CPC Definition - Subclass C12Q

Last Updated Version: 2019.05
MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N 33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
Definition statement

This place covers:

Processes in which there is a direct or indirect qualitative or quantitative measurement or test of a material which contains enzymes, nucleic acids or microorganisms.

Processes in which a material containing enzymes, nucleic acids or microorganisms is used to perform a qualitative or quantitative measurement or test, e.g. testing for antimicrobial activity or cholesterol, geomicrobiological testing.

In vivo or in vitro or in silico measuring or testing processes involving nucleic acid e.g. nucleic acid hybridisation including PCR (Polymerase Chain Reaction).

Compositions or test papers containing enzymes, nucleic acids or microorganisms which can be used to detect or identify a chemical compound or composition, e.g. paper strips for the testing of blood sugar.

Compositions or test papers distinguished by the use of indicators which can be used to detect or identify the presence of enzymes, nucleic acids or microorganisms.

Processes of making such test compositions.

Processes involving enzymes or microorganisms in which a process parameter is measured and that or another process parameter is varied in response to such measurement, i.e. condition responsive control.

Relationships with other classification places

Controlling or regulating in general is classified in G05.

In subclasses C12M-C12Q and within each of these subclasses, in the absence of an indication to the contrary, classification is made in the last appropriate place.

The codes of subclass C12R are only for use as Indexing codes associated with subclasses C12C - C12Q, so as to provide information concerning the microorganisms used in the processes classified in these subclasses.

References
Limiting references

This place does not cover:

Immunoassay

G01N 33/53

Immunoassay with enzyme label

G01N 33/535

Immunoassay with the carrier being a biological cell or cell fragment

G01N 33/554

Immunoassay for microorganisms

G01N 33/569

Immunoassay for venereal diseases

G01N 33/571

Immunoassay for enzymes and isoenzymes

G01N 33/573

Immunoassay for cancer

G01N 33/574

Immunoassay for hepatitis

G01N 33/576

Informative references

Attention is drawn to the following places, which may be of interest for search:

Microorganisms per se

C12N 1/00

Human, animal or plant cells per se

C12N 5/00

Viruses per se

C12N 7/00

Enzymes per se

C12N 9/00, C12N 11/00

Investigating or analysing materials by determining their chemical or physical properties

G01N

Chemical analysis involving blood sugar, e.g. galactose

G01N 33/66

Chemical analysis involving proteins, peptides and amino acids

G01N 33/68

Chemical analysis involving lipids, e.g. cholesterol

G01N 33/92

Special rules of classification

In this subclass, in absence of an indication to the contrary, classification is made in the last appropriate place.

In this subclass, test media are classified in the appropriate group for the relevant test process.

In this subclass, viruses, undifferentiated human, animal or plant cells, protozoa, tissues and unicellular algae are considered as microorganisms.

In this subclass, unless specifically provided for, undifferentiated human, animal or plant cells, protozoa, tissues and unicellular algae are classified together with microorganisms. Sub-cellular parts, unless specifically provided for, are classified with the whole cell.

Glossary of terms

In this place, the following terms or expressions are used with the meaning indicated:

Enzyme

Proteinaceous material which causes a chemical change in a starting material without being consumed in the reaction.

Involving

When used in relation to a substance, includes the testing for the substance as well as employing the substance as a determinant or reactant in a test for a different substance.

Microorganism

Single-celled organisms such as bacteria, actinomycetales or single-celled fungi, e.g. yeasts; for the purposes of classification, this term also includes viruses, undifferentiated human, animal or plant cells, protozoa, tissues and unicellular algae.

Nucleic acid

Comprises nucleic acids as in vitro compounds as well as sub-cellular parts in vivo like chromosome territories within the nucleus, plasmids, gene sequences, genetic information, mutations, polymorphisms such as SNPs, in silico base sequences, aptamers (ligand binding nucleic acids) and ribozymes (catalytic active RNA molecules).

Measuring or testing processes involving enzymes, nucleic acids or microorganisms (measuring or testing apparatus with condition measuring or sensing means, e.g. colony counters, C12M 1/34); Compositions therefor; Processes of preparing such compositions
Definition statement

This place covers:

Processes in which there is a direct or indirect qualitative or quantitative measurement or test of a material which contains enzymes, nucleic acids or microorganisms.

Processes in which a material containing enzymes, nucleic acids or microorganisms is used to perform a qualitative or quantitative measurement or test, e.g. testing for antimicrobial activity or cholesterol, geomicrobiological testing.

In vivo or in vitro or in silico measuring or testing processes involving nucleic acid e.g. nucleic acid hybridisation including Polymerase Chain Reaction [PCR]. See section range C12Q 1/68 - C12Q 1/708.

Compositions or test papers containing enzymes, nucleic acids or microorganisms which can be used to detect or identify a chemical compound or composition, e.g. paper strips for the testing of blood sugar.

Compositions or test papers distinguished by the use of indicators which can be used to detect or identify the presence of enzymes, nucleic acids or microorganisms.

Processes of making such test compositions.

Processes involving enzymes or microorganisms in which a process parameter is measured and that or another process parameter is varied in response to such measurement, i.e. condition responsive control.

Relationships with other classification places

Controlling or regulating in general is classified in G05.

References
Limiting references

This place does not cover:

Measuring or testing apparatus with condition measuring or sensing means, e.g. colony counters

C12M 1/34

Informative references

Attention is drawn to the following places, which may be of interest for search:

Apparatus for condition-responsive control processes

C12M 1/36

Microorganisms per se

C12N 1/00

Human, animal or plant cells per se

C12N 5/00

Viruses per se

C12N 7/00

Enzymes per se

C12N 9/00, C12N 11/00

Investigating or analysing materials by determining their chemical or physical properties

G01N

Observation of the progress or of the result of processes specified in this group by any of the methods specified in groups G01N 3/00 - G01N 29/00

G01N

Investigating or analysing biological material

G01N 33/48- G01N 33/98

Testing involving plant cells

G01N 33/5097

Immunoassay for plant cells

G01N 33/56961

Immunoassay for animal cells

G01N 33/56966

Chemical analysis involving blood sugar, e.g. galactose

G01N 33/66

Chemical analysis involving proteins, peptides and amino acids

G01N 33/68

Chemical analysis involving lipids, e.g. cholesterol

G01N 33/92

Special rules of classification

In this group, test media are classified in the appropriate group for the relevant test process.

In this group, viruses, protozoa, unicellular and multicellular fungi, yeasts and unicellular and multicellular algae are considered as microorganisms. Sub-cellular parts, unless specifically provided for, are classified with the whole cell.

Classification in main group C12Q 1/00 and sub-groups C12Q 1/001 - C12Q 1/66 is further refined using Indexing Codes from the range C12Q 2304/00 - C12Q 2337/52. The definitions and scope of these Indexing Codes are self evident. The codes and definitions are listed at the end of this document.

Due to the strong relationship between the range C12Q 1/00 - C12Q 1/66 and the range G01N 33/50 - G01N 33/98, "Chemical analysis of biological material", and the rather broad nature of the definitions of some of the C12Q 1/001 - C12Q 1/66 sub-groups, refinement of the classification in this area by allocation of Indexing Codes from the range G01N 2333/00 - G01N 2800/60, where possible, is considered mandatory.

Observation of the progress or of the result of processes specified in this group by any of the methods specified in groups G01N 3/00 - G01N 29/00 may require additional classification in these groups.

{Enzyme electrodes}
Definition statement

This place covers:

Enzyme-based Electrochemical sensors where inventive concept lies in the enzyme aspect e.g. enzyme used, how attached to electrode, enzyme mediator involvement, enzyme sensing mechanism/system.

References
Informative references

Attention is drawn to the following places, which may be of interest for search:

Attention is drawn to the following places, which may be of interest for search and classification:

Apparatus specifically adapted for solid-phase testing in biospecific ligand binding assays or immunological testing/immunoassays

G01N 33/54366

Involving physiochemical end-point determination

G01N 33/54373

Electrodes

G01N 33/5438.

{Electrode membranes}
Definition statement

This place covers:

Enzyme electrodes where inventive concept lies in the use of or construction of a membrane on or in which an enzyme or multi-enzyme sensing system is attached or entrapped

Glossary of terms

In this place, the following terms or expressions are used with the meaning indicated:

Membrane

Any non-conductive porous structure

{Functionalisation}
Definition statement

This place covers:

Inventive concept lies in chemical e.g. silylation or physical e.g. plasma treatment of the electrode membrane to alter/create functional groups for attachment of enzyme. May also include crosslinking or other treatments of membrane polymers. Overlap with G01N 33/54353, G01N 33/5436, G01N 33/54393.

Relationships with other classification places

Chemical functionalisation of solid-phases for ligand attachment for use in biospecific ligand binding assays or immunological testing/immunoassays G01N 33/54353.

With the ligand physically entrapped within the solid phase G01N 33/5436.

Treatment of solid-phases (e.g. coating, irradiation) for the purpose of improving reaction conditions (e.g. reduction of non-specific binding, promotion of specific binding G01N 33/54393.

{mediator-assisted}
Definition statement

This place covers:

Enzyme electrodes where the enzyme or multi-enzyme sensing system requires a mediator e.g. co-factors (NAD/FAD), ferrodoxins.

{involving specific analytes or enzymes (including groups of enzymes, e.g. oxydases; C12Q 1/004 takes precedence)}
Definition statement

This place covers:

Enzyme electrodes directed to analysis of specific molecules or use of specific enzymes. Use of multi-enzyme systems such as oxido-reductase systems may also be classified in C12Q 1/004 if the mediator is of importance.

{for glucose}
Definition statement

This place covers:

Enzyme electrodes specifically designed for the analysis of glucose.

{involving isoenzyme profiles (for detection of an individual isoenzyme C12Q 1/25 - C12Q 1/66)}
Definition statement

This place covers:

Methods for determining isoenzyme profiles.Overlap with G01N 33/573, G01N 33/5735.

References
Informative references

Attention is drawn to the following places, which may be of interest for search:

Attention is drawn to the following places, which may be of interest for search and classification:

Biospecific ligand binding assays or immunological testing/immunoassays for isoenzymes

G01N 33/573

{for determining co-enzymes or co-factors, e.g. NAD, ATP}
Definition statement

This place covers:

Methods for detecting, measuring or identifying co-enzymes or co-factors e.g. NAD, ATP involved in enzyme reactions.

References
Informative references

Attention is drawn to the following places, which may be of interest for search:

Attention is drawn to the following places, which may be of interest for search and classification:

Biospecific ligand binding assays or immunological testing/immunoassays for co-enzymes or co-factors

G01N 33/5735

involving viable microorganisms
Definition statement

This place covers:

Methods or processes for living microorganisms which cannot be classified elsewhere in C12Q 1/00- C12Q 1/66. Includes Total Viable Organism (TVO) testing and electrophysical measurements such as ion channel current.

C12Q 1/02 and subgroups includes testing for microorganisms where the desired result indicates non-viability.

References
Limiting references

This place does not cover:

Specific binding assays/Immunoassays for microorganisms are classified in

G01N 33/569 - G01N 33/571

For hepatitis

G01N 33/576

{for testing or evaluating the effect of chemical or biological compounds, e.g. drugs, cosmetics (antimicrobial activity C12Q 1/18)}
Definition statement

This place covers:

Methods or processes for testing or evaluating non antimicrobial chemical or biological compounds such as drugs, cosmetics.

References
Limiting references

This place does not cover:

Testing or evaluating the effect of chemical or biological compounds, e.g. drugs, cosmetics using animal cells

G01N 33/5008

Determining presence or kind of microorganism; Use of selective media for testing antibiotics or bacteriocides; Compositions containing a chemical indicator therefor {(C12Q 1/6897 takes precedence)}
Definition statement

This place covers:

Methods or processes (qualitative testing) designed to determine the presence or identity (variety, species, genus or Gram +/-) of a microorganism, including compositions containing an indicator for presence or identity of a microorganism.

{Culture media therefor}
Definition statement

This place covers:

Methods, processes or compositions wherein the inventive concept lies in the composition or content of the culture media e.g. percentage ratio of components, compounds present in medium itself (carbon source, nitrogen source, vitamins etc.)

Quantitative determination
Definition statement

This place covers:

Methods and processes (quantitative testing) for numerical counting the number of viable microorganisms or viable/non-viable ratio in a sample.

using multifield media
Definition statement

This place covers:

Methods, processes or compositions involving use of a multifield media (single media permitting identification of multiple results or single item e.g. petri dish comprising more than one medium to allow multiple results) in methods and processes (quantitative testing) for numerical counting the number of viable microorganisms or viable/non-viable ratio in a sample.

Enterobacteria
Definition statement

This place covers:

Methods, processes or compositions involving quantitative determination of Enterobacteria e.g. Citrobacter, Serratia, Proteus, Providencia, Morganella, Yesinia, Escherichia, Shigella, Salmonella, Klebsiella, Enterobacter, Erwinia, Hafnia.

Nitrate to nitrite reducing bacteria
Definition statement

This place covers:

Methods, processes or compositions involving quantitative determination of bacteria under nitrate to nitrite reducing conditions. Some bacteria e.g. E.Coli use nitrate under anaerobic growth conditions.

Streptococcus; Staphylococcus
Definition statement

This place covers:

Methods, processes or compositions involving quantitative determination of Streptococcus or Staphylococcus bacteria.

using radioactive material
Definition statement

This place covers:

Methods, processes or compositions for detecting presence or kind of microorganism (qualitative testing) designed to determine the presence or identity (variety, species, genus or Gram +/-) of a microorganism. wherein the inventive concept lies in the use of radioisotopes (e.g. 11C, 13 C, 14C, 2H, 3H, 15N, 35S, 35P).

Testing for antimicrobial activity of a material
Definition statement

This place covers:

Methods or processes for testing of antimicrobial activity of a compound on living microorganisms.

using multifield media
Definition statement

This place covers:

Methods, processes or compositions involving the use of a multifield media (single media permitting identification of multiple results or single item e.g. petri dish comprising more than one medium to allow multiple results) in methods or processes for testing of antimicrobial activity of a compound on living microorganisms.

Testing for sterility conditions
Definition statement

This place covers:

Methods or processes for testing if sterility conditions have been achieved or are being maintained. Examples are labels for food packaging, testing of medical instrument sterilization methods, air or water quality.

Special rules of classification

In the following sub-groups C12Q 1/25 - C12Q 1/66 classification is based on the Enzyme Nomenclature as the IUB internationally agreed method (http://www.chem.qmul.ac.uk/iubmb/enzyme).

Methods of sampling, or inoculating or spreading a sample; Methods of physically isolating an intact microorganisms
Definition statement

This place covers:

Methods for sampling/physically isolating intact microorganisms (including non-viable microorganisms) are classified in C12Q 1/24 irrespective of what becomes of them afterwards. If the isolated microorganisms are further subject to immunoassay/biospecific binding assay a further symbol from G01N 33/569 or subgroups would be added.

involving enzymes not classifiable in groups C12Q 1/26 {- C12Q 1/66}
Definition statement

This place covers:

Methods, processes or compositions involving enzymes having unidentifiable EC number and enzymes which cannot be classified elsewhere in C12Q 1/26-C12Q 1/66. Classified under this symbol are methods, processes or compositions involving enzymes classified EC 6.X.X.X. These enzymes are characterised by bond formation C-O (6.1), C-S (6.2), C-N (6.3), C-C (6.4), P-O (.5), N-Met (6.6) and may commonly be known as ligase, synthase, carboxylase, cyclase, chelatase.

involving oxidoreductase
Definition statement

This place covers:

Methods, processes or compositions involving enzymes classified as EC 1.X.X.X oxidoreductases, not comprising as part of the IUB name 'dehydrogenase' (see C12Q 1/32) and which cannot be classified elsewhere in C12Q 1/26-C12Q 1/32. Enzymes are characterised by the catalysis of oxidation/reduction reactions and may comprise as part of their IUB name reductase, oxidase, synthase, dismutase, hydrogenase, oxygenase

involving peroxidase
Definition statement

This place covers:

Methods, processes or compositions involving peroxidase enzymes classified EC 1.11.1.X including peroxidase enzyme itself (EC 1.11.1.7).

involving catalase
Definition statement

This place covers:

Methods, processes or compositions involving catalase enzyme, EC 1.11.1.6.

involving dehydrogenase
Definition statement

This place covers:

Methods, processes or compositions involving enzymes having an EC number 1.X.X.X and which contain 'dehydrogenase' in the IUB standard enzyme name.

involving hydrolase
Definition statement

This place covers:

Methods, processes or compositions involving enzymes classified as EC 3.X.X.X hydrolases and which cannot be classified elsewhere in C12Q 1/37-C12Q 1/46. Enzymes are characterised by the catalysis of the addition or removal of a water molecule and may comprise as part of their IUB name hydrolase, lipase, lactonase, nuclease, nucleotidase, NTPase, helicase, amidase, sulfatase, depolymerase, glycosylase and variants e.g. ribonuclease. Methods, processes or compositions involving urease (EC 3.5.1.5) - C12Q 1/58. Methods, processes or compositions involving (phospho)lipase - C12Q 1/61.

involving peptidase or proteinase
Definition statement

This place covers:

Methods, processes or compositions involving enzymes classified as EC 3.4.X.X. The enzymes are classified as acting on peptide bonds and may comprise as part of the IUB name peptidase and variants e.g. dipeptidase, aminopeptidase. Methods, processes or compositions involving clotting factors - C12Q 1/56.

There are many enzymes classified in the area EC 3.4.21.X - 3.4.23.X which retain the 'original' names e.g. trypsin, complement factors, kallikrein, subtilisin, papain, Meprin A, renin.

involving amylase
Definition statement

This place covers:

Methods, processes or compositions involving enzymes classified as EC 3.2.1.X. Enzymes are characterised by hydrolysis of O - and S -glycosyl compounds and may comprise as part of the IUB name (sugar residue)sidase e.g. galactosidase, mannosidase.

There are many enzymes classified in the area EC 3.2.1.X which retain the 'original' names e.g. amylase, lysozyme, lactase.

involving phosphatase
Definition statement

This place covers:

Methods, processes or compositions involving enzymes classified as EC 3.1.3.X. Enzymes are characterised by hydrolysis of phosphoric monoesters and usually comprise as part of the IUB name phosphatase.

involving esterase
Definition statement

This place covers:

Methods, processes or compositions involving enzymes classified as EC 3.1.X.X having as part of the IUB name 'esterase' or variant e.g. diesterase, thioesterase. Enzymes are characterised by acting on ester bonds.

involving cholinesterase
Definition statement

This place covers:

Methods, processes or compositions involving acetylcholinesterase, EC 3.1.1.7 or cholinesterase EC 3.1.1.8.

involving transferase
Definition statement

This place covers:

Methods, processes or compositions involving enzymes classified as EC 2.X.X.X transferases and which cannot be classified elsewhere in C12Q 1/485-C12Q 1/52. Enzymes are characterised by the transfer of a functional group and may comprise as part of their IUB name kinase, transferase, synthase, phosphorylase and variants e.g. aminotransferase.

{involving kinase}
Definition statement

This place covers:

Methods, processes or compositions involving enzymes classified as EC 2.7.X.X having as part of the IUB name 'kinase' or variant. Enzymes are characterised by the transfer of phosphorus-containing groups.

involving creatine phosphokinase
Definition statement

This place covers:

Methods, processes or compositions involving enzyme creatine (phospho)kinase, EC 2.7.3.2.

involving transaminase
Definition statement

This place covers:

Methods, processes or compositions involving enzymes classified as EC 2.6.1.X and may comprise as part of the IUB name 'transaminase'. Enzymes are characterised by the transfer of nitrogenous groups.

involving lyase
Definition statement

This place covers:

Methods, processes or compositions involving enzymes classified as EC 4.X.X.X lyases and may comprise as part of the IUB name lyase, carboxylase, aldolase, hydratase and variants e.g. decarboxylase, dehydratase. Enzymes are characterised by the catalysis of reactions involving the formation of or addition to a double bond.

involving isomerase
Definition statement

This place covers:

Methods, processes or compositions involving enzymes classified as EC 5.X.X.X isomerases and may comprise as part of the IUB name racemase, mutase, epimerase, isomerase, tautomerase, synthase and variants e.g. aminomutase. Enzymes are characterised by the catalysis of isomerisation reactions.

Special rules of classification

The sub-groups C12Q 1/54 - C12Q 1/66 are intended to highlight specific subject-matter which might also take an earlier symbol. The sub-groups C12Q 1/54 - C12Q 1/66 take precedence over earlier sub-groups under the Last Place Rule.

involving glucose or galactose
Definition statement

This place covers:

Methods, processes or compositions involving glucose or galactose where glucose or galactose are the final analyte or subject of the test e.g. diabetes testing, glucose demand for testing presence of microorganisms, Glucose Tolerance Test, use of glucose or galactose in the production of enzymes. Electrochemical glucose sensors where the inventive concept is in an electrode or other sensor structure to specifically enhance glucose determinations are classified in C12Q 1/006.

involving blood clotting factors, e.g. involving thrombin, thromboplastin, fibrinogen
Definition statement

This place covers:

Methods, processes or compositions involving blood clotting factors e.g. thrombin, fibrinogen, thromboplastin. Includes investigation and/or identification of compounds which are present in or modulate the clotting pathway.

involving urea or urease
Definition statement

This place covers:

Methods, processes or compositions involving detection of urea or urease (EC 3.5.1.5). Includes measurement of Biological Nitrogen Demand. Urea electrodes where the inventive concept is in the electrode are classified in C12Q 1/001 - C12Q 1/005. Includes detection of ammonia.

involving cholesterol
Definition statement

This place covers:

Methods, processes or compositions involving detection of cholesterol or LDL-cholesterol. Cholesterol electrodes where the inventive concept is in the electrode are classified in C12Q 1/005.

Relationships with other classification places

Overlap with G01N 33/92.

involving triglycerides
Definition statement

This place covers:

Methods, processes or compositions involving detection of triglcerides e.g. as biomarkers for disease, HDL, LDL, CM values or acting as substrate for determination of (phospho)lipase enzymes.

Relationships with other classification places

Overlap with G01N 33/92.

involving uric acid
Definition statement

This place covers:

Methods, processes or compositions involving detection of uric acid, often using the enzyme uricase (EC 1.7.3.3). Includes detection of uric acid as breakdown product indicative of other analytes e.g. purine bases, nucleotides.

Geomicrobiological testing, e.g. for petroleum
Definition statement

This place covers:

Methods, processes or compositions involving detection of microbiological degradation or contamination of in-situ hydrocarbon reserves, hydrocarbon reserve prospecting using microorganisms, monitoring of microorganism contamination of liquid hydrocarbon fuels, carbon dioxide sequestering by subterranean microorganism methane production.

involving luciferase
Definition statement

This place covers:

Methods, processes or compositions involving luciferase (EC 1.13.12.X or EC 1.14.14.3).

Involving nucleic acids

involving nucleic acids
Definition statement

This place covers:

All documents which cannot be classified in any of the other groups but relate to the enzymatic manipulation of nucleic acids.

Relationships with other classification places

Group C12Q 1/00 relates to enzymes. From group C12Q 1/68 onwards, assays and products for analysing or detecting nucleic acids are covered irrespective of whether enzymes or microorganisms are involved. Group C12Q 1/70 similarly relates to nucleic acid assays and products for analysing or detecting viruses or bacteriophages.

Nucleic acid amplification reactions are classified in group C12P 19/34 if the focus of the subject-matter is on the enzymes or the enzyme modifications per se. However, if the enzyme modification results in a changed/improved analytical effect, classification is also effected in group C12Q 1/68.

References
Informative references

Attention is drawn to the following places, which may be of interest for search:

Immunization, vaccines

A61K 39/00

Viral antigens in a vaccine

A61K 39/12

Gene therapy

A61K 48/00

Design and fabrication of microarrays (biochips) wherein the invention resides in the synthesis of polypeptides or polynucleotides; Apparatus and devices for combinatorial chemistry or for making molecular arrays.

B01J 19/0046

Microfuidic systems used for nucleic acid analysis like thermal cyclers (PCR-machines), capillary sequencers

B01L 1/00- B01L 99/00

Chemical synthesis or modification of nucleosides, nucleotides or oligonucleotides (chemically linked to other compounds, fluorescent labels).

C07H 21/00- C07H 21/04

Bacterial, fungal, protozoal, vertebrate antigens.

C07K 14/00 - C07K 14/825

Antibodies

C07K 16/00

Undifferentiated human, animal or plant cells

C12N 5/00

Plant cells

C12N 5/04

Animal cells

C12N 5/06

Cells modified by introduction of foreign genetic material

C12N 5/10

Viruses; Bacteriophages

C12N 7/00

Bacterial, fungal and protozoan enzymes

C12N 9/00

Extraction and purification of nucleic acids from biological samples, e.g. pure separation or isolation methods; Conditions, buffers or apparatuses therefore

- C12N 15/10

Isolating individual clones by screening libraries; making libraries

C12N 15/1034 - C12N 15/1093

DNA or RNA fragments; Modified forms thereof

C12N 15/11

Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression

C12N 15/63

Bacterial vectors

C12N 15/70 -C12N 15/78

Vectors for fungal cells

C12N 15/80 - C12N 15/815

Introduction of foreign genetic material using processes not otherwise provided for, e.g. co-transformation

C12N 15/8201- C12N 15/8214

Animal vectors and their preparation

C12N 15/85,

Sensors and electronic devices involving nucleic acids wherein the electrical detection is important

G01N 27/00, G01N 31/00

Sensors and electronic devices wherein the optical detection is important

G01N 31/00

Protein diagnostics and detection

G01N 33/68

Coulter counters

G01N 35/00- G01N 35/1097

Computer systems using nucleic acids

G11C 13/0019

Bioinformatics

G16B

Special rules of classification

The classification rules for C12Q 1/68, C12Q 1/70, and subgroups are discussed in the following annexes 1 and 2.

Annex 1:

Use of the following classification schemes:

CPC Classes:C12Q 1/68 - C12Q 1/70

The CPC classes in the range C12Q 1/68 - C12Q 1/70 are divided in method groups and nucleic acid product groups (primers, probes, arrays, and other nucleic acid products) as shown in the tables below:

Method classes:

Symbol

Title

C12Q 1/6804

Nucleic acid analysis utilising immunogens

C12Q 1/6806

Preparing nucleic acids for analysis, e.g. for PCR assay

C12Q 1/6809

Sequence identification involving differential detection

C12Q 1/6811

Selection methods for production or design of target specific oligonucleotide or binding molecules

C12Q 1/6813

Hybridisation assays

C12Q 1/6816

characterised by the means of detection

C12Q 1/6818

involving interaction of at least two labels, e.g. resonant energy transfer

C12Q 1/682

Signal amplification

C12Q 1/6823

Release of bound marker

C12Q 1/6825

Nucleic acid detection involving sensors

C12Q 1/6827

for mutation or polymorphism detection

C12Q 1/683

involving restriction enzymes, e.g. RFLP

C12Q 1/6832

Enhancement of hybridisation reaction

C12Q 1/6834

Nucleic acid analysis involving immobilisation; Immobilisation characterised by the carrier or coupling agent

C12Q 1/6837

characterised by the use of probe arrays or probe chips

C12Q 1/6839

Triple helix formation in hybridisation assays

C12Q 1/6841

"In-situ" hybridisation

C12Q 1/6844

Nucleic acid amplification reactions

C12Q 1/6846

Common amplification features

C12Q 1/6848

preventing contamination

C12Q 1/6851

Quantitative amplification

C12Q 1/6853

using modified primers or templates

C12Q 1/6855

Ligating adaptors

C12Q 1/6858

Allele specific amplification

C12Q 1/686

Polymerase Chain Reaction (PCR)

C12Q 1/6862

Ligase Chain Reaction (LCR)

C12Q 1/6865

Promoter based amplification, e.g. NASBA, 3SR, TAS

C12Q 1/6867

Replicase based amplifications, e.g. Q-beta replicase

C12Q 1/6869

Methods for sequencing; sequencing using nanopores and other sequencing systems based on physical properties of nucleic acids e.g. Atomic Force Microscopy (AFM)

C12Q 1/6872

involving mass spectrometry

C12Q 1/6874

involving nucleic acid arrays, e.g. Sequencing By Hybridisation (SBH)

C12Q 1/6897

involving reporter genes operably linked to promoters

C12Q 1/70

involving viruses and Bacteriophages

Nucleic acid product groups:

Symbol

Title

C12Q 1/6876

Hybridisation probes, primers, and other nucleic acid products

C12Q 1/6879

for sex determination

C12Q 1/6881

for tissue and cell typing, e.g. HLA probes

C12Q 1/6883

for diseases caused by alterations of genetic material

C12Q 1/6886

for cancer

C12Q 1/6888

for detection or identification of organisms

C12Q 1/689

for bacteria

C12Q 1/6893

for protozoa

C12Q 1/6895

for plants, fungi, or algae

C12Q 1/701

Specific hybridization probes

C12Q 1/702

for retroviruses

C12Q 1/703

Viruses associated with AIDS

C12Q 1/705

for herpetoviridae, e.g. herpes simplex, varicella zoster

C12Q 1/706

for hepatitis

C12Q 1/707

non-A, non-B Hepatitis, excluding hepatitis D

C12Q 1/708

for papilloma

Depending on which kind of application is being classified (i.e. method or product), different rules for classification apply. In this first Annex 1, only the rules for classifying the method applications are discussed. In Annex 2, the classification rules for product applications and the use of the indexing scheme for non-invention information which applies both to product and method applications are discussed.

1. Rules for classification of method applications

1.1 CPC codes C12Q 2500/00 - C12Q 2565/634 are "technical feature" codes and are used in a C-set in combination with an appropriate base class selected from C12Q 1/68 - C12Q 1/70 to define the essential technical features of the invention.

1.2 Use of CPC codes is restricted to the C-set format and only in combination with the method classes (see above). This means that the use of CPC codes in C-sets where the base class is a analyte/product class (see above) is not allowed.

1.3 During classification, after allocation of an appropriate base class, such as C12Q 1/6827, a CPC indexing code describing the essential technical features of the invention can be added to the base class in a C-set.

1.4 Indexing codes of a C-set must be entered in their full form, e.g. C12Q 2525/191.

1.5 It is important to note that in the C-set, only the essential technical features of the invention are to be represented : only exceptionally more than three " technical feature" codes should make up the C-set.

1.6 All indexing codes from groups C12Q 2500/00 - C12Q 2565/634 are to be used in the context literally expressed in the phrase ascribed to the code, i.e. the use of an indexing code is neither restricted by its hierarchical position in a group nor by the definition of the group in which the code is found.1.7 Indexing codes C12Q 2500/00 - C12Q 2565/634 should not be used outside a C-set as free CPC codes.

Annex 2:

Use of the following classification schemes:

CPC non-invention information: C12Q 1/68 - C12Q 1/70

Symbol

Title

C12Q 2600/00

Oligonucleotides characterized by their use (not used)

C12Q 2600/106

Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism

C12Q 2600/112

Disease subtyping / staging /classification

C12Q 2600/118

Prognosis of disease development

C12Q 2600/124

Animal traits, i.e. production traits, including athletic performance or the like

C12Q 2600/13

Plant traits

C12Q 2600/136

Screening for pharmacological compounds

C12Q 2600/142

Toxicological screening, e.g. expression profiles which identify toxicity

C12Q 2600/148

Screening for cosmetic compounds

C12Q 2600/154

Methylation markers

C12Q 2600/156

Polymorphic markers (excluding Methylation markers)

C12Q 2600/158

Expression markers

C12Q 2600/16

Primer sets for multiplex assays

C12Q 2600/166

Oligonucleotides used as internal standards/controls/normalisation probes

C12Q 2600/172

Haplotypes

C12Q 2600/178

miRNA, siRNA or ncRNA

1.1 Rules for classification:

1.1.1 The use of the C12Q 2600/00 codes is restricted to the nucleic acid product classes in the range C12Q 1/68 - C12Q 1/70:

Symbol

Title

C12Q 1/6876

Hybridisation probes, primers, and other nucleic acid products

C12Q 1/6879

for sex determination

C12Q 1/6881

for tissue and cell typing, e.g. HLA probes

C12Q 1/6883

for diseases caused by alterations of genetic material

C12Q 1/6886

for cancer

C12Q 1/6888

for detection or identification of organisms

C12Q 1/689

for bacteria

C12Q 1/6893

for protozoa

C12Q 1/6895

for plants, fungi, or algae

C12Q 1/701

Specific hybridization probes

C12Q 1/702

for retroviruses

C12Q 1/703

Viruses associated with AIDS

C12Q 1/705

for herpetoviridae, e.g. herpes simplex, varicella zoster

C12Q 1/706

for hepatitis

C12Q 1/707

non-A, non-B Hepatitis, excluding hepatitis D

C12Q 1/708

for papilloma

1.1.2 The C12Q 2600/00 codes are given as independent codes and are not used in a C-set.

1.1.3 The use of the C12Q 2600/00 codes is compulsory. They should be given if the claims and/or examples support a functional use as given by any of the C12Q 2600/00 CPC codes shown above.

1.2 Examples

1) An application relates to the identification of the TNF haplotype TNF-1031C/-857C/-863C/-308G and its association with Crohn's Disease. The invention also relates to the identification of the -857C allele. The methods and means for determining these polymorphisms are trivial.

The CPC code class for this application would be C12Q 1/6883.

The methods for determining these polymorphisms are trivial but adding the CPC code C12Q 2600/156 (polymorphic marker) will aid in retrieving the pertinent information of this application.

The complete classification should therefore be:

2) An application relates to the use of the B1153 gene in testing for an allergic disease. The expression level of this gene is increased in patients with an allergic disease. The methods and means for determining the expression level are trivial.The CPC code for this application would be C12Q 1/6883.

The methods for determining the expression level are trivial but adding the CPC code C12Q 2600/158 (expression marker) will aid in retrieving the pertinent information of this application.

The complete classification should therefore be:

3) An application relates to the use of an SNP for determining if a patient would benefit from an anti-cancer therapy. The methods and means for determining the SNP are trivial.

The CPC code for this application would be C12Q 1/6886.

The methods for determining the SNP are trivial but adding the code C12Q 2600/156 (expression marker) will aid in retrieving the pertinent information of this application.

In addition, the application relates to pharmacogenomics. If the application provides support for this claim, the CPC code C12Q 2600/106 is given. If no support is present, only the code for polymorphic marker is given.

The complete classification should therefore be:

If no support is present

or

If the application provides support for a pharmacogenomics claim.

2. CPC codes C12Q 1/68 - C12Q 1/70: non-invention information (additional information)

Symbol

Title

C12Q 1/68

involving nucleic acids, general aspects

C12Q 1/6804

Nucleic acid analysis utilising immunogens

C12Q 1/6806

Preparing nucleic acids for analysis, e.g. for PCR assay

C12Q 1/6809

Sequence identification involving differential detection

C12Q 1/6811

Selection methods for production or design of target specific oligonucleotide or binding molecules

C12Q 1/6813

Hybridisation assays

C12Q 1/6816

characterised by the means of detection

C12Q 1/6818

involving interaction of at least two labels, e.g. resonant energy transfer

C12Q 1/682

Signal amplification

C12Q 1/6823

Release of bound marker

C12Q 1/6825

Nucleic acid detection involving sensors

C12Q 1/6827

for mutation or polymorphism detection

C12Q 1/683

involving restriction enzymes, e.g. RFLP

C12Q 1/6832

Enhancement of hybridisation reaction

C12Q 1/6834

Nucleic acid analysis involving immobilisation; Immobilisation characterised by the carrier or coupling agent

C12Q 1/6837

characterised by the use of probe arrays or probe chips

C12Q 1/6839

Triple helix formation in hybridisation assays

C12Q 1/6841

"In-situ" hybridisation

C12Q 1/6844

Nucleic acid amplification reactions

C12Q 1/6846

Common amplification features

C12Q 1/6848

preventing contamination

C12Q 1/6851

Quantitative amplification

C12Q 1/6853

using modified primers or templates

C12Q 1/6855

Ligating adaptors

C12Q 1/6858

Allele specific amplification

C12Q 1/686

Polymerase Chain Reaction (PCR)

C12Q 1/6862

Ligase Chain Reaction (LCR)

C12Q 1/6865

Promoter based amplification, e.g. NASBA, 3SR, TAS

C12Q 1/6867

Replicase based amplifications, e.g. Q-beta replicase

C12Q 1/6869

Methods for sequencing

C12Q 1/6872

involving mass spectrometry

C12Q 1/6874

involving nucleic acid arrays, e.g. Sequencing By Hybridisation (SBH)

C12Q 1/6876

Hybridisation probes, primers, and other nucleic acid products

C12Q 1/6879

for sex determination

C12Q 1/6881

for tissue and cell typing, e.g. HLA probes

C12Q 1/6883

for diseases caused by alterations of genetic material

C12Q 1/6886

for cancer

C12Q 1/6888

for detection or identification of organisms

C12Q 1/689

for bacteria

C12Q 1/6893

for protozoa

C12Q 1/6895

for plants, fungi, or algae

C12Q 1/6897

involving reporter genes operably linked to promoters

C12Q 1/70

involving virus or bacteriophage

C12Q 1/701

Specific hybridization probes

C12Q 1/702

for retroviruses

C12Q 1/703

Viruses associated with AIDS

C12Q 1/705

for herpetoviridae, e.g. herpes simplex, varicella zoster

C12Q 1/706

for hepatitis

C12Q 1/707

non-A, non-B Hepatitis, excluding hepatitis D

C12Q 1/708

for papilloma

2.1 Rules for classification for the non-invention indexing codes:

2.1.1 These codes cannot be used as a component of a C-set. Since the use of these indexing codes is not obligatory, the classifier has discretion as to when and how to use these non-invention information indexing codes.

2. 2 Example of use:

An application relates to oligonucleotide probes used for the species-specific identification of parodontophathogenic bacteria by in situ hybridization. The methods for performing the in situ hybridization are trivial.

The CPC group for this application would be C12Q 1/689 for the bacterial detection probes.

The method for determining the in situ hybridization is trivial but adding the code C12Q 1/6841 (pointing towards in situ hybridization) will aid in retrieving additional information for this application.

In search, the combination of C12Q 1/689, C12Q 1/6841, and keywords will directly lead to the most relevant documents.

The complete classification should therefore be:

Nucleic acid analysis using immunogens (immunoassay G01N 33/53)
Definition statement

This place covers:

Applications characterised by immunological compounds which are used in the analysis of nucleic acids. This group also includes applications characterised by nucleic acids which are used for analysing or detecting proteins and immunogens, e.g. immuno PCR).

References
Limiting references

This place does not cover:

Immunoassay

G01N 33/53

Immunoassay for nucleic acids

G01N 33/5308

Informative references

Attention is drawn to the following places, which may be of interest for search:

Antibodies

C07K 16/00

Special rules of classification

See Annex 1 under the "Special rules" section of C12Q 1/68

Documents characterised by an immunological reaction which is used to measure the presence or progress of a hybridization reaction are classified in this subgroup. For example, the use of an antibody specific to double stranded DNA or the use of a hapten label on the hybridization strand which is subsequently detected immunologically.

Also classified in this group are documents characterised by the immunological reaction which is detected by hybridizing a nucleic acid label. (NOTE: As this is a special case and it is often difficult to distinguish where the contribution over the state of the art lies, documents relating to immunoassays using nucleic acid labels are ADDITIONALLY classified in the appropriate subgroup of G01N 33/50 and allocated the G01N 2458/10 symbol.

Glossary of terms

In this place, the following terms or expressions are used with the meaning indicated:

Immunogens

means immunological compounds such as antibodies and antigens

Preparing nucleic acids for analysis, e.g. for polymerase chain reaction [PCR] assay (C12Q 1/6804 takes precedence)
Definition statement

This place covers:

All applications which deal with the preparation/modification of nucleic acids in order to use them or prepare them for subsequent analysis (e.g. amplification techniques (PCR), hybridisation techniques, sequencing of nucleic acids). This group also contains applications dealing with the preservation of DNA or RNA samples.

References
Limiting references

This place does not cover:

Nucleic acid analysis using immunogens

C12Q 1/6804

Informative references

Attention is drawn to the following places, which may be of interest for search:

Extracting or separating nucleic acids from biological samples, e.g. pure separation or isolation methods; Conditions, buffers or apparatuses therefore

C12N 15/1003

Extracting or separating nucleic acids from biological samples by means of a solid support carrier, e.g. particles, polymers

C12N 15/1006

Extracting or separating nucleic acids from biological samples by chromatography, e.g. electrophoresis, ion-exchange, reverse phase

C12N 15/101

Extracting or separating nucleic acids from biological samples by using magnetic beads

C12N 15/1013

Extracting or separating nucleic acids from biological samples by filtration, e.g. using filters, frits, membranes

C12N 15/1017

Special rules of classification

See Annex 1 under the "Special rules" section of C12Q 1/68

Methods for determination or identification of nucleic acids involving differential detection
Definition statement

This place covers:

All documents where the invention concerns a method for determining differential expression (RNA level) and comparative genomics (genomic DNA level) and improvements to such methods. However, if the methods disclosed by an application are known, these applications are classified as products based on the use of the products identified.

References
Informative references

Attention is drawn to the following places, which may be of interest for search:

The screening and making of libraries (e.g. cDNA libraries)

C12N 15/1072

Special rules of classification

See Annex 1 under the "Special rules" section of C12Q 1/68.

Selection methods for production or design of target specific oligonucleotides or binding molecules
Definition statement

This place covers:

The design of primers and probes using enzymatic techniques for obtaining them.

References
Limiting references

This place does not cover:

Isolating an individual clone by screening libraries

C12N 15/1034

Screening libraries presented on the surface of microorganisms, e.g. phage display, E. coli display

C12N 15/1037

Ribosome/Polysome display, e.g. SPERT, ARM

C12N 15/1041

Preparation or screening of libraries displayed on scaffold proteins

C12N 15/1044

SELEX

C12N 15/1048

Gene trapping, e.g. exon-, intron-, IRES-, signal sequence-trap cloning, trap vectors

C12N 15/1051

Protein x Protein interaction, e.g. two hybrid selection

C12N 15/1055

Directional evolution of libraries, e.g. evolution of libraries is achieved by mutagenesis and screening or selection of mixed population of organisms

C12N 15/1058

mRNA-Display, e.g. polypeptide and encoding template are connected covalently]

C12N 15/1062

Preparation or screening of tagged libraries, e.g. tagged microorganisms by STM-mutagenesis, tagged polynucleotides, gene tags

C12N 15/1065

Template (nucleic acid) mediated chemical library synthesis, e.g. chemical and enzymatical DNA-templated organic molecule synthesis, libraries prepared by non ribosomal polypeptide synthesis (NRPS), DNA/RNA-polymerase mediated polypeptide synthesis

C12N 15/1068

Differential gene expression library synthesis, e.g. subtracted libraries, differential screening

C12N 15/1072

By coupling phenotype to genotype, not provided for in other groups of this group

C12N 15/1075

Screening libraries by altering the phenotype or phenotypic trait of the host (reporter assays C12N 15/1086 )

C12N 15/1079

Preparation or screening gene libraries by chromosomal integration of polynucleotide sequences, HR-, site-specific-recombination, transposons, viral vectors

C12N 15/1082

Preparation or screening of expression libraries, e.g. reporter assays

C12N 15/1086

Design, preparation, screening or analysis of libraries using computer algorithms

C12N 15/1089

General methods of preparing gene libraries, not provided for in other subgroups

C12N 15/1093

Phage display

G01N 33/00

Informative references

Attention is drawn to the following places, which may be of interest for search:

Bioinformatics for probe design or probe optimization

G16B 25/20

Special rules of classification

See Annex 1 under the "Special rules" section of C12Q 1/68.

Hybridisation assays
Definition statement

This place covers:

All applications dealing with hybridisation assays which can not be classified in any of the hybridisation subgroups

Special rules of classification

See Annex 1 under the "Special rules" section of C12Q 1/68.

characterised by the detection means (C12Q 1/6804 takes precedence)
Definition statement

This place covers:

Applications dealing with the detection of hybridisation assays characterised by the detection means..

References
Limiting references

This place does not cover:

Nucleic acid analysis using immunogens

C12Q 1/6804

Special rules of classification

See Annex 1 under the "Special rules" section of C12Q 1/68.

Glossary of terms

In this place, the following terms or expressions are used with the meaning indicated:

Means of detection

the mechanism used to detect the hybridisation of a nucleic acid probe to its nucleic acid target (e.g. labels,...)

involving interaction of two or more labels, e.g. resonant energy transfer
Definition statement

This place covers:

All applications dealing with the detection of hybridisation events using the interaction between the labels as principle.

Relationships with other classification places

The use of this detection principle in non-hybridisation based techniques such as nucleic acid amplification in group C12Q 1/6844 or sequencing in group C12Q 1/6869 are not covered by C12Q 1/6818 unless the invention resides in an improvement which has general applicability also for hybridisation assays (for instance an improved Taqman probe). In this case, both C12Q 1/6818 and an amplification or sequencing group can be given.

Special rules of classification

See Annex 1 under the "Special rules" section of C12Q 1/68

Signal amplification
Definition statement

This place covers:

All applications where the detection signal generated in a hybridisation reaction is amplified (for instance the use of branched probes or rolling circle amplification to amplify the hybridisation signal).

Relationships with other classification places

Amplification of target nucleic acids as such wherein the target amplification results in an increase of signal which is not seen as signal amplification and is not classified in C12Q 1/682.

Electronic signal amplification is not classified in group C12Q 1/682.

Special rules of classification

See Annex 1 under the "Special rules" section of C12Q 1/68

Release of bound markers
Definition statement

This place covers:

All applications wherein the hybridisation detection depends on the physical separation and subsequent detection of a signalling moiety.

Relationships with other classification places

The use of this detection principle in non-hybridisation based techniques such as nucleic acid amplification in group C12Q 1/6844 or sequencing in group C12Q 1/6869 are not covered by group C12Q 1/6823 unless the invention resides in an improvement which has general applicability also for hybridisation assays. In this case both C12Q 1/6823 and an amplification or sequencing group can be given.

Nucleic acid detection involving sensors
Definition statement

This place covers:

All applications wherein the detection of the hybridisation reaction depends on the electrical or physical properties of the label or of the nucleic acid molecules themselves.

References
Informative references

Attention is drawn to the following places, which may be of interest for search:

Sensors wherein the optical detection is important

G01N 21/00

Sensors and electronic devices involving nucleic acids wherein the electrical detection is important

G01N 27/00

Special rules of classification

See Annex 1 under the "Special rules" section of C12Q 1/68.

for detection of mutation or polymorphism
Definition statement

This place covers:

All methods dealing with the detection of polymorphisms using an hybridisation assay and which cannot be classified in group C12Q 1/683. The detection of methylation and splice variants is seen as polymorphism detection and therefore classified in this group if the detection principle is based on an hybridisation assay.

Relationships with other classification places

The detection of polymorphisms using amplification based techniques is classified in group C12Q 1/6858. The use of allele specific primer extension is covered by group C12Q 1/6858 and not C12Q 1/6827.

See Annex 1 under the "Special rules" section of C12Q 1/68.

References
Informative references

Attention is drawn to the following places, which may be of interest for search:

Sequence identification involving differential detection

C12Q 1/6809

Allele specific amplification; The detection of polymorphisms using amplification based techniques

C12Q 1/6858

Enhancement of hybridisation reaction
Definition statement

This place covers:

All applications dealing with the enhancement of the binding between a target and its probe, e.g. use of special buffer components, temperatures, probe modifications.

References
Informative references

Attention is drawn to the following places, which may be of interest for search:

Sequence identification involving differential detection

C12Q 1/6809

Increasing the specificity or sensitivity of an amplification reaction

C12Q 1/6848

Allele specific amplification

C12Q 1/6858

Special rules of classification

See Annex 1 under the "Special rules" section of C12Q 1/68.

Enzymatic or biochemical coupling of nucleic acids to a solid phase
Definition statement

This place covers:

All applications dealing with the enzymatic and biochemical coupling of nucleic acids to solid surfaces for the use in low throughput assays and the application of those solid surfaces in the subsequent analysis of a nucleic acid.

References
Informative references

Attention is drawn to the following places, which may be of interest for search:

Design and fabrication of microarrays (biochips) wherein the invention resides in the synthesis of polypeptides or polynucleotides; Apparatus and devices for combinatorial chemistry or for making molecular arrays.

B01J 19/00

Chemical synthesis or modification of nucleosides, nucleotides or oligonucleotides, chemically linked to other compounds (fluorescent labels)

C07H 21/00
-C07H 21/04

Special rules of classification

See Annex 1 under the "Special rules" section of C12Q 1/68.

using probe arrays or probe chips (C12Q 1/6874 takes precedence)
Definition statement

This place covers:

All nucleic acid analysis methods which depend on the use of probe arrays (biochips, microarray). If the use of the array is in the context of a method which can be classified in another group of the hybridisation based assays, e.g. C12Q 1/6813, the classifier has to decide based on the relevance of the method to classify the application in either one of these groups or even to classify the application in both groups if necessary. However, if the use is for sequencing then the application is only classified in group C12Q 1/6874.

References
Limiting references

This place does not cover:

Involving nucleic acid arrays, e.g. sequencing by hybridisation [SBH]

C12Q 1/6874

Informative references

Attention is drawn to the following places, which may be of interest for search:

Design and fabrication of microarrays (biochips) wherein the invention resides in the synthesis of polypeptides or polynucleotides; Apparatus and devices for combinatorial chemistry or for making molecular arrays.

B01J 19/00

Chemical synthesis or modification of nucleosides, nucleotides or oligonucleotides, chemically linked to other compounds (fluorescent labels)

C07H 21/00
-C07H 21/04

Special rules of classification

See Annex 1 under the "Special rules" section of C12Q 1/68.

Triple helix formation or other higher order conformations in hybridisation assays
Definition statement

This place covers:

All methods dealing with the formation of a triple helix DNA conformation. This group also covers other higher order conformations of nucleic acids (quadruplex).

Special rules of classification

See Annex 1 under the "Special rules" section of C12Q 1/68.

In situ hybridisation
Definition statement

This place covers:

All applications dealing with methods for the analysis of a nucleic acid in a cell or positionally in a chromosome like Fluorescent In Situ Hybridisation [FISH].

Special rules of classification

See Annex 1 under the "Special rules" section of C12Q 1/68.

Nucleic acid amplification reactions
Definition statement

This place covers:

All amplification methods which do not belong in any of the amplification groups. Generally, amplification techniques which use a mechanism for amplifying nucleic acids and for which no group exists are classified in group C12Q 1/6844. An example of such an amplification technique is strand displacement amplification [SDA].

References
Informative references

Attention is drawn to the following places, which may be of interest for search:

Microfuidic systems used for nucleic acid analysis like thermal cyclers (PCR-machines), capillary sequencers.

B01L 1/00 - B01L 99/00

Chemical synthesis of oligonucleotides

C07H 21/00

Special rules of classification

See Annex 1 under the "Special rules" section of C12Q 1/68.

characterised by the means for preventing contamination or increasing the specificity or sensitivity of an amplification reaction
Definition statement

This place covers:

Methods for preventing contamination in an amplification reaction such as the use of wax barriers, containers, uracil glycosylase, hot start and nested PCR. In addition, all methods relating to increasing the specificity or sensitivity of an amplification reaction are classified in this group.

This group also covers means for reducing false positive or false negative signals in an amplification reaction.

These include the use of modified nucleotides, e.g. in amplification reactions designed for amplifying GC-rich templates, special buffer components, pH, reaction conditions, etc.

If the method is designed for a specific amplification technique like PCR in group C12Q 1/686, then it is both classified in the specific amplification group, i.e. C12Q 1/686, and in C12Q 1/6848.

References
Informative references

Attention is drawn to the following places, which may be of interest for search:

Methods for preventing contamination before an amplification reaction

C12Q 1/6806

Enhancement of hybridisation reactions

C12Q 1/6832

Special rules of classification

See Annex 1 under the "Special rules" section of C12Q 1/68.

Quantitative amplification
Definition statement

This place covers:

Methods for the quantitative amplification of nucleic acids including the use of standards or mathematical models. This group also covers methods (both again enzymatic and mathematical) for determining the amplification efficiency.

References
Informative references

Attention is drawn to the following places, which may be of interest for search:

ICT specially adapted for hybridisation; ICT specially adapted for gene or protein expression

G16B 25/00

Special rules of classification

See Annex 1 under the "Special rules" section of C12Q 1/68.

using modified primers or templates
Definition statement

This place covers:

methods using modified primers or templates.

Special rules of classification

See Annex 1 under the "Special rules" section of C12Q 1/68.

Ligating adaptors
Definition statement

This place covers:

Methods where the primer or the template is modified by the ligation to an adaptor.

Special rules of classification

See Annex 1 under the "Special rules" section of C12Q 1/68.

Allele-specific amplification
Definition statement

This place covers:

All methods dealing with the detection of polymorphisms using an amplification assay. The detection of methylation and splice variants is seen as polymorphism detection and therefore classified in this group if the detection principle is based on an amplification assay. This includes allele specific primer extension (also when only one dNTP or ddNTP is incorporated using a polymerase).

References
Informative references

Attention is drawn to the following places, which may be of interest for search:

Hybridisation based polymorphism detection

C12Q 1/6827

Hybridisation based polymorphism detection involving restriction enzymes

C12Q 1/683

Sequencing

C12Q 1/6869

Special rules of classification

See Annex 1 under the "Special rules" section of C12Q 1/68.

Polymerase chain reaction [PCR]
Definition statement

This place covers:

all applications dealing with PCR and modifications/improvements thereof (e.g Taqman, multiplex-PCR,...).

Special rules of classification

See Annex 1 under the "Special rules" section of C12Q 1/68.

Ligase chain reaction [LCR]
Definition statement

This place covers:

all applications dealing with LCR and modifications/improvements thereof.

Special rules of classification

See Annex 1 under the "Special rules" section of C12Q 1/68.

Promoter-based amplification, e.g. nucleic acid sequence amplification [NASBA], self-sustained sequence replication [3SR] or transcription-based amplification system [TAS]
Definition statement

This place covers:

all applications dealing with promoter based amplification and modifications/improvements thereof.

Special rules of classification

See Annex 1 under the "Special rules" section of C12Q 1/68.

Glossary of terms

In this place, the following terms or expressions are used with the meaning indicated:

NASBA

Nucleic acid sequence based amplification

3SR

selfsustained sequence replication

TAS

transcription-based amplification system

Replicase-based amplification, e.g. using Q-beta replicase
Definition statement

This place covers:

all applications dealing with replicase based amplifications and modifications/improvements thereof.

Special rules of classification

Annex1.

Methods for sequencing
Definition statement

This place covers:

All nucleic acid sequencing methods which cannot be classified in the subgroups for sequencing using mass spectrometry, i.e. in group C12Q 1/6872 and sequencing using solid surfaces, i.e. in group C12Q 1/6874. This group also covers methods for sequencing using nanopores and other sequencing systems based on physical properties of nucleic acids, e.g. Atomic Force Microscopy [AFM].

References
Informative references

Attention is drawn to the following places, which may be of interest for search:

Allele specific primer extension

C12Q 1/6858

Microfuidic systems used for nucleic acid analysis like thermal cyclers (PCR-machines), capillary sequencers

B01L 1/00
-B01L 99/00

Apparatus for sequencing using nanopores or nanochannels

G01N 33/48721

Special rules of classification

See Annex 1 under the "Special rules" section of C12Q 1/68.

involving mass spectrometry
Definition statement

This place covers:

all applications dealing with mass spectrometry based sequencing and modifications/improvements thereof.

Special rules of classification

See Annex 1 under the "Special rules" section of C12Q 1/68.

involving nucleic acid arrays, e.g. sequencing by hybridisation
Definition statement

This place covers:

all applications dealing with nucleic acid array based sequencing and modifications/improvements thereof.

Special rules of classification

See Annex 1 under the "Special rules" section of C12Q 1/68.

Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes
Definition statement

This place covers:

All nucleic acid products used in the analysis of nucleic acids (e.g. primers, probes, controls) which cannot be classified in any of the subgroups C12Q 1/6879 - C12Q 1/6895. If an application relates both to methods and nucleic acid products, than these applications are classified in both the appropriate method and product subgroups.

References
Informative references

Attention is drawn to the following places, which may be of interest for search:

Differential detection

C12Q 1/6809

Polymorphism detection by hybridisation

C12Q 1/6827

Allele specific amplification

C12Q 1/6858

Probes and primers for the detection of viruses and bacteriophages

C12Q 1/70

Virus antigen in a vaccine

A61K 39/12

Modified nucleosides, nucleotides

C07H 21/00

Bacterial and fungal antigens

C07K 14/195- C07K 14/40

Protozoal antigens

C07K 14/44- C07K 14/455

Antibodies

C07K 16/00

Virus, Bacteriophages

C12N 7/00

Bacterial, fungal and protozoan enzymes

C12N 9/00

DNA or RNA fragments; Modified forms thereof

C12N 15/11

Bacterial vectors

C12N 15/70
-C12N 15/78

Vectors for fungal cells

C12N 15/80
-C12N 15/815

Animal vectors and their preparation

C12N 15/85

Special rules of classification

See Annex 2 under the "Special rules" section of C12Q 1/68.

for diseases caused by alterations of genetic material
Definition statement

This place covers:

All nucleic acid based diagnostic products. Those include both products for detecting the alterations (polymorphisms including methylation and splice variants) of genetic material and for detecting differential expression of a disease gene. If an application also discloses methods for detecting such polymorphisms or differential expression, the classifier should decide based on the relevance of this method to classify the application also in the appropriate method groups, e.g. C12Q 1/6827, C12Q 1/683, C12Q 1/6858, or C12Q 1/6809.

References
Informative references

Attention is drawn to the following places, which may be of interest for search:

Primers and probes for cancer assays

C12Q 1/6886

Diagnostic immunoassays

G01N 33/53

Special rules of classification

See Annex 2 under the "Special rules" section of C12Q 1/68.

for cancer (immunoassay for cancer G01N 33/574)
Definition statement

This place covers:

All nucleic acid based cancer diagnostic products.

References
Limiting references

This place does not cover:

Cancer diagnostic immunoassays

G01N 33/574

Special rules of classification

See Annex 2 under the "Special rules" section of C12Q 1/68.

involving reporter genes operably linked to promoters
Definition statement

This place covers:

All methods which use the detection of reporter genes operably linked to promoters for screening and nucleic acid analysis.

References
Informative references

Attention is drawn to the following places, which may be of interest for search:

Preparation or screening of expression libraries, e.g. reporter assays

C12N 15/10

If the screening or the analysis focuses on protein interaction, expression or activity

G01N 33/5008

Special rules of classification

See Annex 1 under the "Special rules" section of C12Q 1/68.

involving virus or bacteriophage
Definition statement

This place covers:

all methods which are specifically designed for the analysis of viral nucleic acids or for the analysis of nucleic acids of bacteriophages. (NOTE: According to the hierarchy this subgroup should not be limited to analysis involving nucleic acids. In practice, however, as Immunoassays/protein based Biospecific binding assays for viruses are classified in G01N, this subgroup is effectively limited to analysis of viral/bacteriophagal nucleic acids). Methods which are generally applicable to nucleic acid analysis should also be classified in the relevant C12Q 1/68 subgroup.

References
Limiting references

This place does not cover:

Virus antigen in a vaccine

A61K 39/12

Virus

C12N 7/00

Immunoassay/protein based Biospecific binding assay for viruses

G01N 33/56983

Special rules of classification

See annex 1 and 2 under the "special rules" section of C12Q 1/68.

{Specific hybridization probes}
Definition statement

This place covers:

all probes and primers for the detection and analysis of viruses and bacteriophages not covered by any of the subgroups C12Q 1/703 - C12Q 1/708.

Special rules of classification

See Annexes 1 and 2 under the "Special rules" section of C12Q 1/68.

{for retroviruses}
Definition statement

This place covers:

probes and primers for the detection and analysis of retroviruses. Methods specifically designed for retroviruses are covered in C12Q 1/70 and C12Q 1/68 if necessary.

Special rules of classification

See Annexes 1 and 2 under the "Special rules" section of C12Q 1/68.

{Viruses associated with AIDS}
Definition statement

This place covers:

probes and primers for the detection and analysis of AIDS associated viruses. Methods specifically designed for AIDS associated viruses are covered in C12Q 1/70 and C12Q 1/68 if necessary.

Special rules of classification

See Annexes 1 and 2 under the "Special rules" section of C12Q 1/68.

{for herpetoviridae, e.g. herpes simplex, varicella zoster}
Definition statement

This place covers:

probes and primers for the detection and analysis of herpetoviridae. Methods specifically designed for herpetoviridae are covered in C12Q 1/70 and C12Q 1/68 if necessary.

Special rules of classification

See Annexes 1 and 2 under the "Special rules" section of C12Q 1/68.

{for hepatitis}
Definition statement

This place covers:

probes and primers for the detection and analysis of hepatitis. Methods specifically designed for hepatitis are covered in C12Q 1/70 and C12Q 1/68 if necessary.

Special rules of classification

See Annexes 1 and 2 under the "Special rules" section of C12Q 1/68.

{non-A, non-B Hepatitis, excluding hepatitis D}
Definition statement

This place covers:

probes and primers for the detection and analysis of non-A, non-B, and non-D hepatitis. Methods specifically designed for non-A, non-B, and non-D hepatitis are covered in C12Q 1/70 and C12Q 1/68 if necessary.

Special rules of classification

See Annexes 1 and 2 under the "Special rules" section of C12Q 1/68.

{for papilloma}
Definition statement

This place covers:

probes and primers for the detection and analysis of papilloma. Methods specifically designed for papilloma are covered in C12Q 1/70 and C12Q 1/68 if necessary.

Special rules of classification

See Annexes 1 and 2 under the "Special rules" section of C12Q 1/68.

Condition responsive control processes (apparatus therefor C12M 1/36; controlling or regulating in general G05)
Definition statement

This place covers:

Processes involving enzymes or microorganisms in which a process parameter is measured and that or another process parameter is varied in response to such measurement.