29620 federal register /vol. 63, no. 104/monday, june … federal register/vol. 63, no. 104/monday,...

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

(1) Examination will begin after theearliest of:

(i) Receipt of the amendment;(ii) Receipt of applicant’s statement

that no amendment will be made; or(iii) Expiration of the time period set

in the notification.(2) No international preliminary

examination report will be establishedprior to issuance of an internationalsearch report.* * * * *

17. Section 1.485 is amended byrevising paragraph (a) to read as follows:

§ 1.485 Amendment by applicant duringinternational preliminary examination.

(a) The applicant may makeamendments at the time of filing theDemand. The applicant may also makeamendments within the time limit setby the International PreliminaryExamining Authority for reply to anynotification under § 1.484(b) or to anywritten opinion. Any such amendmentsmust:

(1) Be made by submitting areplacement sheet in compliance withPCT Rules 10 and 11.1 to 11.13 for everysheet of the application which differsfrom the sheet it replaces unless anentire sheet is cancelled; and

(2) Include a description of how thereplacement sheet differs from thereplaced sheet. Amendments that do notcomply with PCT Rules 10 and 11.1 to11.13 may not be entered.* * * * *

18. Section 1.494 is amended byrevising paragraph (c) to read as follows:

§ 1.494 Entering the national stage in theUnited States of America as a DesignatedOffice.

* * * * *(c) If applicant complies with

paragraph (b) of this section beforeexpiration of 20 months from thepriority date but omits:

(1) A translation of the internationalapplication, as filed, into the Englishlanguage, if it was originally filed inanother language (35 U.S.C. 371(c)(2))and/or

(2) The oath or declaration of theinventor (35 U.S.C. 371(c)(4); see§ 1.497), applicant will be so notifiedand given a period of time within whichto file the translation and/or oath ordeclaration in order to preventabandonment of the application. Thepayment of the processing fee set forthin § 1.492(f) is required for acceptanceof an English translation later than theexpiration of 20 months after thepriority date. The payment of thesurcharge set forth in § 1.492(e) isrequired for acceptance of the oath ordeclaration of the inventor later than the

expiration of 20 months after thepriority date. A ‘‘Sequence Listing’’need not be translated if the ‘‘SequenceListing’’ complies with PCT Rule 12.1(d)and the description complies with PCTRule 5.2(b).* * * * *

19. Section 1.495 is amended byrevising paragraph (c) to read as follows:

§ 1.495 Entering the national stage in theUnited States of America as an ElectedOffice.

* * * * *(c) If applicant complies with

paragraph (b) of this section beforeexpiration of 30 months from thepriority date but omits:

(1) A translation of the internationalapplication, as filed, into the Englishlanguage, if it was originally filed inanother language (35 U.S.C. 371(c)(2))and/or

(2) The oath or declaration of theinventor (35 U.S.C. 371(c)(4); see§ 1.497), applicant will be so notifiedand given a period of time within whichto file the translation and/or oath ordeclaration in order to preventabandonment of the application. Thepayment of the processing fee set forthin § 1.492(f) is required for acceptanceof an English translation later than theexpiration of 30 months after thepriority date. The payment of thesurcharge set forth in § 1.492(e) isrequired for acceptance of the oath ordeclaration of the inventor later than theexpiration of 30 months after thepriority date.

A ‘‘Sequence Listing’’ need not betranslated if the ‘‘Sequence Listing’’complies with PCT Rule 12.1(d) and thedescription complies with PCT Rule5.2(b).* * * * *

Dated: May 22, 1998.Bruce A. Lehman,Assistant Secretary of Commerce andCommissioner of Patents and Trademarks.[FR Doc. 98–14195 Filed 5–29–98; 8:45 am]BILLING CODE 3510–16–P

DEPARTMENT OF COMMERCE

Patent and Trademark Office

37 CFR Part 1

[Docket No: 960828235–8109–02]

RIN: 0651–AA88

Requirements for Patent ApplicationsContaining Nucleotide Sequence and/or Amino Acid Disclosures

AGENCY: Patent and Trademark Office,Commerce.

ACTION: Final rule.

SUMMARY: The Patent and TrademarkOffice (PTO) is amending the rules forsubmitting nucleotide or amino acidsequences in computer readable form(CRF) for patent applications. Theseamendments simplify the requirementsof the rules, rearrange portions of therules for better understanding andestablish consistent rules to permit asingle internationally acceptablecomputer readable form. SequenceListings will be presented in aninternational, language neutral formatusing numeric identifiers rather than thecurrent subject headings. The PaperSequence Listing will preferably be aseparately numbered section of thepatent application. Sequences whichcontain fewer than four specificallyidentified nucleotides or amino acidswill no longer be required to besubmitted in computer readable form.DATES: Effective date: July 1, 1998. Theincorporation by reference of certainpublications listed in the regulations isapproved by the Director of the FederalRegister as of July 1, 1998.

Applicability date: Sections 1.821through 1.825 as amended apply toapplications filed on or after July 1,1998, except for: (1) applications thatclaim the benefit of a prior applicationunder 35 U.S.C. 120 filed before July 1,1998, and which do not add subjectmatter involving a sequence listingsubject to §§ 1.821 through 1.825; and(2) reissue applications in which theapplication for the patent sought to bereissued was filed before July 1, 1998.Sections 1.821 through 1.825 applyduring a reexamination proceeding ifthe application for the patent sought tobe reexamined was filed on or after July1, 1998.FOR FURTHER INFORMATION CONTACT:Esther M. Kepplinger, by telephone at(703) 308–1495; by mail addressed to:Box Comments—Patents, AssistantCommissioner for Patents, Washington,DC 20231 marked to her attention; byfacsimile to (703) 305–3935; or byelectronic mail [email protected] INFORMATION: Sections1.821 through 1.825 of title 37 providea standardized format for thedescription of nucleotide and aminoacid sequence data in patentapplications and require the submissionof such sequences in computer readableform (CRF). Sections 1.821 through1.825 provide the following benefits tothe PTO: (1) Improved searchcapabilities; (2) improved interferencedetection; (3) more efficientexamination; (4) cost savings for theinput of the sequence data; (5) more

29621Federal Register / Vol. 63, No. 104 / Monday, June 1, 1998 / Rules and Regulations

efficient and accurate printing ofsequences in patents; (6) exchange ofthe sequence data with other patentoffices electronically; and (7) improvedpublic access to the sequenceselectronically.

Reasons for the Changes

In response to the needs of ourcustomers, the procedural requirementsfound in former §§ 1.821 through 1.825have been reduced. Sections 1.821through 1.825 are being amended to beconsistent with World IntellectualProperty Organization (WIPO) StandardST.25 (signed in 1998 and effective July1, 1998). ST.25 replaces WIPOStandards ST.23 and ST.24 which dealwith paper and electronic submissionsof sequence listings.

A Meeting of International Authorities(MIA) under the Patent CooperationTreaty (PCT) was held in November of1994 to discuss simplification ofsequence listing submissionrequirements. Under the previous PCTRegulations, each InternationalSearching Authority, each InternationalPreliminary Examining Authority andeach designated/elected office was freeto set the requirements for submissionof sequence listings in paper andelectronic form. This imposed a burdenon applicants by requiring them toprepare sequence listings in manydifferent formats. In addition, sequencelistings were required to be translatedfor consideration in the national stage atconsiderable cost to applicants and atthe risk that the information could beinaccurately translated.

After the November 1994 MIA, thePTO, the European Patent Office (EPO)and the Japanese Patent Office (JPO)worked together with WIPO to create anew international standard which formsthe basis of WIPO Standard ST.25(1998). Sections 1.821 through 1.825 of37 CFR, as amended herein, areconsistent with WIPO Standard ST.25(1998) and the PCT sequence listingrequirements. Sequence listingsprepared in accordance with §§ 1.821through 1.825 as amended generallywill be acceptable in all countries whichadhere to WIPO Standard ST.25 (1998).In addition, a sequence listing preparedin accordance with the §§ 1.821 through1.825 as amended will be acceptable forthe national stage in all PCT membercountries which require the submissionof a sequence listing. As a result of thisrule change, applicants will experiencea reduction in cost since only onesequence listing in paper and electronicform will need to be prepared andtranslations of this listing will not beneeded.

All necessary changes to the text of§§ 1.821 through 1.825 to reflect thenew WIPO Standard ST.25 (1998), havebeen made. Each change is describedbelow.

Overview of the ChangesThe changes in this Final Rule

include:(1) Use of numeric identifiers to

replace the language subject headingswithin the submission;

(2) Elimination of unnecessary andconfusing data elements;

(3) Movement of the paper SequenceListing to the end of the application,preferably with separately numberedpages;

(4) Elimination of the requirement toprovide a submission for sequenceswith fewer than four specificallydefined nucleotides or amino acids;

(5) Use of lower-case one-letter codesfor nucleotide bases;

(6) Rearrangement of portions of therules to improve their context;

(7) Clarification and simplification ofthe rules to aid in understanding; and

(8) Minor changes to accomplishharmonization with WIPO StandardST.25 (1998) as well as the EPO and theJPO standards.

Amended §§ 1.821 through 1.825 arenot mandatory for: (1) applications thatclaim the benefit of a prior applicationunder 35 U.S.C. 120 filed before July 1,1998, and which do not add subjectmatter involving a sequence listingsubject to §§ 1.821 through 1.825; (2)reissue applications in which theapplication for the patent sought to bereissued was filed before July 1, 1998;and (3) reexamination proceedings if theapplication for the patent sought to bereexamined was filed before July 1,1998. The PTO will accept andencourages the submission of sequencelistings in compliance with amended§§ 1.821 through 1.825 for anyapplication or reexaminationproceeding. All sequence listings(including the entire computer readableform) must be submitted in compliancewith either §§ 1.821 through 1.825 asamended in this Final Rule or (whenpermitted) former §§ 1.821 through1.825.

If the CRF for a new applicationwould be identical to a compliant CRFalready on file in the PTO, the applicantmay make reference to the otherapplication and the CRF in lieu of filinga duplicate CRF in the new applicationby following the procedures set forth in§ 1.821(e). If exceptional circumstancesdo arise and certain applicantsexperience specific hardships inattempting to comply with amended§§ 1.821 through 1.825, the PTO will

consider a petition under § 1.183 towaive certain requirements of §§ 1.821through 1.825.

A Notice of Proposed Rulemakingentitled ‘‘Changes ImplementingNucleotide and/or Amino AcidSequence Listings’’ (Notice of ProposedRulemaking) was published in theFederal Register at 61 FR 51855(October 4, 1996), and in the OfficialGazette of the Patent and TrademarkOffice, at 1191 Off. Gaz. Pat. Office 168(October 29, 1996). Sections 1.821through 1.825 as adopted containseveral changes from these sections.This Final Rule provides a discussion ofthe content of the specific rules beingamended, description of the changes inthe text of the proposed rules, andexplanation of the reasons supportingthe changes. In addition, commentsreceived in response to the Notice ofProposed Rulemaking are analyzed.

Discussion of Specific Rules andChanges from the Proposed Rules:

Title 37 of the Code of FederalRegulations, Part 1, is amended asfollows.

Section 1.77

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

Section 1.821

Section 1.821 incorporates byreference the World IntellectualProperty Organization (WIPO)Handbook on Industrial PropertyInformation and Documentation,Standard ST.25 (1998), including Tables1 through 6 of Appendix 2, inaccordance with 5 U.S.C. 552(a) and 1CFR part 51. Copies may be obtainedfrom the World Intellectual PropertyOrganization; 34 chemin desColombettes; 1211 Geneva 20Switzerland. Copies may be inspected atthe Patent Search Room; Crystal Plaza 3,Lobby Level; 2021 South Clark Place;Arlington, VA 22202. Copies may alsobe inspected at the Office of the FederalRegister, 800 North Capitol Street, NW,Suite 700, Washington, DC 20408. TheseTables are reproduced below.

WIPO Standard ST.25 (1998),Appendix 2, Table 1, provides that thebases of a nucleotide sequence shouldbe represented using the following one-letter code for nucleotide sequencecharacters:


TABLE 1.—ONE LETTER CODES FOR NUCLEOTIDE SEQUENCES

Symbol Meaning Origin of designation

a ................................................................................. a ................................................................................. adenine.g ................................................................................. g ................................................................................. guanine.c ................................................................................. c ................................................................................. cytosine.t .................................................................................. t .................................................................................. thymine.u ................................................................................. u ................................................................................. uracil.r .................................................................................. g or a ......................................................................... purine.y ................................................................................. t/u or c ....................................................................... pyrimidine.m ................................................................................ a or c ......................................................................... amino.k ................................................................................. g or t/u ....................................................................... keto.s ................................................................................. g or c ......................................................................... strong interactions 3 H-bonds.w ................................................................................. a or t/u ....................................................................... weak interactions 2 H-bonds.b ................................................................................. g or c or t/u ................................................................ not a.d ................................................................................. a or g or t/u ................................................................ not c.h ................................................................................. a or c or t/u ................................................................ not g.v ................................................................................. a or g or c .................................................................. not t, not u.n ................................................................................. (a or g or c or t/u) or (unknown or other) .................. any

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


TABLE 2.—MODIFIED BASES—Continued

Symbol Meaning

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

WIPO Standard ST.25 (1998),Appendix 2, Table 3, provides that theamino acids should be representedusing the following three-letter codewith the first letter as a capital.

TABLE 3.—AMINO ACID THREE-LETTERCODES

Symbol Meaning

Ala ............................. Alanine.Cys ............................ Cysteine.Asp ............................ Aspartic Acid.Glu ............................. Glutamic Acid.Phe ............................ Phenylalanine.Gly ............................. Glycine.His ............................. Histidine.Ile ............................... Isoleucine.Lys ............................. Lysine.

TABLE 3.—AMINO ACID THREE-LETTERCODES—Continued

Symbol Meaning

Leu ............................ Leucine.Met ............................ Methionine.Asn ............................ Asparagine.Pro ............................. Proline.Gln ............................. Glutamine.Arg ............................. Arginine.Ser ............................. Serine.Thr ............................. Threonine.Val ............................. Valine.Trp ............................. Tryptophan.Tyr ............................. Tyrosine.Asx ............................ Asp or Asn.Glx ............................. Glu or Gln.Xaa ............................ Unknown or other.

WIPO Standard ST.25 (1998),Appendix 2, Table 4, provides thatmodified and unusual amino acids maybe represented as the correspondingunmodified amino acids in the sequenceitself if the modified or unusual aminoacid is one of those listed below and themodification is further described in theFeature section of the Sequence Listing.The codes from the list below may beused in the description (i.e., thespecification and drawings, or in theSequence Listing) but these codes maynot 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 featurekeys related to DNA sequences.

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Further in paragraph (a) of § 1.821,both occurrences of ‘‘Copies of ST.23’’have been changed to ‘‘Copies of WIPOStandard ST.25 (1998).’’ This change isnecessary to reflect the new standardnumber.

In paragraph (a)(1) of § 1.821, ‘‘ST.23(April 1994), paragraph 8’’ has beenchanged to ‘‘ST.25 (1998), Appendix 2,Table 1.’’ This change reflects thecorrect information with regard to theincorporated WIPO standard and the listof symbols to be used for nucleotidesequence characters.

Further in paragraph (a)(1) of § 1.821,‘‘ST.23 (April 1994), paragraph 9’’ hasbeen changed to ‘‘ST.25 (1998),Appendix 2, Table 2.’’ This changereflects the correct information withregard to the incorporated WIPOstandard and the list of modified baseswhich can be presented as unmodifiednucleotide sequence characters.

In paragraph (a)(2) of § 1.821, all threeoccurrences of ‘‘ST.23 (April 1994),paragraph 11’’ have been changed to‘‘ST.25 (1998), Appendix 2, Table 3.’’This change reflects the correctinformation with regard to theincorporated WIPO standard and the listof symbols to be used for amino acidsequence characters.

Further in paragraph (a)(2) of § 1.821,‘‘ST.23 (April 1994), paragraph 12’’ hasbeen changed to ‘‘ST.25 (1998),Appendix 2, Table 4.’’ This changereflects the correct information withregard to the incorporated WIPOstandard and the list of modified orunusual amino acids which can be

presented as unmodified amino acidsequence characters.

In paragraph (c) of § 1.821, each of thethree occurrences of the words ‘‘integeridentifier’’ or ‘‘integer identifiers’’ hasbeen changed to ‘‘sequence identifier’’or ‘‘sequence identifiers’’ as appropriate.WIPO Standard ST.25 (1998), uses theterm ‘‘sequence identifier’’ rather than‘‘integer identifier.’’ Thus, this change isnecessary to achieve harmonizationwith the international standard.

In the last sentence of paragraph (c) of§ 1.821, the phrase ‘‘The sequenceomitted shall appear following theinteger identifier’’ of the proposed rulehas 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 ofSEQ ID NOs, whether followed by asequence or by the code ‘‘000’’. Thecode ‘‘000’’ should be put into <400>.This change permits flexibility in thepreparation and amendment ofSequence Listings. It also makes the rulelanguage-neutral and is consistent withWIPO Standard ST.25 (1998).

In paragraph (d) of § 1.821, the words‘‘integer identifier’’ have been changedto ‘‘sequence identifier.’’ WIPOStandard ST.25 (1998) uses the term‘‘sequence identifier’’ rather than‘‘integer identifier.’’ Thus, this change isnecessary to achieve harmonizationwith the international standard.

In paragraphs (f), (g) and (h) of§ 1.821, the sentence ‘‘Such a statementmust be a verified statement if made bya person not registered to practice beforethe Office’’ has been deleted. Theseparate verification requirements in

§ 1.821 have been eliminated in view ofthe recent amendment to §§ 1.4(d) and10.18. See Changes to Patent Practiceand Procedure; Final Rule, 62 FR. 53131(October 10, 1997), 1203 Off. Gaz. Pat.Office 63 (October 21, 1997). Paragraph(g) of § 1.821 has also been amended toprovide that the Office will provide a‘‘period of time’’ (rather than onemonth) within which the applicantmust comply with the requirements of§ 1.821(b) through (f) in order to avoidabandonment.

Further in paragraph (f) of § 1.821, thefollowing has been added at the end ofthe first sentence, ’’, e.g., theinformation recorded in computerreadable form is identical to the writtensequence listing.’’ WIPO Standard ST.25(1998), paragraph 39, requires thelanguage which has been added as anacceptable example for phrasing therequired statement that the computerreadable form and the written sequencelisting are the same.

Section 1.822In paragraph (b) of § 1.822, both

references to WIPO Standard ST.23(April 1994), paragraphs 8 and 11, asproposed have been changed to ‘‘WIPOStandard ST.25 (1998), Appendix 2,Tables 1 and 3.’’ These changes reflectthe correct information with regard tothe incorporated WIPO standard and thelists of symbols for nucleotide andamino acid sequence characters.

Further in paragraph (b) of § 1.822,‘‘WIPO Standard ST.23 (April 1994),paragraphs 9 and 12’’ as proposed hasbeen changed to ‘‘WIPO Standard ST.25(1998), Appendix 2, Tables 2 and 4.’’


This change reflects the correctinformation with regard to theincorporated WIPO standard and thelists of modified bases and modified orunusual amino acids which can bedepicted in the Sequence Listing via thesymbols for a corresponding unmodifiedbase or amino acid.

Further in paragraph (b) of § 1.822,the symbol designating an unknownnucleotide base or a nucleotide baseother than those listed in the WIPOstandard was proposed as an upper caseletter ‘‘N.’’ This symbol has beenchanged to a lower case letter ‘‘n.’’ Thischange is consistent with the use oflower case letters for the symbolsrepresenting the nucleotide bases.

Further in paragraph (b) of § 1.822,the language has been clarified tospecifically state that each ‘‘n’’ or ‘‘Xaa’’represents only a single residue. Thus,for example, a single ‘‘Xaa’’ may not beused to designate a string of four aminoacids, each of which is unknown. Thisrepresents a codification of existingpractice.

Further in paragraph (b) of § 1.822,the information required in the Featuresection to explain the use of ‘‘n’’ or‘‘Xaa’’ in a given sequence is referred to‘‘as appropriate.’’ Additional instructionis added at the end of paragraph (b) of§ 1.822 following ‘‘the Feature section’’indicating’’, preferably by including oneor more feature keys listed in WIPOStandard ST.25 (1998), Appendix 2,Tables 5 and 6.’’ This change specifiesthe preference for using the feature keyslisted in the WIPO standard in order toaid applicants in filing a CRF whichwill comply with WIPO Standard ST.25(1998). These feature keys are controlledvocabulary and are considered languageneutral. Their use is required in a PCTpatent application or a patentapplication in a foreign country whichhas adopted WIPO Standard ST.25(1998).

In paragraph (c)(1) of § 1.822, ‘‘WIPOStandard ST.23 (April 1994), paragraph8’’ as proposed has been changed to‘‘WIPO Standard ST.25 (1998),Appendix 2, Table 1.’’ This changereflects the correct information withregard to the incorporated WIPOstandard and the list of symbols to beused for nucleotide sequence characters.

In paragraph (d)(1) of § 1.822, ‘‘WIPOStandard ST.23 (April 1994), paragraph11, as proposed has been changed to‘‘WIPO Standard ST.25 (1998),Appendix 2, Table 3.’’ This changereflects the correct information withregard to the incorporated WIPOstandard and the list of symbols to beused for amino acid sequencecharacters.

In paragraph (d)(4) of § 1.822, thesection notes that enumerationrequirements are applicable to aminoacid sequences that are circular inconfiguration. The following languagehas been added to the end of theparagraph ’’, with the exception that thedesignation of the first amino acid of thesequence may be made at the option ofthe applicant.’’ This change is necessaryto provide consistency with itscounterpart of circular nucleotidesequences as provided in paragraph(c)(7) of § 1.822. This change is alsoconsistent with WIPO Standard ST.25(1998), paragraph 21.

In paragraph (e) of § 1.822, the words‘‘integer identifiers’’ have been changedto ‘‘sequence identifiers .’’ WIPOStandard ST.25 (1998) uses the term‘‘sequence identifier’’ rather than‘‘integer identifier.’’ Thus, this change isnecessary to achieve harmonizationwith the international standard.

Section 1.823In paragraph (a) of § 1.823, the entire

second sentence which read ‘‘On aseparate page of the applicationspecification, immediately prior to theclaims, there shall be a reference to thepresence of the ‘Sequence Listing’ in a‘Sequence Listing Annex.’’’ has beeneliminated. The designation of theSequence Listing as an annex to thespecification was initially proposed inan early version of the internationalstandard. This terminology is not usedin WIPO Standard ST.25 (1998),however, and so it has also beeneliminated from paragraph (a) of § 1.823,as proposed. Simplification results aswell by the elimination of therequirement that the Sequence Listingmust be designated as an annex to thespecification.

In paragraph (a) of § 1.823, the thirdsentence has been modified by deletingthe words ‘‘shall appear in the‘Sequence Listing Annex,’ which is.’’ Asexplained above, the current version ofthe international standard does notrequire designating the Sequence Listingas an annex to the specification.

In paragraph (a) of § 1.823, the words‘‘preferably should be’’ have been addedto the third sentence, before ‘‘numberedindependently of the numbering of theremainder of the application’’ todescribe the independent pagenumbering of the Sequence Listing inpaper copy form. The term ‘‘preferably’’was added for purposes ofharmonization with WIPO StandardST.25 (1998).

In paragraph (a) of § 1.823, the lastclause of the third sentence ‘‘and shallbe placed in the application file’’ hasbeen deleted as unnecessary and

potentially confusing now that thereference to a ‘‘Sequence ListingAnnex’’ has been removed from thisparagraph.

In paragraph (a) of § 1.823, the fourthsentence has been eliminated in itsentirety. As explained above, thecurrent version of the internationalstandard does not require designatingthe Sequence Listing as an annex to thespecification.

In paragraph (a) of § 1.823, in bothoccurrences in the fifth sentence and inthe single occurrence in the sixthsentence, the word ‘‘shall’’ has beenchanged to ‘‘should.’’ These changes arenecessary for purposes of achievingconsistency with WIPO Standard ST.25(1998).

In paragraph (b) of § 1.823, the firstsentence has been modified by thedeletion of the words ‘‘in addition toand immediately preceding.’’ Thischange is consistent with WIPOStandard ST.25 (1998).

In paragraph (b) of § 1.823, the fifthsentence has been deleted, eliminatingthe prohibition of any item ofinformation occupying more than oneline. This change is consistent withWIPO Standard ST.25 (1998).

In paragraph (b) of § 1.823, the lastsentence has been deleted to eliminatethe ‘‘rep’’ designation for data elementsof the ‘‘Sequence Listing.’’ Certain dataelements may still be repeated withinthe listing but this change was made forharmonization of the table with WIPOStandard ST.25 (1998).

In paragraph (b) of § 1.823, the eighthsentence has been modified to reflectthe new numeric numbering scheme, forharmonization with WIPO StandardST.25 (1998). Specifically, ‘‘<100>through <193>’’ of the proposed rulehas been changed to ‘‘<110> through<170>.’’

The table in paragraph (b) of § 1.823,has been changed to reflect the revisednumbering scheme and data elementsused in WIPO Standard ST.25 (1998).The specific changes are as follows:

Numeric identifier ‘‘<100>, GeneralInformation,’’ has been deleted from theproposed rules, as it is not present inWIPO Standard ST.25 (1998).

Numeric identifier ‘‘<110>,Applicant,’’ in the proposed rule, hasbeen changed to indicate that‘‘preferably ’’ a maximum of ten namesmay be indicated. This change allowsfor more than ten names in theApplicant field for those instances inwhich such would be appropriate. Thischange is consistent with WIPOStandard ST.25 (1998).

Numeric identifier ‘‘<120>, Title ofInvention,’’ in the proposed rule, hasbeen changed to eliminate the limitation


that the title be a maximum of fourlines. This change allows applicantsmore flexibility with respect to the title.This change is consistent with WIPOStandard ST.25 (1998).

Numeric identifier ‘‘<130>, Numberof Sequences,’’ in the proposed rule, hasbeen changed to reflect ‘‘<130>, FileReference,’’ as stated in WIPO StandardST.25 (1998). This numeric identifierwas indicated as ‘‘<183>, FileReference/Docket Number ’’, in the ruleas proposed. As proposed this was anoptional numeric identifier. Thenumeric identifier remains optionalonce the application has been assignedan application number, e.g., a serialnumber. This numeric identifier is nowMANDATORY when an applicationnumber has not yet been assigned to theapplication, such as on the day theapplication is initially filed. Thischange will assist in the matching ofsequence information submissions withan application in the event that eitherthe paper copy or the computer readableform were to become separated from theremainder of the application. Thischange is consistent with WIPOStandard ST.25 (1998).

The Number of Sequences fieldidentified as ‘‘<130>’’ in the proposedrule is now numbered ‘‘<160>’’ in§ 1.823 as adopted and redefined as‘‘Number of SEQ ID NOs.’’

The information associated withnumeric identifiers ‘‘<140>’’ through‘‘<153>,’’ ‘‘Correspondence Address’’through ‘‘Operating System’’ of theproposed rule, has been eliminated toreduce the burden on the applicant andto harmonize with WIPO StandardST.25 (1998). Some of these numericidentifiers have been used in the newnumbering scheme and have beenassociated with different information asindicated herein and in the Table of§ 1.823.

One remaining numeric identifierwithin the Computer Readable Formsection, ‘‘<154>, Software,’’ of theproposed rule, will remain, with theexception that it has been reassigned thenumeric identifier of ‘‘<170>’’ to reflectthe numbering scheme presented inWIPO Standard ST.25 (1998).

The main headings ‘‘<160>, CurrentApplication Data’’ and ‘‘<170>, PriorApplication Data,’’ of the proposedrules, have been eliminated toharmonize with WIPO Standard ST.25(1998) and reduce the number of fieldsin the Sequence Listing. Theinformation that was to appear underthese main headings remains in therules but has been reassigned numericidentifiers <140> through <151>. Thespecific changes are as follows: ‘‘<160>’’has been redefined as ‘‘Number of SEQ

ID NOs ’’; ‘‘<161>, ApplicationNumber,’’ of the proposed rule is nownumbered as ‘‘<140>,’’ and is defined as‘‘Current Application Number’; ‘‘<162>,Filing Date,’’ of the proposed rule isnow numbered ‘‘<141>,’’ and is definedas ‘‘Current Filing Date’’; ‘‘<170>’’ hasbeen redefined as ‘‘Software ‘‘; ‘‘<171>,Application Number,’’ of the proposedrule is now numbered as ‘‘<150>,’’ andis defined as ‘‘Prior ApplicationNumber’’; ‘‘<172>, Filing Date,’’ of theproposed rule is now numbered as‘‘<151>,’’ and is defined as ‘‘PriorApplication Filing Date.’’

The numeric identifiers nownumbered ‘‘<150>, Prior ApplicationNumber,’’, and ‘‘<151>, PriorApplication Filing Date,’’ are nowmandatory only in those instances inwhich a claim for priority with respectto those prior applications is beingmade under either 35 U.S.C. 119 or 120.This change will provide information inthis regard when it is most useful andwas necessary to harmonize these ruleswith WIPO Standard ST.25 (1998).Throughout the Sequence Listing,application numbers must be set forth asa combination of the two digit countrycode, as set forth in WIPO StandardST.3, as well as an application numberin accordance with WIPO StandardST.13 or for an internationalapplication, the numbering system asset out in Section 307(a) of theAdministrative Instructions under thePCT.

Numeric identifiers ‘‘<180>,Attorney/Agent Information,’’ through‘‘<182>, Registration Number,’’ of theproposed rule, have been eliminated toharmonize with WIPO Standard ST.25(1998) and reduce the number of fieldsin the Sequence Listing.

Numeric identifier ‘‘<183>, FileReference/Docket Number’’ of theproposed rule has been reassigned asnumeric identifier ‘‘<130>,’’ andredefined as ‘‘File Reference’’ in aneffort to harmonize with WIPO StandardST.25 (1998).

The Telecommunication Informationsection, ‘‘<190>’’ through ‘‘<193>’’ ofthe proposed rules, has been eliminatedin order to reduce the number of fieldsin the Sequence Listing and harmonizewith WIPO Standard ST.25 (1998).

Numeric identifier ‘‘<200>,Information for SEQ ID NO:#:’’, has beenreassigned the numeric identifier‘‘<210>, SEQ ID NO: #:’’ This numericidentifier indicates the integer, referredto in these final rules as the sequenceidentifier for both the sequenceinformation and the actual sequencewhich follows the information.

Numeric identifier ‘‘<210>, SequenceCharacteristics,’’ of the proposed rule

has been eliminated in order to reducethe number of required elements in theSequence Listing and harmonize withWIPO Standard ST.25 (1998).

The valid responses for the mandatorynumeric identifier ‘‘<212>, Type,’’ havebeen changed from ‘‘N’’ and ‘‘A’’, asstated in the proposed rule, to ‘‘DNA,’’‘‘RNA,’’ and ‘‘PRT’’ (protein) in order toharmonize with WIPO Standard ST.25(1998). A compound that is a mixture ofDNA and RNA should be represented by‘‘DNA.’’ This change is consistent withWIPO Standard ST.25 (1998).

Numeric identifier ‘‘<213>,Organism,’’ has been added to theSequence Listing of these final rules inan effort to harmonize with WIPOStandard ST.25 (1998). A response forthe Organism identifier isMANDATORY. The valid responses arethe scientific name, i.e. ‘‘Genusspecies’’, ‘‘Artificial Sequence’’, or‘‘Unknown.’’

Numeric identifier ‘‘<214>,Topology,’’ of the proposed rule, hasbeen eliminated to harmonize withWIPO Standard ST.25 (1998), and toreduce the burden on the applicant.

Numeric identifier ‘‘<290>, Feature,’’has become numeric identifier ‘‘<220>,Feature.’’ This numeric identifier hasbecome MANDATORY for thosesequences in which numeric identifier‘‘<213>, Organism,’’ is completed witheither ‘‘Artificial Sequence’’ or‘‘Unknown.’’ This numeric identifier isalso required if the compound sequenceis a mixture of DNA and RNA. Numericidentifier ‘‘<220>, Feature’’ is a headeronly. No data are added immediatelyfollowing this numeric identifier. Thesechanges are required to achieveharmonization with WIPO StandardST.25 (1998).

Numeric identifier ‘‘<291>, Name/Key,’’ has become numeric identifier‘‘<221>, Name/Key.’’ As proposed, theinformation provided was restricted to amaximum of four lines. The four linerestriction has been removed to reducethe limitations on this field. Thecomment section of this numericidentifier has been changed in that itnow indicates that the selection of afeature name or feature key is preferablymade from those listed in Tables 5 and6 of WIPO Standard ST.25 (1998). Thesetables are reproduced above and thispreference for the listed feature namesand keys is consistent with therequirement of WIPO Standard ST.25(1998).

Numeric identifier ‘‘<292>, Location,’’has become ‘‘<222>, Location,’’ so as tobe consistent with the numericidentifiers contained in WIPO StandardST.25 (1998).


Numeric identifier ‘‘<294>, OtherInformation,’’ has become numericidentifier ‘‘<223>, Other Information,’’so as to be consistent with the numericidentifiers contained in WIPO StandardST.25 (1998). This numeric identifierhas become MANDATORY for thosesequences in which numeric identifier‘‘<213>, Organism,’’ is completed witheither ‘‘Artificial Sequence’’ or‘‘Unknown’’. Numeric identifier‘‘<223>, Other Information,’’ shouldcontain source information in thoseinstances when the organism isunknown or is an artificial sequence.For example, the source may beunknown because the material wasisolated from a mixed bacterial culturerather than a pure culture. In such acase, numeric identifier ‘‘<223>, OtherInformation,’’ should be completed byexplaining the mixed culture source ofthe sequenced material. If a sequence iscompletely synthesized this should beindicated in numeric identifier ‘‘<223>,Other Information,’’ while numericidentifier ‘‘<213>, Organism,’’ wouldindicate ‘‘Artificial Sequence.’’ Thischange has been made to accomplishharmonization between these rules andWIPO Standard ST.25 (1998) whichcontains the same mandatoryrequirement in this regard.

Numeric identifiers ‘‘<308>’’ through‘‘<310>,’’ referring to the ‘‘ PatentDocument Number,’’ ‘‘Filing Date’’ and‘‘ Publication Date,’’ of the proposedrule, have been moved to numericidentifiers ‘‘<310>’’ to ‘‘<312>,’’respectively, of this Final Rule in orderto harmonize with the numericnumbering scheme of WIPO StandardST.25 (1998). Citations in the SequenceListing must comply with WIPOStandard ST.6 for publication numbersand WIPO Standard ST.16 for documentcodes.

New numeric identifiers ‘‘<308>,Database Accession Number,’’ and‘‘<309> Database Entry Date,’’ have beenadded to the final rules to harmonizewith WIPO Standard ST.25 (1998).These fields were added to thepublication information section ofWIPO Standard ST.25 (1998) to give anapplicant more opportunity to furtheridentify a published citation.

Numeric identifier <400> ‘‘SequenceDescription: SEQ ID NO:#:’’ has beenchanged to ‘‘Sequence ‘‘ for clarity. Alsofor clarity, the explanation in the tablehas been changed to ‘‘SEQ ID NO shallfollow the numeric identifier andshould appear on the line preceding thesequence.’’

The format of the date fields has beenchanged throughout the SequenceListing to accommodate forinternational conventions. All date

fields referenced in the SequenceListing shall conform to WIPO StandardST.2. Because compliance with §§ 1.821through 1.825 as amended shouldproduce Sequence Listings that areacceptable to all receiving offices, astandardized date field convention wasrequired.

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

date on which the data were recordedon the computer readable form’’ wasadded after ‘‘title of the invention’’ toharmonize with WIPO Standard ST.25(1998) requirements. While thisrequirement of § 1.824 was proposed tobe eliminated, that proposal is notadopted for purposes of harmonizationwith WIPO Standard ST.25 (1998). Alsoin paragraph (a)(6) of § 1.824, ‘‘ nameand type of computer and’’ was deletedto reduce the requirements.

Section 1.825In paragraphs (a), (b), and (d) of

§ 1.825, the sentence ‘‘Such a statementmust be a verified statement if made bya person not registered to practice beforethe Office’’ has been deleted. Theseparate verification requirements in§ 1.825 have been eliminated in view ofthe recent amendment to §§ 1.4(d) and10.18. See Changes to Patent Practiceand Procedure; Final Rule, 62 FR. 53131(October 10, 1997), 1203 Off. Gaz. Pat.Office 63 (October 21, 1997).

Response to and Analysis of CommentsSix written comments were received

in response to the Notice of ProposedRulemaking. Several of these commentsaddress the three specific queries setforth in the Notice of ProposedRulemaking.

The first query posed in the Notice ofProposed Rulemaking was: (1) Shouldthe PTO accept voluntary submissionsof computer readable forms andSequence Listings where a D-amino acidis contained in the sequence? If suchvoluntary submissions are accepted,should there be a restriction on thechoice of identifying a D-amino acid byan Xaa or by its L-amino acidcounterpart abbreviation?

Comment: One comment indicatedthat not only should the PTO acceptvoluntary submissions under these ruleswhere a D-amino acid is contained inthe sequence, the Office should makesuch submissions mandatory anddesignated by an Xaa. One commentindicated that sequences containing D-amino acids should not be in the PTOdatabases.

Response: Upon carefulconsideration, the PTO has decided toaccept voluntary submissions of protein

sequences containing D-amino acids.The PTO strongly encourages anyonemaking such voluntary submissions toidentify a D-amino acid with an Xaa,describing the D-amino acid in theFeatures section of the SequenceListing. This section is indicated bynumeric identifiers <220> through<223> in 37 CFR 1.823. Proceduralconcerns compel this acceptance ofvoluntary submissions. Computerreadable forms are processed prior toexamination. It is cumbersome toestablish a viable procedure to redactany voluntary submissions out of thePTO database. The use of Xaa toindicate a D-amino acid, should suchsequence information be submitted inaccordance with these rules, isencouraged so as to alert anyonereviewing the sequence that a particularamino acid is other than a naturallyoccurring L-amino acid and to moreaccurately depict the extent ofsimilarities between such a sequenceand the L-amino acid containingsequences present in a database beingsearched for examination or otherpurposes.

Because the sequence databases donot currently include D-amino acids insequences and thus are not searchablefor such sequences, the submission ofthose sequences containing D-aminoacids will not be made mandatory.

The second query posed in theproposed rules was: (2) Should theprovisions of 37 CFR 1.821(c) be alteredto exclude some prior art sequencesfrom inclusion in the Sequence Listingeven though they are presented in apatent application disclosure assequences? Should the reference to anaccession number of an admitted priorart sequence in a publicly available,electronic, sequence database sufficeand exclude that sequence from therequirements of the sequence rules?

Comment: Four comments indicatedthat known ‘‘prior art’’ sequencesshould not be required in the SequenceListing. A referral to a publiclyavailable, electronic, sequence databasefor access to such ‘‘prior art’’ sequenceswould be an acceptable alternative totwo of those commenting on this aspect;the other two did not address this point.The reasons given for excluding suchsequences are the expense and timerequired by applicants and theirrepresentatives in the inclusion of‘‘prior art’’ sequences that areconsidered to be ‘‘non-inventive’’.Reducing the bulk of the paper copy ofthe Sequence Listing was alsomentioned.

Response: The requirement to submitall disclosed sequences in the formatrequired by §§ 1.821 through 1.825 is


maintained. This point was discussedwith officials from the JPO and EPO.The offices have considered the statedconcerns with regard to costs toapplicants. Sections 1.821 through 1.825do not require any information to bedisclosed in the form of a sequence, butrather require a particular formatwhenever information is presented inthe form of a sequence. Thoseapplicants for whom compliance withthe rules remains a significant hardshipmay petition under § 1.183 for a waiverof the applicable requirement of§§ 1.821 through 1.825.

The technical and legal concernsmentioned in the Notice of ProposedRulemaking still exist concerning theuse of an alternative reference to apublicly available, electronic, sequencedatabase. These concerns are: (1) Whatconstitutes a publicly available,electronic, sequence database? (2)Would the USPTO and the other patentoffices which have similar rules berequired to produce a list ofinternationally accepted databases? (3)What would be the criteria for suchacceptance? (4) An additional issuewould exist involving electronic recordsmaintenance: is there any assurance thatonce information is contained in adatabase that it will be retained andavailable indefinitely withoutalteration? Changes to the informationin nucleic acid sequence databasesresulting from the discovery ofsequencing errors are well-known.

(5) Does the mere existence of thesequence information in such a recordconstitute reasonable means of retrieval?In other words, would one need sometext basis or other identifier to retrievethe information?

Additional reasons for the inclusionof these prior art sequences remainrelevant. These reasons are: (1) theassessment of whether a particularsequence falls within the requirementsof the current rules is simple; (2) thegeneral public is assured that all patentswhich contain any sequenceinformation contain all of the sequenceinformation in the Sequence Listing andall sequences are available in acomputer accessible form; and (3) as apublication, the contextual associationof new and old information ispotentially unique to the patent andvery valuable to anyone assessing thestate of the art at the time of a patentedinvention, and thus are desirable to bepresent in electronic form in associationwith that patent.

The third query posed in theproposed rules was: (3) ShouldSequence Listings filed in aninternational application filed under thePCT be published only electronically

and made available for retrievalelectronically by an accession numberfrom several sequence repositories?

Comment: Two comments werereceived in response to this query, onein favor and one opposed to limiting thepublication of the Sequence Listing toan electronic form for published PCTapplications in the international phase.

Response: At this time paper copies ofthe Sequence Listings filed as part of thedescription will continue to bepublished in applications filed underPCT. The PTO together with the EPO,JPO and WIPO will continue to discussthe possibility of electronic publication.However, any implementation of suchelectronic publication in lieu ofpublication in paper form will not beundertaken until further study has beencompleted.

Comment: One comment suggestedthat informative English words beplaced next to the numerical headingsin the Sequence Listing as printed in aU.S. patent.

Response: The PTO will provideEnglish words corresponding to thenumeric identifiers in the printed U.S.patents.

Comment: One comment suggestedaddition of a descriptive comment lineto the Sequence Listing.

Response: The ‘‘Other Information’’line in the Features section, which isnumeric identifier <223> in § 1.823,provides for a description of a sequence.While completion of this section is onlymandatory when the sequence contains‘‘n’’, ‘‘Xaa’’, a modified or unusual L-amino acid or a modified base, it isfrequently completed in othercircumstances.

Comment: One comment requestedwe harmonize §§ 1.821 through 1.825with PCT, EPO and other authoritiessuch that the differences in therequirements for Sequence Listingsubmissions are minimal.

Response: This change to §§ 1.821through 1.825 is the result of such aneffort to harmonize the PTO, PCT, EPOand JPO Sequence Listing requirementsto the extent possible. The requirementsof newly developed WIPO ST.25 aresubstantially identical to therequirements of amended §§ 1.821through 1.825. PatentIn Version 2.0software, now available, is drafted tomeet all of the requirements of WIPOStandard ST.25 (1998). Therequirements of §§ 1.821 through 1.825,however, are less stringent than therequirements of WIPO Standard ST.25(1998). Thus, applicants who wish tofile in countries which adhere to WIPOStandard ST.25 (1998) should considerthe following when not using PatentInVersion 2.0:

1. The WIPO Standard ST.25 (1998)does not permit submissions using aMacintosh computer.

2. The WIPO Standard ST.25 (1998)does not accept the range of mediapermitted by amended §§ 1.821 through1.825.

3. The answers in field <221> and<222> must use selections from Tables5 and 6 of WIPO Standard ST.25 (1998)to comply with that standard. The termsfrom these Tables are consideredlanguage neutral vocabulary.

4. Any free text in numeric identifier<223> of a Sequence Listing will not betranslated and thus must also appear inthe specification of applications filedunder WIPO Standard ST.25 (1998) forcompliance.

5. A CRF filed after the filing of anapplication under the PCT does notform part of the disclosure and will notbe published in the pamphlet.

6. Paragraph 39 of WIPO StandardST.25 (1998) requires the specificwording ‘‘the information recorded onthe form is identical to the writtensequence listing.’’

7. WIPO Standard ST.25 (1998),paragraph 24, requires spaces betweenspecified numeric identifiers in theSequence Listing.

Comment: One comment requested aWINDOWS based version of PatentIn.

Response: A WINDOWS basedversion of PatentIn, PatentIn 2.0, hasbeen developed through a Trilaterally-sponsored joint initiative and is beingmade available.

Comment: One comment expressedconcern over application of the doctrineof equivalents by the courts to sequence-based claim language.

Response: Sections 1.821 through1.825 do not establish a disclosurerequirement, nor do they alter therequirements of 35 U.S.C. § 112. Theymerely require a particular formatwhenever information is presented inthe form of a sequence. The use ofsequence identification numbers(SEQ ID NO: #) only provides ashorthand way for applicants to refer tosequence information. Theseidentification numbers do not in anyway restrict the manner in which aninvention can be claimed. Similarly, theuse of this format does not impact thepotential interpretations and legaldeterminations that could be made withrespect to claims containing informationin the form of a nucleotide or aminoacid sequence.

Comment: One comment requestedthe flexibility to use single-letter aminoacid codes.

Response: Sections 1.821 through1.825 as amended do not constrain anapplicant from using single letter codes


in the disclosure. The requirements ofthe sequence searching and thesequence storage mechanisms includeonly the three-letter codes, thus theneed for the constraint on the SequenceListing information. There is no suchrestriction on the sequence format in thebody of the disclosure or in the figuresimposed by §§ 1.821 through 1.825, orany of the rules of practice; only theformat for the Sequence Listing isspecified by §§ 1.821 through 1.825.

Review Under the PaperworkReduction Act of 1995

Notwithstanding any other provisionof law, no person is required to respondto nor shall a person be subject to apenalty for failure to comply with acollection of information subject to therequirements of the PaperworkReduction Act (PRA) unless thatcollection of information displays acurrently valid OMB control number.

This rule contains collections ofinformation requirements subject to thePRA. The principal impact of this FinalRule is: (1) Elimination of certainrequirements of §§ 1.821 through 1.825;and (2) revision of §§ 1.821 through1.825 for consistency with WIPOStandard ST.25 (1998), which willpermit Sequence Listings to bepresented in an international, languageneutral format.

The public reporting burden for thesecollections of information have beenapproved by the Office of Managementand Budget (OMB) under OMB controlnumber 0651–0024. The publicreporting burden for this collection ofinformation is estimated to average 80minutes per response, including thetime for reviewing instructions,searching existing data sources,gathering and maintaining theinformation. Send comments regardingthis burden estimate or any other aspectof the data requirements, includingsuggestions for reducing this burden, toEsther M. Kepplinger at the addressspecified above or to the Office ofInformation and Regulatory Affairs ofOMB, New Executive Office Bldg., 72517th St. NW, rm. 10235, Washington,DC 20230, Attn: Desk Officer for thePatent and Trademark Office.

Other ConsiderationsThis Final Rule is in conformity with

the requirements of the RegulatoryFlexibility Act (5 U.S.C. 601 et seq.),Executive Order 12612 (October 26,1987), and the Paperwork Reduction Actof 1995 (44 U.S.C. 3501 et seq.). It hasbeen determined that this rulemaking isnot significant for the purposes ofExecutive Order 12866 (September 30,1993).

The Assistant General Counsel forLegislation and Regulation of theDepartment of Commerce has certifiedto the Chief Counsel for Advocacy,Small Business Administration that thisFinal Rule would not have a significantimpact on a substantial number of smallentities (Regulatory Flexibility Act, 5U.S.C. 605(b)). The principal impact ofthis Final Rule is: (1) Elimination ofcertain requirements of §§ 1.821 through1.825; and (2) revision of §§ 1.821through 1.825 for consistency withWIPO Standard ST.25 (1998), whichwill permit Sequence Listings to bepresented in an international, languageneutral format.

The Office has determined that thisFinal Rule has no Federalismimplications affecting the relationshipbetween the National Government andthe States as outlined in ExecutiveOrder 12612.

List of Subjects in 37 CFR Part 1

Administrative practice andprocedure, Courts, Freedom ofinformation, Inventions and patents,Incorporation by reference, Reportingand recordkeeping requirements, Smallbusinesses.

For the reasons set forth in thepreamble and under the authoritygranted to the Commissioner of Patentsand Trademarks by 35 U.S.C. 6, Title 37of the Code of Federal Regulations, part1, is amended as follows:

PART 1—RULES OF PRACTICE INPATENT CASES

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

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

2. Section 1.821 is revised to read asfollows:

§ 1.821 Nucleotide and/or amino acidsequence disclosures in patentapplications.

(a) Nucleotide and/or amino acidsequences as used in §§ 1.821 through1.825 are interpreted to mean anunbranched sequence of four or moreamino acids or an unbranched sequenceof ten or more nucleotides. Branchedsequences are specifically excludedfrom this definition. Sequences withfewer than four specifically definednucleotides or amino acids arespecifically excluded from this section.‘‘Specifically defined’’ means thoseamino acids other than ‘‘Xaa’’ and thosenucleotide bases other than ‘‘n’’ definedin accordance with the WorldIntellectual Property Organization(WIPO) Handbook on IndustrialProperty Information and

Documentation, Standard ST.25:Standard for the Presentation ofNucleotide and Amino Acid SequenceListings in Patent Applications (1998),including Tables 1 through 6 inAppendix 2, herein incorporated byreference. (Hereinafter ‘‘WIPO StandardST.25 (1998)’’). This incorporation byreference was approved by the Directorof the Federal Register in accordancewith 5 U.S.C. 552(a) and 1 CFR part 51.Copies of WIPO Standard ST.25 (1998)may be obtained from the WorldIntellectual Property Organization; 34chemin des Colombettes; 1211 Geneva20 Switzerland. Copies of ST.25 may beinspected at the Patent Search Room;Crystal Plaza 3, Lobby Level; 2021South Clark Place; Arlington, VA 22202.Copies may also be inspected at theOffice of the Federal Register, 800 NorthCapitol Street, NW, Suite 700,Washington, DC. Nucleotides and aminoacids are further defined as follows:

(1) Nucleotides: Nucleotides areintended to embrace only thosenucleotides that can be representedusing the symbols set forth in WIPOStandard ST.25 (1998), Appendix 2,Table 1. Modifications, e.g., methylatedbases, may be described as set forth inWIPO Standard ST.25 (1998), Appendix2, Table 2, but shall not be shownexplicitly in the nucleotide sequence.

(2) Amino acids: Amino acids arethose L-amino acids commonly found innaturally occurring proteins and arelisted in WIPO Standard ST.25 (1998),Appendix 2, Table 3. Those amino acidsequences containing D-amino acids arenot intended to be embraced by thisdefinition. Any amino acid sequencethat contains post-translationallymodified amino acids may be describedas the amino acid sequence that isinitially translated using the symbolsshown in WIPO Standard ST.25 (1998),Appendix 2, Table 3 with the modifiedpositions; e.g., hydroxylations orglycosylations, being described as setforth in WIPO Standard ST.25 (1998),Appendix 2, Table 4, but thesemodifications shall not be shownexplicitly in the amino acid sequence.Any peptide or protein that can beexpressed as a sequence using thesymbols in WIPO Standard ST.25(1998), Appendix 2, Table 3 inconjunction with a description in theFeature section to describe, for example,modified linkages, cross links and endcaps, non-peptidyl bonds, etc., isembraced by this definition.

(b) Patent applications which containdisclosures of nucleotide and/or aminoacid sequences, in accordance with thedefinition in paragraph (a) of thissection, shall, with regard to the mannerin which the nucleotide and/or amino


acid sequences are presented anddescribed, conform exclusively to therequirements of §§ 1.821 through 1.825.

(c) Patent applications which containdisclosures of nucleotide and/or aminoacid sequences must contain, as aseparate part of the disclosure, a papercopy disclosing the nucleotide and/oramino acid sequences and associatedinformation using the symbols andformat in accordance with therequirements of §§ 1.822 and 1.823. Thispaper copy is hereinafter referred to asthe ‘‘Sequence Listing.’’ Each sequencedisclosed must appear separately in the‘‘Sequence Listing.’’ Each sequence setforth in the ‘‘Sequence Listing’’ shall beassigned a separate sequence identifier.The sequence identifiers shall beginwith 1 and increase sequentially byintegers. If no sequence is present for asequence identifier, the code ‘‘000’’shall be used in place of the sequence.The response for the numeric identifier<160> shall include the total number ofSEQ ID NOs, whether followed by asequence or by the code ‘‘000.’’

(d) Where the description or claims ofa patent application discuss a sequencethat is set forth in the ‘‘SequenceListing’’ in accordance with paragraph(c) of this section, reference must bemade to the sequence by use of thesequence identifier, preceded by ‘‘SEQID NO:’’ in the text of the description orclaims, even if the sequence is alsoembedded in the text of the descriptionor claims of the patent application.

(e) A copy of the ‘‘Sequence Listing’’referred to in paragraph (c) of thissection must also be submitted incomputer readable form in accordancewith the requirements of § 1.824. Thecomputer readable form is a copy of the‘‘Sequence Listing’’ and will notnecessarily be retained as a part of thepatent application file. If the computerreadable form of a new application is tobe identical with the computer readableform of another application of theapplicant on file in the Patent andTrademark Office, reference may bemade to the other application andcomputer readable form in lieu of filinga duplicate computer readable form inthe new application if the computerreadable form in the other applicationwas compliant with all of therequirements of these rules. The newapplication shall be accompanied by aletter making such reference to the otherapplication and computer readableform, both of which shall be completelyidentified. In the new application,applicant must also request the use ofthe compliant computer readable‘‘Sequence Listing’’ that is already onfile for the other application and muststate that the paper copy of the

‘‘Sequence Listing’’ in the newapplication is identical to the computerreadable copy filed for the otherapplication.

(f) In addition to the paper copyrequired by paragraph (c) of this sectionand the computer readable formrequired by paragraph (e) of this section,a statement that the content of the paperand computer readable copies are thesame must be submitted with thecomputer readable form, e.g., astatement that ‘‘the informationrecorded in computer readable form isidentical to the written sequencelisting.’’

(g) If any of the requirements ofparagraphs (b) through (f) of this sectionare not satisfied at the time of filingunder 35 U.S.C. 111(a) or at the time ofentering the national stage under 35U.S.C. 371, applicant will be notifiedand given a period of time within whichto comply with such requirements inorder to prevent abandonment of theapplication. Any submission in reply toa requirement under this paragraphmust be accompanied by a statementthat the submission includes no newmatter.

(h) If any of the requirements ofparagraphs (b) through (f) of this sectionare not satisfied at the time of filing aninternational application under thePatent Cooperation Treaty (PCT), whichapplication is to be searched by theUnited States International SearchingAuthority or examined by the UnitedStates International PreliminaryExamining Authority, applicant will besent a notice necessitating compliancewith the requirements within aprescribed time period. Any submissionin reply to a requirement under thisparagraph must be accompanied by astatement that the submission does notinclude matter which goes beyond thedisclosure in the internationalapplication as filed. If applicant fails totimely provide the required computerreadable form, the United StatesInternational Searching Authority shallsearch only to the extent that ameaningful search can be performedwithout the computer readable form andthe United States InternationalPreliminary Examining Authority shallexamine only to the extent that ameaningful examination can beperformed without the computerreadable form.


§ 1.822 Symbols and format to be used fornucleotide and/or amino acid sequencedata.

(a) The symbols and format to be usedfor nucleotide and/or amino acid

sequence data shall conform to therequirements of paragraphs (b) through(e) of this section.

(b) The code for representing thenucleotide and/or amino acid sequencecharacters shall conform to the code setforth in the tables in WIPO StandardST.25 (1998), Appendix 2, Tables 1 and3. This incorporation by reference wasapproved by the Director of the FederalRegister in accordance with 5 U.S.C.552(a) and 1 CFR part 51. Copies ofST.25 may be obtained from the WorldIntellectual Property Organization; 34chemin des Colombettes; 1211 Geneva20 Switzerland. Copies of ST.25 may beinspected at the Patent Search Room;Crystal Plaza 3, Lobby Level; 2021South Clark Place; Arlington, VA 22202.Copies may also be inspected at theOffice of the Federal Register, 800 NorthCapitol Street, NW, Suite 700,Washington, DC. No code other thanthat specified in these sections shall beused in nucleotide and amino acidsequences. A modified base or modifiedor unusual amino acid may be presentedin a given sequence as thecorresponding unmodified base oramino acid if the modified base ormodified or unusual amino acid is oneof those listed in WIPO Standard ST.25(1998), Appendix 2, Tables 2 and 4, andthe modification is also set forth in theFeature section. Otherwise, eachoccurrence of a base or amino acid notappearing 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 furtherinformation, as appropriate, given in theFeature section, preferably by includingone or more feature keys listed in WIPOStandard ST.25 (1998), Appendix 2,Tables 5 and 6.

(c) Format representation ofnucleotides. (1) A nucleotide sequenceshall be listed using the lower-caseletter for representing the one-lettercode for the nucleotide bases set forthin WIPO Standard ST.25 (1998),Appendix 2, Table 1.

(2) The bases in a nucleotide sequence(including introns) shall be listed ingroups of 10 bases except in the codingparts of the sequence. Leftover bases,fewer than 10 in number, at the end ofnoncoding parts of a sequence shall begrouped together and separated fromadjacent groups of 10 or 3 bases by aspace.

(3) The bases in the coding parts of anucleotide sequence shall be listed astriplets (codons). The amino acidscorresponding to the codons in thecoding parts of a nucleotide sequenceshall be typed immediately below thecorresponding codons. Where a codonspans an intron, the amino acid symbol


shall be typed below the portion of thecodon containing two nucleotides.

(4) A nucleotide sequence shall belisted with a maximum of 16 codons or60 bases per line, with a space providedbetween each codon or group of 10bases.

(5) A nucleotide sequence shall bepresented, only by a single strand, in the5 to 3 direction, from left to right.

(6) The enumeration of nucleotidebases shall start at the first base of thesequence with number 1. Theenumeration shall be continuousthrough the whole sequence in thedirection 5 to 3. The enumeration shallbe marked in the right margin, next tothe line containing the one-letter codesfor the bases, and giving the number ofthe last base of that line.

(7) For those nucleotide sequencesthat are circular in configuration, theenumeration method set forth inparagraph (c)(6) of this section remainsapplicable with the exception that thedesignation of the first base of thenucleotide sequence may be made at theoption of the applicant.

(d) Representation of amino acids. (1)The amino acids in a protein or peptidesequence shall be listed using the three-letter abbreviation with the first letter asan upper case character, as in WIPOStandard ST.25 (1998), Appendix 2,Table 3.

(2) A protein or peptide sequenceshall be listed with a maximum of 16amino acids per line, with a spaceprovided between each amino acid.

(3) An amino acid sequence shall bepresented in the amino to carboxydirection, from left to right, and theamino and carboxy groups shall not bepresented in the sequence.

(4) The enumeration of amino acidsmay start at the first amino acid of thefirst mature protein, with the number 1.When presented, the amino acidspreceding the mature protein, e.g., pre-sequences, pro-sequences, pre-pro-sequences and signal sequences, shallhave negative numbers, countingbackwards starting with the amino acidnext to number 1. Otherwise, theenumeration of amino acids shall startat the first amino acid at the aminoterminal as number 1. It shall be markedbelow the sequence every 5 aminoacids. The enumeration method foramino acid sequences that is set forth inthis section remains applicable foramino acid sequences that are circularin configuration, with the exception thatthe designation of the first amino acidof the sequence may be made at theoption of the applicant.

(5) An amino acid sequence thatcontains internal terminator symbols(e.g., ‘‘Ter’’, ‘‘*’’, or ‘‘.’’, etc.) may not berepresented as a single amino acidsequence, but shall be presented asseparate amino acid sequences.

(e) A sequence with a gap or gapsshall be presented as a plurality ofseparate sequences, with separatesequence identifiers, with the number ofseparate sequences being equal innumber to the number of continuousstrings of sequence data. A sequencethat is made up of one or morenoncontiguous segments of a largersequence or segments from differentsequences shall be presented as aseparate sequence.


§ 1.823 Requirements for nucleotide and/or amino acid sequences as part of theapplication papers.

(a) The ‘‘Sequence Listing’’ requiredby § 1.821(c), setting forth thenucleotide and/or amino acid sequencesand associated information inaccordance with paragraph (b) of thissection, must begin on a new page andmust be titled ‘‘Sequence Listing’’. The‘‘Sequence Listing’’ preferably should benumbered independently of thenumbering of the remainder of theapplication. Each page of the ‘‘SequenceListing’’ should contain no more than 66lines and each line should contain nomore than 72 characters. A fixed-widthfont should be used exclusivelythroughout the ‘‘Sequence Listing.’’

(b) The ‘‘Sequence Listing’’ shall,except as otherwise indicated, includethe actual nucleotide and/or amino acidsequence, the numeric identifiers andtheir accompanying information asshown in the following table. Thenumeric identifier shall be used only inthe ‘‘Sequence Listing.’’ The order andpresentation of the items of informationin the ‘‘Sequence Listing’’ shall conformto the arrangement given below. Eachitem of information shall begin on a newline and shall begin with the numericidentifier enclosed in angle brackets asshown. The submission of those itemsof information designated with an ‘‘M’’is mandatory. The submission of thoseitems of information designated with an‘‘O’’ is optional. Numeric identifiers<110> through <170> shall only be setforth at the beginning of the ‘‘SequenceListing.’’ The following table illustratesthe numeric identifiers.

Numeric iden-tifier Definition Comments and format Mandatory (M) or optional (O).

<110> ........... Applicant ........................ Preferably max. of 10 names; one name per line;preferable format: Surname, Other Names and/or Initials.

M.

<120> ........... Title of Invention ............ ................................................................................ M.<130> ........... File Reference ............... Personal file reference .......................................... M when filed prior to assignment of appl. num-

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

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

<141> ........... Current Filing Date ........ Specify as: yyyy–mm–dd ...................................... M, if available.<150> ........... Prior Application Num-

ber.Specify as: US 07/999,999 or PCT/US96/99999 M, if applicable include priority documents under

35 USC 119 and 120.<151> ........... Prior Application Filing

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

<160> ........... Number of SEQ ID NOs Count includes total number of SEQ ID NOs ....... M.<170> ........... Software ........................ Name of software used to create the Sequence

Listing.O.

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

M.

<211> ........... Length ........................... Respond with an integer expressing the numberof bases or amino acid residues.

M.


Numeric iden-tifier Definition Comments and format Mandatory (M) or optional (O).

<212> ........... Type .............................. Whether presented sequence molecule is DNA,RNA, or PRT (protein). If a nucleotide se-quence contains both DNA and RNA frag-ments, the type shall be ‘‘DNA.’’ In addition,the combined DNA/RNA molecule shall be fur-ther described in the <220> to <223> featuresection.

M.

<213> ........... Organism ....................... Scientific name, i.e. Genus/ species, Unknown orArtificial Sequence. In addition, the ‘‘Unknown’’or ‘‘Artificial Sequence’’ organisms shall be fur-ther described in the <220> to <223> featuresection.

M

<220> ........... Feature .......................... Leave blank after <220>. <221–223> provide fora description of points of biological significancein the sequence..

M, under the following conditions: if ‘‘n,’’ ‘‘Xaa,’’or a modified or unusual L-amino acid or modi-fied base was used in a sequence; if ORGA-NISM is ‘‘Artificial Sequence’’ or ‘‘Unknown’; ifmolecule is combined DNA/RNA’’

<221> ........... Name/Key ...................... Provide appropriate identifier for feature, pref-erably from WIPO Standard ST.25 (1998), Ap-pendix 2, Tables 5 and 6.

M, under the following conditions: if ‘‘n,’’ ‘‘Xaa,’’or a modified or unusual L-amino acid or modi-fied base was used in a sequence.

<222> ........... Location ......................... Specify location within sequence; where appro-priate state number of first and last bases/amino acids in feature.

M, under the following conditions: if ‘‘n,’’ ‘‘Xaa,’’or a modified or unusual L-amino acid or modi-fied base was used in a sequence.

<223> ........... Other Information .......... Other relevant information; four lines maximum ... M, under the following conditions: if ‘‘n,’’ ‘‘Xaa,’’or a modified or unusual L-amino acid or modi-fied base was used in a sequence; if ORGA-NISM is ‘‘Artificial Sequence’’ or ‘‘Unknown’’; ifmolecule is combined DNA/RNA.

<300> ........... Publication Information .. Leave blank after <300> ....................................... O.<301> ........... Authors .......................... Preferably max of ten named authors of publica-

tion; specify one name per line; preferable for-mat: Surname, Other Names and/or Initials.

O.

<302> ........... Title ................................ ................................................................................ O.<303> ........... Journal ........................... ................................................................................ O.<304> ........... Volume .......................... ................................................................................ O.<305> ........... Issue .............................. ................................................................................ O.<306> ........... Pages ............................ ................................................................................ O.<307> ........... Date ............................... Journal date on which data published; specify as

yyyy–mm–dd, MMM–yyyy or Season-yyyy.O.

<308> ........... Database AccessionNumber.

Accession number assigned by database includ-ing database name.

O.

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

O.

<310> ........... Patent Document Num-ber.

Document number; for patent-type citations only.Specify as, for example, US 07/999,999.

O.

<311> ........... Patent Filing Date ......... Document filing date, for patent-type citationsonly; specify as yyyy–mm–dd.

O.

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

O.

<313> ........... Relevant Residues ........ FROM (position) TO (position) .............................. O.<400> ........... Sequence ...................... SEQ ID NO should follow the numeric identifier

and should appear on the line preceding theactual sequence.

M.


§ 1.824 Form and format for nucleotideand/or amino acid sequence submissions incomputer readable form.

(a) The computer readable formrequired by § 1.821(e) shall meet thefollowing specifications:

(1) The computer readable form shallcontain a single ‘‘Sequence Listing’’ aseither a diskette, series of diskettes, orother permissible media outlined inparagraph (c) of this section.

(2) The ‘‘Sequence Listing’’ inparagraph (a) (l) of this section shall be

submitted in American Standard Codefor Information Interchange (ASCII) text.No other formats shall be allowed.

(3) The computer readable form maybe created by any means, such as wordprocessors, nucleotide/amino acidsequence editors or other customcomputer programs; however, it shallconform to all specifications detailed inthis section.

(4) File compression is acceptablewhen using diskette media, so long asthe compressed file is in a self-extracting format that will decompress

on one of the systems described inparagraph (b) of this section.

(5) Page numbering shall not appearwithin the computer readable formversion of the ‘‘Sequence Listing’’ file.

(6) All computer readable forms shallhave a label permanently affixed theretoon which has been hand-printed ortyped: the name of the applicant, thetitle of the invention, the date on whichthe data were recorded on the computerreadable form, the operating systemused, a reference number, and anapplication serial number and filingdate, if known.


(b) Computer readable formsubmissions must meet these formatrequirements:

(1) Computer: IBM PC/XT/AT, orcompatibles, or Apple Macintosh;

(2) Operating System: MS–DOS, Unixor Macintosh;

(3) Line Terminator: ASCII CarriageReturn plus ASCII Line Feed;

(4) Pagination: Continuous file (no‘‘hard page break’’ codes permitted);

(c) Computer readable form filessubmitted may be in any of thefollowing media:

(1) Diskette : 3.50 inch, 1.44 Mbstorage; 3.50 inch, 720 Kb storage; 5.25inch, 1.2 Mb storage; 5.25 inch, 360 Kbstorage.

(2) Magnetic tape: 0.5 inch, up to24000 feet; Density: 1600 or 6250 bitsper inch, 9 track; Format: Unix tarcommand; specify blocking factor (not‘‘block size’’); Line Terminator: ASCIICarriage Return plus ASCII Line Feed.

(3) 8mm Data Cartridge: Format: Unixtar command; specify blocking factor(not ‘‘block size’’); Line Terminator:

ASCII Carriage Return plus ASCII LineFeed.

(4) CD–ROM: Format: ISO 9660 orHigh Sierra Format

(5) Magneto Optical Disk: Size/Storage Specifications: 5.25 inch, 640Mb.

(d) Computer readable forms that aresubmitted to the Office will not bereturned to the applicant.


§ 1.825 Amendments to or replacement ofsequence listing and computer readablecopy thereof.

(a) Any amendment to the paper copyof the ‘‘Sequence Listing’’ (§ 1.821(c))must be made by the submission ofsubstitute sheets. Amendments must beaccompanied by a statement thatindicates support for the amendment inthe application, as filed, and a statementthat the substitute sheets include nonew matter.

(b) Any amendment to the paper copyof the ‘‘Sequence Listing,’’ inaccordance with paragraph (a) of this

section, must be accompanied by asubstitute copy of the computerreadable form (§ 1.821(e)) including allpreviously submitted data with theamendment incorporated therein,accompanied by a statement that thecopy in computer readable form is thesame as the substitute copy of the‘‘Sequence Listing.’’

(c) Any appropriate amendments tothe ‘‘Sequence Listing’’ in a patent; e.g.,by reason of reissue or certificate ofcorrection, must comply with therequirements of paragraphs (a) and (b) ofthis section.

(d) If, upon receipt, the computerreadable form is found to be damaged orunreadable, applicant must provide,within such time as set by theCommissioner, a substitute copy of thedata in computer readable formaccompanied by a statement that thesubstitute data is identical to thatoriginally filed.

7. Appendix A To Subpart G to Part1 is revised to read as follows:

BILLING CODE 3510–16–P


Appendix A To Subpart G to Part 1—Sample Sequence Listing


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

29620 federal register /vol. 63, no. 104/monday, june … federal register/vol. 63, no. 104/monday,...

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