to appear under

these main headings remains in the

rules but has been reassigned numeric

identifiers <140> through <151>. The

specific changes are as follows: ‘‘<160>’’

has been redefined as ‘‘Number of SEQ

ID NOs ’’; ‘‘<161>, Application

Number,’’ of the proposed rule is now

numbered as ‘‘<140>,’’ and is defined as

‘‘Current Application Number’; ‘‘<162>,

Filing Date,’’ of the proposed rule is

now numbered ‘‘<141>,’’ and is defined

as ‘‘Current Filing Date’’; ‘‘<170>’’ has

been redefined as ‘‘Software ‘‘; ‘‘<171>,

Application Number,’’ of the proposed

rule is now numbered as ‘‘<150>,’’ and

is defined as ‘‘Prior Application

Number’’; ‘‘<172>, Filing Date,’’ of the

proposed rule is now numbered as

‘‘<151>,’’ and is defined as ‘‘Prior

Application Filing Date.’’

The numeric identifiers now

numbered ‘‘<150>, Prior Application

Number,’’, and ‘‘<151>, Prior

Application Filing Date,’’ are now

mandatory only in those instances in

which a claim for priority with respect

to those prior applications is being

made under either 35 U.S.C. 119 or 120.

This change will provide information in

this regard when it is most useful and

was necessary to harmonize these rules

with WIPO Standard ST.25 (1998).

Throughout the Sequence Listing,

application numbers must be set forth as

a combination of the two digit country

code, as set forth in WIPO Standard

ST.3, as well as an application number

in accordance with WIPO Standard

ST.13 or for an international

application, the numbering system as

set out in Section 307(a) of the

Administrative Instructions under the

PCT.

Numeric identifiers ‘‘<180>,

Attorney/Agent Information,’’ through

‘‘<182>, Registration Number,’’ of the

proposed rule, have been eliminated to

harmonize with WIPO Standard ST.25

(1998) and reduce the number of fields

in the Sequence Listing.

Numeric identifier ‘‘<183>, File

Reference/Docket Number’’ of the

proposed rule has been reassigned as

numeric identifier ‘‘<130>,’’ and

redefined as ‘‘File Reference’’ in an

effort to harmonize with WIPO Standard

ST.25 (1998).

The Telecommunication Information

section, ‘‘<190>’’ through ‘‘<193>’’ of

the proposed rules, has been eliminated

in order to reduce the number of fields

in the Sequence Listing and harmonize

with WIPO Standard ST.25 (1998).

Numeric identifier ‘‘<200>,

Information for SEQ ID NO:#:’’, has been

reassigned the numeric identifier

‘‘<210>, SEQ ID NO: #:’’ This numeric

identifier indicates the integer, referred

to in these final rules as the sequence

identifier for both the sequence

information and the actual sequence

which follows the information.

Numeric identifier ‘‘<210>, Sequence

Characteristics,’’ of the proposed rule

has been eliminated in order to reduce

the number of required elements in the

Sequence Listing and harmonize with

WIPO Standard ST.25 (1998).

The valid responses for the mandatory

numeric identifier ‘‘<212>, Type,’’ have

been changed from ‘‘N’’ and ‘‘A’’, as

stated in the proposed rule, to ‘‘DNA,’’

‘‘RNA,’’ and ‘‘PRT’’ (protein) in order to

harmonize with WIPO Standard ST.25

(1998). A compound that is a mixture of

DNA and RNA should be represented by

‘‘DNA.’’ This change is consistent with

WIPO Standard ST.25 (1998).

Numeric identifier ‘‘<213>,

Organism,’’ has been added to the

Sequence Listing of these final rules in

an effort to harmonize with WIPO

Standard ST.25 (1998). A response for

the Organism identifier is

MANDATORY. The valid responses are

the scientific name, i.e. ‘‘Genus

species’’, ‘‘Artificial Sequence’’, or

‘‘Unknown.’’

Numeric identifier ‘‘<214>,

Topology,’’ of the proposed rule, has

been eliminated to harmonize with

WIPO Standard ST.25 (1998), and to

reduce the burden on the applicant.

Numeric identifier ‘‘<290>, Feature,’’

has become numeric identifier ‘‘<220>,

Feature.’’ This numeric identifier has

become MANDATORY for those

sequences in which numeric identifier

‘‘<213>, Organism,’’ is completed with

either ‘‘Artificial Sequence’’ or

‘‘Unknown.’’ This numeric identifier is

also required if the compound sequence

is a mixture of DNA and RNA. Numeric

identifier ‘‘<220>, Feature’’ is a header

only. No data are added immediately

following this numeric identifier. These

changes are required to achieve

harmonization with WIPO Standard

ST.25 (1998).

Numeric identifier ‘‘<291>, Name/

Key,’’ has become numeric identifier

‘‘<221>, Name/Key.’’ As proposed, the

information provided was restricted to a

maximum of four lines. The four line

restriction has been removed to reduce

the limitations on this field. The

comment section of this numeric

identifier has been changed in that it

now indicates that the selection of a

feature name or feature key is preferably

made from those listed in Tables 5 and

6 of WIPO Standard ST.25 (1998). These

tables are reproduced above and this

preference for the listed feature names

and keys is consistent with the

requirement of WIPO Standard ST.25

(1998).

Numeric identifier ‘‘<292>, Location,’’

has become ‘‘<222>, Location,’’ so as to

be consistent with the numeric

identifiers contained in WIPO Standard

ST.25 (1998).
29632 Federal Register / Vol. 63, No. 104 / Monday, June 1, 1998 /Rules and Regulations

Numeric identifier ‘‘<294>, Other

Information,’’ has become numeric

identifier ‘‘<223>, Other Information,’’

so as to be consistent with the numeric

identifiers contained in WIPO Standard

ST.25 (1998). This numeric identifier

has become MANDATORY for those

sequences in which numeric identifier

‘‘<213>, Organism,’’ is completed with

either ‘‘Artificial Sequence’’ or

‘‘Unknown’’. Numeric identifier

‘‘<223>, Other Information,’’ should

contain source information in those

instances when the organism is

unknown or is an artificial sequence.

For example, the source may be

unknown because the material was

isolated from a mixed bacterial culture

rather than a pure culture. In such a

case, numeric identifier ‘‘<223>, Other

Information,’’ should be completed by

explaining the mixed culture source of

the sequenced material. If a sequence is

completely synthesized this should be

indicated in numeric identifier ‘‘<223>,

Other Information,’’ while numeric

identifier ‘‘<213>, Organism,’’ would

indicate ‘‘Artificial Sequence.’’ This

change has been made to accomplish

harmonization between these rules and

WIPO Standard ST.25 (1998) which

contains the same mandatory

requirement in this regard.

Numeric identifiers ‘‘<308>’’ through

‘‘<310>,’’ referring to the ‘‘ Patent

Document Number,’’ ‘‘Filing Date’’ and

‘‘ Publication Date,’’ of the proposed

rule, have been moved to numeric

identifiers ‘‘<310>’’ to ‘‘<312>,’’

respectively, of this Final Rule in order

to harmonize with the numeric

numbering scheme of WIPO Standard

ST.25 (1998). Citations in the Sequence

Listing must comply with WIPO

Standard ST.6 for publication numbers

and WIPO Standard ST.16 for document

codes.

New numeric identifiers ‘‘<308>,

Database Accession Number,’’ and

‘‘<309> Database Entry Date,’’ have been

added to the final rules to harmonize

with WIPO Standard ST.25 (1998).

These fields were added to the

publication information section of

WIPO Standard ST.25 (1998) to give an

applicant more opportunity to further

identify a published citation.

Numeric identifier <400> ‘‘Sequence

Description: SEQ ID NO:#:’’ has been

changed to ‘‘Sequence ‘‘ for clarity. Also

for clarity, the explanation in the table

has been changed to ‘‘SEQ ID NO shall

follow the numeric identifier and

should appear on the line preceding the

sequence.’’

The format of the date fields has been

changed throughout the Sequence

Listing to accommodate for

international conventions. All date

fields referenced in the Sequence

Listing shall conform to WIPO Standard

ST.2. Because compliance with §§ 1.821

through 1.825 as amended should

produce Sequence Listings that are

acceptable to all receiving offices, a

standardized date field convention was

required.

Section 1.824

In paragraph (a)(6) of § 1.824, ‘‘, the

date on which the data were recorded

on the computer readable form’’ was

added after ‘‘title of the invention’’ to

harmonize with WIPO Standard ST.25

(1998) requirements. While this

requirement of § 1.824 was proposed to

be eliminated, that proposal is not

adopted for purposes of harmonization

with WIPO Standard ST.25 (1998). Also

in paragraph (a)(6) of § 1.824, ‘‘ name

and type of computer and’’ was deleted

to reduce the requirements.

Section 1.825

In paragraphs (a), (b), and (d) of

§ 1.825, the sentence ‘‘Such a statement

must be a verified statement if made by

a person not registered to practice before

the Office’’ has been deleted. The

separate verification requirements in

§ 1.825 have been eliminated in view of

the recent amendment to §§ 1.4(d) and

10.18. See Changes to Patent Practice

and Procedure; Final Rule, 62 FR. 53131

(October 10, 1997), 1203 Off. Gaz. Pat.

Office 63 (October 21, 1997).

Response to and Analysis of Comments

Six written comments were received

in response to the Notice of Proposed

Rulemaking. Several of these comments

address the three specific queries set

forth in the Notice of Proposed

Rulemaking.

The first query posed in the Notice of

Proposed Rulemaking was: (1) Should

the PTO accept voluntary submissions

of computer readable forms and

Sequence Listings where a D-amino acid

is contained in the sequence? If such

voluntary submissions are accepted,

should there be a restriction on the

choice of identifying a D-amino acid by

an Xaa or by its L-amino acid

counterpart abbreviation?

Comment: One comment indicated

that not only should the PTO accept

voluntary submissions under these rules

where a D-amino acid is contained in

the sequence, the Office should make

such submissions mandatory and

designated by an Xaa. One comment

indicated that sequences containing Damino acids should not be in the PTO

databases.

Response: Upon careful

consideration, the PTO has decided to

accept voluntary submissions of protein

sequences containing D-amino acids.

The PTO strongly encourages anyone

making such voluntary submissions to

identify a D-amino acid with an Xaa,

describing the D-amino acid in the

Features section of the Sequence

Listing. This section is indicated by

numeric identifiers <220> through

<223> in 37 CFR 1.823. Procedural

concerns compel this acceptance of

voluntary submissions. Computer

readable forms are processed prior to

examination. It is cumbersome to

establish a viable procedure to redact

any voluntary submissions out of the

PTO database. The use of Xaa to

indicate a D-amino acid, should such

sequence information be submitted in

accordance with these rules, is

encouraged so as to alert anyone

reviewing the sequence that a particular

amino acid is other than a naturally

occurring L-amino acid and to more

accurately depict the extent of

similarities between such a sequence

and the L-amino acid containing

sequences present in a database being

searched for examination or other

purposes.

Because the sequence databases do

not currently include D-amino acids in

sequences and thus are not searchable

for such sequences, the submission of

those sequences containing D-amino

acids will not be made mandatory.

The second query posed in the

proposed rules was: (2) Should the

provisions of 37 CFR 1.821(c) be altered

to exclude some prior art sequences

from inclusion in the Sequence Listing

even though they are presented in a

patent application disclosure as

sequences? Should the reference to an

accession number of an admitted prior

art sequence in a publicly available,

electronic, sequence database suffice

and exclude that sequence from the

requirements of the sequence rules?

Comment: Four comments indicated

that known ‘‘prior art’’ sequences

should not be required in the Sequence

Listing. A referral to a publicly

available, electronic, sequence database

for access to such ‘‘prior art’’ sequences

would be an acceptable alternative to

two of those commenting on this aspect;

the other two did not address this point.

The reasons given for excluding such

sequences are the expense and time

required by applicants and their

representatives in the inclusion of

‘‘prior art’’ sequences that are

considered to be ‘‘non-inventive’’.

Reducing the bulk of the paper copy of

the Sequence Listing was also

mentioned.

Response: The requirement to submit

all disclosed sequences in the format

required by §§ 1.821 through 1.825 is
Federal Register / Vol. 63, No. 104 / Monday, June 1, 1998 /Rules and Regulations 29633

maintained. This point was discussed

with officials from the JPO and EPO.

The offices have considered the stated

concerns with regard to costs to

applicants. Sections 1.821 through 1.825

do not require any information to be

disclosed in the form of a sequence, but

rather require a particular format

whenever information is presented in

the form of a sequence. Those

applicants for whom compliance with

the rules remains a significant hardship

may petition under § 1.183 for a waiver

of the applicable requirement of

§§ 1.821 through 1.825.

The technical and legal concerns

mentioned in the Notice of Proposed

Rulemaking still exist concerning the

use of an alternative reference to a

publicly available, electronic, sequence

database. These concerns are: (1) What

constitutes a publicly available,

electronic, sequence database? (2)

Would the USPTO and the other patent

offices which have similar rules be

required to produce a list of

internationally accepted databases? (3)

What would be the criteria for such

acceptance? (4) An additional issue

would exist involving electronic records

maintenance: is there any assurance that

once information is contained in a

database that it will be retained and

available indefinitely without

alteration? Changes to the information

in nucleic acid sequence databases

resulting from the discovery of

sequencing errors are well-known.

(5) Does the mere existence of the

sequence information in such a record

constitute reasonable means of retrieval?

In other words, would one need some

text basis or other identifier to retrieve

the information?

Additional reasons for the inclusion

of these prior art sequences remain

relevant. These reasons are: (1) the

assessment of whether a particular

sequence falls within the requirements

of the current rules is simple; (2) the

general public is assured that all patents

which contain any sequence

information contain all of the sequence

information in the Sequence Listing and

all sequences are available in a

computer accessible form; and (3) as a

publication, the contextual association

of new and old information is

potentially unique to the patent and

very valuable to anyone assessing the

state of the art at the time of a patented

invention, and thus are desirable to be

present in electronic form in association

with that patent.

The third query posed in the

proposed rules was: (3) Should

Sequence Listings filed in an

international application filed under the

PCT be published only electronically

and made available for retrieval

electronically by an accession number

from several sequence repositories?

Comment: Two comments were

received in response to this query, one

in favor and one opposed to limiting the

publication of the Sequence Listing to

an electronic form for published PCT

applications in the international phase.

Response: At this time paper copies of

the Sequence Listings filed as part of the

description will continue to be

published in applications filed under

PCT. The PTO together with the EPO,

JPO and WIPO will continue to discuss

the possibility of electronic publication.

However, any implementation of such

electronic publication in lieu of

publication in paper form will not be

undertaken until further study has been

completed.

Comment: One comment suggested

that informative English words be

placed next to the numerical headings

in the Sequence Listing as printed in a

U.S. patent.

Response: The PTO will provide

English words corresponding to the

numeric identifiers in the printed U.S.

patents.

Comment: One comment suggested

addition of a descriptive comment line

to the Sequence Listing.

Response: The ‘‘Other Information’’

line in the Features section, which is

numeric identifier <223> in § 1.823,

provides for a description of a sequence.

While completion of this section is only

mandatory when the sequence contains

‘‘n’’, ‘‘Xaa’’, a modified or unusual Lamino acid or a modified base, it is

frequently completed in other

circumstances.

Comment: One comment requested

we harmonize §§ 1.821 through 1.825

with PCT, EPO and other authorities

such that the differences in the

requirements for Sequence Listing

submissions are minimal.

Response: This change to §§ 1.821

through 1.825 is the result of such an

effort to harmonize the PTO, PCT, EPO

and JPO Sequence Listing requirements

to the extent possible. The requirements

of newly developed WIPO ST.25 are

substantially identical to the

requirements of amended §§ 1.821

through 1.825. PatentIn Version 2.0

software, now available, is drafted to

meet all of the requirements of WIPO

Standard ST.25 (1998). The

requirements of §§ 1.821 through 1.825,

however, are less stringent than the

requirements of WIPO Standard ST.25

(1998). Thus, applicants who wish to

file in countries which adhere to WIPO

Standard ST.25 (1998) should consider

the following when not using PatentIn

Version 2.0:

1. The WIPO Standard ST.25 (1998)

does not permit submissions using a

Macintosh computer.

2. The WIPO Standard ST.25 (1998)

does not accept the range of media

permitted by amended §§ 1.821 through

1.825.

3. The answers in field <221> and

<222> must use selections from Tables

5 and 6 of WIPO Standard ST.25 (1998)

to comply with that standard. The terms

from these Tables are considered

language neutral vocabulary.

4. Any free text in numeric identifier

<223> of a Sequence Listing will not be

translated and thus must also appear in

the specification of applications filed

under WIPO Standard ST.25 (1998) for

compliance.

5. A CRF filed after the filing of an

application under the PCT does not

form part of the disclosure and will not

be published in the pamphlet.

6. Paragraph 39 of WIPO Standard

ST.25 (1998) requires the specific

wording ‘‘the information recorded on

the form is identical to the written

sequence listing.’’

7. WIPO Standard ST.25 (1998),

paragraph 24, requires spaces between

specified numeric identifiers in the

Sequence Listing.

Comment: One comment requested a

WINDOWS based version of PatentIn.

Response: A WINDOWS based

version of PatentIn, PatentIn 2.0, has

been developed through a Trilaterallysponsored joint initiative and is being

made available.

Comment: One comment expressed

concern over application of the doctrine

of equivalents by the courts to sequencebased claim language.

Response: Sections 1.821 through

1.825 do not establish a disclosure

requirement, nor do they alter the

requirements of 35 U.S.C. § 112. They

merely require a particular format

whenever information is presented in

the form of a sequence. The use of

sequence identification numbers

(SEQ ID NO: #) only provides a

shorthand way for applicants to refer to

sequence information. These

identification numbers do not in any

way restrict the manner in which an

invention can be claimed. Similarly, the

use of this format does not impact the

potential interpretations and legal

determinations that could be made with

respect to claims containing information

in the form of a nucleotide or amino

acid sequence.

Comment: One comment requested

the flexibility to use single-letter amino

acid codes.

Response: Sections 1.821 through

1.825 as amended do not constrain an

applicant from using single letter codes
29634 Federal Register / Vol. 63, No. 104 / Monday, June 1, 1998 /Rules and Regulations

in the disclosure. The requirements of

the sequence searching and the

sequence storage mechanisms include

only the three-letter codes, thus the

need for the constraint on the Sequence

Listing information. There is no such

restriction on the sequence format in the

body of the disclosure or in the figures

imposed by §§ 1.821 through 1.825, or

any of the rules of practice; only the

format for the Sequence Listing is

specified by §§ 1.821 through 1.825.

Review Under the Paperwork

Reduction Act of 1995

Notwithstanding any other provision

of law, no person is required to respond

to nor shall a person be subject to a

penalty for failure to comply with a

collection of information subject to the

requirements of the Paperwork

Reduction Act (PRA) unless that

collection of information displays a

currently valid OMB control number.

This rule contains collections of

information requirements subject to the

PRA. The principal impact of this Final

Rule is: (1) Elimination of certain

requirements of §§ 1.821 through 1.825;

and (2) revision of §§ 1.821 through

1.825 for consistency with WIPO

Standard ST.25 (1998), which will

permit Sequence Listings to be

presented in an international, language

neutral format.

The public reporting burden for these

collections of information have been

approved by the Office of Management

and Budget (OMB) under OMB control

number 0651–0024. The public

reporting burden for this collection of

information is estimated to average 80

minutes per response, including the

time for reviewing instructions,

searching existing data sources,

gathering and maintaining the

information. Send comments regarding

this burden estimate or any other aspect

of the data requirements, including

suggestions for reducing this burden, to

Esther M. Kepplinger at the address

specified above or to the Office of

Information and Regulatory Affairs of

OMB, New Executive Office Bldg., 725

17th St. NW, rm. 10235, Washington,

DC 20230, Attn: Desk Officer for the

Patent and Trademark Office.

Other Considerations

This Final Rule is in conformity with

the requirements of the Regulatory

Flexibility Act (5 U.S.C. 601 et seq.),

Executive Order 12612 (October 26,

1987), and the Paperwork Reduction Act

of 1995 (44 U.S.C. 3501 et seq.). It has

been determined that this rulemaking is

not significant for the purposes of

Executive Order 12866 (September 30,

1993).

The Assistant General Counsel for

Legislation and Regulation of the

Department of Commerce has certified

to the Chief Counsel for Advocacy,

Small Business Administration that this

Final Rule would not have a significant

impact on a substantial number of small

entities (Regulatory Flexibility Act, 5

U.S.C. 605(b)). The principal impact of

this Final Rule is: (1) Elimination of

certain requirements of §§ 1.821 through

1.825; and (2) revision of §§ 1.821

through 1.825 for consistency with

WIPO Standard ST.25 (1998), which

will permit Sequence Listings to be

presented in an international, language

neutral format.

The Office has determined that this

Final Rule has no Federalism

implications affecting the relationship

between the National Government and

the States as outlined in Executive

Order 12612.

List of Subjects in 37 CFR Part 1

Administrative practice and

procedure, Courts, Freedom of

information, Inventions and patents,

Incorporation by reference, Reporting

and recordkeeping requirements, Small

businesses.

For the reasons set forth in the

preamble and under the authority

granted to the Commissioner of Patents

and Trademarks by 35 U.S.C. 6, Title 37

of the Code of Federal Regulations, part

1, is amended as follows:

PART 1—RULES OF PRACTICE IN

PATENT CASES

1. The authority citation for 37 CFR

part 1 continues to read as follows:

Authority: 35 U.S.C. 6, unless otherwise

noted.

2. Section 1.821 is revised to read as

follows:

§ 1.821 Nucleotide and/or amino acid

sequence disclosures in patent

applications.

(a) Nucleotide and/or amino acid

sequences as used in §§ 1.821 through

1.825 are interpreted to mean an

unbranched sequence of four or more

amino acids or an unbranched sequence

of ten or more nucleotides. Branched

sequences are specifically excluded

from this definition. Sequences with

fewer than four specifically defined

nucleotides or amino acids are

specifically excluded from this section.

‘‘Specifically defined’’ means those

amino acids other than ‘‘Xaa’’ and those

nucleotide bases other than ‘‘n’’ defined

in accordance with the World

Intellectual Property Organization

(WIPO) Handbook on Industrial

Property Information and

Documentation, Standard ST.25:

Standard for the Presentation of

Nucleotide and Amino Acid Sequence

Listings in Patent Applications (1998),

including Tables 1 through 6 in

Appendix 2, herein incorporated by

reference. (Hereinafter ‘‘WIPO Standard

ST.25 (1998)’’). This incorporation by

reference was approved by the Director

of the Federal Register in accordance

with 5 U.S.C. 552(a) and 1 CFR part 51.

Copies of WIPO Standard ST.25 (1998)

may be obtained from the World

Intellectual Property Organization; 34

chemin des Colombettes; 1211 Geneva

20 Switzerland. Copies of ST.25 may be

inspected at the Patent Search Room;

Crystal Plaza 3, Lobby Level; 2021

South Clark Place; Arlington, VA 22202.

Copies may also be inspected at the

Office of the Federal Register, 800 North

Capitol Street, NW, Suite 700,

Washington, DC. Nucleotides and amino

acids are further defined as follows:

(1) Nucleotides: Nucleotides are

intended to embrace only those

nucleotides that can be represented

using the symbols set forth in WIPO

Standard ST.25 (1998), Appendix 2,

Table 1. Modifications, e.g., methylated

bases, may be described as set forth in

WIPO Standard ST.25 (1998), Appendix

2, Table 2, but shall not be shown

explicitly in the nucleotide sequence.

(2) Amino acids: Amino acids are

those L-amino acids commonly found in

naturally occurring proteins and are

listed in WIPO Standard ST.25 (1998),

Appendix 2, Table 3. Those amino acid

sequences containing D-amino acids are

not intended to be embraced by this

definition. Any amino acid sequence

that contains post-translationally

modified amino acids may be described

as the amino acid sequence that is

initially translated using the symbols

shown in WIPO Standard ST.25 (1998),

Appendix 2, Table 3 with the modified

positions; e.g., hydroxylations or

glycosylations, being described as set

forth in WIPO Standard ST.25 (1998),

Appendix 2, Table 4, but these

modifications shall not be shown

explicitly in the amino acid sequence.

Any peptide or protein that can be

expressed as a sequence using the

symbols in WIPO Standard ST.25

(1998), Appendix 2, Table 3 in

conjunction with a description in the

Feature section to describe, for example,

modified linkages, cross links and end

caps, non-peptidyl bonds, etc., is

embraced by this definition.

(b) Patent applications which contain

disclosures of nucleotide and/or amino

acid sequences, in accordance with the

definition in paragraph (a) of this

section, shall, with regard to the manner

in which the nucleotide and/or amino
Federal Register / Vol. 63, No. 104 / Monday, June 1, 1998 /Rules and Regulations 29635

acid sequences are presented and

described, conform exclusively to the

requirements of §§ 1.821 through 1.825.

(c) Patent applications which contain

disclosures of nucleotide and/or amino

acid sequences must contain, as a

separate part of the disclosure, a paper

copy disclosing the nucleotide and/or

amino acid sequences and associated

information using the symbols and

format in accordance with the

requirements of §§ 1.822 and 1.823. This

paper copy is hereinafter referred to as

the ‘‘Sequence Listing.’’ Each sequence

disclosed must appear separately in the

‘‘Sequence Listing.’’ Each sequence set

forth in the ‘‘Sequence Listing’’ shall be

assigned a separate sequence identifier.

The sequence identifiers shall begin

with 1 and increase sequentially by

integers. If no sequence is present for a

sequence identifier, the code ‘‘000’’

shall be used in place of the sequence.

The response for the numeric identifier

<160> shall include the total number of

SEQ ID NOs, whether followed by a

sequence or by the code ‘‘000.’’

(d) Where the description or claims of

a patent application discuss a sequence

that is set forth in the ‘‘Sequence

Listing’’ in accordance with paragraph

(c) of this section, reference must be

made to the sequence by use of the

sequence identifier, preceded by ‘‘SEQ

ID NO:’’ in the text of the description or

claims, even if the sequence is also

embedded in the text of the description

or claims of the patent application.

(e) A copy of the ‘‘Sequence Listing’’

referred to in paragraph (c) of this

section must also be submitted in

computer readable form in accordance

with the requirements of § 1.824. The

computer readable form is a copy of the

‘‘Sequence Listing’’ and will not

necessarily be retained as a part of the

patent application file. If the computer

readable form of a new application is to

be identical with the computer readable

form of another application of the

applicant on file in the Patent and

Trademark Office, reference may be

made to the other application and

computer readable form in lieu of filing

a duplicate computer readable form in

the new application if the computer

readable form in the other application

was compliant with all of the

requirements of these rules. The new

application shall be accompanied by a

letter making such reference to the other

application and computer readable

form, both of which shall be completely

identified. In the new application,

applicant must also request the use of

the compliant computer readable

‘‘Sequence Listing’’ that is already on

file for the other application and must

state that the paper copy of the

‘‘Sequence Listing’’ in the new

application is identical to the computer

readable copy filed for the other

application.

(f) In addition to the paper copy

required by paragraph (c) of this section

and the computer readable form

required by paragraph (e) of this section,

a statement that the content of the paper

and computer readable copies are the

same must be submitted with the

computer readable form, e.g., a

statement that ‘‘the information

recorded in computer readable form is

identical to the written sequence

listing.’’

(g) If any of the requirements of

paragraphs (b) through (f) of this section

are not satisfied at the time of filing

under 35 U.S.C. 111(a) or at the time of

entering the national stage under 35

U.S.C. 371, applicant will be notified

and given a period of time within which

to comply with such requirements in

order to prevent abandonment of the

application. Any submission in reply to

a requirement under this paragraph

must be accompanied by a statement

that the submission includes no new

matter.

(h) If any of the requirements of

paragraphs (b) through (f) of this section

are not satisfied at the time of filing an

international application under the

Patent Cooperation Treaty (PCT), which

application is to be searched by the

United States International Searching

Authority or examined by the United

States International Preliminary

Examining Authority, applicant will be

sent a notice necessitating compliance

with the requirements within a

prescribed time period. Any submission

in reply to a requirement under this

paragraph must be accompanied by a

statement that the submission does not

include matter which goes beyond the

disclosure in the international

application as filed. If applicant fails to

timely provide the required computer

readable form, the United States

International Searching Authority shall

search only to the extent that a

meaningful search can be performed

without the computer readable form and

the United States International

Preliminary Examining Authority shall

examine only to the extent that a

meaningful examination can be

performed without the computer

readable form.

3. Section 1.822 is revised to read as

follows:

§ 1.822 Symbols and format to be used for

nucleotide and/or amino acid sequence

data.

(a) The symbols and format to be used

for nucleotide and/or amino acid

sequence data shall conform to the

requirements of paragraphs (b) through

(e) of this section.

(b) The code for representing the

nucleotide and/or amino acid sequence

characters shall conform to the code set

forth in the tables in WIPO Standard

ST.25 (1998), Appendix 2, Tables 1 and

3. This incorporation by reference was

approved by the Director of the Federal

Register in accordance with 5 U.S.C.

552(a) and 1 CFR part 51. Copies of

ST.25 may be obtained from the World

Intellectual Property Organization; 34

chemin des Colombettes; 1211 Geneva

20 Switzerland. Copies of ST.25 may be

inspected at the Patent Search Room;

Crystal Plaza 3, Lobby Level; 2021

South Clark Place; Arlington, VA 22202.

Copies may also be inspected at the

Office of the Federal Register, 800 North

Capitol Street, NW, Suite 700,

Washington, DC. No code other than

that specified in these sections shall be

used in nucleotide and amino acid

sequences. A modified base or modified

or unusual amino acid may be presented

in a given sequence as the

corresponding unmodified base or

amino acid if the modified base or

modified or unusual amino acid is one

of those listed in WIPO Standard ST.25

(1998), Appendix 2, Tables 2 and 4, and

the modification is also set forth in the

Feature section. Otherwise, each

occurrence of a base or amino acid not

appearing in WIPO Standard ST.25

(1998), Appendix 2, Tables 1 and 3,

shall be listed in a given sequence as

‘‘n’’ or ‘‘Xaa,’’ respectively, with further

information, as appropriate, given in the

Feature section, preferably by including

one or more feature keys listed in WIPO

Standard ST.25 (1998), Appendix 2,

Tables 5 and 6.

(c) Format representation of

nucleotides. (1) A nucleotide sequence

shall be listed using the lower-case

letter for representing the one-letter

code for the nucleotide bases set forth

in WIPO Standard ST.25 (1998),

Appendix 2, Table 1.

(2) The bases in a nucleotide sequence

(including introns) shall be listed in

groups of 10 bases except in the coding

parts of the sequence. Leftover bases,

fewer than 10 in number, at the end of

noncoding parts of a sequence shall be

grouped together and separated from

adjacent groups of 10 or 3 bases by a

space.

(3) The bases in the coding parts of a

nucleotide sequence shall be listed as

triplets (codons). The amino acids

corresponding to the codons in the

coding parts of a nucleotide sequence

shall be typed immediately below the

corresponding codons. Where a codon

spans an intron, the amino acid symbol
29636 Federal Register / Vol. 63, No. 104 / Monday, June 1, 1998 /Rules and Regulations

shall be typed below the portion of the

codon containing two nucleotides.

(4) A nucleotide sequence shall be

listed with a maximum of 16 codons or

60 bases per line, with a space provided

between each codon or group of 10

bases.

(5) A nucleotide sequence shall be

presented, only by a single strand, in the

5 to 3 direction, from left to right.

(6) The enumeration of nucleotide

bases shall start at the first base of the

sequence with number 1. The

enumeration shall be continuous

through the whole sequence in the

direction 5 to 3. The enumeration shall

be marked in the right margin, next to

the line containing the one-letter codes

for the bases, and giving the number of

the last base of that line.

(7) For those nucleotide sequences

that are circular in configuration, the

enumeration method set forth in

paragraph (c)(6) of this section remains

applicable with the exception that the

designation of the first base of the

nucleotide sequence may be made at the

option of the applicant.

(d) Representation of amino acids. (1)

The amino acids in a protein or peptide

sequence shall be listed using the threeletter abbreviation with the first letter as

an upper case character, as in WIPO

Standard ST.25 (1998), Appendix 2,

Table 3.

(2) A protein or peptide sequence

shall be listed with a maximum of 16

amino acids per line, with a space

provided between each amino acid.

(3) An amino acid sequence shall be

presented in the amino to carboxy

direction, from left to right, and the

amino and carboxy groups shall not be

presented in the sequence.

(4) The enumeration of amino acids

may start at the first amino acid of the

first mature protein, with the number 1.

When presented, the amino acids

preceding the mature protein, e.g., presequences, pro-sequences, pre-prosequences and signal sequences, shall

have negative numbers, counting

backwards starting with the amino acid

next to number 1. Otherwise, the

enumeration of amino acids shall start

at the first amino acid at the amino

terminal as number 1. It shall be marked

below the sequence every 5 amino

acids. The enumeration method for

amino acid sequences that is set forth in

this section remains applicable for

amino acid sequences that are circular

in configuration, with the exception that

the designation of the first amino acid

of the sequence may be made at the

option of the applicant.

(5) An amino acid sequence that

contains internal terminator symbols

(e.g., ‘‘Ter’’, ‘‘*’’, or ‘‘.’’, etc.) may not be

represented as a single amino acid

sequence, but shall be presented as

separate amino acid sequences.

(e) A sequence with a gap or gaps

shall be presented as a plurality of

separate sequences, with separate

sequence identifiers, with the number of

separate sequences being equal in

number to the number of continuous

strings of sequence data. A sequence

that is made up of one or more

noncontiguous segments of a larger

sequence or segments from different

sequences shall be presented as a

separate sequence.

4. Section 1.823 is revised to read as

follows:

§ 1.823 Requirements for nucleotide and/

or amino acid sequences as part of the

application papers.

(a) The ‘‘Sequence Listing’’ required

by § 1.821(c), setting forth the

nucleotide and/or amino acid sequences

and associated information in

accordance with paragraph (b) of this

section, must begin on a new page and

must be titled ‘‘Sequence Listing’’. The

‘‘Sequence Listing’’ preferably should be

numbered independently of the

numbering of the remainder of the

application. Each page of the ‘‘Sequence

Listing’’ should contain no more than 66

lines and each line should contain no

more than 72 characters. A fixed-width

font should be used exclusively

throughout the ‘‘Sequence Listing.’’

(b) The ‘‘Sequence Listing’’ shall,

except as otherwise indicated, include

the actual nucleotide and/or amino acid

sequence, the numeric identifiers and

their accompanying information as

shown in the following table. The

numeric identifier shall be used only in

the ‘‘Sequence Listing.’’ The order and

presentation of the items of information

in the ‘‘Sequence Listing’’ shall conform

to the arrangement given below. Each

item of information shall begin on a new

line and shall begin with the numeric

identifier enclosed in angle brackets as

shown. The submission of those items

of information designated with an ‘‘M’’

is mandatory. The submission of those

items of information designated with an

‘‘O’’ is optional. Numeric identifiers

<110> through <170> shall only be set

forth at the beginning of the ‘‘Sequence

Listing.’’ The following table illustrates

the numeric identifiers.

Numeric identifier Definition Comments and format Mandatory (M) or optional (O).

<110> ........... Applicant ........................ Preferably max. of 10 names; one name per line;

preferable format: Surname, Other Names and/

or Initials.

M.

<120> ........... Title of Invention ............ ................................................................................ M.

<130> ........... File Reference ............... Personal file reference .......................................... M when filed prior to assignment of appl. number.

<140> ........... Current Application

Number.

Specify as: US 07/999,999 or PCT/US96/99999 M, if available.

<141> ........... Current Filing Date ........ Specify as: yyyy–mm–dd ...................................... M, if available.

<150> ........... Prior Application Number.Specify as: US 07/999,999 or PCT/US96/99999 M, if applicable include priority documents under

35 USC 119 and 120.

<151> ........... Prior Application Filing

Date.

Specify as: yyyy–mm–dd ...................................... M, if applicable.

<160> ........... Number of SEQ ID NOs Count includes total number of SEQ ID NOs ....... M.

<170> ........... Software ........................ Name of software used to create the Sequence

Listing.

O.

<210> ........... SEQ ID NO:#: ................ Response shall be an integer representing the

SEQ ID NO shown.

M.

<211> ........... Length ........................... Respond with an integer expressing the number

of bases or amino acid residues.

M.
Federal Register / Vol. 63, No. 104 / Monday, June 1, 1998 /Rules and Regulations 29637

Numeric identifier Definition Comments and format Mandatory (M) or optional (O).

<212> ........... Type .............................. Whether presented sequence molecule is DNA,

RNA, or PRT (protein). If a nucleotide sequence contains both DNA and RNA fragments, the type shall be ‘‘DNA.’’ In addition,

the combined DNA/RNA molecule shall be further described in the <220> to <223> feature

section.

M.

<213> ........... Organism ....................... Scientific name, i.e. Genus/ species, Unknown or

Artificial Sequence. In addition, the ‘‘Unknown’’

or ‘‘Artificial Sequence’’ organisms shall be further described in the <220> to <223> feature

section.

M

<220> ........... Feature .......................... Leave blank after <220>. <221–223> provide for

a description of points of biological significance

in the sequence..

M, under the following conditions: if ‘‘n,’’ ‘‘Xaa,’’

or a modified or unusual L-amino acid or modified base was used in a sequence; if ORGANISM is ‘‘Artificial Sequence’’ or ‘‘Unknown’; if

molecule is combined DNA/RNA’’

<221> ........... Name/Key ...................... Provide appropriate identifier for feature, preferably from WIPO Standard ST.25 (1998), Appendix 2, Tables 5 and 6.M, under the following conditions: if ‘‘n,’’ ‘‘Xaa,’’

or a modified or unusual L-amino acid or modified base was used in a sequence.

<222> ........... Location ......................... Specify location within sequence; where appropriate state number of first and last bases/

amino acids in feature.

M, under the following conditions: if ‘‘n,’’ ‘‘Xaa,’’

or a modified or unusual L-amino acid or modified base was used in a sequence.

<223> ........... Other Information .......... Other relevant information; four lines maximum ... M, under the following conditions: if ‘‘n,’’ ‘‘Xaa,’’

or a modified or unusual L-amino acid or modified base was used in a sequence; if ORGANISM is ‘‘Artificial Sequence’’ or ‘‘Unknown’’; if

molecule is combined DNA/RNA.

<300> ........... Publication Information .. Leave blank after <300> ....................................... O.

<301> ........... Authors .......................... Preferably max of ten named authors of publication; specify one name per line; preferable format: Surname, Other Names and/or Initials.O.

<302> ........... Title ................................ ................................................................................ O.

<303> ........... Journal ........................... ................................................................................ O.

<304> ........... Volume .......................... ................................................................................ O.

<305> ........... Issue .............................. ................................................................................ O.

<306> ........... Pages ............................ ................................................................................ O.

<307> ........... Date ............................... Journal date on which data published; specify as

yyyy–mm–dd, MMM–yyyy or Season-yyyy.

O.

<308> ........... Database Accession

Number.

Accession number assigned by database including database name.O.

<309> ........... Database Entry Date ..... Date of entry in database; specify as yyyy–mm–

dd or MMM–yyyy.

O.

<310> ........... Patent Document Number.Document number; for patent-type citations only.

Specify as, for example, US 07/999,999.

O.

<311> ........... Patent Filing Date ......... Document filing date, for patent-type citations

only; specify as yyyy–mm–dd.

O.

<312> ........... Publication Date ............ Document publication date, for patent-type citations only; specify as yyyy–mm–dd.O.

<313> ........... Relevant Residues ........ FROM (position) TO (position) .............................. O.

<400> ........... Sequence ...................... SEQ ID NO should follow the numeric identifier

and should appear on the line preceding the

actual sequence.

M.

5. Section 1.824 is revised to read as

follows:

§ 1.824 Form and format for nucleotide

and/or amino acid sequence submissions in

computer readable form.

(a) The computer readable form

required by § 1.821(e) shall meet the

following specifications:

(1) The computer readable form shall

contain a single ‘‘Sequence Listing’’ as

either a diskette, series of diskettes, or

other permissible media outlined in

paragraph (c) of this section.

(2) The ‘‘Sequence Listing’’ in

paragraph (a) (l) of this section shall be

submitted in American Standard Code

for Information Interchange (ASCII) text.

No other formats shall be allowed.

(3) The computer readable form may

be created by any means, such as word

processors, nucleotide/amino acid

sequence editors or other custom

computer programs; however, it shall

conform to all specifications detailed in

this section.

(4) File compression is acceptable

when using diskette media, so long as

the compressed file is in a selfextracting format that will decompress

on one of the systems described in

paragraph (b) of this section.

(5) Page numbering shall not appear

within the computer readable form

version of the ‘‘Sequence Listing’’ file.

(6) All computer readable forms shall

have a label permanently affixed thereto

on which has been hand-printed or

typed: the name of the applicant, the

title of the invention, the date on which

the data were recorded on the computer

readable form, the operating system

used, a reference number, and an

application serial number and filing

date, if known.
29638 Federal Register / Vol. 63, No. 104 / Monday, June 1, 1998 /Rules and Regulations

(b) Computer readable form

submissions must meet these format

requirements:

(1) Computer: IBM PC/XT/AT, or

compatibles, or Apple Macintosh;

(2) Operating System: MS–DOS, Unix

or Macintosh;

(3) Line Terminator: ASCII Carriage

Return plus ASCII Line Feed;

(4) Pagination: Continuous file (no

‘‘hard page break’’ codes permitted);

(c) Computer readable form files

submitted may be in any of the

following media:

(1) Diskette : 3.50 inch, 1.44 Mb

storage; 3.50 inch, 720 Kb storage; 5.25

inch, 1.2 Mb storage; 5.25 inch, 360 Kb

storage.

(2) Magnetic tape: 0.5 inch, up to

24000 feet; Density: 1600 or 6250 bits

per inch, 9 track; Format: Unix tar

command; specify blocking factor (not

‘‘block size’’); Line Terminator: ASCII

Carriage Return plus ASCII Line Feed.

(3) 8mm Data Cartridge: Format: Unix

tar command; specify blocking factor

(not ‘‘block size’’); Line Terminator:

ASCII Carriage Return plus ASCII Line

Feed.

(4) CD–ROM: Format: ISO 9660 or

High Sierra Format

(5) Magneto Optical Disk: Size/

Storage Specifications: 5.25 inch, 640

Mb.

(d) Computer readable forms that are

submitted to the Office will not be

returned to the applicant.

6. Section 1.825 is revised to read as

follows:

§ 1.825 Amendments to or replacement of

sequence listing and computer readable

copy thereof.

(a) Any amendment to the paper copy

of the ‘‘Sequence Listing’’ (§ 1.821(c))

must be made by the submission of

substitute sheets. Amendments must be

accompanied by a statement that

indicates support for the amendment in

the application, as filed, and a statement

that the substitute sheets include no

new matter.

(b) Any amendment to the paper copy

of the ‘‘Sequence Listing,’’ in

accordance with paragraph (a) of this

section, must be accompanied by a

substitute copy of the computer

readable form (§ 1.821(e)) including all

previously submitted data with the

amendment incorporated therein,

accompanied by a statement that the

copy in computer readable form is the

same as the substitute copy of the

‘‘Sequence Listing.’’

(c) Any appropriate amendments to

the ‘‘Sequence Listing’’ in a patent; e.g.,

by reason of reissue or certificate of

correction, must comply with the

requirements of paragraphs (a) and (b) of

this section.

(d) If, upon receipt, the computer

readable form is found to be damaged or

unreadable, applicant must provide,

within such time as set by the

Commissioner, a substitute copy of the

data in computer readable form

accompanied by a statement that the

substitute data is identical to that

originally filed.

7. Appendix A To Subpart G to Part

1 is revised to read as follows:

BILLING CODE 3510–16–P
Federal Register / Vol. 63, No. 104 / Monday, June 1, 1998 /Rules and Regulations 29639

Appendix A To Subpart G to Part 1—Sample Sequence Listing
29640 Federal Register / Vol. 63, No. 104 / Monday, June 1, 1998 /Rules and Regulations
Federal Register / Vol. 63, No. 104 / Monday, June 1, 1998 /Rules and Regulations 29641
29642 Federal Register / Vol. 63, No. 104 / Monday, June 1, 1998 /Rules and Regulations
Federal Register / Vol. 63, No. 104 / Monday, June 1, 1998 /Rules and Regulations 29643

Dated: May 22, 1998.

Bruce A. Lehman,

Assistant Secretary of Commerce and

Commissioner of Patents and Trademarks.

[FR Doc. 98–14194 Filed 5–29–98; 8:45 am]

BILLING CODE 3510–16–C