[Federal Register Volume 61, Number 194 (Friday, October 4, 1996)]
[Proposed Rules]
[Pages 51855-51875]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-25074]
[[Page 51855]]
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DEPARTMENT OF COMMERCE
Patent and Trademark Office
37 CFR Part 1
[Docket No: 960828235-6235-01]
RIN 0651-AA88
Changes Implementing Nucleotide and/or Amino Acid Sequence
Listings
AGENCY: Patent and Trademark Office, Commerce.
ACTION: Notice of proposed rulemaking and request for comments.
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SUMMARY: The Patent and Trademark Office (PTO) is proposing to amend
the rules for submitting nucleic acid or amino acid sequences in
computer readable form (CRF) for patent applications to simplify the
requirements of the rules, to rearrange portions of the rules for
better understanding and to establish consistent rules to permit a
single internationally acceptable computer readable form. The Sequence
Listing will be presented in an international, language neutral format
using numeric identifiers rather than the current subject headings and
the paper Sequence Listing will be a separately numbered section of the
patent application. Sequences which contain fewer than four (4)
specifically identified nucleotides or amino acids will no longer be
required to be submitted in computer readable form.
DATE: Written comments must be received by December 3, 1996.
ADDRESSES: Address written comments to: Box Comments--Patents,
Assistant Commissioner for Patents, Washington, DC 20231, Attention:
Esther M. Kepplinger or by Fax to (703) 305-3601 to her attention.
Comments may be sent by mail message over the Internet addressed to
seqrule@uspto.gov. The written comments will be available for public
inspection in Suite 520, Crystal Park One, 2011 Crystal Drive,
Arlington, Virginia.
FOR FURTHER INFORMATION CONTACT: Esther M. Kepplinger, by telephone at
(703) 308-2339 or by mail addressed to: Box Comments--Patents,
Assistant Commissioner for Patents, Washington, DC 20231 marked to her
attention or by Fax to (703) 305-3601 or by electronic mail at
ekepplin@uspto.gov.
SUPPLEMENTARY INFORMATION: The existing sequence rules (37 CFR 1.821-
1.825) 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). The
existing sequence rules have provided 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 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.
In an effort to streamline and reduce the procedural requirements
of the existing rules and to respond to the needs of our customers
while establishing an internationally acceptable standard, the PTO
proposes to modify the current rules requiring the submission of
computer readable forms for nucleotide and amino acid sequences.
To decrease the burden on applicants who file applications
containing nucleotide and amino acid sequence information under the
Patent Cooperation Treaty (PCT), the PTO entered into discussions at
the PCT Meeting of International Authorities (MIA) in November 1994 on
changing the applicable rules for submission and transfer of Sequence
Listings. Under the current PCT rules, each International Searching
Authority and national Office may set the standard for submission of
the paper and electronic Sequence Listing information. This may impose
a burden on applicants of providing several different formats of
Sequence Listings in different languages during the international and
national phases of the PCT procedure.
Under the current PCT practice, the applicant serves as the data
repository for requests during each stage of the PCT practice for new
electronic copies of the Sequence Listings.
Under national practice, a Sequence Listing may be required to be
translated into the national language at considerable cost and posing
the danger that the data could be inadvertently altered.
At the November 1994 MIA to address these problems, rule changes
were proposed to require a language neutral Sequence Listing submission
which would suffice for PCT and national stage sequence information
processing. Initial Trilateral meetings and correspondence suggest that
such a sequence submission would be acceptable under European Patent
Office (EPO) and Japanese Patent Office (JPO) procedures, thus further
lessening the burden on applicants.
These sequence rules are proposed to be revised in concert with
World Intellectual Property Organization (WIPO) International Standards
ST.23 and ST.24 for the paper and electronic submission of sequence
information in patent applications, as well as PCT requirements. This
should result in an applicant having to produce a single Sequence
Listing that would satisfy the filing requirements in all countries, as
well as permitting an applicant to submit only a single electronic
Sequence Listing in PCT applications.
In an effort to profit from the experiences of the nucleotide
database information providers which pioneered the electronic
submission of sequence information, the PTO discussed with them the
possible simplification of the PTO sequence submission rules. In
response to their advice (which confirmed the PTO experience), the
number of mandatory data elements is proposed to be reduced.
Thus, the proposed rule changes 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 as a section with separately numbered pages;
(4) Modification of 37 CFR Sec. 1.77 to include the paper Sequence
Listing as a part of the specification and to provide a place for the
paper Sequence Listing in the printed patent;
(5) Elimination of the requirement to provide a submission for
sequences with fewer than four specifically defined nucleotides or
amino acids;
(6) Use of lower-case one-letter codes for nucleotide bases;
(7) Rearrangement of portions of the rules to improve their
context; and
(8) Clarification and simplification of the rules to aid in
understanding of the requirements that they set forth.
Request for Comments
The PTO is particularly interested in receiving comments on three
queries. Currently sequences containing D-amino acids need not be
provided in the ``Sequence Listing'', but the PTO has accepted
voluntary submissions of sequences containing D-amino acids.
The commercially available sequence searching software used to
search prior art databases is not capable of discerning D-amino acids
since they do not have distinct designators. It is for this reason that
the rules do not require a computer readable form for the disclosure of
sequences which contain D-amino acids.
Those seeking to volunteer the information in accordance with these
[[Page 51856]]
rules might be seeking assurance that a machine search of the closest
prior art will be conducted by the PTO or they consider the information
useful and wish it to be in the database. If the PTO does not accept
voluntary submissions, that would exclude information from the
databases that at least some applicants believe to be valuable
information.
The potential conflict created by accepting these D-amino acid-
containing sequences is that the published database will contain
sequences with D-amino acids and those using the published database may
be operating on the assumption that it does not, given the indication
in Sec. 1.821(a)(2) that D-amino acid-containing sequences are not
intended to be included. For this reason, there may be an advantage to
having the D-amino acids indicated by Xaa to alert the user that the
Feature section must be consulted. A disadvantage of voluntary
submissions is that they will result in the generation of a database
which is incomplete and cannot be relied upon to provide a complete
search of the U.S. patent literature including sequences containing D-
amino acids.
The PTO seeks comments on the following query:
(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?
Section 1.821(c) will continue to require that all sequence
information contained in a disclosure, including in the specification,
drawings or claims, be presented in the Sequence Listing in accordance
with Secs. 1.821--1.825. This provision does not discriminate between
prior art sequences and ``new'' sequences. The PTO has received
comments in the past and is seeking additional comments on this issue.
The suggestion has been made that sequences which are prior art, and/or
are contained in a database at the time of filing, need not be provided
to the PTO in computer readable form since the sequence information is
obtainable by other means. Responsive to these public comments, the PTO
is considering amending the rules to permit omission of some sequences
from the Sequence Listing if these sequences are admitted prior art to
applicant and are in a publicly available, electronic, sequence
database and the database accession number is supplied.
The suggestion to exclude prior art sequences was made when
Secs. 1.821-1.825 were originally adopted. 55 FR 18230, 18237 (1990).
The final rules, however, required the submission of all sequence
information in computer readable form. The reasons for that decision
include: (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;
(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; and (4) these rules 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. These reasons continue to be relevant.
The PTO is concerned about how such a provision would be drafted
without creating difficult questions. A provision which excludes
sequences whenever a sequence is prior art and has previously been
included in a publicly available, electronic, sequence database appears
to be straightforward; however, many technical and legal issues would
result. What constitutes a publicly available, electronic, sequence
database? Would the USPTO and the other patent offices which have
similar rules be required to produce a list of internationally accepted
databases? What would be the criteria for such acceptance? 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. Does the mere
existence of the sequence information in such a record constitute
reasonable means of retrieval? Would not one need some text basis or
other identifier to retrieve the information?
Concerns have been voiced that the redundancy of including old
sequences in the PTO database creates electronic searching problems,
such as increased cost and reduced speed. Upon investigation, it has
been found that requiring all disclosed sequences to be included in the
Sequence Listing does not cause search processing problems at the PTO
or incur increased costs. The PTO seeks comments on the following
query:
(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?
At the November 1994 MIA, it was proposed that the Sequence
Listings submitted in an international application filed under the PCT
would no longer be published on paper. It was suggested that the
Sequence Listings be published electronically and be available in the
electronic form from several sequence repositories throughout the
world. These repositories would have the Sequence Listings available in
electronic form at the time of publication of the PCT pamphlet.
The PTO seeks comments on the following query:
(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?
Written comments will be available for public inspection and will
be available on the Internet (address: www.uspto.gov). Commentators
should note that since their comments will be made publicly available,
information that is not desired to be made public, such as the address
and phone number of the commentator, should not be included in the
comments. A public hearing will not be conducted.
Discussion of Specific Rules
Section 1.77 is proposed to be amended by revising paragraph (g),
which would provide for a reference to a Sequence Listing Annex, if any
exists. In the application as filed, on a separate page immediately
before the claims, reference would be made to a Sequence Listing Annex
and the Sequence Listing would be provided as a separately numbered
section or Annex to the application. In a printed patent the Sequence
Listing would appear immediately before the claims.
Section 1.77 is proposed to be amended to redesignate existing
paragraphs (g)-(j) as paragraphs (h)-(k) and add an additional
paragraph (l) Sequence Listing Annex. In the application as filed, the
Sequence Listing would be provided by applicants as a separately
numbered section or
[[Page 51857]]
Annex of the application. The pages of the Sequence Listing Annex
should be numbered independently from the specification using
sequential integers preceded by ``A'' to identify them as a part of the
Annex and to prevent any confusion which might arise from using numbers
already used in the specification. In a printed patent the Sequence
Listing would be printed immediately before the claims. In cases where
the Sequence Listing is voluminous, the files are difficult to handle.
This change would permit easier storage of very large Sequence Listings
apart from the main part of the application during pendency. The
presentation of the Sequence Listing as a separate Annex would also
facilitate compliance with PCT requirements and other national patent
office rules.
Sections 1.821(a)(1) and (2) are proposed to be amended by
referring to sections in World Intellectual Property Organization
(WIPO) Handbook on Industrial Property Information and Documentation,
Standard ST.23, paragraphs 8 through 12, April 1994, herein
incorporated by reference, rather than to paragraphs in Sec. 1.822. The
WIPO Standard ST. 23 (April 1994) is consistent with Sec. 1.822 except
for certain corrections which are noted herein and the requirement of
the use of the lower case for the one-letter code for nucleotide bases.
The proposed rule states that the incorporation has been approved. This
language is required by the Federal Register. This incorporation by
reference will be reviewed by the Director of the Federal Register in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51 before any Final Rule
is adopted. 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; or at the
Office of the Federal Register, 800 North Capitol Street, NW, Suite
700, Washington, DC 20408.
Section 1.821(a) is proposed to be amended so that sequences with
fewer than four specifically defined amino acids or nucleotides would
be expressly excluded from this rule. ``Specifically defined'' means
those amino acids other than ``Xaa'' and those nucleotide bases other
than ``N'' defined in accordance with WIPO Standard ST.23.
This change is being proposed to reduce the burden on applicants
for those sequences that contain only a minimal amount of sequence
information. For example, if an amino acid sequence is disclosed as
being entirely ``Xaa'' residues, the 1990 version of the sequence rules
would require this sequence to be submitted in computer readable form.
However, this sequence has no value as sequence information because
each of the positions is represented as a ``wild card.'' Such low-
information sequences are not very useful in any sequence matching and
alignment algorithm. In order to minimize the inclusion of such low-
information-value sequence data in the database and to relieve the
burden on applicants to submit low-information-value sequences, the
Office proposes this change to the sequence rules. If applicants should
wish to voluntarily submit a CRF for such sequences, they would be
accepted and entered in the PTO's database.
It is not necessary that any of the non-N or non-Xaa residues be
adjacent to any other non-N or non-Xaa residue in order for a sequence
to be subject to Sec. 1.821(a).
Sections 1.821(a)(2) and 1.822(b) are proposed to be amended by
changing ``elsewhere in the `Sequence Listing' '' to ``in the Feature
section.'' The purpose of this change is to enhance clarity of the
rule. The only place in the ``Sequence Listing'' where additional
information is permitted is in the Feature section. The current
language implies that there are other acceptable portions of the
``Sequence Listing'' appropriate for additional information and thus is
ambiguous and misleading.
Section 1.821(a)(2) will continue to indicate that sequences
containing D-amino acids need not comply with the provisions of
Secs. 1.822-1.825. To date, the PTO has accepted voluntary submissions
of sequences which contain D-amino acids. The sequence information has
either indicated an Xaa at each occurrence of a D-amino acid or has
indicated the amino acid (or imino acid) by abbreviation as if it were
an L-amino acid (or imino acid) and explained the existence of the D-
amino acid in the Feature section associated with that sequence.
Section 1.821(c) is proposed to be amended by clarifying and
establishing a language neutral format sequence listing. Specifically,
the use of integer identifiers is proposed for identifying sequences.
Where a sequence integer identifier is intentionally omitted, it must
be noted by applicant to avoid confusion in the published document.
Section 1.821(d) is proposed to be amended by changing ``assigned
identifier'' to ``integer identifier'' to be consistent with the term
used in Sec. 1.821(c).
Section 1.821(d) is proposed to be amended by adding the phrase,
``preceded by `SEQ ID NO:' ''. This change is necessitated by the
change to Sec. 1.821(c). Since the integer identifier in the ``Sequence
Listing'' would be defined now as a numeral only, it is necessary that
any reference to a particular sequence in the specification and claims
be preceded by ``SEQ ID NO:''. It is not acceptable to use only a
numeric identifier, such as ``<200>'' or ``<400>''--see infra Sequence
Listing table, in the description or the claims because one reading a
patent may not reasonably be presumed to be familiar with the meanings
of numeric identifiers.
Section 1.821(e) is proposed to be amended by setting forth the
procedure for transferring an accepted computer readable Sequence
Listing from one application to a subsequently filed application. The
existing rules did not adequately describe the process of transferring
a computer readable Sequence Listing into a new application if an
identical CRF was previously accepted by the PTO for another
application. A further description of the intended procedures has been
added for purposes of clarity. This section is intended to describe
that if a computer readable Sequence Listing is identical to one that
is error-free and already on file at the PTO, an applicant has two
options. A new diskette may be submitted, or an applicant may submit a
statement clearly directing the PTO to use the previously submitted CRF
since they are identical, and that the paper copy of the Sequence
Listing in the new application is identical to the disk in the previous
application.
Section 1.821(g) is proposed to be amended by correcting the
reference to 35 U.S.C. 111(a) applications. Section 1.821(h) is
proposed to be amended by clarifying that this rule applies to all
international applications searched and examined by the PTO. In
addition to international applications filed in the United States
Receiving Office, the United States is a competent International
Searching Authority (ISA) for applications filed in receiving Offices
of, or acting for, Brazil, Israel, Mexico, and Trinidad and Tobago. The
United States is also a competent ISA for applications filed in the
International Bureau where at least one of the applicants is a resident
or national of the United States or a resident or national of Barbados.
In addition, the United States acts as an International Preliminary
Examining Authority for certain applications searched in the EPO. The
language change regarding the time limit for compliance and statement
accompanying the submission are
[[Page 51858]]
necessary to conform with the language found in PCT Rule 13ter.1.
Section 1.822 is proposed to be revised for clarity and better
organization and to accommodate an international request for the use of
lower case one-letter codes for nucleotide bases.
Section 1.822 (b) is proposed to be amended to refer to WIPO
Standard ST.23 (April 1994) and incorporate the information therein.
The reorganization groups all nucleotide and all amino acid formats
together.
Section 1.822 (c)(1) is proposed to be amended by requiring the use
of lower case one-letter code for the nucleotide bases. This change
would put the PTO requirements in conformance with most large
databases. Additionally, the use of lower case letters in a sequence
makes the confusion of ``g'' for ``c'' and vice versa less likely.
Current paragraph (d) is proposed to be redesignated as a part of
subparagraph (c)(3) and current paragraph (e) is proposed to be deleted
with the substance of the paragraph being incorporated into (d)(1).
Current paragraph (f) is proposed to be redesignated as subparagraph
(c)(2); current paragraph (g) is proposed to be redesignated as
subparagraph (c)(3) and amended to incorporate current paragraph (d).
Current paragraph (h) is proposed to be redesignated as subparagraph
(d)(2). Current paragraphs (i) and (j) are proposed to be redesignated
as (c)(4) and (c)(5). Current paragraph (k) is proposed to be
redesignated as (d)(3). Current paragraph (l) is proposed to be
redesignated as (c)(6) and current paragraph (m) is proposed to be
redesignated as (d)(4). Current paragraph (n) is proposed to be
redesignated as (c)(7) and amended to delete a sentence, the substance
of which is incorporated into (d)(4).
Paragraph (d)(1) is proposed to be added to include a reference to
WIPO Standard ST.23 (April 1994). Paragraphs (d)(2-4) incorporate the
material from current paragraphs (h), (k), (m) and a sentence of (n).
Paragraph (d)(5) is proposed to be added to clarify that the use of
terminator symbols is not acceptable in amino acid sequences either as
``internal'' terminator symbols or following the carboxy terminal amino
acid of a peptide or polypeptide.
Current paragraph (o) is proposed to be redesignated as paragraph
(e) and amended to recite integer identifier to be consistent with
Sec. 1.821 (c) and to permit the language neutral submission.
Current paragraph (p) is proposed to be deleted.
The lists of nucleic acid and amino acid abbreviations and the
lists of modified base controlled vocabulary and the modified and
unusual amino acids would be replaced by reference to WIPO Standard
ST.23 RECOMMENDATION FOR THE PRESENTATION OF NUCLEOTIDE AND AMINO ACID
SEQUENCE LISTINGS IN PATENT APPLICATIONS AND IN PUBLISHED PATENT
DOCUMENTS (April 1994) to simplify and shorten the rules. This
information will also appear in an appropriate section of the Manual of
Patent Examining Procedure to assist applicants in preparing Sequence
Listings. For purposes of facilitating review of these proposed rule
changes, appropriate corrected excerpts of paragraphs 8, 9, 11 and 12
of WIPO Standard ST.23 are provided below.
WIPO Standard ST.23, paragraph 8, provides that the bases of a
nucleotide sequence should be represented using the following one-
letter code for nucleotide sequence characters.
------------------------------------------------------------------------
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 3H-
bonds.
W................... A or T/U................ Weak interactions 2H-
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 aNy.
(unknown or other).
------------------------------------------------------------------------
WIPO Standard ST.23, paragraph 9, provides: 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 elsewhere in the Sequence Listing.
The codes from the list below may be used in the description or the
Sequence Listing but not in the sequence itself.
----------------------------------------------------------------------------------------------------------------
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-galactosylqueosine.
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.
[[Page 51859]]
man q............................................................ *beta, D-mannosylqueosine.
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 (v).
osyw............................................................. wybutoxosine.
p................................................................ pseudouridine.
q................................................................ *queosine.
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.
yw............................................................... wybutosine.
x................................................................ 3-(3-amino-3-carboxy-propyl)uridine, (acp3)u.
----------------------------------------------------------------------------------------------------------------
*Indicates a correction of minor typographical errors.
WIPO Standard ST.23, paragraph 11, provides that the amino acids
should be represented using the following three-letter code with the
first letter as a capital.
------------------------------------------------------------------------
Symbol Meaning
------------------------------------------------------------------------
Ala................................. Alanine.
Cys................................. Cysteine.
Asp................................. Aspartic Acid.
Glu................................. Glutamic Acid.
Phe................................. Phenylalanine.
Gly................................. Glycine.
His................................. Histidine.
Ile................................. Isoleucine.
Lys................................. Lysine.
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.23, paragraph 12, provides: Modified and unusual
amino acids may be represented as the corresponding unmodified amino
acids in the sequence itself if the modified amino acid is one of those
listed below and the modification is further described elsewhere in the
Sequence Listing. The codes from the list below may be used in the
description or the Sequence Listing but not in the sequence itself.
------------------------------------------------------------------------
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.
------------------------------------------------------------------------
* Indicates a correction of a minor typographical error.
Section 1.823(a) is proposed to be amended to provide for a
reference to a Sequence Listing Annex in the application immediately
before the claims and to provide the paper Sequence Listing as an
Annex, which is a separately numbered section of the application. This
is an internationally desired change and also would facilitate easier
storage of very large Sequence Listings separate from the main part of
the file during pendency of the application.
Section 1.823(b) is proposed to be amended to insert a table to
depict items of information (data elements) which are to be included in
the Sequence Listing and to indicate whether they are mandatory or
optional. The proposed revisions reflect the change to a language
neutral submission. The English language data elements headings would
be replaced by numeric identifiers. The numeric identifiers are similar
to INID codes (``Internationally agreed Numbers for the Identification
of Data'' as per WIPO Standard ST.9, December 1990) already utilized
internationally in patent documents. This change would facilitate a
single international standard which would eliminate the need for
translations into non-English languages.
Large portions of Section 1.823(b) are proposed to be deleted to
lessen the burden on applicants and to eliminate collections of
material which is of limited use to the Office. The following items are
typical of material which would be deleted:
(1)(vi)(C) CLASSIFICATION;
(2)(i)(C) STRANDEDNESS;
(2)(ii) MOLECULE TYPE through (2)(vii)(C) UNITS; and
(2)(ix)(C) IDENTIFICATION METHOD.
In order to clarify the rule, the proposed change would identify
specifically those items which can be enumerated once in a Sequence
Listing. It is proposed that the recommended designation be eliminated,
leaving only mandatory and optional elements. Accordingly, it is
proposed to change element <140> Correspondence Address
[[Page 51860]]
and elements <150> through <154> from mandatory to optional. Elements
<100> General Information, <200> Information for SEQ ID NO, and <400>
Sequence Description: SEQ ID NO have been clarified as mandatory. In
element <193>, it is proposed to change TELEX to Electronic mail
address to be current with technology.
It is proposed to eliminate Strandedness because the information is
of limited use to the Office. It is proposed to limit the response for
Topology to linear or circular because any other response does not
permit an adequate search. Because it is essential to the search to
know whether the sequence is circular, providing one of these two
responses to this data element is mandatory in the Sequence Listing.
Consistent with the international desire for eliminating language in
the Sequence Listing, Topology would be identified as L (linear) or C
(circular), and sequence Type would be N (nucleotide) or A (amino
acid).
It is proposed to change Feature from a recommended to a mandatory
element if the sequence contains ``N'', ``Xaa'', a modified or unusual
L-amino acid or a modified base. This change would highlight the
presence of an unusual residue in the sequence which is important to
anyone using Sequence Listing information.
Section 1.824 is proposed to be amended by revising the current
paragraphs (a) through (h) into paragraphs (a) through (c).
Specifically, the following changes are proposed for Sec. 1.824:
Current Sec. 1.824, paragraph (a), is proposed to be redesignated
as paragraph (a)(1). In addition, the term ``series of diskettes''
would be added to indicate the acceptability of receiving numerous
disks for large submissions. Current paragraph (b) is proposed to be
redesignated as paragraph (a)(2). Current paragraph (c) is proposed to
be redesignated as paragraph (a)(3). Current paragraph (d) is proposed
to be deleted because it is incorporated into subparagraph (a)(1).
Current paragraph (e) is proposed to be deleted since the PTO has not
found it to be necessary and feels it should not be a requirement
placed on the applicant, although the applicant may optionally continue
the practice of using write-protection if desired. In proposed
paragraph (a)(4), a ``compressed file'' format would be introduced as
an acceptable means to submit a large sequence listing, and in proposed
paragraph (a)(5), directions on suppressing page numbering on the
computer readable form version would be added for clarity.
The text of current paragraph (f) is proposed to be deleted, but
the list of computer readable files is proposed to be redesignated as
subparagraphs under new (b) and (c). In proposed paragraph (b), the
explanation for ``pagination'' is proposed to be revised to reflect the
correct format required. Proposed paragraph (b)(1) is proposed to be
revised by deleting diskettes from PS/2 operating system as an accepted
format. In proposed paragraph (c), the diskette requirements are
proposed to be rearranged so that the most common diskette size used
for submissions is at the top of the list. Also in proposed paragraph
(c)(2), ``format'' is proposed to be amended to accommodate the current
PTO equipment, and in proposed new paragraphs (c)(3), (4), and (5),
additional items would be added to the list of acceptable media types
due to the changes in available equipment at the PTO.
Current paragraph (g) is proposed to be redesignated as paragraph
(d).
Current paragraph (h) is proposed to be deleted because the text is
proposed to be incorporated into paragraph (a)(6). The label
requirements would be rewritten more concisely than with the previous
rules. In addition, fewer items would be required to be placed on the
label under this proposed paragraph because the other items are no
longer deemed necessary by the PTO.
Current Appendix A is proposed to be rewritten to reflect the
correct format of a Sequence Listing. The proposed Appendix A is
presented to provide a sample listing in the correct format as
described in the Table of amended Sec. 1.823(b). This sample includes
the use of numeric identifiers which reflect the change to a language
neutral submission. Current Appendix B is proposed to be deleted as the
information it presents is no longer valid under changes in this
proposed rule.
Review Under the Paperwork Reduction Act of 1995
This proposed rule change contains information collection
requirements which are subject to review by the Office of Management
and Budget (OMB) under the Paperwork Reduction Act of 1995, 44 U.S.C.
3501, et seq. The title, description and respondent description of the
information collection is shown below with an estimate of the annual
reporting burdens. Included in the estimate is the time for reviewing
instructions, gathering and maintaining the data needed, and completing
and reviewing the collection of information. With respect to the
following collection of information, the PTO invites comments on: (1)
Whether the proposed collection of information is necessary for the
proper performance of the PTO's functions, including whether the
information will have practical utility; (2) the accuracy of the PTO's
estimate of the burden of the proposed collection of information,
including the validity of the methodology and assumptions used; (3)
ways to enhance the quality, utility, and clarity of the information to
be collected; and (4) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques, when appropriate, and other forms of information
technology.
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 unless that collection of information
displays a currently valid OMB control number.
OMB Number: 0651-0024.
Title: Requirements for Patent Applications Containing Nucleotide
Sequence and/or Amino Acid Sequence Disclosures.
Form Numbers: None.
Type of Review: Revision of currently approved collection.
Affected Public: Individuals or households, business or other for-
profit institutions, not-for-profit institutions, and Federal
Government.
Estimated Number of Respondents: 4,600.
Estimated Time Per Response: 80 minutes.
Estimated Total Annual Burden Hours: 6,133.
Needs and Uses: The PTO requires biotechnology patent applicants to
submit sequence information to enable the PTO to properly examine and
process their applications.
As required by the Paperwork Reduction Act of 1995, 44 U.S.C.
3507(d), the PTO has submitted a copy of this proposed rulemaking to
OMB for its review of this information collection. Interested persons
are requested to send comments regarding this information collections,
including suggestions for reducing this burden, to the Office of
Information and Regulatory Affairs of OMB, New Executive Office Bldg.,
725 17th Street, NW., Room 10235, Washington, D.C. 20503, Attn: Desk
Officer for the Patent and Trademark Office.
OMB is required to make a decision concerning the collection of
information in these proposed regulations between 30 and 60 days after
the publication of this document in the Federal Register.
[[Page 51861]]
Therefore, a comment to OMB is best assured of having its full effect
if OMB receives it within 30 days of publication. This does not affect
the deadline for the public to comment to the PTO on the proposed
regulations.
Other Considerations
This proposed rule change is in conformity with the requirements of
the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), Executive Order
12612, and the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.
It has been determined that this proposed rule is not significant for
the purposes of Executive Order 12866.
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 proposed rule change would not
have a significant economic impact on a substantial number of small
entities (Regulatory Flexibility Act, 5 U.S.C. 601 et seq.). The
principal effect of this rule change is to simplify and clarify the
rules governing the submission of Sequence Listings for patent
applications containing nucleic acid and/or amino acid sequences.
The PTO has also determined that this proposed rule change 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, Reporting and record-keeping
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,
the PTO proposes to amend 37 CFR part 1 as set forth below. Removals
are indicated by brackets ( [] ) and additions indicated by arrows (>
<). part="" 1--rules="" of="" practice="" in="" patent="" cases="" 1.="" the="" authority="" citation="" for="" 37="" cfr="" part="" 1="" would="" continue="" to="" read="" as="" follows:="" authority:="" 35="" u.s.c.="" 6="" unless="" otherwise="" noted.="" 2.="" section="" 1.77="" is="" proposed="" to="" be="" amended="" by="" redesignating="" current="" paragraphs="" (g)="" through="" (j)="" as="" paragraphs="" (h)="" through="" (k)="" and="" by="" adding="" new="" paragraphs="" (g)="" and="" (l)="" to="" read="" as="" follows:="" sec.="" 1.77="" arrangement="" of="" application="" elements.="" *="" *="" *="" *="" *="">(g) Reference to Sequence Listing Annex.< [(g)]="">(h)< claim="" or="" claims.="" [(h)]="">(i)< abstract="" of="" the="" disclosure.="" [(i)]="">(j)< signed="" oath="" or="" declaration.="" [(j)]="">(k)< drawings.="">(l) Sequence Listing Annex.< 3.="" section="" 1.821="" is="" proposed="" to="" be="" amended="" by="" revising="" paragraphs="" (a)="" and="" (c)="" through="" (h)="" to="" read="" as="" follows:="" sec.="" 1.821="" nucleotide="" and/or="" amino="" acid="" sequence="" disclosures="" in="" patent="" applications.="" (a)="" nucleotide="" and/or="" amino="" acid="" sequences="" as="" used="" in="" secs.="" 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 rule. ``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.23: Recommendation
for the Presentation of Nucleotide and Amino Acid Sequence Listings in
Patent Applications and in Published Patent Documents, paragraphs 8
through 12, April 1994, herein incorporated by reference. (Hereinafter
``WIPO Standard ST.23 (April, 1994)''). 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.23 may be obtained from
the World Intellectual Property Organization; 34 chemin des
Colombettes; 1211 Geneva 20 Switzerland. Copies of ST.23 may be
inspected at the Patent Search Room; Crystal Plaza 3, Lobby Level; 2021
South Clark Place; Arlington, VA 22202; or 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="" are="" intended="" to="" embrace="" only="" those="" nucleotides="" that="" can="" be="" represented="" using="" the="" symbols="" set="" forth="" in="" [sec.="" 1.822(b)(1)]="">WIPO Standard ST.23 (April 1994), paragraph 8<. modifications,="" e.g.,="" methylated="" bases,="" may="" be="" described="" as="" set="" forth="" in="" [sec.="" 1.822(b)]="">WIPO Standard ST.23 (April 1994), paragraph 9< ,="" but="" shall="" not="" be="" shown="" explicitly="" in="" the="" nucleotide="" sequence.="" (2)="" amino="" acids="" are="" those="" l-amino="" acids="" commonly="" found="" in="" naturally="" occurring="" proteins="" and="" are="" listed="" in="" [sec.="" 1.822(b)(2)]="">WIPO Standard
ST.23 (April 1994), paragraph 11<. 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="" [sec.="" 1.822(b)(2)]="">WIPO Standard ST.23 (April 1994), paragraph 11< with="" the="" modified="" positions;="" e.g.,="" hydroxylations="" or="" glycosylations,="" being="" described="" as="" set="" forth="" in="" [sec.="" 1.822(b)]="">WIPO Standard ST.23 (April 1994),
paragraph 12<, 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="" [sec.="" 1.822(b)(2)]="">WIPO Standard
ST.23 (April 1994), paragraph 11< in="" conjunction="" with="" a="" description="" [elsewhere="" in="" the="" ``sequence="" listing'']="">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)="" *="" *="" *="" (c)="" patent="" applications="" which="" contain="" disclosures="" of="" nucleotide="" and/or="" amino="" acid="" sequences="" must="" contain,="" as="" a="" separate="" part="" of="" the="" disclosure="" on="" paper="" copy,="" hereinafter="" referred="" to="" as="" the="" ``sequence="" listing,''="" a="" disclosure="" of="" the="" nucleotide="" and/or="" amino="" acid="" sequences="" and="" associated="" information="" using="" the="" symbols="" and="" format="" in="" accordance="" with="" the="" requirements="" of="" secs.="" 1.822="" and="" 1.823.="" each="" sequence="" disclosed="" must="" appear="" separately="" in="" the="" ``sequence="" listing.''="" each="" sequence="" set="" forth="" in="" the="" ``sequence="" listing''="" shall="" be="" assigned="" a="" separate="">integer< identifier="" [written="" as="" seq="" id="" no:1,="" seq="" id="" no:2,="" seq="" id="" no:3,="" etc].="">The integer identifiers shall begin with 1 and increase
sequentially by integers. If no sequence is present for an integer
identifier, the words ``This sequence omitted'' shall appear following
the integer identifier.< (d)="" where="" the="" description="" or="" claims="" of="" a="" patent="" application="" discuss="" a="" sequence="" listing="" 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="" [assigned]="">integer< 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.="" [[page="" 51862]]="" (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="" sec.="" 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="" 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.="" such="" a="" statement="" must="" be="" a="" verified="" statement="" if="" made="" by="" a="" person="" not="" registered="" to="" practice="" before="" the="" office.="" (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), 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< requiring="" compliance="" with="" the="" requirements="" [,or="" such="" other="" time="" as="" may="" be="" set="" by="" the="" commissioner,="" in="" which="" to="" comply]="">within a prescribed time period<. any="" submission="" in="" response="" to="" a="" requirement="" under="" this="" paragraph="" must="" be="" accompanied="" by="" a="" statement="" that="" the="" submission="" does="" not="" include="" [new]="" matter="" [or="" go]="">which goes< beyond="" the="" disclosure="" in="" the="" international="" application="" as="" filed.="" such="" a="" statement="" must="" be="" a="" verified="" statement="" if="" made="" by="" a="" person="" not="" registered="" to="" practice="" before="" the="" office.="" 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="">and the United States
International Preliminary Examining Authority shall examine only to the
extent that a meaningful examination can be performed<. *="" *="" *="" *="" *="" 4.="" section="" 1.822="" is="" proposed="" to="" be="" revised="" to="" read="" as="" follows:="" sec.="" 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="" [(p)]="">(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="" [paragraphs="" (b)(1)="" and="" (b)(2)="" of="" this="" section]="">WIPO Standard ST.23
(April 1994), paragraphs 8 and 11. 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.23 may be obtained from
the World Intellectual Property Organization; 34 chemin des
Colombettes; 1211 Geneva 20 Switzerland. Copies of ST.23 may be
inspected at the Patent Search Room; Crystal Plaza 3, Lobby Level; 2021
South Clark Place; Arlington, VA 22202; or at the Office of the Federal
Register, 800 North Capitol Street, NW, Suite 700, Washington, DC<. no="" code="" other="" than="" that="" specified="" in="" [this="" section]="">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="" [paragraphs="" (p)(1)="" or="" (p)(2)="" of="" this="" section]="">WIPO Standard ST.23
(April 1994), paragraphs 9 and 12< and="" the="" modification="" is="" also="" set="" forth="" [elsewhere="" in="" the="" sequence="" listing="" (for="" example,="" features="" sec.="" 1.823(b)(2)(ix))]="">in the Feature section<. otherwise,="" all="" bases="" or="" amino="" acids="" not="" appearing="" in="" paragraphs="" [(b)(1)="" or="" (b)(2)="" of="" this="" section]="">8 and 11 of the WIPO Standard ST.23 (April 1994)< shall="" be="" listed="" in="" a="" given="" sequence="" as="" ``n''="" or="" ``xaa,''="" respectively,="" with="" further="" information,="" as="" appropriate,="" given="" [elsewhere="" in="" the="" sequence="" listing]="">in the Feature section<. [(1)="" base="" codes:="" ------------------------------------------------------------------------="" symbol="" meaning="" ------------------------------------------------------------------------="" a...................................="" a;="" adenine.="" c...................................="" c;="" cytosine.="" g...................................="" g;="" guanine.="" t...................................="" t;="" thymine.="" u...................................="" u;="" uracil.="" m...................................="" a="" or="" c.="" r...................................="" a="" or="" g.="" w...................................="" a="" or="" t/u.="" s...................................="" c="" or="" g.="" y...................................="" c="" or="" t/u.="" k...................................="" g="" or="" t/u.="" v...................................="" a="" or="" c="" or="" g;="" not="" t/u.="" h...................................="" a="" or="" c="" or="" t/u;="" not="" g.="" d...................................="" a="" or="" g="" or="" t/u;="" not="" c.="" b...................................="" c="" or="" g="" or="" t/u;="" not="" a.="" n...................................="" (a="" or="" c="" or="" g="" or="" t/u)="" or="" (unknown="" or="" other).="" ------------------------------------------------------------------------="" (2)="" amino="" acid="" three-letter="" abbreviations:="" ------------------------------------------------------------------------="" abbreviation="" amino="" acid="" name="" ------------------------------------------------------------------------="" ala.................................="" alanine.="" arg.................................="" arginine.="" asn.................................="" asparagine.="" asp.................................="" aspartic="" acid.="" asx.................................="" aspartic="" acid="" or="" asparagine.="" cys.................................="" cysteine.="" glu.................................="" glutamic="" acid.="" gln.................................="" glutamine.="" glx.................................="" glutamine="" or="" glutamic="" acid.="" gly.................................="" glycine.="" his.................................="" histidine.="" ile.................................="" isoleucine.="" leu.................................="" leucine.="" lys.................................="" lysine.="" met.................................="" methionine.="" phe.................................="" phenylalanine.="" pro.................................="" proline.="" ser.................................="" serine.="" thr.................................="" threonine.="" trp.................................="" tryptophan.="" tyr.................................="" tyrosine.="" val.................................="" valine.="" xaa.................................="" unknown="" or="" other].="" ------------------------------------------------------------------------="" (c)="">Format representation of nucleotides:
(1)< a="" nucleotide="" sequence="" shall="" be="" listed="" using="" the="">lower-case
letter for
[[Page 51863]]
representing the< one-letter="" code="" for="" the="" nucleotide="" bases[,="" as]="">set
forth< in="" [paragraph="" (b)(1)="" of="" this="" section]="">WIPO Standard ST.23
(April 1994), paragraph 8<. [(d)="" 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="" shall="" be="" typed="" below="" the="" portion="" of="" the="" codon="" containing="" two="" nucleotides.="" (e)="" the="" amino="" acids="" in="" a="" protein="" or="" peptide="" sequence="" shall="" be="" listed="" using="" the="" three-letter="" abbreviation="" with="" the="" first="" letter="" as="" an="" upper="" case="" character,="" as="" in="" paragraph="" (b)(2)="" of="" this="" section.]="" [(f)]="">(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.="" [(g)]="">(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 shall be typed below the portion of the
codon containing two nucleotides.< [(h)="" 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.]="" [(i)]="">(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.="" [(j)]="">(5)< a="" nucleotide="" sequence="" shall="" be="" presented,="" only="" by="" a="" single="" strand,="" in="" the="" 5'="" to="" 3'="" direction,="" from="" left="" to="" right.="" [(k)="" 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.]="" [(l)]="">(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.="" [(m)="" the="" enumeration="" of="" amino="" acids="" may="" start="" at="" the="" first="" amino="" acid="" of="" the="" first="" mature="" protein,="" with="" the="" number="" 1.="" the="" amino="" acids="" preceding="" the="" mature="" protein,="" e.g.,="" pre-sequences,="" pro-sequences,="" pre-="" pro-sequences="" and="" signal="" sequences,="" when="" presented,="" 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.]="" [(n)]="">(7)< for="" those="" nucleotide="" sequences="" that="" are="" circular="" in="" configuration,="" the="" enumeration="" method="" set="" forth="" in="" paragraph="" [(l)]="">(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.="" [the="" enumeration="" method="" for="" amino="" acid="" sequences="" that="" is="" set="" forth="" in="" paragraph="" (m)="" of="" this="" section="" remains="" applicable="" for="" amino="" acid="" sequences="" that="" are="" circular="" in="" configuration.]="">(d) Representation of amino acids:
(1) The amino acids in a protein or peptide sequence shall be
listed using the three-letter abbreviation with the first letter as an
upper case character, as in WIPO Standard ST.23 (April 1994), paragraph
11.
(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. The amino acids
preceding the mature protein, e.g., pre-sequences, pro-sequences, pre-
pro-sequences and signal sequences, when presented, 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.
(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)< [(o)]="" a="" sequence="" with="" a="" gap="" or="" gaps="" shall="" be="" presented="" as="" a="" plurality="" of="" separate="" sequences,="" with="" separate="" [sequence]="">integer< 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.="" [(p)="" the="" code="" for="" representing="" modified="" nucleotide="" bases="" and="" modified="" or="" unusual="" amino="" acids="" shall="" conform="" to="" the="" code="" set="" forth="" in="" the="" tables="" in="" paragraphs="" (p)(1)="" and="" (p)(2)="" of="" this="" section.="" the="" modified="" base="" controlled="" vocabulary="" in="" paragraph="" (p)(1)="" of="" this="" section="" and="" the="" modified="" and="" unusual="" amino="" acids="" in="" paragraph="" (p)(2)="" of="" this="" section="" shall="" not="" be="" used="" in="" the="" nucleotide="" and/or="" amino="" acid="" sequences;="" but="" may="" be="" used="" in="" the="" description="" and/or="" the="" ``sequence="" listing''="" corresponding="" to,="" but="" not="" including,="" the="" nucleotide="" and/or="" amino="" acid="" sequence.="" (1)="" modified="" base="" controlled="" vocabulary:="" ----------------------------------------------------------------------------------------------------------------="" abbreviation="" modified="" base="" description="" ----------------------------------------------------------------------------------------------------------------="" ac4c.............................................................="" 4-acetylcytidine.="" chm5u............................................................="" 5-(carboxyhydroxylmethyl)uridine.="" cm...............................................................="" 2'-o-methylcytidine.="" cmnm5s2u.........................................................="" 5-carboxymethylaminomethyl-2-thioridine.="" cmnm5u...........................................................="" 5-carboxymethylaminomethyluridine.="" d................................................................="" dihydrouridine.="" fm...............................................................="" 2'-o-methylpseudouridine.="" galq.............................................................="" beta,d-galactosylqueosine.="" gm...............................................................="" 2'-o-methylguanosine.="" i................................................................="" inosine.="" i6a..............................................................="" n6-isopentenyladenosine.="" m1a..............................................................="" 1-methyladenosine.="" m1f..............................................................="" 1-methylpseudouridine.="" [[page="" 51864]]="" m1g..............................................................="" 1-methylguanosine.="" m1l..............................................................="" 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.="" manq.............................................................="" beta,d-mannosylqueosine.="" mcm5s2u..........................................................="" 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-="" methyl-carbamoyl)threonine.="" mv...............................................................="" uridine-5-oxyacetic="" acid="" methylester.="" o5u..............................................................="" uridine-5-oxyacetic="" acid="" (v).="" osyw.............................................................="" wybutoxosine.="" p................................................................="" pseudouridine.="" q................................................................="" queosine.="" 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.="" yw...............................................................="" wybutosine.="" x................................................................="" 3-(3-amino-3-carboxypropyl)uridine,="" (acp3)u.="" ----------------------------------------------------------------------------------------------------------------="" (2)="" modified="" and="" unusual="" amino="" acids:="" ------------------------------------------------------------------------="" abbreviation="" modified="" and="" unusual="" amino="" acid="" ------------------------------------------------------------------------="" 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...............................="" n-methylvaline.="" nva.................................="" norvaline.="" nle.................................="" norleucine.="" orn.................................="" ornithine.]="" ------------------------------------------------------------------------="" 5.="" section="" 1.823="" is="" proposed="" to="" be="" revised="" to="" read="" as="" follows:="" sec.="" 1.823="" requirements="" for="" nucleotide="" and/or="" amino="" acid="" sequences="" as="" part="" of="" the="" application="" papers.="" (a)="" the="" ``sequence="" listing''="" required="" by="" sec.="" 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="" be="" titled="" ``sequence="" listing''="" [and="" appear]="">.
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.'' The ``Sequence
Listing'' shall appear in the ``Sequence Listing Annex,'' which is
numbered independently of the numbering of the remainder of the
application and shall be placed in the application file. Upon printing
the application as a patent, the ``Sequence Listing Annex'' containing
the paper ``Sequence Listing'' shall be printed immediately before the
patented claims.< each="" page="" of="" the="" ``sequence="" listing''="" shall="" contain="" no="" more="" than="" 66="" lines="" and="" each="" line="" shall="" contain="" no="" more="" than="" 72="" characters.="" a="" fixed-width="" font="" shall="" be="" used="" exclusively="" throughout="" the="" ``sequence="" listing.''="" (b)="" the="" ``sequence="" listing''="" shall,="" except="" as="" otherwise="" indicated,="" include,="" in="" addition="" to="" and="" immediately="" preceding="" the="" actual="" nucleotide="" and/or="" amino="" acid="" sequence,="" the="" [following="" items="" of="" information.]="">
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="" [,except="" that="" parenthetical="" explanatory="" information="" following="" the="" headings="" (identifiers)="" is="" to="" be="" omitted].="" each="" item="" of="" information="" shall="" begin="" on="" a="" new="" line="" [,="" enumerated="" with="" the="" number/numeral/letter="" in="" parentheses="" as="" shown="" below,="" with="" the="" heading="" (identifier)="" in="" upper="" case="" characters,="" followed="" by="" a="" colon,="" and="" then="" followed="" by="" the="" information="" provided]=""> beginning with the numeric
identifier enclosed in angle brackets as shown<. except="" as="" allowed="" below,="" no="" item="" of="" information="" shall="" occupy="" more="" than="" one="" line.="" [those="" items="" of="" information="" that="" are="" applicable="" for="" all="" sequences="" shall="" only="" be="" set="" forth="" once="" in="" the="" ``sequence="" listing.'']="" the="" submission="" of="" those="" items="" of="" information="" designated="" with="" an="" ``m''="" is="" mandatory.="" [the="" submission="" of="" those="" items="" of="" information="" designated="" with="" an="" ``r''="" is="" recommended,="" but="" not="" required.]="" the="" submission="" of="" those="" items="" of="" information="" designated="" with="" an="" ``o''="" is="" optional.="">Numeric identifiers
<100>
[[Page 51865]]
through <193> shall only be set forth at the beginning of the
``Sequence Listing.''< those="" items="" designated="" with="" ``rep''="" may="" have="" multiple="" responses="" and,="" as="" such,="" the="" item="" may="" be="" repeated="" in="" the="" ``sequence="" listing.="" [(1)="" general="" information="" (application,="" diskette/tape="" and="" publication="" information):="" (i)="" applicant="" (maximum="" of="" first="" ten="" named="" applicants;="" specify="" one="" name="" per="" line:="" surname="" comma="" other="" names="" and/or="" initials--m/rep):="" (ii)="" title="" of="" invention="" (title="" of="" the="" invention,="" as="" elsewhere="" in="" application,="" four="" lines="" maximum--m):="" (iii)="" number="" of="" sequences="" (number="" of="" sequences="" in="" the="" ``sequence="" listing''="" (m):="" (iv)="" correspondence="" address="" (m):="" (a)="" addressee="" (name="" of="" applicant,="" firm,="" company="" or="" institution,="" as="" may="" be="" appropriate):="" (b)="" street="" (correspondence="" street="" address,="" as="" elsewhere="" in="" application,="" four="" lines="" maximum):="" (c)="" city="" (correspondence="" city="" address,="" as="" elsewhere="" in="" application):="" (d)="" state="" (correspondence="" state,="" as="" elsewhere="" in="" application):="" (e)="" country="" (correspondence="" country,="" as="" elsewhere="" in="" application):="" (f)="" zip="" (correspondence="" zip="" or="" postal="" code,="" as="" elsewhere="" in="" application):="" (v)="" computer="" readable="" form="" (m):="" (a)="" medium="" type="" (type="" of="" diskette/tape="" submitted):="" (b)="" computer="" (type="" of="" computer="" used="" with="" diskette/tape="" submitted):="" (c)="" operating="" system="" (type="" of="" operating="" system="" used):="" (d)="" software="" (type="" of="" software="" used="" to="" create="" computer="" readable="" form):="" (vi)="" current="" application="" data="" (m,="" if="" available):="" (a)="" application="" number="" (u.s="" application="" number,="" including="" a="" series="" code,="" a="" slash="" and="" a="" serial="" number,="" or="" u.s.="" pct="" application="" number,="" including="" the="" letters="" pct,="" a="" slash,="" a="" two-letter="" code="" indicating="" the="" u.s.="" as="" the="" receiving="" office,="" a="" two-digit="" indication="" of="" the="" year,="" a="" slash="" and="" a="" five-digit="" number,="" if="" available):="" (b)="" filing="" date="" (u.s.="" or="" pct="" application="" filing="" date,="" if="" available;="" specify="" as="" dd-mmm-yyyy):="" (c)="" classification="" (ipc/us="" classification="" or="" f-term="" designation,="" where="" f-terms="" have="" been="" developed,="" if="" assigned,="" specify="" each="" designation,="" left="" justified,="" within="" an="" eighteen-position="" alpha="" numeric="" field--rep,="" to="" a="" maximum="" of="" ten="" classification="" designations):="" (vii)="" prior="" application="" data="" (prior="" domestic,="" foreign="" priority="" or="" international="" application="" data,="" if="" applicable--m/rep):="" (a)="" application="" number="" (application="" number;="" specify="" as="" two-letter="" country="" code="" and="" an="" eight-digit="" application="" number;="" or="" if="" a="" pct="" application,="" specify="" as="" the="" letters="" pct,="" a="" slash,="" a="" two-letter="" code="" indicating="" the="" receiving="" office,="" a="" two-digit="" indication="" of="" the="" year,="" a="" slash="" and="" a="" five-digit="" number):="" (b)="" filing="" date="" (document="" filing="" date,="" specify="" as="" dd-mmm-yyyy):="" (viii)="" attorney/agent="" information="" (o):="" (a)="" name="" (attorney/agent="" name;="" surname="" comma="" other="" names="" and/or="" initials):="" (b)="" registration="" number="" (attorney/agent="" registration="" number):="" (c)="" reference/docket="" number="" (attorney/agent="" reference="" or="" docket="" number):="" (ix)="" telecommunication="" information="" (o):="" (a)="" telephone="" (telephone="" number="" of="" applicant="" or="" attorney/agent):="" (b)="" telefax="" (telefax="" number="" of="" applicant="" or="" attorney/agent):="" (c)="" telex="" (telex="" number="" of="" applicant="" or="" attorney/agent):="" (2)="" information="" for="" seq="" id="" no:="" x="" (rep):="" (i)="" sequence="" characteristics="" (m):="" (a)="" length="" (sequence="" length,="" expressed="" as="" number="" of="" base="" pairs="" or="" amino="" acid="" residues):="" (b)="" type="" (sequence="" type,="" i.e.,="" whether="" nucleic="" acid="" or="" amino="" acid):="" (c)="" strandedness="" (if="" nucleic="" acid,="" number="" of="" strands="" of="" source="" organism="" molecule,="" i.e.,="" whether="" single-stranded,="" double-stranded,="" both="" or="" unknown="" to="" applicant):="" (d)="" topology="" (whether="" source="" organism="" molecule="" is="" circular,="" linear,="" both="" or="" unknown="" to="" applicant):="" (ii)="" molecule="" type="" (type="" of="" molecule="" sequenced="" in="" seq="" id="" no:x="" (at="" least="" one="" of="" the="" following="" should="" be="" included="" with="" subheadings,="" if="" any,="" in="" sequence="" listing--r)):="" --genomic="" rna;="" --genomic="" dna;="" --mrna="" --trna;="" --rrna;="" --snrna;="" --scrna;="" --prerna;="" --cdna="" to="" genomic="" rna;="" --cdna="" to="" mrna;="" --cdna="" to="" trna;="" --cdna="" to="" rrna;="" --cdna="" to="" snrna;="" --cdna="" to="" scrna;="" --other="" nucleic="" acid;="" (a)="" description="" (four="" lines="" maximum):="" --protein="" and="" --peptide.="" (iii)="" hypothetical="" (yes/no--r):="" (iv)="" anti-sense="" (yes/no--r):="" (v)="" fragment="" type="" (for="" proteins="" and="" peptides="" only,="" at="" least="" one="" of="" the="" following="" should="" be="" included="" in="" the="" sequence="" listing--r):="" --n-terminal="" fragment;="" --c-terminal="" fragment="" and="" --internal="" fragment.="" (vi)="" original="" source="" (original="" source="" of="" molecule="" sequenced="" in="" seq="" id="" no:x--r):="" (a)="" organism="" (scientific="" name="" of="" source="" organism):="" (b)="" strain:="" (c)="" individual="" isolate="" (name/number="" of="" individual/isolate):="" (d)="" developmental="" stage="" (give="" developmental="" stage="" of="" source="" organism="" and="" indicate="" whether="" derived="" from="" germ-line="" or="" rearranged="" developmental="" pattern):="" (e)="" haplotype:="" (f)="" tissue="" type:="" (g)="" cell="" type:="" (h)="" cell="" line:="" (i)="" organelle:="" (vii)="" immediate="" source="" (immediate="" experimental="" source="" of="" the="" sequence="" in="" seq="" id="" no:x--r):="" (a)="" library="" (library="" -type,="" name):="" (b)="" clone="" (clone(s)):="" (viii)="" position="" in="" genome="" (position="" of="" sequence="" in="" seq="" id="" no:x="" in="" genome--r):="" (a)="" chromosome/segment="" (chromosome/segment--name/number):="" (b)="" map="" position:="" (c)="" units="" (units="" for="" map="" position,="" i.e.,="" whether="" units="" are="" genome="" percent,="" nucleotide="" number="" or="" other/specify):="" (ix)="" feature="" (description="" of="" points="" of="" biological="" significance="" in="" the="" sequence="" in="" seq="" id="" no:x="" -r/rep):="" a)="" name/key="" (provide="" appropriate="" identifier="" for="" feature--four="" lines="" maximum):="" (b)="" location="" (specify="" location="" according="" to="" syntax="" of="" ddbj/embl/="" genbank="" feature="" tables="" definition,="" including="" whether="" feature="" is="" on="" complement="" of="" presented="" sequence;="" where="" appropriate="" state="" number="" of="" first="" and="" last="" bases/amino="" acids="" in="" feature--four="" lines="" maximum):="" (c)="" identification="" method="" (method="" by="" which="" the="" feature="" was="" identified,="" i.e.,="" by="" experiment,="" by="" similarity="" with="" known="" sequence="" or="" to="" an="" established="" consensus="" sequence,="" or="" by="" similarity="" to="" some="" other="" pattern--four="" lines="" maximum):="" (d)="" other="" information="" (include="" information="" on="" phenotype="" conferred,="" [[page="" 51866]]="" biological="" activity="" of="" sequence="" or="" its="" product,="" macromolecules="" which="" bind="" to="" sequence="" or="" its="" product,="" or="" other="" relevant="" information--four="" lines="" maximum):="" (x)="" publication="" information="" (repeat="" section="" for="" each="" relevant="" publication--o/rep):="" (a)="" authors="" (maximum="" of="" first="" ten="" named="" authors="" of="" publication;="" specify="" one="" name="" per="" line:="" surname="" comma="" other="" names="" and/or="" initials--="" rep):="" (b)="" title="" (title="" of="" publication):="" (c)="" journal="" (journal="" name="" in="" which="" data="" published):="" (d)="" volume="" (journal="" volume="" in="" which="" data="" published):="" (e)="" issue="" (journal="" issue="" number="" in="" which="" data="" published):="" (f)="" pages="" (journal="" page="" numbers="" in="" which="" data="" published):="" (g)="" date="" (journal="" date="" in="" which="" data="" published;="" specify="" as="" dd-mmm-="" yyyy,="" mmm-yyyy="" or="" season-yyyy):="" (h)="" document="" number="" (document="" number,="" for="" patent="" type="" citations="" only;="" specify="" as="" two-letter="" country="" code,="" eight-digit="" document="" number="" (right="" justified),="" one="" letter="" and="" as="" appropriate,="" one="" number="" or="" a="" space="" as="" a="" document="" type="" code;="" or="" if="" a="" pct="" application="" specify="" as="" the="" letters="" pct,="" a="" slash,="" a="" two-letter="" code="" indicating="" the="" receiving="" office,="" a="" two-="" digit="" indication="" of="" the="" year,="" a="" slash="" and="" a="" five-digit="" number;="" or="" if="" a="" pct="" publication,="" specify="" as="" the="" two="" letters="" wo,="" a="" two-digit="" indication="" of="" the="" year,="" a="" slash="" and="" a="" five-digit="" publication="" number):="" (i)="" filing="" date="" (document="" filing="" date,="" for="" patent-type="" citations="" only;="" specify="" as="" dd-mmm-yyyy):="" (j)="" publication="" date="" (document="" publication="" date;="" for="" patent-type="" citations="" only,="" specify="" as="" dd-mmm-yyyy):="" (k)="" relevant="" residues="" in="" seq="" id="" no:x="" (rep):="" from="" position)="" to="" position)="" (xi)="" sequence="" description:="" seq="" id="" no:x:]="" ----------------------------------------------------------------------------------------------------------------="" mandatory="" (m)="" or="" optional="" numeric="" identifier="" definition="" comments="" and="" format="" (o)="" ----------------------------------------------------------------------------------------------------------------=""><100>...................... General Information........ Leave blank after <100>... M
<110>...................... Applicant.................. Max. of 10 names; one name M
per line; use format:
Surname, Other Names and/
or Initials; rep.
<120>...................... Title of Invention......... Four lines maximum........ M
<130>...................... Number of Sequences........ Use an integer as a M
response.
<140>...................... Correspondence Address..... 140> must be present if O
subheadings <141>-<146>
are used.
<141>...................... Addressee.................. .......................... O
<142>...................... Street..................... Four lines maximum........ O
<143>...................... City....................... .......................... O
<144>...................... State or Province.......... .......................... O
<145>...................... Country.................... .......................... O
<146>...................... Zip or Postal Code......... .......................... O
<150>...................... Computer Readable Form..... Leave blank after <150>... O
<151>...................... Medium Type................ Type of diskette/tape O
submitted.
<152>...................... Computer................... Type of computer used to O
create diskette/tape.
<153>...................... Operating System........... Type of operating system O
on computer.
<154>...................... Software................... Type of software used to O
create computer readable
form.
<160>...................... Current Application Data... Leave blank after <160>; M, if available.
<160> must be present if
subheadings <161> & <162>
are used.
<161>...................... Application Number......... Specify as: US 07/999,999 M, if available.
or PCT/US96/99999.
<162>...................... Filing Date................ Specify as: dd-MMM-yyyy... M, if available
<170>...................... Prior Application Data..... Insert heading/subheadings M, if applicable
only if applicable; leave
blank after <170>; <170>
must be present if
subheadings <171> & <172>
are used; rep.
<171>...................... Application Number......... Specify as: US 07/999,999 M, if applicable.
or PCT/US96/99999.
<172>...................... Filing Date................ Specify as: dd-MMM-yyyy... M, if applicable.
<180>...................... Attorney/Agent Information Leave blank after <180>... O
<181>...................... Name....................... Use format: Surname, Other O
Names and/or Initials.
<182>...................... Registration Number........ .......................... O
<183>...................... File Reference/Docket .......................... O
Number.
<190>...................... Telecommunication Leave blank after <190>... O
Information.
<191>...................... Telephone.................. .......................... O
<192>...................... Telefax.................... .......................... O
<193>...................... Electronic mail address.... .......................... O
<200>...................... Information for SEQ ID Response shall be an M
NO:#:. integer representing the
SEQ ID NO shown; rep.
<210>...................... Sequence Characteristics... Leave blank after <210>... M
<211>...................... Length..................... Respond with an integer M
expressing the number of
bases or amino acid
residues.
<212>...................... Type....................... Whether presented sequence M
molecule is nucleotide or
amino acid, indicated by
N or A.
<214>...................... Topology................... Whether presented sequence M
molecule is linear or
circular, indicated as L
or C.
<290>...................... Feature.................... Description of points of M, if ``N'', ``Xaa'', or a
biological significance modified or unusual L-
in the sequence; leave amino acid or modified
blank after <290>; rep. base was used in the
sequence.
[[Page 51867]]
<291>...................... Name/Key................... Provide appropriate M, if ``N'', ``Xaa'', or a
identifier for feature; modified or unusual L-
four lines maximum. amino acid or modified
base was used in the
sequence.
<292>...................... Location................... Specify location within M, if ``N'', ``Xaa'', or a
sequence; where modified or unusual L-
appropriate state number amino acid or modified
of first and last bases/ base was used in the
amino acids in feature; sequence.
four lines maximum.
<294>...................... Other Information.......... Other relevant M, if ``N'', ``Xaa'', or a
information; four lines modified or unusual L-
maximum. amino acid or modified
base was used in the
sequence.
<300>...................... Publication Information.... Leave blank after <300>; O
rep.
<301>...................... Authors.................... Maximum of ten named O
authors of publication;
specify one name per
line; use format:
Surname, Other Names and/
or Initials.
<302>...................... Title...................... .......................... O
<303>...................... Journal.................... .......................... O
<304>...................... Volume..................... .......................... O
<305>...................... Issue...................... .......................... O
<306>...................... Pages...................... .......................... O
<307>...................... Date....................... Journal date in which data O
published; specify as dd-
MMM-yyyy, MMM-yyyy or
Season-yyyy.
<308>...................... Patent Document Number..... Document number; for O
patent-type citations
only.
<309>...................... Filing Date................ Document filing date, for O
patent-type citations
only; specify as dd-MMM-
yyyy.
<310>...................... Publication Date........... Document publication date, O
for patent-type citations
only; specify as dd-MMM-
yyyy.
<311>...................... Relevant Residues.......... FROM (position) TO O
(position).
<400>...................... Sequence Description: SEQ Response shall be an M
ID NO:#:. integer representing the
SEQ ID NO shown; rep.
----------------------------------------------------------------------------------------------------------------
6. Section 1.824 is proposed to be revised to read as follows:
Sec. 1.824 Form and format for nucleotide and/or amino acid sequence
submissions in computer readable form.
(a) The computer readable form required by Sec. 1.821(e) shall
[contain a printable copy of the ``Sequence Listing,'' as defined in
Secs. 1.821(c), 1.822 and 1.823, recorded as] >meet the following
specifications:
(1) The computer readable form shall contain< a="" single="" [file="" on]="">''Sequence Listing'' as< either="" a="" diskette,="" [or="" a="" magnetic="" tape]="">series of diskettes, or other permissible media outlined in
Sec. 1.824(c)<. [the="" computer="" readable="" form="" shall="" be="" encoded="" and="" formatted="" such="" that="" a="" printed="" copy="" of="" the="" ``sequence="" listing''="" may="" be="" recreated="" using="" the="" print="" commands="" of="" the="" computer/operating-system="" configurations="" specified="" in="" paragraph="" (f)="" of="" this="" section.]="" [(b)]="">(2)< the="" [file]="">``Sequence Listing''< in="" paragraph="" (a)="">(l)< of="" this="" section="" shall="" be="" [encoded="" in="" a="" subset="" of="" the]="">submitted
in< american="" standard="" code="" for="" information="" interchange="" (ascii)="">text<. [this="" subset="" shall="" consist="" of="" all="" printable="" ascii="" characters="" including="" the="" ascii="" space="" character="" plus="" line-termination,="" pagination="" and="" end-of-="" file="" characters="" associated="" with="" the="" computer/operating-system="" configurations="" specified="" in="" paragraph="" (f)="" of="" this="" section.]="" no="" other="" [characters]="">formats< shall="" be="" allowed.="" [(c)]="">(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="" [be="" readable="" by="" one="" of="" the="" computer/operating-system="" configurations="" specified="" in="" paragraph="" (f)="" of="" this="" section,="" and="" shall]="" conform="" to="" [the]="">all< specifications="" [in="" paragraphs="" (a)="" and="" (b)="" of]="">detailed in< this="" section.="" [(d)="" the="" entire="" printable="" copy="" of="" the="" ``sequence="" listing="" shall="" be="" contained="" within="" one="" file="" on="" a="" single="" diskette="" or="" magnetic="" tape="" unless="" it="" is="" shown="" to="" the="" satisfaction="" of="" the="" commissioner="" that="" it="" is="" not="" practical="" or="" possible="" to="" submit="" the="" entire="" printable="" copy="" of="" the="" ``sequence="" listing''="" within="" one="" file="" on="" a="" single="" diskette="" or="" magnetic="" tape.="" (e)="" the="" submitted="" diskette="" or="" tape="" shall="" be="" write-protected="" such="" as="" by="" covering="" or="" uncovering="" diskette="" holes,="" removing="" diskette="" write="" tabs="" or="" removing="" tape="" write="" rings.="" (f)="" as="" set="" forth="" in="" paragraph="" (c),="" above,="" any="" means="" may="" be="" used="" to="" create="" the="" computer="" readable="" form,="" as="" long="" as="" the="" following="" conditions="" are="" satisfied.="" a="" submitted="" diskette="" shall="" be="" readable="" on="" one="" of="" the="" computer/operating-system="" configurations="" described="" in="" paragraphs="" (1)="" through="" (3),="" below.="" a="" submitted="" tape="" shall="" satisfy="" the="" format="" specifications="" described="" in="" paragraph="" (4),="" below.]="">(4) File compression is acceptable when using diskette media, so
long as the compressed file is in a self-extracting format that will
decompress on one of the systems described in paragraph (b) of this
section.
[[Page 51868]]
(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 name and type of
computer and operating system used, and application serial number and
filing date, if known.
(b) Computer readable form files submitted must meet these format
requirements:< (1)="" computer:="" ibm="" pc/xt/at,="">or compatibles< [="" ibm="" ps/2="" or="" compatibles]="">, or Apple Macintosh<; [(i)]="">(2)< operating="" system:="" [pc-dos="" or]="" ms-dos="" [(versions="" 2.1="" or="" above)]="">, Unix or Macintosh<; [(ii)]="">(3)< line="" terminator:="" ascii="" carriage="" return="" plus="" ascii="" line="" feed;="" [(iii)]="">(4)< pagination:="" [ascii="" form="" feed="" or="" series="" of="" line="" terminators]="">Continuous file (no ``hard page break'' codes
permitted)<; [(iv)="" end-of-file:="" ascii="" sub="" (ctrl-z);="" (v)="" media:]="">(c) Computer readable form files submitted may be in any of the
following media:< [(a)="" diskette--5.25="" inch,="" 360="" kb="" storage;="" (b)="" diskette--5.25="" inch,="" 1.2="" mb="" storage;="" (c)="" diskette--3.50="" inch,="" 720="" kb="" storage;="" (d)="" diskette--3.5="" inch,="" 1.44="" mb="" storage;]="">(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;< [(vi)="" print="" command:="" print="" filename.extension;="" (2)="" computer:="" ibm="" pc/xt/at,="" ibm="" ps/2="" or="" compatibles;="" (i)="" operating="" system:="" xenix;="" (ii)="" line="" terminator:="" ascii="" carriage="" return;="" (iii)="" pagination:="" ascii="" form="" feed="" or="" series="" of="" line="" terminators;="" (iv)="" end-of-file:="" none;="" (v)="" media:="" (a)="" diskette--5.25="" inch,="" 360="" kb="" storage;="" (b)="" diskette--5.25="" inch,="" 1.2="" mb="" storage;="" (c)="" diskette--3.50="" inch,="" 720="" kb="" storage;="" (d)="" diskette--3.5="" inch,="" 1.44="" mb="" storage;="" (vi)="" print="" command:="" ipr="" filename;="" (3)="" computer:="" apple="" macintosh;="" (i)="" operating="" system:="" macintosh;="" (ii)="" macintosh="" file="" type:="" text="" with="" line="" termination="" (iii)="" line="" terminator:="" pre-defined="" by="" text="" type="" file;="" (iv)="" pagination:="" pre-defined="" by="" text="" type="" file;="" (v)="" end-of-file:="" pre-defined="" by="" text="" type="" file;="" (vi)="" media:="" (a)="" diskette--3.50="" inch,="" 400="" kb="" storage;="" (b)="" diskette--3.50="" inch,="" 800="" kb="" storage;="" (c)="" diskette--3.50="" inch,="" 1.4="" mb="" storage;="" (vii)="" print="" command:="" use="" print="" command="" from="" any="" macintosh="" application="" that="" processes="" text="" files,="" such="" as="" mac-write="" or="" teachtext;="" (4)="" magnetic="" tape:="" 0.5="" inch,="" up="" to="" 2400="" feet;="" (i)="" density:="" 1600="" or="" 6250="" bits="" per="" inch,="" 9="" track;="" (ii)="" format:="" raw,="" unblocked;="" (iii)="" line="" terminator:="" ascii="" carriage="" return="" plus="" optional="" ascii="" line="" feed;="" (iv)="" pagination:="" ascii="" form="" feed="" or="" series="" of="" line="" terminators;="" (v)="" print="" command="" (unix="" shell="" version="" given="" here="" as="" sample="" response--mt/dev/rmt0;="" 1pr/dev/rmt0):]="">(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< [(g)]="">(d)< computer="" readable="" forms="" that="" are="" submitted="" to="" the="" office="" will="" not="" be="" returned="" to="" the="" applicant.="" [(h)="" all="" computer="" readable="" forms="" shall="" have="" a="" label="" permanently="" affixed="" thereto="" on="" which="" has="" been="" hand-printed="" or="" typed,="" a="" description="" of="" the="" format="" of="" the="" computer="" readable="" form="" as="" well="" as="" the="" name="" of="" the="" applicant,="" the="" title="" of="" the="" invention,="" the="" date="" on="" which="" the="" data="" were="" recorded="" on="" the="" computer="" readable="" form="" and="" the="" name="" and="" type="" of="" computer="" and="" operating="" system="" which="" generated="" the="" files="" on="" the="" computer="" readable="" form.="" if="" all="" this="" information="" cannot="" be="" printed="" on="" a="" label="" affixed="" to="" the="" computer="" readable="" form,="" by="" reason="" of="" size="" or="" otherwise,="" the="" label="" shall="" include="" the="" name="" of="" the="" applicant="" and="" the="" title="" of="" the="" invention="" and="" a="" reference="" number,="" and="" the="" additional="" information="" may="" be="" provided="" on="" a="" container="" for="" the="" computer="" readable="" form="" with="" the="" name="" of="" the="" applicant,="" the="" title="" of="" the="" invention,="" the="" reference="" number="" and="" the="" additional="" information="" affixed="" to="" the="" container.="" if="" the="" computer="" readable="" form="" is="" submitted="" after="" the="" date="" of="" filing="" under="" 35="" u.s.c.="" 111,="" after="" the="" date="" of="" entry="" in="" the="" national="" stage="" under="" 35="" u.s.c.="" 371="" or="" after="" the="" time="" of="" filing,="" in="" the="" united="" states="" receiving="" office,="" an="" international="" application="" under="" the="" pct,="" the="" labels="" mentioned="" herein="" must="" also="" include="" the="" date="" of="" the="" application="" number,="" including="" series="" code="" and="" serial="" number.]="" 7.="" section="" 1.825="" is="" proposed="" to="" be="" amended="" by="" revising="" paragraphs="" (a),="" (b)="" and="" (d="" )="" to="" read="" as="" follows:="" sec.="" 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''="" (sec.="" 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.="" such="" a="" statement="" must="" be="" a="" verified="" statement="" if="" made="" by="" a="" person="" not="" registered="" to="" practice="" before="" the="" office.="" (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="" (sec.="" 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.''="" such="" a="" statement="" must="" be="" a="" verified="" statement="" if="" made="" by="" a="" person="" not="" registered="" to="" practice="" before="" the="" office.="" (c)="" *="" *="" *="" (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.="" such="" a="" statement="" must="" be="" a="" verified="" statement="" if="" made="" by="" a="" person="" not="" registered="" to="" practice="" before="" the="" office.="" 8.="" appendix="" a="" to="" subpart="" g="" is="" proposed="" to="" be="" revised="" to="" read="" as="" follows:="" [[page="" 51869]]="" appendix="" a="" to="" subpart="" g="" of="" part="" 1--sample="" sequence="" listing="" [(1)="" general="" information:="" (i)="" applicant:="" doe,="" joan="" x,="" doe,="" john="" q="" (ii)="" title="" of="" invention:="" isolation="" and="" characterization="" of="" a="" gene="" encoding="" a="" protease="" from="" paramecium="" sp.="" (iii)="" number="" of="" sequences:="" 2="" (iv)="" correspondence="" addresses:="" (a)="" addressee:="" smith="" and="" jones="" (b)="" street:="" 123="" main="" street="" (c)="" city:="" smalltown="" (d)="" state:="" anystate="" (e)="" country:="" usa="" (f)="" zip:="" 12345="" (v)="" computer="" readable="" form:="" (a)="" medium="" type:="" diskette,="" 3.50="" inch,="" 800="" kb="" storage="" (b)="" computer:="" apple="" macintosh="" (c)="" operating="" system:="" macintosh="" 5.0="" (d)="" software:="" macwrite="" (vi)="" current="" application="" data:="" (a)="" application="" number:="" 09/999,999="" (b)="" filing="" date:="" 28-feb-1989="" (c)="" classification:="" 999/99="" (vii)="" prior="" application="" data:="" (a)="" application="" number:="" pct/us88/99999="" (b)="" filing="" date:="" 01-mar-1988="" (viii)="" attorney/agent="" information:="" (a)="" name:="" smith,="" john="" a="" (b)="" registration="" number:="" 00001="" (c)="" reference/docket="" number:="" 01-0001="" (ix)="" telecommunications="" information:="" (a)="" telephone:="" (909)="" 999-001="" (b)="" telefax:="" (909)="" 999-0002="" (2)="" information="" for="" seq="" id="" no:="" 1:="" (i)="" sequence="" characteristics:="" (a)="" length:="" 954="" base="" pairs="" (b)="" type:="" nucleic="" acid="" (c)="" strandedness:="" single="" (d)="" topology:="" linear="" (ii)="" molecule="" type:="" genomic="" dna="" (iii)="" hypothetical:="" yes="" (iv)="" anti-sense:="" no="" (vi)="" original="" source:="" (a)="" organism:="" paramecium="" sp="" (c)="" individual/isolate:="" xyz2="" (g)="" cell="" type:="" unicellular="" organism="" (vii)="" immediate="" source:="" (a)="" library:="" genomic="" (b)="" clone:="" para-xyz2/36="" (x)="" publication="" information:="" (a)="" authors:="" doe,="" joan="" x,="" doe,="" john="" q="" (b)="" title:="" isolation="" and="" characterization="" of="" a="" gene="" encoding="" a="" protease="" from="" paramecium="" sp.="" (c)="" journal:="" fictional="" genes="" (d)="" volume:="" i="" (e)="" issue:="" 1="" (f)="" pages:="" 1-20="" (g)="" date:="" 02-mar-1988="" (k)="" relevant="" residues="" in="" seq="" id="" no:="" 1:="" from="" 1="" to="" 954="" billing="" code="" 3510-16-p="" [[page="" 51870]]="" [graphic]="" [tiff="" omitted]="" tp04oc96.056="" billing="" code="" 3510-16-c="" [[page="" 51871]]="" (2)="" information="" for="" seq="" id="" no:="" 2:="" (i)="" sequence="" characteristics:="" (a)="" length:="" 82="" amino="" acids="" (b)="" type:="" amino="" acid="" (c)="" topology:="" linear="" (ii)="" molecule="" type:="" protein="" (ix)="" feature:="" (a)="" name/key:="" signal="" sequence="" (b)="" location:="" -34="" to="" -1="" (c)="" identification="" method:="" similarity="" to="" other="" signal="" sequences,="" hydrophobic="" (d)="" other="" information:="" expresses="" protease="" (x)="" publication="" information:="" (a)="" authors:="" doe,="" joan="" x,="" doe,="" john="" q="" (b)="" title:="" isolation="" and="" characterization="" of="" a="" gene="" encoding="" a="" protease="" from="" paramecium="" sp.="" (c)="" journal:="" fictional="" genes="" (d)="" volume:="" i="" (e)="" issue:="" 1="" (f)="" pages:="" 1-20="" (g)="" date:="" 02-mar-1988="" (h)="" relevant="" residues="" in="" seq="" id="" no:2:="" from="" -34="" to="" 48="" billing="" code="" 3510-16-p="" [graphic]="" [tiff="" omitted]="" tp04oc96.057="" billing="" code="" 3510-16-c="">
<100>
<110> Doe, Joan X, Doe, John Q
<120> Isolation and Characterization of a Gene Encoding a
Protease from Paramecium sp.
<130> 2
<140>
<141> Smith and Jones
<142> 123 Main Street
<143> Smalltown
<144> Anystate
<145> USA
<146> 12345
<150>
<151> Floppy disk
<152> IBM PC compatible
<153> PC-DOS/MS-DOS
<154> PatentIn Release #2.00
<160>
<161> 09/999,999
<162> 28-FEB-1989
<170>
<171> PCT/US/88/99999
<172> 01-MAR-1988
<180>
<181> Smith, John A
<182> REGISTRATION NUMBER: 00001
<183> 01-0001
<190>
<191> (909) 999-0001
<192> (909) 999-0002
<200> 1
<210>
<211> 954 base pairs
<212> N
<214> L
<290>
<291> CDS
<292> join(275..373, 448..498, 679..774)
<290>
<291> mat__peptide
<292> join(451..498, 679..774)
<300>
<301> Doe, Joan X, Doe, John Q
<302> Isolation and Characterization of a Gene Encoding a
Protease from Paramecium sp.
<303> Fictional Genes
<304> 1
<305> 1
<306> 1-20
<307> 02-MAR-1988
<308> FROM 1 TO 957
<400> 1
BILLING CODE 3510-16-P
[[Page 51872]]
atcgggatag tactggtcaa gaccggtgga caccggttaa ccccggttaa gtaccggtta 60
taggccattt caggccaaat gtgcccaact acgccaattg ttttgccaac ggccaacgtt 120
acgttcgtac gcacgtatgt acctaggtac ttacggacgt gactacggac acttccgtac 180
gtacgtacgt ttacgtaccc atcccaacgt aaccacagtg tggtcgcagt gtcccagtgt 240
acacagactg ccagacattc ttcacagaca cccc atg aca cca cct gaa cgt 292
Met Thr Pro Pro Glu Arg
-30
ctc ttc ctc cca agg gtg tgt ggc acc acc cta cac ctc ctc ctt ctg 340
Leu Phe Leu Pro Arg Val Cys Gly Thr Thr Leu His Leu Leu Leu Leu
-25 -20 -15
ggg ctg ctg ctg gtt ctg ctg cct ggg gcc cat gtgaggcagc aggagaatgg 393
Gly Leu Leu Leu Val Leu Leu Pro Gly Ala His
-10 -5
ggtggctcag ccaaaccttg agccctagag cccccctcaa ctctgttctc ctag ggg 450
Gly
ctc atg cat ctt gcc cac agc aac ctc aaa cct gct gct cac ctc att 498
Leu Met His Leu Ala His Ser Asn Leu Lys Pro Ala Ala His Leu Ile
1 5 10 15
gtaaacatcc acctgacctc ccagacatgt ccccaccagc tctcctccta cccctgcctc 558
aggaacccaa gcatccaccc ctctccccca acttccccca cgctaaaaaa aacagaggga 618
gcccactcct atgcctcccc ctgccatccc ccaggaactc agttgttcag tgcccacttc 678
tac ccc agc aag cag aac tca ctg ctc tgg aga gca aac acg gac cgt 726
Tyr Pro Ser Lys Gln Asn Ser Leu Leu Trp Arg Ala Asn Thr Asp Arg
20 25 30
gcc ttc ctc cag gat ggt ttc tcc ttg agc aac aat tct ctc ctg gtc 774
Ala Phe Leu Gln Asp Gly Phe Ser Leu Ser Asn Asn Ser Leu Leu Val
35 40 45
tagaaaaaat aattgatttc aagaccttct ccccattctg cctccattct gaccatttca 834
ggggtcgtca ccacctctcc tttggccatt ccaacagctc aagtcttccc tgatcaagtc 894
accggagctt tcaaagaagg aattctaggc atcccagggg acccacacct ccctgaacca 954
BILLING CODE 3510-16-P
[[Page 51873]]
[GRAPHIC] [TIFF OMITTED] TP04OC96.058
BILLING CODE 3510-16-C
<200> 2
<210>
<211> 82 amino acids
<212> A
<214> L
[[Page 51874]]
<400> 2
Met Thr Pro Pro Glu Arg Leu Phe Leu Pro Arg Val Cys Gly Thr Thr
-30 -25 -20
Leu His Leu Leu Leu Leu Gly Leu Leu Leu Val Leu Leu Pro Gly Ala
-15 -10 -5
His Gly Leu Met His Leu Ala His Ser Asn Leu Lys Pro Ala Ala His
1 5 10
Leu Ile Tyr Pro Ser Lys Gln Asn Ser Leu Leu Trp Arg Ala Asn Thr
15 20 25 30
Asp Arg Ala Phe Leu Gln Asp Gly Phe Ser Leu Ser Asn Asn Ser Leu
35 40 45
Leu Val < billing="" code="" 3510-16-p="" [graphic]="" [tiff="" omitted]="" tp04oc96.059="" billing="" code="" 3510-16-c="" 9.="" appendix="" b="" to="" subpart="" g="" is="" proposed="" to="" be="" removed.="" [appendix="" b="" to="" subpart="" g="" of="" part="" 1--headings="" for="" information="" items="" in="" sec.="" 1.823="" (1)="" general="" information:="" (i)="" applicant:="" (ii)="" title="" of="" invention:="" (iii)="" number="" of="" sequences:="" (iv)="" correspondence="" address:="" (a)="" addressee:="" (b)="" street:="" (c)="" city:="" (d)="" state:="" (e)="" country:="" (f)="" zip:="" (v)="" computer="" readable="" form:="" (a)="" medium="" type:="" (b)="" computer:="" (c)="" operating="" system:="" [[page="" 51875]]="" (d)="" software="" (vi)="" current="" application="" data:="" (a)="" application="" number:="" (b)="" filing="" date:="" (c)="" classification:="" (vii)="" prior="" application="" data:="" (a)="" application="" number:="" (b)="" filing="" date:="" (viii)="" attorney/agent="" information:="" (a)="" name:="" (b)="" registration="" number:="" (c)="" reference/docket="" number:="" (ix)="" telecommunications="" information:="" (a)="" telephone:="" (b)="" telefax:="" (c)="" telex:="" (2)="" information="" for="" seq="" id="" no:="" x:="" (i)="" sequence="" characteristics:="" (a)="" length:="" (b)="" type:="" (c)="" strandedness:="" (d)="" topology:="" (ii)="" molecule="" type:="" --genomic="" rna;="" --genomic="" dna;="" --mrna;="" --trna;="" --rrna;="" --snrna;="" --scrna;="" --prerna;="" --cdna="" to="" genomic="" rna;="" --cdna="" to="" mrna;="" --cdna="" to="" trna;="" --cdna="" to="" rrna;="" --cdna="" to="" snrna;="" --cdna="" to="" scrna;="" --other="" nucleic="" acid;="" (a)="" description:="" --protein="" and="" --peptide.="" (iii)="" hypothetical:="" (iv)="" anti-sense:="" (v)="" fragment="" type:="" (vi)="" original="" source:="" (a)="" organism:="" (b)="" strain:="" (c)="" individual="" isolate:="" (d)="" developmental="" stage:="" (e)="" haplotype:="" (f)="" tissue="" type:="" (g)="" cell="" type:="" (h)="" cell="" line:="" (i)="" organelle:="" (vii)="" immediate="" source:="" (a)="" library:="" (b)="" clone:="" (viii)="" position="" in="" genome:="" (a)="" chromosome/segment:="" (b)="" map="" position:="" (c)="" units:="" (ix)="" feature:="" (a)="" name/key:="" (b)="" location:="" (c)="" identification="" method:="" (d)="" other="" information:="" (x)="" publication="" information:="" (a)="" authors:="" (b)="" title:="" (c)="" journal:="" (d)="" volume:="" (e)="" issue:="" (f)="" pages:="" (g)="" date:="" (h)="" document="" number:="" (i)="" filing="" dates:="" (j)="" publication="" date:="" (k)="" relevant="" residues:="" (xi)="" sequence="" description:="" seq="" id="" no:x:="" ]="" dated:="" september="" 23,="" 1996.="" bruce="" a.="" lehman,="" assistant="" secretary="" of="" commerce="" and="" commissioner="" of="" patents="" and="" trademarks.="" [fr="" doc.="" 96-25074="" filed="" 10-3-96;="" 8:45="" am]="" billing="" code="" 3510-16-p="">