[Federal Register Volume 63, Number 104 (Monday, June 1, 1998)]
[Rules and Regulations]
[Pages 29620-29643]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-14194]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office

37 CFR Part 1

[Docket No: 960828235-8109-02]
RIN: 0651-AA88


Requirements for Patent Applications Containing Nucleotide 
Sequence and/or Amino Acid Disclosures

AGENCY: Patent and Trademark Office, Commerce.

ACTION: Final rule.

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SUMMARY: The Patent and Trademark Office (PTO) is amending the rules 
for submitting nucleotide or amino acid sequences in computer readable 
form (CRF) for patent applications. These amendments simplify the 
requirements of the rules, rearrange portions of the rules for better 
understanding and establish consistent rules to permit a single 
internationally acceptable computer readable form. Sequence Listings 
will be presented in an international, language neutral format using 
numeric identifiers rather than the current subject headings. The Paper 
Sequence Listing will preferably be a separately numbered section of 
the patent application. Sequences which contain fewer than four 
specifically identified nucleotides or amino acids will no longer be 
required to be submitted in computer readable form.

DATES: Effective date: July 1, 1998. The incorporation by reference of 
certain publications listed in the regulations is approved by the 
Director of the Federal Register as of July 1, 1998.
    Applicability date: Sections 1.821 through 1.825 as amended apply 
to applications filed on or after July 1, 1998, except for: (1) 
applications that claim the benefit of a prior application under 35 
U.S.C. 120 filed before July 1, 1998, and which do not add subject 
matter involving a sequence listing subject to Secs. 1.821 through 
1.825; and (2) reissue applications in which the application for the 
patent sought to be reissued was filed before July 1, 1998. Sections 
1.821 through 1.825 apply during a reexamination proceeding if the 
application for the patent sought to be reexamined was filed on or 
after July 1, 1998.
FOR FURTHER INFORMATION CONTACT: Esther M. Kepplinger, by telephone at 
(703) 308-1495; by mail addressed to: Box Comments--Patents, Assistant 
Commissioner for Patents, Washington, DC 20231 marked to her attention; 
by facsimile to (703) 305-3935; or by electronic mail at 
<a href="/cdn-cgi/l/email-protection#385d4b4c505d4a16535d48485451565f5d4a784d4b484c57165f574e"><span class="__cf_email__" data-cfemail="402533342825326e2b2530302c292e27253200353330342f6e272f36">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: Sections 1.821 through 1.825 of title 37 
provide a standardized format for the description of nucleotide and 
amino acid sequence data in patent applications and require the 
submission of such sequences in computer readable form (CRF). Sections 
1.821 through 1.825 provide the following benefits to the PTO: (1) 
Improved search capabilities; (2) improved interference detection; (3) 
more efficient examination; (4) cost savings for the input of the 
sequence data; (5) more

[[Page 29621]]

efficient and accurate printing of sequences in patents; (6) exchange 
of the sequence data with other patent offices electronically; and (7) 
improved public access to the sequences electronically.

Reasons for the Changes

    In response to the needs of our customers, the procedural 
requirements found in former Secs. 1.821 through 1.825 have been 
reduced. Sections 1.821 through 1.825 are being amended to be 
consistent with World Intellectual Property Organization (WIPO) 
Standard ST.25 (signed in 1998 and effective July 1, 1998). ST.25 
replaces WIPO Standards ST.23 and ST.24 which deal with paper and 
electronic submissions of sequence listings.
    A Meeting of International Authorities (MIA) under the Patent 
Cooperation Treaty (PCT) was held in November of 1994 to discuss 
simplification of sequence listing submission requirements. Under the 
previous PCT Regulations, each International Searching Authority, each 
International Preliminary Examining Authority and each designated/
elected office was free to set the requirements for submission of 
sequence listings in paper and electronic form. This imposed a burden 
on applicants by requiring them to prepare sequence listings in many 
different formats. In addition, sequence listings were required to be 
translated for consideration in the national stage at considerable cost 
to applicants and at the risk that the information could be 
inaccurately translated.
    After the November 1994 MIA, the PTO, the European Patent Office 
(EPO) and the Japanese Patent Office (JPO) worked together with WIPO to 
create a new international standard which forms the basis of WIPO 
Standard ST.25 (1998). Sections 1.821 through 1.825 of 37 CFR, as 
amended herein, are consistent with WIPO Standard ST.25 (1998) and the 
PCT sequence listing requirements. Sequence listings prepared in 
accordance with Secs. 1.821 through 1.825 as amended generally will be 
acceptable in all countries which adhere to WIPO Standard ST.25 (1998). 
In addition, a sequence listing prepared in accordance with the 
Secs. 1.821 through 1.825 as amended will be acceptable for the 
national stage in all PCT member countries which require the submission 
of a sequence listing. As a result of this rule change, applicants will 
experience a reduction in cost since only one sequence listing in paper 
and electronic form will need to be prepared and translations of this 
listing will not be needed.
    All necessary changes to the text of Secs. 1.821 through 1.825 to 
reflect the new WIPO Standard ST.25 (1998), have been made. Each change 
is described below.

Overview of the Changes

    The changes in this Final Rule include:
    (1) Use of numeric identifiers to replace the language subject 
headings within the submission;
    (2) Elimination of unnecessary and confusing data elements;
    (3) Movement of the paper Sequence Listing to the end of the 
application, preferably with separately numbered pages;
    (4) Elimination of the requirement to provide a submission for 
sequences with fewer than four specifically defined nucleotides or 
amino acids;
    (5) Use of lower-case one-letter codes for nucleotide bases;
    (6) Rearrangement of portions of the rules to improve their 
context;
    (7) Clarification and simplification of the rules to aid in 
understanding; and
    (8) Minor changes to accomplish harmonization with WIPO Standard 
ST.25 (1998) as well as the EPO and the JPO standards.
    Amended Secs. 1.821 through 1.825 are not mandatory for: (1) 
applications that claim the benefit of a prior application under 35 
U.S.C. 120 filed before July 1, 1998, and which do not add subject 
matter involving a sequence listing subject to Secs. 1.821 through 
1.825; (2) reissue applications in which the application for the patent 
sought to be reissued was filed before July 1, 1998; and (3) 
reexamination proceedings if the application for the patent sought to 
be reexamined was filed before July 1, 1998. The PTO will accept and 
encourages the submission of sequence listings in compliance with 
amended Secs. 1.821 through 1.825 for any application or reexamination 
proceeding. All sequence listings (including the entire computer 
readable form) must be submitted in compliance with either Secs. 1.821 
through 1.825 as amended in this Final Rule or (when permitted) former 
Secs. 1.821 through 1.825.
    If the CRF for a new application would be identical to a compliant 
CRF already on file in the PTO, the applicant may make reference to the 
other application and the CRF in lieu of filing a duplicate CRF in the 
new application by following the procedures set forth in Sec. 1.821(e). 
If exceptional circumstances do arise and certain applicants experience 
specific hardships in attempting to comply with amended Secs. 1.821 
through 1.825, the PTO will consider a petition under Sec. 1.183 to 
waive certain requirements of Secs. 1.821 through 1.825.
    A Notice of Proposed Rulemaking entitled ``Changes Implementing 
Nucleotide and/or Amino Acid Sequence Listings'' (Notice of Proposed 
Rulemaking) was published in the Federal Register at 61 FR 51855 
(October 4, 1996), and in the Official Gazette of the Patent and 
Trademark Office, at 1191 Off. Gaz. Pat. Office 168 (October 29, 1996). 
Sections 1.821 through 1.825 as adopted contain several changes from 
these sections. This Final Rule provides a discussion of the content of 
the specific rules being amended, description of the changes in the 
text of the proposed rules, and explanation of the reasons supporting 
the changes. In addition, comments received in response to the Notice 
of Proposed Rulemaking are analyzed.

Discussion of Specific Rules and Changes from the Proposed Rules:

    Title 37 of the Code of Federal Regulations, Part 1, is amended as 
follows.

Section 1.77

    The proposed change to 37 CFR 1.77 was previously adopted. See 
Miscellaneous Changes to Patent Practice; Final Rule, 61 FR 42790 
(August 19, 1996), 1190 Off. Gaz. Pat. Office 67 (September 17, 1996).

Section 1.821

    Section 1.821 incorporates by reference the World Intellectual 
Property Organization (WIPO) Handbook on Industrial Property 
Information and Documentation, Standard ST.25 (1998), including Tables 
1 through 6 of Appendix 2, in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. Copies may be obtained from the World Intellectual Property 
Organization; 34 chemin des Colombettes; 1211 Geneva 20 Switzerland. 
Copies may be inspected at the Patent Search Room; Crystal Plaza 3, 
Lobby Level; 2021 South Clark Place; Arlington, VA 22202. Copies may 
also be inspected at the Office of the Federal Register, 800 North 
Capitol Street, NW, Suite 700, Washington, DC 20408. These Tables are 
reproduced below.
    WIPO Standard ST.25 (1998), Appendix 2, Table 1, provides that the 
bases of a nucleotide sequence should be represented using the 
following one-letter code for nucleotide sequence characters:

[[Page 29622]]



                               Table 1.--One Letter Codes for Nucleotide Sequences                              
----------------------------------------------------------------------------------------------------------------
               Symbol                         Meaning                        Origin of designation              
----------------------------------------------------------------------------------------------------------------
a...................................  a......................  adenine.                                         
g...................................  g......................  guanine.                                         
c...................................  c......................  cytosine.                                        
t...................................  t......................  thymine.                                         
u...................................  u......................  uracil.                                          
r...................................  g or a.................  purine.                                          
y...................................  t/u or c...............  pyrimidine.                                      
m...................................  a or c.................  amino.                                           
k...................................  g or t/u...............  keto.                                            
s...................................  g or c.................  strong interactions 3 H-bonds.                   
w...................................  a or t/u...............  weak interactions 2 H-bonds.                     
b...................................  g or c or t/u..........  not a.                                           
d...................................  a or g or t/u..........  not c.                                           
h...................................  a or c or t/u..........  not g.                                           
v...................................  a or g or c............  not t, not u.                                    
n...................................  (a or g or c or t/u) or  any                                              
                                       (unknown or other).                                                      
----------------------------------------------------------------------------------------------------------------

    WIPO Standard ST.25 (1998), Appendix 2, Table 2, provides that 
modified bases may be represented as the corresponding unmodified bases 
in the sequence itself, if the modified base is one of those listed 
below and the modification is further described in the Feature section 
of the Sequence Listing. The codes from the list below may be used in 
the description (i.e., the specification and drawings, or in the 
Sequence Listing) but these codes may not be used in the sequence 
itself.

                        Table 2.--Modified Bases                        
------------------------------------------------------------------------
            Symbol                              Meaning                 
------------------------------------------------------------------------
ac4c.........................  4-acetylcytidine.                        
chm5u........................  5-(carboxyhydroxylmethyl)uridine.        
cm...........................  2-O-methylcytidine.                      
cmnm5s2u.....................  5-carboxymethylaminomethyl-2-thiouridine.
cmnm5u.......................  5-carboxymethylaminomethyluridine.       
d............................  dihydrouridine.                          
fm...........................  2-O-methylpseudouridine.                 
gal q........................  beta, D-galactosylqueuosine.             
gm...........................  2-O-methylguanosine.                     
I............................  inosine.                                 
i6a..........................  N6-isopentenyladenosine.                 
m1a..........................  1-methyladenosine.                       
m1f..........................  1-methylpseudouridine.                   
m1g..........................  1-methylguanosine.                       
m1i..........................  1-methylinosine.                         
m22g.........................  2,2-dimethylguanosine.                   
m2a..........................  2-methyladenosine.                       
m2g..........................  2-methylguanosine.                       
m3c..........................  3-methylcytidine.                        
m5c..........................  5-methylcytidine.                        
m6a..........................  N6-methyladenosine.                      
m7g..........................  7-methylguanosine.                       
mam5u........................  5-methylaminomethyluridine.              
mam5s2u......................  5-methoxyaminomethyl-2-thiouridine.      
man q........................  beta, D-mannosylqueuosine.               
mcm5s2u......................  5-methoxycarbonylmethyl-2-thiouridine.   
mcm5u........................  5-methoxycarbonylmethyluridine.          
mo5u.........................  5-methoxyuridine.                        
ms2i6a.......................  2-methylthio-N6-isopentenyladenosine.    
ms2t6a.......................  N-((9-beta-D-ribofuranosyl-2-            
                                methylthiopurine-6-yl) carbamoyl)       
                                threonine.                              
mt6a.........................  N-((9-beta-D-ribofuranosylpurine-6-yl)N- 
                                methylcarbamoyl) threonine.             
mv...........................  uridine-5-oxyacetic acid-methylester.    
o5u..........................  uridine-5-oxyacetic acid.                
osyw.........................  wybutoxosine.                            
p............................  pseudouridine.                           
q............................  queuosine.                               
s2c..........................  2-thiocytidine.                          
s2t..........................  5-methyl-2-thiouridine.                  
s2u..........................  2-thiouridine.                           
s4u..........................  4-thiouridine.                           
t............................  5-methyluridine.                         
t6a..........................  N-((9-beta-D-ribofuranosylpurine-6-yl)-  
                                carbamoyl)threonine.                    
tm...........................  2-O-methyl-5-methyluridine.              
um...........................  2-O-methyluridine.                       

[[Page 29623]]

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

    WIPO Standard ST.25 (1998), Appendix 2, Table 3, provides that the 
amino acids should be represented using the following three-letter code 
with the first letter as a capital.

                 Table 3.--Amino Acid Three-Letter Codes                
------------------------------------------------------------------------
                  Symbol                               Meaning          
------------------------------------------------------------------------
Ala.......................................  Alanine.                    
Cys.......................................  Cysteine.                   
Asp.......................................  Aspartic Acid.              
Glu.......................................  Glutamic Acid.              
Phe.......................................  Phenylalanine.              
Gly.......................................  Glycine.                    
His.......................................  Histidine.                  
Ile.......................................  Isoleucine.                 
Lys.......................................  Lysine.                     
Leu.......................................  Leucine.                    
Met.......................................  Methionine.                 
Asn.......................................  Asparagine.                 
Pro.......................................  Proline.                    
Gln.......................................  Glutamine.                  
Arg.......................................  Arginine.                   
Ser.......................................  Serine.                     
Thr.......................................  Threonine.                  
Val.......................................  Valine.                     
Trp.......................................  Tryptophan.                 
Tyr.......................................  Tyrosine.                   
Asx.......................................  Asp or Asn.                 
Glx.......................................  Glu or Gln.                 
Xaa.......................................  Unknown or other.           
------------------------------------------------------------------------

    WIPO Standard ST.25 (1998), Appendix 2, Table 4, provides that 
modified and unusual amino acids may be represented as the 
corresponding unmodified amino acids in the sequence itself if the 
modified or unusual amino acid is one of those listed below and the 
modification is further described in the Feature section of the 
Sequence Listing. The codes from the list below may be used in the 
description (i.e., the specification and drawings, or in the Sequence 
Listing) but these codes may not be used in the sequence itself.

                                 Table 4.--Modified and Unusual Amino Acid Codes                                
----------------------------------------------------------------------------------------------------------------
                   Symbol                                                  Meaning                              
----------------------------------------------------------------------------------------------------------------
Aad........................................  2-Aminoadipic acid.                                                
bAad.......................................  3-aminoadipic acid.                                                
bAla.......................................  beta-Alanine, beta-Aminopropionic acid.                            
Abu........................................  2-Aminobutyric acid.                                               
4Abu.......................................  4-Aminobutyric acid, piperidinic acid.                             
Acp........................................  6-Aminocaproic acid.                                               
Ahe........................................  2-Aminoheptanoic acid.                                             
Aib........................................  2-Aminoisobutyric acid.                                            
bAib.......................................  3-Aminoisobutyric acid.                                            
Apm........................................  2-Aminopimelic acid.                                               
Dbu........................................  2,4-Diaminobutyric acid.                                           
Des........................................  Desmosine.                                                         
Dpm........................................  2,2-Diaminopimelic acid.                                           
Dpr........................................  2,3-Diaminopropionic acid.                                         
EtGly......................................  N-Ethylglycine.                                                    
EtAsn......................................  N-Ethylasparagine.                                                 
Hyl........................................  Hydroxylysine.                                                     
aHyl.......................................  allo-Hydroxylysine.                                                
3Hyp.......................................  3-Hydroxyproline.                                                  
4Hyp.......................................  4-Hydroxyproline.                                                  
Ide........................................  Isodesmosine.                                                      
aIle.......................................  allo-Isoleucine.                                                   
MeGly......................................  N-Methylglycine, sarcosine.                                        
MeIle......................................  N-Methylisoleucine.                                                
MeLys......................................  6-N-Methyllysine.                                                  
MeVal......................................  N-Methylvaline.                                                    
Nva........................................  Norvaline.                                                         
Nle........................................  Norleucine.                                                        
Orn........................................  Ornithine.                                                         
----------------------------------------------------------------------------------------------------------------

    WIPO Standard ST.25 (1998), Appendix 2, Table 5 provides for 
feature keys related to DNA sequences.

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BILLING CODE 3510-16-C
    Further in paragraph (a) of Sec. 1.821, both occurrences of 
``Copies of ST.23'' have been changed to ``Copies of WIPO Standard 
ST.25 (1998).'' This change is necessary to reflect the new standard 
number.
    In paragraph (a)(1) of Sec. 1.821, ``ST.23 (April 1994), paragraph 
8'' has been changed to ``ST.25 (1998), Appendix 2, Table 1.'' This 
change reflects the correct information with regard to the incorporated 
WIPO standard and the list of symbols to be used for nucleotide 
sequence characters.
    Further in paragraph (a)(1) of Sec. 1.821, ``ST.23 (April 1994), 
paragraph 9'' has been changed to ``ST.25 (1998), Appendix 2, Table 
2.'' This change reflects the correct information with regard to the 
incorporated WIPO standard and the list of modified bases which can be 
presented as unmodified nucleotide sequence characters.
    In paragraph (a)(2) of Sec. 1.821, all three occurrences of ``ST.23 
(April 1994), paragraph 11'' have been changed to ``ST.25 (1998), 
Appendix 2, Table 3.'' This change reflects the correct information 
with regard to the incorporated WIPO standard and the list of symbols 
to be used for amino acid sequence characters.
    Further in paragraph (a)(2) of Sec. 1.821, ``ST.23 (April 1994), 
paragraph 12'' has been changed to ``ST.25 (1998), Appendix 2, Table 
4.'' This change reflects the correct information with regard to the 
incorporated WIPO standard and the list of modified or unusual amino 
acids which can be presented as unmodified amino acid sequence 
characters.
    In paragraph (c) of Sec. 1.821, each of the three occurrences of 
the words ``integer identifier'' or ``integer identifiers'' has been 
changed to ``sequence identifier'' or ``sequence identifiers'' as 
appropriate. WIPO Standard ST.25 (1998), uses the term ``sequence 
identifier'' rather than ``integer identifier.'' Thus, this change is 
necessary to achieve harmonization with the international standard.
    In the last sentence of paragraph (c) of Sec. 1.821, the phrase 
``The sequence omitted shall appear following the integer identifier'' 
of the proposed rule has been replaced by ``the code `000' shall be 
used in place of the sequence.'' The response for the numeric 
identifier <160> shall include the total number of SEQ ID NOs, whether 
followed by a sequence or by the code ``000''. The code ``000'' should 
be put into <400>. This change permits flexibility in the preparation 
and amendment of Sequence Listings. It also makes the rule language-
neutral and is consistent with WIPO Standard ST.25 (1998).
    In paragraph (d) of Sec. 1.821, the words ``integer identifier'' 
have been changed to ``sequence identifier.'' WIPO Standard ST.25 
(1998) uses the term ``sequence identifier'' rather than ``integer 
identifier.'' Thus, this change is necessary to achieve harmonization 
with the international standard.
    In paragraphs (f), (g) and (h) of Sec. 1.821, the sentence ``Such a 
statement must be a verified statement if made by a person not 
registered to practice before the Office'' has been deleted. The 
separate verification requirements in Sec. 1.821 have been eliminated 
in view of the recent amendment to Secs. 1.4(d) and 10.18. See Changes 
to Patent Practice and Procedure; Final Rule, 62 FR. 53131 (October 10, 
1997), 1203 Off. Gaz. Pat. Office 63 (October 21, 1997). Paragraph (g) 
of Sec. 1.821 has also been amended to provide that the Office will 
provide a ``period of time'' (rather than one month) within which the 
applicant must comply with the requirements of Sec. 1.821(b) through 
(f) in order to avoid abandonment.
    Further in paragraph (f) of Sec. 1.821, the following has been 
added at the end of the first sentence, '', e.g., the information 
recorded in computer readable form is identical to the written sequence 
listing.'' WIPO Standard ST.25 (1998), paragraph 39, requires the 
language which has been added as an acceptable example for phrasing the 
required statement that the computer readable form and the written 
sequence listing are the same.

Section 1.822

    In paragraph (b) of Sec. 1.822, both references to WIPO Standard 
ST.23 (April 1994), paragraphs 8 and 11, as proposed have been changed 
to ``WIPO Standard ST.25 (1998), Appendix 2, Tables 1 and 3.'' These 
changes reflect the correct information with regard to the incorporated 
WIPO standard and the lists of symbols for nucleotide and amino acid 
sequence characters.
    Further in paragraph (b) of Sec. 1.822, ``WIPO Standard ST.23 
(April 1994), paragraphs 9 and 12'' as proposed has been changed to 
``WIPO Standard ST.25 (1998), Appendix 2, Tables 2 and 4.''

[[Page 29630]]

This change reflects the correct information with regard to the 
incorporated WIPO standard and the lists of modified bases and modified 
or unusual amino acids which can be depicted in the Sequence Listing 
via the symbols for a corresponding unmodified base or amino acid.
    Further in paragraph (b) of Sec. 1.822, the symbol designating an 
unknown nucleotide base or a nucleotide base other than those listed in 
the WIPO standard was proposed as an upper case letter ``N.'' This 
symbol has been changed to a lower case letter ``n.'' This change is 
consistent with the use of lower case letters for the symbols 
representing the nucleotide bases.
    Further in paragraph (b) of Sec. 1.822, the language has been 
clarified to specifically state that each ``n'' or ``Xaa'' represents 
only a single residue. Thus, for example, a single ``Xaa'' may not be 
used to designate a string of four amino acids, each of which is 
unknown. This represents a codification of existing practice.
    Further in paragraph (b) of Sec. 1.822, the information required in 
the Feature section to explain the use of ``n'' or ``Xaa'' in a given 
sequence is referred to ``as appropriate.'' Additional instruction is 
added at the end of paragraph (b) of Sec. 1.822 following ``the Feature 
section'' indicating'', preferably by including one or more feature 
keys listed in WIPO Standard ST.25 (1998), Appendix 2, Tables 5 and 
6.'' This change specifies the preference for using the feature keys 
listed in the WIPO standard in order to aid applicants in filing a CRF 
which will comply with WIPO Standard ST.25 (1998). These feature keys 
are controlled vocabulary and are considered language neutral. Their 
use is required in a PCT patent application or a patent application in 
a foreign country which has adopted WIPO Standard ST.25 (1998).
    In paragraph (c)(1) of Sec. 1.822, ``WIPO Standard ST.23 (April 
1994), paragraph 8'' as proposed has been changed to ``WIPO Standard 
ST.25 (1998), Appendix 2, Table 1.'' This change reflects the correct 
information with regard to the incorporated WIPO standard and the list 
of symbols to be used for nucleotide sequence characters.
    In paragraph (d)(1) of Sec. 1.822, ``WIPO Standard ST.23 (April 
1994), paragraph 11, as proposed has been changed to ``WIPO Standard 
ST.25 (1998), Appendix 2, Table 3.'' This change reflects the correct 
information with regard to the incorporated WIPO standard and the list 
of symbols to be used for amino acid sequence characters.
    In paragraph (d)(4) of Sec. 1.822, the section notes that 
enumeration requirements are applicable to amino acid sequences that 
are circular in configuration. The following language has been added to 
the end of the paragraph '', with the exception that the designation of 
the first amino acid of the sequence may be made at the option of the 
applicant.'' This change is necessary to provide consistency with its 
counterpart of circular nucleotide sequences as provided in paragraph 
(c)(7) of Sec. 1.822. This change is also consistent with WIPO Standard 
ST.25 (1998), paragraph 21.
    In paragraph (e) of Sec. 1.822, the words ``integer identifiers'' 
have been changed to ``sequence identifiers .'' WIPO Standard ST.25 
(1998) uses the term ``sequence identifier'' rather than ``integer 
identifier.'' Thus, this change is necessary to achieve harmonization 
with the international standard.

Section 1.823

    In paragraph (a) of Sec. 1.823, the entire second sentence which 
read ``On a separate page of the application specification, immediately 
prior to the claims, there shall be a reference to the presence of the 
`Sequence Listing' in a `Sequence Listing Annex.''' has been 
eliminated. The designation of the Sequence Listing as an annex to the 
specification was initially proposed in an early version of the 
international standard. This terminology is not used in WIPO Standard 
ST.25 (1998), however, and so it has also been eliminated from 
paragraph (a) of Sec. 1.823, as proposed. Simplification results as 
well by the elimination of the requirement that the Sequence Listing 
must be designated as an annex to the specification.
    In paragraph (a) of Sec. 1.823, the third sentence has been 
modified by deleting the words ``shall appear in the `Sequence Listing 
Annex,' which is.'' As explained above, the current version of the 
international standard does not require designating the Sequence 
Listing as an annex to the specification.
    In paragraph (a) of Sec. 1.823, the words ``preferably should be'' 
have been added to the third sentence, before ``numbered independently 
of the numbering of the remainder of the application'' to describe the 
independent page numbering of the Sequence Listing in paper copy form. 
The term ``preferably'' was added for purposes of harmonization with 
WIPO Standard ST.25 (1998).
    In paragraph (a) of Sec. 1.823, the last clause of the third 
sentence ``and shall be placed in the application file'' has been 
deleted as unnecessary and potentially confusing now that the reference 
to a ``Sequence Listing Annex'' has been removed from this paragraph.
    In paragraph (a) of Sec. 1.823, the fourth sentence has been 
eliminated in its entirety. As explained above, the current version of 
the international standard does not require designating the Sequence 
Listing as an annex to the specification.
    In paragraph (a) of Sec. 1.823, in both occurrences in the fifth 
sentence and in the single occurrence in the sixth sentence, the word 
``shall'' has been changed to ``should.'' These changes are necessary 
for purposes of achieving consistency with WIPO Standard ST.25 (1998).
    In paragraph (b) of Sec. 1.823, the first sentence has been 
modified by the deletion of the words ``in addition to and immediately 
preceding.'' This change is consistent with WIPO Standard ST.25 (1998).
    In paragraph (b) of Sec. 1.823, the fifth sentence has been 
deleted, eliminating the prohibition of any item of information 
occupying more than one line. This change is consistent with WIPO 
Standard ST.25 (1998).
    In paragraph (b) of Sec. 1.823, the last sentence has been deleted 
to eliminate the ``rep'' designation for data elements of the 
``Sequence Listing.'' Certain data elements may still be repeated 
within the listing but this change was made for harmonization of the 
table with WIPO Standard ST.25 (1998).
    In paragraph (b) of Sec. 1.823, the eighth sentence has been 
modified to reflect the new numeric numbering scheme, for harmonization 
with WIPO Standard ST.25 (1998). Specifically, ``<100> through <193>'' 
of the proposed rule has been changed to ``<110> through <170>.''
    The table in paragraph (b) of Sec. 1.823, has been changed to 
reflect the revised numbering scheme and data elements used in WIPO 
Standard ST.25 (1998). The specific changes are as follows:
    Numeric identifier ``<100>, General Information,'' has been deleted 
from the proposed rules, as it is not present in WIPO Standard ST.25 
(1998).
    Numeric identifier ``<110>, Applicant,'' in the proposed rule, has 
been changed to indicate that ``preferably '' a maximum of ten names 
may be indicated. This change allows for more than ten names in the 
Applicant field for those instances in which such would be appropriate. 
This change is consistent with WIPO Standard ST.25 (1998).
    Numeric identifier ``<120>, Title of Invention,'' in the proposed 
rule, has been changed to eliminate the limitation

[[Page 29631]]

that the title be a maximum of four lines. This change allows 
applicants more flexibility with respect to the title. This change is 
consistent with WIPO Standard ST.25 (1998).
    Numeric identifier ``<130>, Number of Sequences,'' in the proposed 
rule, has been changed to reflect ``<130>, File Reference,'' as stated 
in WIPO Standard ST.25 (1998). This numeric identifier was indicated as 
``<183>, File Reference/Docket Number '', in the rule as proposed. As 
proposed this was an optional numeric identifier. The numeric 
identifier remains optional once the application has been assigned an 
application number, e.g., a serial number. This numeric identifier is 
now MANDATORY when an application number has not yet been assigned to 
the application, such as on the day the application is initially filed. 
This change will assist in the matching of sequence information 
submissions with an application in the event that either the paper copy 
or the computer readable form were to become separated from the 
remainder of the application. This change is consistent with WIPO 
Standard ST.25 (1998).
    The Number of Sequences field identified as ``<130>'' in the 
proposed rule is now numbered ``<160>'' in Sec. 1.823 as adopted and 
redefined as ``Number of SEQ ID NOs.''
    The information associated with numeric identifiers ``<140>'' 
through ``<153>,'' ``Correspondence Address'' through ``Operating 
System'' of the proposed rule, has been eliminated to reduce the burden 
on the applicant and to harmonize with WIPO Standard ST.25 (1998). Some 
of these numeric identifiers have been used in the new numbering scheme 
and have been associated with different information as indicated herein 
and in the Table of Sec. 1.823.
    One remaining numeric identifier within the Computer Readable Form 
section, ``<154>, Software,'' of the proposed rule, will remain, with 
the exception that it has been reassigned the numeric identifier of 
``<170>'' to reflect the numbering scheme presented in WIPO Standard 
ST.25 (1998).
    The main headings ``<160>, Current Application Data'' and ``<170>, 
Prior Application Data,'' of the proposed rules, have been eliminated 
to harmonize with WIPO Standard ST.25 (1998) and reduce the number of 
fields in the Sequence Listing. The information that was to appear 
under these main headings remains in the rules but has been reassigned 
numeric identifiers <140> through <151>. The specific changes are as 
follows: ``<160>'' has been redefined as ``Number of SEQ ID NOs ''; 
``<161>, Application Number,'' of the proposed rule is now numbered as 
``<140>,'' and is defined as ``Current Application Number'; ``<162>, 
Filing Date,'' of the proposed rule is now numbered ``<141>,'' and is 
defined as ``Current Filing Date''; ``<170>'' has been redefined as 
``Software ``; ``<171>, Application Number,'' of the proposed rule is 
now numbered as ``<150>,'' and is defined as ``Prior Application 
Number''; ``<172>, Filing Date,'' of the proposed rule is now numbered 
as ``<151>,'' and is defined as ``Prior Application Filing Date.''
    The numeric identifiers now numbered ``<150>, Prior Application 
Number,'', and ``<151>, Prior Application Filing Date,'' are now 
mandatory only in those instances in which a claim for priority with 
respect to those prior applications is being made under either 35 
U.S.C. 119 or 120. This change will provide information in this regard 
when it is most useful and was necessary to harmonize these rules with 
WIPO Standard ST.25 (1998). Throughout the Sequence Listing, 
application numbers must be set forth as a combination of the two digit 
country code, as set forth in WIPO Standard ST.3, as well as an 
application number in accordance with WIPO Standard ST.13 or for an 
international application, the numbering system as set out in Section 
307(a) of the Administrative Instructions under the PCT.
    Numeric identifiers ``<180>, Attorney/Agent Information,'' through 
``<182>, Registration Number,'' of the proposed rule, have been 
eliminated to harmonize with WIPO Standard ST.25 (1998) and reduce the 
number of fields in the Sequence Listing.
    Numeric identifier ``<183>, File Reference/Docket Number'' of the 
proposed rule has been reassigned as numeric identifier ``<130>,'' and 
redefined as ``File Reference'' in an effort to harmonize with WIPO 
Standard ST.25 (1998).
    The Telecommunication Information section, ``<190>'' through 
``<193>'' of the proposed rules, has been eliminated in order to reduce 
the number of fields in the Sequence Listing and harmonize with WIPO 
Standard ST.25 (1998).
    Numeric identifier ``<200>, Information for SEQ ID NO:#:'', has 
been reassigned the numeric identifier ``<210>, SEQ ID NO: #:'' This 
numeric identifier indicates the integer, referred to in these final 
rules as the sequence identifier for both the sequence information and 
the actual sequence which follows the information.
    Numeric identifier ``<210>, Sequence Characteristics,'' of the 
proposed rule has been eliminated in order to reduce the number of 
required elements in the Sequence Listing and harmonize with WIPO 
Standard ST.25 (1998).
    The valid responses for the mandatory numeric identifier ``<212>, 
Type,'' have been changed from ``N'' and ``A'', as stated in the 
proposed rule, to ``DNA,'' ``RNA,'' and ``PRT'' (protein) in order to 
harmonize with WIPO Standard ST.25 (1998). A compound that is a mixture 
of DNA and RNA should be represented by ``DNA.'' This change is 
consistent with WIPO Standard ST.25 (1998).
    Numeric identifier ``<213>, Organism,'' has been added to the 
Sequence Listing of these final rules in an effort to harmonize with 
WIPO Standard ST.25 (1998). A response for the Organism identifier is 
MANDATORY. The valid responses are the scientific name, i.e. ``Genus 
species'', ``Artificial Sequence'', or ``Unknown.''
    Numeric identifier ``<214>, Topology,'' of the proposed rule, has 
been eliminated to harmonize with WIPO Standard ST.25 (1998), and to 
reduce the burden on the applicant.
    Numeric identifier ``<290>, Feature,'' has become numeric 
identifier ``<220>, Feature.'' This numeric identifier has become 
MANDATORY for those sequences in which numeric identifier ``<213>, 
Organism,'' is completed with either ``Artificial Sequence'' or 
``Unknown.'' This numeric identifier is also required if the compound 
sequence is a mixture of DNA and RNA. Numeric identifier ``<220>, 
Feature'' is a header only. No data are added immediately following 
this numeric identifier. These changes are required to achieve 
harmonization with WIPO Standard ST.25 (1998).
    Numeric identifier ``<291>, Name/Key,'' has become numeric 
identifier ``<221>, Name/Key.'' As proposed, the information provided 
was restricted to a maximum of four lines. The four line restriction 
has been removed to reduce the limitations on this field. The comment 
section of this numeric identifier has been changed in that it now 
indicates that the selection of a feature name or feature key is 
preferably made from those listed in Tables 5 and 6 of WIPO Standard 
ST.25 (1998). These tables are reproduced above and this preference for 
the listed feature names and keys is consistent with the requirement of 
WIPO Standard ST.25 (1998).
    Numeric identifier ``<292>, Location,'' has become ``<222>, 
Location,'' so as to be consistent with the numeric identifiers 
contained in WIPO Standard ST.25 (1998).

[[Page 29632]]

    Numeric identifier ``<294>, Other Information,'' has become numeric 
identifier ``<223>, Other Information,'' so as to be consistent with 
the numeric identifiers contained in WIPO Standard ST.25 (1998). This 
numeric identifier has become MANDATORY for those sequences in which 
numeric identifier ``<213>, Organism,'' is completed with either 
``Artificial Sequence'' or ``Unknown''. Numeric identifier ``<223>, 
Other Information,'' should contain source information in those 
instances when the organism is unknown or is an artificial sequence. 
For example, the source may be unknown because the material was 
isolated from a mixed bacterial culture rather than a pure culture. In 
such a case, numeric identifier ``<223>, Other Information,'' should be 
completed by explaining the mixed culture source of the sequenced 
material. If a sequence is completely synthesized this should be 
indicated in numeric identifier ``<223>, Other Information,'' while 
numeric identifier ``<213>, Organism,'' would indicate ``Artificial 
Sequence.'' This change has been made to accomplish harmonization 
between these rules and WIPO Standard ST.25 (1998) which contains the 
same mandatory requirement in this regard.
    Numeric identifiers ``<308>'' through ``<310>,'' referring to the 
`` Patent Document Number,'' ``Filing Date'' and `` Publication Date,'' 
of the proposed rule, have been moved to numeric identifiers ``<310>'' 
to ``<312>,'' respectively, of this Final Rule in order to harmonize 
with the numeric numbering scheme of WIPO Standard ST.25 (1998). 
Citations in the Sequence Listing must comply with WIPO Standard ST.6 
for publication numbers and WIPO Standard ST.16 for document codes.
    New numeric identifiers ``<308>, Database Accession Number,'' and 
``<309> Database Entry Date,'' have been added to the final rules to 
harmonize with WIPO Standard ST.25 (1998). These fields were added to 
the publication information section of WIPO Standard ST.25 (1998) to 
give an applicant more opportunity to further identify a published 
citation.
    Numeric identifier <400> ``Sequence Description: SEQ ID NO:#:'' has 
been changed to ``Sequence `` for clarity. Also for clarity, the 
explanation in the table has been changed to ``SEQ ID NO shall follow 
the numeric identifier and should appear on the line preceding the 
sequence.''
    The format of the date fields has been changed throughout the 
Sequence Listing to accommodate for international conventions. All date 
fields referenced in the Sequence Listing shall conform to WIPO 
Standard ST.2. Because compliance with Secs. 1.821 through 1.825 as 
amended should produce Sequence Listings that are acceptable to all 
receiving offices, a standardized date field convention was required.

Section 1.824

    In paragraph (a)(6) of Sec. 1.824, ``, the date on which the data 
were recorded on the computer readable form'' was added after ``title 
of the invention'' to harmonize with WIPO Standard ST.25 (1998) 
requirements. While this requirement of Sec. 1.824 was proposed to be 
eliminated, that proposal is not adopted for purposes of harmonization 
with WIPO Standard ST.25 (1998). Also in paragraph (a)(6) of 
Sec. 1.824, `` name and type of computer and'' was deleted to reduce 
the requirements.

Section 1.825

    In paragraphs (a), (b), and (d) of Sec. 1.825, the sentence ``Such 
a statement must be a verified statement if made by a person not 
registered to practice before the Office'' has been deleted. The 
separate verification requirements in Sec. 1.825 have been eliminated 
in view of the recent amendment to Secs. 1.4(d) and 10.18. See Changes 
to Patent Practice and Procedure; Final Rule, 62 FR. 53131 (October 10, 
1997), 1203 Off. Gaz. Pat. Office 63 (October 21, 1997).

Response to and Analysis of Comments

    Six written comments were received in response to the Notice of 
Proposed Rulemaking. Several of these comments address the three 
specific queries set forth in the Notice of Proposed Rulemaking.
    The first query posed in the Notice of Proposed Rulemaking was: (1) 
Should the PTO accept voluntary submissions of computer readable forms 
and Sequence Listings where a D-amino acid is contained in the 
sequence? If such voluntary submissions are accepted, should there be a 
restriction on the choice of identifying a D-amino acid by an Xaa or by 
its L-amino acid counterpart abbreviation?
    Comment: One comment indicated that not only should the PTO accept 
voluntary submissions under these rules where a D-amino acid is 
contained in the sequence, the Office should make such submissions 
mandatory and designated by an Xaa. One comment indicated that 
sequences containing D-amino acids should not be in the PTO databases.
    Response: Upon careful consideration, the PTO has decided to accept 
voluntary submissions of protein sequences containing D-amino acids. 
The PTO strongly encourages anyone making such voluntary submissions to 
identify a D-amino acid with an Xaa, describing the D-amino acid in the 
Features section of the Sequence Listing. This section is indicated by 
numeric identifiers <220> through <223> in 37 CFR 1.823. Procedural 
concerns compel this acceptance of voluntary submissions. Computer 
readable forms are processed prior to examination. It is cumbersome to 
establish a viable procedure to redact any voluntary submissions out of 
the PTO database. The use of Xaa to indicate a D-amino acid, should 
such sequence information be submitted in accordance with these rules, 
is encouraged so as to alert anyone reviewing the sequence that a 
particular amino acid is other than a naturally occurring L-amino acid 
and to more accurately depict the extent of similarities between such a 
sequence and the L-amino acid containing sequences present in a 
database being searched for examination or other purposes.
    Because the sequence databases do not currently include D-amino 
acids in sequences and thus are not searchable for such sequences, the 
submission of those sequences containing D-amino acids will not be made 
mandatory.
    The second query posed in the proposed rules was: (2) Should the 
provisions of 37 CFR 1.821(c) be altered to exclude some prior art 
sequences from inclusion in the Sequence Listing even though they are 
presented in a patent application disclosure as sequences? Should the 
reference to an accession number of an admitted prior art sequence in a 
publicly available, electronic, sequence database suffice and exclude 
that sequence from the requirements of the sequence rules?
    Comment: Four comments indicated that known ``prior art'' sequences 
should not be required in the Sequence Listing. A referral to a 
publicly available, electronic, sequence database for access to such 
``prior art'' sequences would be an acceptable alternative to two of 
those commenting on this aspect; the other two did not address this 
point. The reasons given for excluding such sequences are the expense 
and time required by applicants and their representatives in the 
inclusion of ``prior art'' sequences that are considered to be ``non-
inventive''. Reducing the bulk of the paper copy of the Sequence 
Listing was also mentioned.
    Response: The requirement to submit all disclosed sequences in the 
format required by Secs. 1.821 through 1.825 is

[[Page 29633]]

maintained. This point was discussed with officials from the JPO and 
EPO. The offices have considered the stated concerns with regard to 
costs to applicants. Sections 1.821 through 1.825 do not require any 
information to be disclosed in the form of a sequence, but rather 
require a particular format whenever information is presented in the 
form of a sequence. Those applicants for whom compliance with the rules 
remains a significant hardship may petition under Sec. 1.183 for a 
waiver of the applicable requirement of Secs. 1.821 through 1.825.
    The technical and legal concerns mentioned in the Notice of 
Proposed Rulemaking still exist concerning the use of an alternative 
reference to a publicly available, electronic, sequence database. These 
concerns are: (1) What constitutes a publicly available, electronic, 
sequence database? (2) Would the USPTO and the other patent offices 
which have similar rules be required to produce a list of 
internationally accepted databases? (3) What would be the criteria for 
such acceptance? (4) An additional issue would exist involving 
electronic records maintenance: is there any assurance that once 
information is contained in a database that it will be retained and 
available indefinitely without alteration? Changes to the information 
in nucleic acid sequence databases resulting from the discovery of 
sequencing errors are well-known.
    (5) Does the mere existence of the sequence information in such a 
record constitute reasonable means of retrieval? In other words, would 
one need some text basis or other identifier to retrieve the 
information?
    Additional reasons for the inclusion of these prior art sequences 
remain relevant. These reasons are: (1) the assessment of whether a 
particular sequence falls within the requirements of the current rules 
is simple; (2) the general public is assured that all patents which 
contain any sequence information contain all of the sequence 
information in the Sequence Listing and all sequences are available in 
a computer accessible form; and (3) as a publication, the contextual 
association of new and old information is potentially unique to the 
patent and very valuable to anyone assessing the state of the art at 
the time of a patented invention, and thus are desirable to be present 
in electronic form in association with that patent.
    The third query posed in the proposed rules was: (3) Should 
Sequence Listings filed in an international application filed under the 
PCT be published only electronically and made available for retrieval 
electronically by an accession number from several sequence 
repositories?
    Comment: Two comments were received in response to this query, one 
in favor and one opposed to limiting the publication of the Sequence 
Listing to an electronic form for published PCT applications in the 
international phase.
    Response: At this time paper copies of the Sequence Listings filed 
as part of the description will continue to be published in 
applications filed under PCT. The PTO together with the EPO, JPO and 
WIPO will continue to discuss the possibility of electronic 
publication. However, any implementation of such electronic publication 
in lieu of publication in paper form will not be undertaken until 
further study has been completed.
    Comment: One comment suggested that informative English words be 
placed next to the numerical headings in the Sequence Listing as 
printed in a U.S. patent.
    Response: The PTO will provide English words corresponding to the 
numeric identifiers in the printed U.S. patents.
    Comment: One comment suggested addition of a descriptive comment 
line to the Sequence Listing.
    Response: The ``Other Information'' line in the Features section, 
which is numeric identifier <223> in Sec. 1.823, provides for a 
description of a sequence. While completion of this section is only 
mandatory when the sequence contains ``n'', ``Xaa'', a modified or 
unusual L-amino acid or a modified base, it is frequently completed in 
other circumstances.
    Comment: One comment requested we harmonize Secs. 1.821 through 
1.825 with PCT, EPO and other authorities such that the differences in 
the requirements for Sequence Listing submissions are minimal.
    Response: This change to Secs. 1.821 through 1.825 is the result of 
such an effort to harmonize the PTO, PCT, EPO and JPO Sequence Listing 
requirements to the extent possible. The requirements of newly 
developed WIPO ST.25 are substantially identical to the requirements of 
amended Secs. 1.821 through 1.825. PatentIn Version 2.0 software, now 
available, is drafted to meet all of the requirements of WIPO Standard 
ST.25 (1998). The requirements of Secs. 1.821 through 1.825, however, 
are less stringent than the requirements of WIPO Standard ST.25 (1998). 
Thus, applicants who wish to file in countries which adhere to WIPO 
Standard ST.25 (1998) should consider the following when not using 
PatentIn Version 2.0:
    1. The WIPO Standard ST.25 (1998) does not permit submissions using 
a Macintosh computer.
    2. The WIPO Standard ST.25 (1998) does not accept the range of 
media permitted by amended Secs. 1.821 through 1.825.
    3. The answers in field <221> and <222> must use selections from 
Tables 5 and 6 of WIPO Standard ST.25 (1998) to comply with that 
standard. The terms from these Tables are considered language neutral 
vocabulary.
    4. Any free text in numeric identifier <223> of a Sequence Listing 
will not be translated and thus must also appear in the specification 
of applications filed under WIPO Standard ST.25 (1998) for compliance.
    5. A CRF filed after the filing of an application under the PCT 
does not form part of the disclosure and will not be published in the 
pamphlet.
    6. Paragraph 39 of WIPO Standard ST.25 (1998) requires the specific 
wording ``the information recorded on the form is identical to the 
written sequence listing.''
    7. WIPO Standard ST.25 (1998), paragraph 24, requires spaces 
between specified numeric identifiers in the Sequence Listing.
    Comment: One comment requested a WINDOWS<SUP></SUP> based version 
of PatentIn.
    Response: A WINDOWS<SUP></SUP> based version of PatentIn, PatentIn 
2.0, has been developed through a Trilaterally-sponsored joint 
initiative and is being made available.
    Comment: One comment expressed concern over application of the 
doctrine of equivalents by the courts to sequence-based claim language.
    Response: Sections 1.821 through 1.825 do not establish a 
disclosure requirement, nor do they alter the requirements of 35 U.S.C. 
Sec. 112. They merely require a particular format whenever information 
is presented in the form of a sequence. The use of sequence 
identification numbers (SEQ ID NO: #) only provides a shorthand way for 
applicants to refer to sequence information. These identification 
numbers do not in any way restrict the manner in which an invention can 
be claimed. Similarly, the use of this format does not impact the 
potential interpretations and legal determinations that could be made 
with respect to claims containing information in the form of a 
nucleotide or amino acid sequence.
    Comment: One comment requested the flexibility to use single-letter 
amino acid codes.
    Response: Sections 1.821 through 1.825 as amended do not constrain 
an applicant from using single letter codes

[[Page 29634]]

in the disclosure. The requirements of the sequence searching and the 
sequence storage mechanisms include only the three-letter codes, thus 
the need for the constraint on the Sequence Listing information. There 
is no such restriction on the sequence format in the body of the 
disclosure or in the figures imposed by Secs. 1.821 through 1.825, or 
any of the rules of practice; only the format for the Sequence Listing 
is specified by Secs. 1.821 through 1.825.

Review Under the Paperwork Reduction Act of 1995

    Notwithstanding any other provision of law, no person is required 
to respond to nor shall a person be subject to a penalty for failure to 
comply with a collection of information subject to the requirements of 
the Paperwork Reduction Act (PRA) unless that collection of information 
displays a currently valid OMB control number.
    This rule contains collections of information requirements subject 
to the PRA. The principal impact of this Final Rule is: (1) Elimination 
of certain requirements of Secs. 1.821 through 1.825; and (2) revision 
of Secs. 1.821 through 1.825 for consistency with WIPO Standard ST.25 
(1998), which will permit Sequence Listings to be presented in an 
international, language neutral format.
    The public reporting burden for these collections of information 
have been approved by the Office of Management and Budget (OMB) under 
OMB control number 0651-0024. The public reporting burden for this 
collection of information is estimated to average 80 minutes per 
response, including the time for reviewing instructions, searching 
existing data sources, gathering and maintaining the information. Send 
comments regarding this burden estimate or any other aspect of the data 
requirements, including suggestions for reducing this burden, to Esther 
M. Kepplinger at the address specified above or to the Office of 
Information and Regulatory Affairs of OMB, New Executive Office Bldg., 
725 17th St. NW, rm. 10235, Washington, DC 20230, Attn: Desk Officer 
for the Patent and Trademark Office.

Other Considerations

    This Final Rule is in conformity with the requirements of the 
Regulatory Flexibility Act (5 U.S.C. 601 et seq.), Executive Order 
12612 (October 26, 1987), and the Paperwork Reduction Act of 1995 (44 
U.S.C. 3501 et seq.). It has been determined that this rulemaking is 
not significant for the purposes of Executive Order 12866 (September 
30, 1993).
    The Assistant General Counsel for Legislation and Regulation of the 
Department of Commerce has certified to the Chief Counsel for Advocacy, 
Small Business Administration that this Final Rule would not have a 
significant impact on a substantial number of small entities 
(Regulatory Flexibility Act, 5 U.S.C. 605(b)). The principal impact of 
this Final Rule is: (1) Elimination of certain requirements of 
Secs. 1.821 through 1.825; and (2) revision of Secs. 1.821 through 
1.825 for consistency with WIPO Standard ST.25 (1998), which will 
permit Sequence Listings to be presented in an international, language 
neutral format.
    The Office has determined that this Final Rule has no Federalism 
implications affecting the relationship between the National Government 
and the States as outlined in Executive Order 12612.

List of Subjects in 37 CFR Part 1

    Administrative practice and procedure, Courts, Freedom of 
information, Inventions and patents, Incorporation by reference, 
Reporting and recordkeeping requirements, Small businesses.
    For the reasons set forth in the preamble and under the authority 
granted to the Commissioner of Patents and Trademarks by 35 U.S.C. 6, 
Title 37 of the Code of Federal Regulations, part 1, is amended as 
follows:

PART 1--RULES OF PRACTICE IN PATENT CASES

    1. The authority citation for 37 CFR part 1 continues to read as 
follows:

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

    2. Section 1.821 is revised to read as follows:


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 section. ``Specifically 
defined'' means those amino acids other than ``Xaa'' and those 
nucleotide bases other than ``n'' defined in accordance with the World 
Intellectual Property Organization (WIPO) Handbook on Industrial 
Property Information and Documentation, Standard ST.25: Standard for 
the Presentation of Nucleotide and Amino Acid Sequence Listings in 
Patent Applications (1998), including Tables 1 through 6 in Appendix 2, 
herein incorporated by reference. (Hereinafter ``WIPO Standard ST.25 
(1998)''). This incorporation by reference was approved by the Director 
of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. Copies of WIPO Standard ST.25 (1998) may be obtained from the 
World Intellectual Property Organization; 34 chemin des Colombettes; 
1211 Geneva 20 Switzerland. Copies of ST.25 may be inspected at the 
Patent Search Room; Crystal Plaza 3, Lobby Level; 2021 South Clark 
Place; Arlington, VA 22202. Copies may also be inspected at the Office 
of the Federal Register, 800 North Capitol Street, NW, Suite 700, 
Washington, DC. Nucleotides and amino acids are further defined as 
follows:
    (1) Nucleotides: Nucleotides are intended to embrace only those 
nucleotides that can be represented using the symbols set forth in WIPO 
Standard ST.25 (1998), Appendix 2, Table 1. Modifications, e.g., 
methylated bases, may be described as set forth in WIPO Standard ST.25 
(1998), Appendix 2, Table 2, but shall not be shown explicitly in the 
nucleotide sequence.
    (2) Amino acids: Amino acids are those L-amino acids commonly found 
in naturally occurring proteins and are listed in WIPO Standard ST.25 
(1998), Appendix 2, Table 3. Those amino acid sequences containing D-
amino acids are not intended to be embraced by this definition. Any 
amino acid sequence that contains post-translationally modified amino 
acids may be described as the amino acid sequence that is initially 
translated using the symbols shown in WIPO Standard ST.25 (1998), 
Appendix 2, Table 3 with the modified positions; e.g., hydroxylations 
or glycosylations, being described as set forth in WIPO Standard ST.25 
(1998), Appendix 2, Table 4, but these modifications shall not be shown 
explicitly in the amino acid sequence. Any peptide or protein that can 
be expressed as a sequence using the symbols in WIPO Standard ST.25 
(1998), Appendix 2, Table 3 in conjunction with a description in the 
Feature section to describe, for example, modified linkages, cross 
links and end caps, non-peptidyl bonds, etc., is embraced by this 
definition.
    (b) Patent applications which contain disclosures of nucleotide 
and/or amino acid sequences, in accordance with the definition in 
paragraph (a) of this section, shall, with regard to the manner in 
which the nucleotide and/or amino

[[Page 29635]]

acid sequences are presented and described, conform exclusively to the 
requirements of Secs. 1.821 through 1.825.
    (c) Patent applications which contain disclosures of nucleotide 
and/or amino acid sequences must contain, as a separate part of the 
disclosure, a paper copy disclosing the nucleotide and/or amino acid 
sequences and associated information using the symbols and format in 
accordance with the requirements of Secs. 1.822 and 1.823. This paper 
copy is hereinafter referred to as the ``Sequence Listing.'' Each 
sequence disclosed must appear separately in the ``Sequence Listing.'' 
Each sequence set forth in the ``Sequence Listing'' shall be assigned a 
separate sequence identifier. The sequence identifiers shall begin with 
1 and increase sequentially by integers. If no sequence is present for 
a sequence identifier, the code ``000'' shall be used in place of the 
sequence. The response for the numeric identifier <160> shall include 
the total number of SEQ ID NOs, whether followed by a sequence or by 
the code ``000.''
    (d) Where the description or claims of a patent application discuss 
a sequence that is set forth in the ``Sequence Listing'' in accordance 
with paragraph (c) of this section, reference must be made to the 
sequence by use of the sequence identifier, preceded by ``SEQ ID NO:'' 
in the text of the description or claims, even if the sequence is also 
embedded in the text of the description or claims of the patent 
application.
    (e) A copy of the ``Sequence Listing'' referred to in paragraph (c) 
of this section must also be submitted in computer readable form in 
accordance with the requirements of 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 
Patent and Trademark Office, reference may be made to the other 
application and computer readable form in lieu of filing a duplicate 
computer readable form in the new application if the computer readable 
form in the other application was compliant with all of the 
requirements of these rules. The new application shall be accompanied 
by a letter making such reference to the other application and computer 
readable form, both of which shall be completely identified. In the new 
application, applicant must also request the use of the compliant 
computer readable ``Sequence Listing'' that is already on file for the 
other application and must state that the paper copy of the ``Sequence 
Listing'' in the new application is identical to the computer readable 
copy filed for the other application.
    (f) In addition to the paper copy required by paragraph (c) of this 
section and the computer readable form required by paragraph (e) of 
this section, a statement that the content of the paper and computer 
readable copies are the same must be submitted with the computer 
readable form, e.g., a statement that ``the information recorded in 
computer readable form is identical to the written sequence listing.''
    (g) If any of the requirements of paragraphs (b) through (f) of 
this section are not satisfied at the time of filing under 35 U.S.C. 
111(a) or at the time of entering the national stage under 35 U.S.C. 
371, applicant will be notified and given a period of time within which 
to comply with such requirements in order to prevent abandonment of the 
application. Any submission in reply to a requirement under this 
paragraph must be accompanied by a statement that the submission 
includes no new matter.
    (h) If any of the requirements of paragraphs (b) through (f) of 
this section are not satisfied at the time of filing an international 
application under the Patent Cooperation Treaty (PCT), which 
application is to be searched by the United States International 
Searching Authority or examined by the United States International 
Preliminary Examining Authority, applicant will be sent a notice 
necessitating compliance with the requirements within a prescribed time 
period. Any submission in reply to a requirement under this paragraph 
must be accompanied by a statement that the submission does not include 
matter which goes beyond the disclosure in the international 
application as filed. If applicant fails to timely provide the required 
computer readable form, the United States International Searching 
Authority shall search only to the extent that a meaningful search can 
be performed without the computer readable form and the United States 
International Preliminary Examining Authority shall examine only to the 
extent that a meaningful examination can be performed without the 
computer readable form.
    3. Section 1.822 is revised to read as follows:


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 (e) of this section.
    (b) The code for representing the nucleotide and/or amino acid 
sequence characters shall conform to the code set forth in the tables 
in WIPO Standard ST.25 (1998), Appendix 2, Tables 1 and 3. This 
incorporation by reference was approved by the Director of the Federal 
Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies 
of ST.25 may be obtained from the World Intellectual Property 
Organization; 34 chemin des Colombettes; 1211 Geneva 20 Switzerland. 
Copies of ST.25 may be inspected at the Patent Search Room; Crystal 
Plaza 3, Lobby Level; 2021 South Clark Place; Arlington, VA 22202. 
Copies may also be inspected at the Office of the Federal Register, 800 
North Capitol Street, NW, Suite 700, Washington, DC. No code other than 
that specified in these sections shall be used in nucleotide and amino 
acid sequences. A modified base or modified or unusual amino acid may 
be presented in a given sequence as the corresponding unmodified base 
or amino acid if the modified base or modified or unusual amino acid is 
one of those listed in WIPO Standard ST.25 (1998), Appendix 2, Tables 2 
and 4, and the modification is also set forth in the Feature section. 
Otherwise, each occurrence of a base or amino acid not appearing in 
WIPO Standard ST.25 (1998), Appendix 2, Tables 1 and 3, shall be listed 
in a given sequence as ``n'' or ``Xaa,'' respectively, with further 
information, as appropriate, given in the Feature section, preferably 
by including one or more feature keys listed in WIPO Standard ST.25 
(1998), Appendix 2, Tables 5 and 6.
    (c) Format representation of nucleotides. (1) A nucleotide sequence 
shall be listed using the lower-case letter for representing the one-
letter code for the nucleotide bases set forth in WIPO Standard ST.25 
(1998), Appendix 2, Table 1.
    (2) The bases in a nucleotide sequence (including introns) shall be 
listed in groups of 10 bases except in the coding parts of the 
sequence. Leftover bases, fewer than 10 in number, at the end of 
noncoding parts of a sequence shall be grouped together and separated 
from adjacent groups of 10 or 3 bases by a space.
    (3) The bases in the coding parts of a nucleotide sequence shall be 
listed as triplets (codons). The amino acids corresponding to the 
codons in the coding parts of a nucleotide sequence shall be typed 
immediately below the corresponding codons. Where a codon spans an 
intron, the amino acid symbol

[[Page 29636]]

shall be typed below the portion of the codon containing two 
nucleotides.
    (4) A nucleotide sequence shall be listed with a maximum of 16 
codons or 60 bases per line, with a space provided between each codon 
or group of 10 bases.
    (5) A nucleotide sequence shall be presented, only by a single 
strand, in the 5 to 3 direction, from left to right.
    (6) The enumeration of nucleotide bases shall start at the first 
base of the sequence with number 1. The enumeration shall be continuous 
through the whole sequence in the direction 5 to 3. The enumeration 
shall be marked in the right margin, next to the line containing the 
one-letter codes for the bases, and giving the number of the last base 
of that line.
    (7) For those nucleotide sequences that are circular in 
configuration, the enumeration method set forth in paragraph (c)(6) of 
this section remains applicable with the exception that the designation 
of the first base of the nucleotide sequence may be made at the option 
of the applicant.
    (d) Representation of amino acids. (1) The amino acids in a protein 
or peptide sequence shall be listed using the three-letter abbreviation 
with the first letter as an upper case character, as in WIPO Standard 
ST.25 (1998), Appendix 2, Table 3.
    (2) A protein or peptide sequence shall be listed with a maximum of 
16 amino acids per line, with a space provided between each amino acid.
    (3) An amino acid sequence shall be presented in the amino to 
carboxy direction, from left to right, and the amino and carboxy groups 
shall not be presented in the sequence.
    (4) The enumeration of amino acids may start at the first amino 
acid of the first mature protein, with the number 1. When presented, 
the amino acids preceding the mature protein, e.g., pre-sequences, pro-
sequences, pre-pro-sequences and signal sequences, shall have negative 
numbers, counting backwards starting with the amino acid next to number 
1. Otherwise, the enumeration of amino acids shall start at the first 
amino acid at the amino terminal as number 1. It shall be marked below 
the sequence every 5 amino acids. The enumeration method for amino acid 
sequences that is set forth in this section remains applicable for 
amino acid sequences that are circular in configuration, with the 
exception that the designation of the first amino acid of the sequence 
may be made at the option of the applicant.
    (5) An amino acid sequence that contains internal terminator 
symbols (e.g., ``Ter'', ``*'', or ``.'', etc.) may not be represented 
as a single amino acid sequence, but shall be presented as separate 
amino acid sequences.
    (e) A sequence with a gap or gaps shall be presented as a plurality 
of separate sequences, with separate sequence identifiers, with the 
number of separate sequences being equal in number to the number of 
continuous strings of sequence data. A sequence that is made up of one 
or more noncontiguous segments of a larger sequence or segments from 
different sequences shall be presented as a separate sequence.
    4. Section 1.823 is revised to read as follows:


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 must be titled ``Sequence Listing''. The 
``Sequence Listing'' preferably should be numbered independently of the 
numbering of the remainder of the application. Each page of the 
``Sequence Listing'' should contain no more than 66 lines and each line 
should contain no more than 72 characters. A fixed-width font should be 
used exclusively throughout the ``Sequence Listing.''
    (b) The ``Sequence Listing'' shall, except as otherwise indicated, 
include the actual nucleotide and/or amino acid sequence, the numeric 
identifiers and their accompanying information as shown in the 
following table. The numeric identifier shall be used only in the 
``Sequence Listing.'' The order and presentation of the items of 
information in the ``Sequence Listing'' shall conform to the 
arrangement given below. Each item of information shall begin on a new 
line and shall begin with the numeric identifier enclosed in angle 
brackets as shown. The submission of those items of information 
designated with an ``M'' is mandatory. The submission of those items of 
information designated with an ``O'' is optional. Numeric identifiers 
<110> through <170> shall only be set forth at the beginning of the 
``Sequence Listing.'' The following table illustrates the numeric 
identifiers.

----------------------------------------------------------------------------------------------------------------
                                                                                      Mandatory (M) or optional 
    Numeric identifier            Definition              Comments and format                   (O).            
----------------------------------------------------------------------------------------------------------------
<110>....................  Applicant...............  Preferably max. of 10 names;   M.                          
                                                      one name per line;                                        
                                                      preferable format: Surname,                               
                                                      Other Names and/or Initials.                              
<120>....................  Title of Invention......  .............................  M.                          
<130>....................  File Reference..........  Personal file reference......  M when filed prior to       
                                                                                     assignment of appl. number.
<140>....................  Current Application       Specify as: US 07/999,999 or   M, if available.            
                            Number.                   PCT/US96/99999.                                           
<141>....................  Current Filing Date.....  Specify as: yyyy-mm-dd.......  M, if available.            
<150>....................  Prior Application Number  Specify as: US 07/999,999 or   M, if applicable include    
                                                      PCT/US96/99999.                priority documents under 35
                                                                                     USC 119 and 120.           
<151>....................  Prior Application Filing  Specify as: yyyy-mm-dd.......  M, if applicable.           
                            Date.                                                                               
<160>....................  Number of SEQ ID NOs....  Count includes total number    M.                          
                                                      of SEQ ID NOs.                                            
<170>....................  Software................  Name of software used to       O.                          
                                                      create the Sequence Listing.                              
<210>....................  SEQ ID NO:#:............  Response shall be an integer   M.                          
                                                      representing the SEQ ID NO                                
                                                      shown.                                                    
<211>....................  Length..................  Respond with an integer        M.                          
                                                      expressing the number of                                  
                                                      bases or amino acid residues.                             

[[Page 29637]]

                                                                                                                
<212>....................  Type....................  Whether presented sequence     M.                          
                                                      molecule is DNA, RNA, or PRT                              
                                                      (protein). If a nucleotide                                
                                                      sequence contains both DNA                                
                                                      and RNA fragments, the type                               
                                                      shall be ``DNA.'' In                                      
                                                      addition, the combined DNA/                               
                                                      RNA molecule shall be                                     
                                                      further described in the                                  
                                                      <220> to <223> feature                                    
                                                      section.                                                  
<213>....................  Organism................  Scientific name, i.e. Genus/   M                           
                                                      species, Unknown or                                       
                                                      Artificial Sequence. In                                   
                                                      addition, the ``Unknown'' or                              
                                                      ``Artificial Sequence''                                   
                                                      organisms shall be further                                
                                                      described in the <220> to                                 
                                                      <223> feature section.                                    
<220>....................  Feature.................  Leave blank after <220>. <221- M, under the following      
                                                      223> provide for a             conditions: if ``n,''      
                                                      description of points of       ``Xaa,'' or a modified or  
                                                      biological significance in     unusual L-amino acid or    
                                                      the sequence..                 modified base was used in a
                                                                                     sequence; if ORGANISM is   
                                                                                     ``Artificial Sequence'' or 
                                                                                     ``Unknown'; if molecule is 
                                                                                     combined DNA/RNA''         
<221>....................  Name/Key................  Provide appropriate            M, under the following      
                                                      identifier for feature,        conditions: if ``n,''      
                                                      preferably from WIPO           ``Xaa,'' or a modified or  
                                                      Standard ST.25 (1998),         unusual L-amino acid or    
                                                      Appendix 2, Tables 5 and 6.    modified base was used in a
                                                                                     sequence.                  
<222>....................  Location................  Specify location within        M, under the following      
                                                      sequence; where appropriate    conditions: if ``n,''      
                                                      state number of first and      ``Xaa,'' or a modified or  
                                                      last bases/amino acids in      unusual L-amino acid or    
                                                      feature.                       modified base was used in a
                                                                                     sequence.                  
<223>....................  Other Information.......  Other relevant information;    M, under the following      
                                                      four lines maximum.            conditions: if ``n,''      
                                                                                     ``Xaa,'' or a modified or  
                                                                                     unusual L-amino acid or    
                                                                                     modified base was used in a
                                                                                     sequence; if ORGANISM is   
                                                                                     ``Artificial Sequence'' or 
                                                                                     ``Unknown''; if molecule is
                                                                                     combined DNA/RNA.          
<300>....................  Publication Information.  Leave blank after <300>......  O.                          
<301>....................  Authors.................  Preferably max of ten named    O.                          
                                                      authors of publication;                                   
                                                      specify one name per line;                                
                                                      preferable 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 on which data     O.                          
                                                      published; specify as yyyy-                               
                                                      mm-dd, MMM-yyyy or Season-                                
                                                      yyyy.                                                     
<308>....................  Database Accession        Accession number assigned by   O.                          
                            Number.                   database including database                               
                                                      name.                                                     
<309>....................  Database Entry Date.....  Date of entry in database;     O.                          
                                                      specify as yyyy-mm-dd or MMM-                             
                                                      yyyy.                                                     
<310>....................  Patent Document Number..  Document number; for patent-   O.                          
                                                      type citations only. Specify                              
                                                      as, for example, US 07/                                   
                                                      999,999.                                                  
<311>....................  Patent Filing Date......  Document filing date, for      O.                          
                                                      patent-type citations only;                               
                                                      specify as yyyy-mm-dd.                                    
<312>....................  Publication Date........  Document publication date,     O.                          
                                                      for patent-type citations                                 
                                                      only; specify as yyyy-mm-dd.                              
<313>....................  Relevant Residues.......  FROM (position) TO (position)  O.                          
<400>....................  Sequence................  SEQ ID NO should follow the    M.                          
                                                      numeric identifier and                                    
                                                      should appear on the line                                 
                                                      preceding the actual                                      
                                                      sequence.                                                 
----------------------------------------------------------------------------------------------------------------

    5. Section 1.824 is 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 meet 
the following specifications:
    (1) The computer readable form shall contain a single ``Sequence 
Listing'' as either a diskette, series of diskettes, or other 
permissible media outlined in paragraph (c) of this section.
    (2) The ``Sequence Listing'' in paragraph (a) (l) of this section 
shall be submitted in American Standard Code for Information 
Interchange (ASCII) text. No other formats shall be allowed.
    (3) The computer readable form may be created by any means, such as 
word processors, nucleotide/amino acid sequence editors or other custom 
computer programs; however, it shall conform to all specifications 
detailed in this section.
    (4) File compression is acceptable when using diskette media, so 
long as the compressed file is in a self-extracting format that will 
decompress on one of the systems described in paragraph (b) of this 
section.
    (5) Page numbering shall not appear within the computer readable 
form version of the ``Sequence Listing'' file.
    (6) All computer readable forms shall have a label permanently 
affixed thereto on which has been hand-printed or typed: the name of 
the applicant, the title of the invention, the date on which the data 
were recorded on the computer readable form, the operating system used, 
a reference number, and an application serial number and filing date, 
if known.

[[Page 29638]]

    (b) Computer readable form submissions must meet these format 
requirements:
    (1) Computer: IBM PC/XT/AT, or compatibles, or Apple Macintosh;
    (2) Operating System: MS-DOS, Unix or Macintosh;
    (3) Line Terminator: ASCII Carriage Return plus ASCII Line Feed;
    (4) Pagination: Continuous file (no ``hard page break'' codes 
permitted);
    (c) Computer readable form files submitted may be in any of the 
following media:
    (1) Diskette : 3.50 inch, 1.44 Mb storage; 3.50 inch, 720 Kb 
storage; 5.25 inch, 1.2 Mb storage; 5.25 inch, 360 Kb storage.
    (2) Magnetic tape: 0.5 inch, up to 24000 feet; Density: 1600 or 
6250 bits per inch, 9 track; Format: Unix tar command; specify blocking 
factor (not ``block size''); Line Terminator: ASCII Carriage Return 
plus ASCII Line Feed.
    (3) 8mm Data Cartridge: Format: Unix tar command; specify blocking 
factor (not ``block size''); Line Terminator: ASCII Carriage Return 
plus ASCII Line Feed.
    (4) CD-ROM: Format: ISO 9660 or High Sierra Format
    (5) Magneto Optical Disk: Size/Storage Specifications: 5.25 inch, 
640 Mb.
    (d) Computer readable forms that are submitted to the Office will 
not be returned to the applicant.
    6. Section 1.825 is revised to read as follows:


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.
    (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.''
    (c) Any appropriate amendments to the ``Sequence Listing'' in a 
patent; e.g., by reason of reissue or certificate of correction, must 
comply with the requirements of paragraphs (a) and (b) of this section.
    (d) If, upon receipt, the computer readable form is found to be 
damaged or unreadable, applicant must provide, within such time as set 
by the Commissioner, a substitute copy of the data in computer readable 
form accompanied by a statement that the substitute data is identical 
to that originally filed.
    7. Appendix A To Subpart G to Part 1 is revised to read as follows:

BILLING CODE 3510-16-P

[[Page 29639]]

Appendix A To Subpart G to Part 1--Sample Sequence Listing
[GRAPHIC] [TIFF OMITTED] TR01JN98.006


[[Page 29640]]

[GRAPHIC] [TIFF OMITTED] TR01JN98.007



[[Page 29641]]

[GRAPHIC] [TIFF OMITTED] TR01JN98.008



[[Page 29642]]

[GRAPHIC] [TIFF OMITTED] TR01JN98.009



[[Page 29643]]

[GRAPHIC] [TIFF OMITTED] TR01JN98.010



    Dated: May 22, 1998.
Bruce A. Lehman,
Assistant Secretary of Commerce and Commissioner of Patents and 
Trademarks.
[FR Doc. 98-14194 Filed 5-29-98; 8:45 am]
BILLING CODE 3510-16-C


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