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MEASURING OR TESTING PROCESSES INVOLVING ENZYMES OR MICRO-ORGANISMS (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 subclass/group covers:

Processes in which there is a direct or indirect qualitative or quantitative measurement or test of a material which contains enzymes or micro-organisms or processes in which a material containing enzymes or micro-organisms 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 micro-organisms or enzymes 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 micro-organisms or enzymes.

Processes of making such test compositions.

Processes involving enzymes or micro-organisms 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.

Relationship between large subject matter areas

Controlling or regulating in general is classified in G05.

In groups C12M-C12Q or C12S, and within each of these groups, in the absence of an indication to the contrary, classification is made in the last appropriate place.

The codes of group C12R are only for use as Indexing Codes associated with groups C12C-C12Q or C12S, so as to provide information concerning the micro-organisms used in the processes classified in these groups.

References relevant to classification in this group
This subclass/group does not cover:

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

Apparatus for condition-responsive control processes

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

Immunoassay

Immunoassay with enzyme label

Immunoassay with the carrier being a biological cell or cell fragment

Immunoassay for micro-organisms

Immunoassay for venereal diseases

Immunoassay for enzymes and isoenzymes

Immunoassay for cancer

Immunoassay for hepatitis

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

Micro-organisms per se

Human, animal or plant cells per se

Viruses per se

Enzymes per se

Investigating or analysing materials by determining their chemical or physical properties

Investigating or analysing biological material

Chemical analysis involving blood sugar, e.g. galactose

Chemical analysis involving proteins, peptides and amino acids

Chemical analysis involving lipids, e.g. cholesterol

Special rules of classification within this group

In this group classification is made according to the most relevant feature rather than according to the last-place-rule.

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 micro-organisms. 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 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.

Glossary of terms
In this subclass/group, 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.

Micro-organism

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 micro-organisms (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 subclass/group covers:

Processes in which there is a direct or indirect qualitative or quantitative measurement or test of a material which contains enzymes or micro-organisms or processes in which a material containing enzymes or micro-organisms 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). See section range C12Q 1/68 - C12Q 1/708.

Compositions or test papers containing micro-organisms or enzymes 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 micro-organisms or enzymes.

Processes of making such test compositions.

Processes involving enzymes or micro-organisms 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.

Relationship between large subject matter areas

Controlling or regulating in general is classified in G05.

References relevant to classification in this group
This subclass/group does not cover:

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

Apparatus for condition-responsive control processes

Testing involving animal cells

Testing involving plant cells

Immunoassay

Immunoassay with enzyme label

Immunoassay with the carrier being a biological cell or cell fragment

Immunoassay for micro-organisms

Immunoassay for animal cells

Immunoassay for plant cells

Immunoassay for venereal diseases

Immunoassay for enzymes and isoenzymes

Immunoassay for cancer

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

Micro-organisms per se

Human, animal or plant cells per se

Viruses per se

Enzymes per se

Investigating or analysing materials by determining their chemical or physical properties

Investigating or analysing biological material

Chemical analysis involving blood sugar, e.g. galactose

Chemical analysis involving proteins, peptides and amino acids

Chemical analysis involving lipids, e.g. cholesterol

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

Special rules of classification within this group

In this group classification is made according to the most relevant feature rather than according to the last-place-rule.

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 micro-organisms. 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 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 subclass/group 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.

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

Involving physiochemical end-point determination

Electrodes

{Electrode membranes}
Definition statement
This subclass/group 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 subclass/group, the following terms (or expressions) are used with the meaning indicated:

Membrane

Any non-conductive porous structure

{Functionalisation}
Definition statement
This subclass/group 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.

Relationship between large subject matter areas

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 subclass/group 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 subclass/group 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 subclass/group covers:

Enzyme electrodes specifically designed for the analysis of glucose.

{involving isoenzyme profiles (for detection of an individual isoenzyme C12Q 1/25 to C12Q 1/66)}
Definition statement
This subclass/group covers:

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

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

{for determining co-enzymes or co-factors, e.g. NAD, ATP}
Definition statement
This subclass/group covers:

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

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

involving viable micro-organisms
Definition statement
This subclass/group 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 relevant to classification in this group
This subclass/group does not cover:

Specific binding assays/Immunoassays for microorganisms are classified in

For hepatitis

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

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

References relevant to classification in this subclass/group
This subclass/group does not cover:

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

Determining presence or kind of micro-organism; Use of selective media for testing antibiotics or bacteriocides; Compositions containing a chemical indicator therefor{(C12Q 1/6897 takes precedence)}
Definition statement
This subclass/group 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 subclass/group 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 subclass/group 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 subclass/group 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 subclass/group 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 subclass/group 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 subclass/group covers:

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

using radioactive material
Definition statement
This subclass/group 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 subclass/group covers:

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

using multifield media
Definition statement
This subclass/group 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 subclass/group 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 within this group

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 micro-organisms
Definition statement
This subclass/group 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 { to C12Q 1/66}
Definition statement
This subclass/group 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 subclass/group 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 subclass/group 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 subclass/group covers:

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

involving dehydrogenase
Definition statement
This subclass/group 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 subclass/group 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 subclass/group 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 subclass/group 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 subclass/group 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 subclass/group 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 subclass/group covers:

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

involving transferase
Definition statement
This subclass/group 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 subclass/group 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 subclass/group covers:

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

involving transaminase
Definition statement
This subclass/group 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 subclass/group 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 subclass/group 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 within this group

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 subclass/group 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 subclass/group 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 subclass/group 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 subclass/group 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.

Relationship between large subject matter areas

Overlap with G01N 33/92.

involving triglycerides
Definition statement
This subclass/group 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.

Relationship between large subject matter areas

Overlap with G01N 33/92.

involving uric acid
Definition statement
This subclass/group 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 subclass/group 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 subclass/group 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 subclass/group covers:

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

Relationship between large subject matter areas

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

References relevant to classification in this group
This subclass/group does not cover:

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.

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

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

Apparatuses and devices used for the enzymatic analysis of nucleic acids are not classified in

C12Q 1/68 and groups.

Coultier counters

Sensors and electronic devices wherein the optical detection is important

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

Bioinformatics

Computer systems using nucleic acids

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

Immunization, vaccines

Viral antigens in a vaccine

Gene therapy

Bacterial, fungal, protozoal, vertebrate antigens.

Antibodies

Undifferentiated human, animal or plant cells

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

Isolating individual clones by screening libraries; making libraries

Non-coding nucleic acids modulating the expression of genes (e.g. siRNA, miRNA,..); aptamers

DNA/RNA encoding protein; preparation by recombinant DNA technology

Bacterial vectors

Vectors for fungal cells

Animal vectors and their preparation

Plant cells

Animal cells

Cells modified by introduction of foreign genetic material

Viruses; Bacteriophages

Bacterial, fungal and protozoan enzymes

Protein diagnostics and detection

Special rules of classification within this group

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

CPC (500) codes:C12Q 2500/00 - C12Q 2565/60

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

involving nucleic acids

General aspects

Nucleic acid analysis utilising immunogens

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

Sequence identification involving differential detection

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

Hybridisation assays

characterised by the means of detection

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

Signal amplification

Release of bound marker

Nucleic acid detection involving sensors

for mutation or polymorphism detection

involving restriction enzymes, e.g. RFLP

Enhancement of hybridisation reaction

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

characterised by the use of probe arrays or probe chips

Triple helix formation in hybridisation assays

"In-situ" hybridisation

Nucleic acid amplification reactions

Common amplification features

preventing contamination

Quantitative amplification

using modified primers or templates

Ligating adaptors

Allele specific amplification

Polymerase Chain Reaction (PCR)

Ligase Chain Reaction (LCR)

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

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

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

involving mass spectrometry

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

involving reporter genes operably linked to promoters

involving viruses and Bacteriophages

Nucleic acid product groups:

Symbol

Title

Hybridisation probes, primers, and other nucleic acid products

for sex determination

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

for diseases caused by alterations of genetic material

for cancer

for detection or identification of organisms

for bacteria

for protozoa

for plants, fungi, or algae

Specific hybridization probes

for retroviruses

Viruses associated with AIDS

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

for hepatitis

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

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 to 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 to C12Q 1/70 to define the essential technical features of the invention.

1.2 Use of CPC500 codes is restricted to the C-set format and only in combination with the method classes (see above). This means that the use of CPC500 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 CPC500 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 to 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 to C12Q 2565/634 should not be used outside a C-set as free CPC codes.

1.8 Examples

A method is described for detecting the presence of a nucleic acid or protein target molecule in a sample which method involves, inter alia, the formation of an active ribozyme and cleavage of an assayable marker dependent on the presence or absence of the target:

CPC: C12Q 1/6823 (methods for detection involving release of bound labels/markers)essential technical feature: C12Q 2521/337 (use of ribozyme)

Retrieval during search: (just a few possibilities)

(retrieves all C-sets with ribozyme)

(retrieves all EC classes where ribozyme is in a C-set)

(retrieves all application having at least the EC class C12Q 1/6823 and the indexing code C12Q 2521/337 in a C-set (not necessarily a C-set with C12Q 1/6823 as a base class))

To facilitate finding of an appropriate code(s), the codes have been arranged within groups arranged in a directory. The codes assigned to the Main groups and to Header groups within the directory are not to be used as indexing codes for the purpose of classification. Main groups and Header groups serve merely as means to assist in the logical retrieval of an appropriate indexing code within the directory.

Annex 2:

Use of the following classification schemes:

CPC (600) codes: C12Q 2600/00 - C12Q 2600/178

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

Symbol

Title

Oligonucleotides characterized by their use (not used)

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

Disease subtyping / staging /classification

Prognosis of disease development

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

Plant traits

Screening for pharmacological compounds

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

Screening for cosmetic compounds

Methylation markers

Polymorphic markers (excluding Methylation markers)

Expression markers

Primer sets for multiplex assays

Oligonucleotides used as internal standards/controls/normalisation probes

Haplotypes

miRNA, siRNA or ncRNA

1.1 Rules for classification:

1.1.1 The use of the C12Q600 ICO codes is restricted to the nucleic acid product classes in the range C12Q 1/68 - C12Q 1/70:

Symbol

Title

Hybridisation probes, primers, and other nucleic acid products

for sex determination

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

for diseases caused by alterations of genetic material

for cancer

for detection or identification of organisms

for bacteria

for protozoa

for plants, fungi, or algae

Specific hybridization probes

for retroviruses

Viruses associated with AIDS

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

for hepatitis

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

for papilloma

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

1.1.3 The use of the C12Q 2600/00 ICO 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

a) 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 EC class for this application would be C12Q 1/6883.

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

In search, the combination of C12Q 1/6883, C12Q 2600/156, and keywords will directly lead to the most relevant documents.

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 EC class for this application would be C12Q 1/6883.

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

In search, the combination of C12Q 1/6883, C12Q 2600/158, and keywords will directly lead to the most relevant documents.

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 EC class 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 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 to C12Q 1/70: non-invention information (additional information)

Symbol

Title

involving nucleic acids

General aspects

Nucleic acid analysis utilising immunogens

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

Sequence identification involving differential detection

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

Hybridisation assays

characterised by the means of detection

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

Signal amplification

Release of bound marker

Nucleic acid detection involving sensors

for mutation or polymorphism detection

involving restriction enzymes, e.g. RFLP

Enhancement of hybridisation reaction

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

characterised by the use of probe arrays or probe chips

Triple helix formation in hybridisation assays

"In-situ" hybridisation

Nucleic acid amplification reactions

Common amplification features

preventing contamination

Quantitative amplification

using modified primers or templates

Ligating adaptors

Allele specific amplification

Polymerase Chain Reaction (PCR)

Ligase Chain Reaction (LCR)

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

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

Methods for sequencing

involving mass spectrometry

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

Hybridisation probes, primers, and other nucleic acid products

for sex determination

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

for diseases caused by alterations of genetic material

for cancer

for detection or identification of organisms

for bacteria

for protozoa

for plants, fungi, or algae

involving reporter genes operably linked to promoters

involving virus or bacteriphage

Specific hybridization probes

for retroviruses

Viruses associated with AIDS

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

for hepatitis

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

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 EC class 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 utilising immunogens}
Definition statement
This subclass/group covers:

All applications where immunological compounds are used in the analysis of nucleic acids. (antibodies specific for single or double stranded DNA) This group also includes these applications where nucleic acid detection is used for analysing or detecting proteins and immunogens. (e.g.. immuno PCR)

References relevant to classification in this group
This subclass/group does not cover:

Antibodies

Immunoassays where the invention is in the immunological part of the application and immunoassays as such

Immunoassay for nucleic acids

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

Immunoassays

Special rules of classification within this group

See Annex 1

Documents in which an immunological reaction 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 subgroup are immunoassays in which the immunological reaction 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 subclass/group, 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 PCR assay (C12Q 1/6804 takes precedence)}
Definition statement
This subclass/group 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 relevant to classification in this group
This subclass/group does not cover:

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

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

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

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

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

Special rules of classification within this group

Annex 1

{Sequence identification involving differential detection}
Definition statement
This subclass/group covers:

All document 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 relevant to classification in this group
This subclass/group does not cover:

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

Special rules of classification within this group

Annex 1.

{Selection methods for production or design of target specific oligonucleotide or binding molecules}
Definition statement
This subclass/group covers:

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

References relevant to classification in this group
This subclass/group does not cover:

Bioinformatics for probe design or probe optimisation

Isolating an individual clone by screening libraries

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

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

Preparation or screening of libraries displayed on scaffold proteins

SELEX

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

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

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

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

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

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

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

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

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

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

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

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

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

Phage display

Probe design or optimisation using bioinformatics

Special rules of classification within this group

Annex 1.

{Hybridisation assays}
Definition statement
This subclass/group covers:

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

Special rules of classification within this group

Annex 1

{characterised by the means of detection (C12Q 1/6804 takes precedence)}
Definition statement
This subclass/group covers:

All applications dealing with the detection of hybridisation assays which can not be classified in any of the subgroups: C12Q 1/6818,C12Q 1/682,C12Q 1/6823, and C12Q 1/6825.

If the detection depends on the use of immunogens, the application is classified in C12Q 1/6804.

Special rules of classification within this group

Annex 1.

Glossary of terms
In this subclass/group, 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 at least two labels, e.g. resonant energy transfer}
Definition statement
This subclass/group covers:

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

References relevant to classification in this group
This subclass/group does not cover:

the use of this detection principle in non-hybridisation based techniques such as nucleic acid amplification (C12Q 1/6844) or sequencing (C12Q 1/6869) 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. In all other cases, the class for either NA amplification or NA sequencing is used in combination with an appropriate technical Indexing Code as explained in Annex1.

Special rules of classification within this group

Annex 1

{Signal amplification}
Definition statement
This subclass/group 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).

References relevant to classification in this group
This subclass/group does not cover:

amplification of target nucleic acids as such wherein the target amplification results in an increase of signal is not seen as signal amplification. In these cases, the class for either NA amplification or NA sequencing is used in combination with an appropriate technical Indexing Code as explained in Annex1.

electronic signal amplification

Special rules of classification within this group

Annex 1

{Release of bound marker}
Definition statement
This subclass/group covers:

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

References relevant to classification in this group
This subclass/group does not cover:

the use of this detection principle in non-hybridisation based techniques such as nucleic acid amplification (C12Q 1/6844) or sequencing (C12Q 1/6869) 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. In all other cases, the class for either NA amplification or NA sequencing is used in combination with an appropriate technical Indexing Code as explained in Annex1.

{Nucleic acid detection involving sensors}
Definition statement
This subclass/group 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 relevant to classification in this group
This subclass/group does not cover:

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

Sensors wherein the optical detection is important

Sensors and electronic devices involving proteins

Special rules of classification within this group

Annex 1.

{for mutation or polymorphism detection}
Definition statement
This subclass/group covers:

all methods dealing with the detection of polymorphisms using an hybridisation assay and which can not be classified in 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 a hybridisation assay.

References relevant to classification in this group
This subclass/group does not cover:

Allele specific amplification

The detection of polymorphisms using amplification based techniques which are classified in

Examples of places where the subject matter of this class is covered when specially adapted, used for a particular purpose, or incorporated in a larger system

Sequence identification involving differential detection

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

Allele specific amplification

Special rules of classification within this group

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

Annex 1.

{involving restriction enzymes, e.g. RFLP}
Definition statement
This subclass/group 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 relevant to classification in this group
This subclass/group does not cover:

Improving the efficiency of amplification reactions

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

Allele specific amplification

Sequence identification involving differential detection

Special rules of classification within this group

Annex 1.

{Nucleic acid analysis involving immobilisation; Immobilisation characterised by the carrier or coupling agent}
Definition statement
This subclass/group 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 relevant to classification in this group
This subclass/group does not cover:

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.

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

Special rules of classification within this group

Annex 1.

{characterised by the use of probe arrays or probe chips (C12Q 1/6874 takes precedence)}
Definition statement
This subclass/group 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 C12Q 1/6874.

References relevant to classification in this group
This subclass/group does not cover:

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.

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

Special rules of classification within this group

Annex 1.

{Triple helix formation in hybridisation assays}
Definition statement
This subclass/group 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 within this group

Annex 1.

{"In-situ" hybridisation}
Definition statement
This subclass/group 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 within this group

Annex 1.

{Nucleic acid amplification reactions}
Definition statement
This subclass/group covers:

all amplification methods which do not belong in any of the amplification groups (C12Q 1/6846-D10). Generally amplification techniques which use a mechanism for amplifying nucleic acids and for which no group exists are classified in C12Q 1/6844. An example of such an amplification technique is strand displacement amplification (SDA).

References relevant to classification in this group
This subclass/group does not cover:

Chemical synthesis of oligonucleotides

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

Special rules of classification within this group

Annex 1.

{preventing contamination}
Definition statement
This subclass/group 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 of an amplification reaction are classified in this group. These include the use of modified nucleotides (e.g. in amplification reactions designed for amplifying GC-rich templates), special buffer components, pH,,reaction conditions,... If the method is designed for a specific amplification technique like PCR (C12Q 1/686), than it is both classified in the specific amplification group, i.e. C12Q 1/686, and in C12Q 1/6848.

References relevant to classification in this group
This subclass/group does not cover:

Improving the efficiency of hybridisation reactions

Special rules of classification within this group

Annex 1.

{Quantitative amplification}
Definition statement
This subclass/group 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 relevant to classification in this group
This subclass/group does not cover:

Quantitation of nucleic acids in array (hybridisation) based formats and in differential expression arrays using mathematical models

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

Quantitation of nucleic acids in array (hybridisation) based formats and in differential expression arrays using mathematical models

Special rules of classification within this group

Annex 1.

{using modified primers or templates}
Definition statement
This subclass/group covers:

methods using modified primers or templates.

Special rules of classification within this group

Annex 1.

{Ligating adaptors}
Definition statement
This subclass/group covers:

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

Special rules of classification within this group

Annex 1.

{Allele specific amplification}
Definition statement
This subclass/group 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 relevant to classification in this group
This subclass/group does not cover:

Hybridisation based polymorphism detection

Hybridisation based polymorphism detection involving restriction enzymes

Sequencing

Special rules of classification within this group

Annex 1.

{Polymerase Chain Reaction (PCR)}
Definition statement
This subclass/group covers:

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

Special rules of classification within this group

Annex 1.

{Ligase Chain Reaction (LCR)}
Definition statement
This subclass/group covers:

all applications dealing with LCR and modifications/improvements thereof.

Special rules of classification within this group

Annex 1.

{Promoter based amplification, e.g. NASBA, 3SR, TAS}
Definition statement
This subclass/group covers:

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

Special rules of classification within this group

Annex 1.

Glossary of terms
In this subclass/group, 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 amplifications, e.g. Q-beta replicase}
Definition statement
This subclass/group covers:

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

Special rules of classification within this group

Annex1.

{Methods for sequencing}
Definition statement
This subclass/group covers:

all nucleic acid sequencing methods which can not be classified in the subgroups for sequencing using mass spectrometry (C12Q 1/6872) and sequencing using solid surfaces (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 relevant to classification in this group
This subclass/group does not cover:

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

Apparatus for sequencing using nanopores or nanochannels

Allele specific primer extension

Special rules of classification within this group

Annex 1.

{involving mass spectrometry}
Definition statement
This subclass/group covers:

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

Special rules of classification within this group

Annex 1.

{involving nucleic acid arrays, e.g. Sequencing By Hybridisation (SBH)}
Definition statement
This subclass/group covers:

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

Special rules of classification within this group

Annex 1.

{Hybridisation probes}
Definition statement
This subclass/group covers:

all nucleic acid products used in the analysis of nucleic acids (primers, probes, controls,...) which can not 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 relevant to classification in this group
This subclass/group does not cover:

Virus antigen in a vaccine

Modified nucleosides, nucleotides

Bacterial, fungal and protozoal antigens.

Antibodies

Virus, Bacteriophages

Non-coding nucleic acids modulating the expression of genes (e.g. siRNA, miRNA,..); aptamers

Bacterial vectors

Vectors for fungal cells

Animal vectors and their preparation

Bacterial, fungal and protozoan enzymes

Differential detection

Polymorphism detection by Hybridisation

Allele specific amplification

Probes and primers for the detection of viruses and bacteriophages

Special rules of classification within this group

Annex 2.

{for diseases caused by alterations of genetic material}
Definition statement
This subclass/group 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 , C12Q 1/6809).

References relevant to classification in this group
This subclass/group does not cover:

Diagnostic immunoassays

Primers and probes for cancer assays

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

Diagnostic immunoassays

Special rules of classification within this group

Annex 2.

{for cancer}
Definition statement
This subclass/group covers:

all nucleic acid based cancer diagnostic products.

References relevant to classification in this group
This subclass/group does not cover:

Cancer diagnostic immunoassays

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

Cancer diagnostic immunoassays

Special rules of classification within this group

Annex 2.

{involving reporter genes operably linked to promoters}
Definition statement
This subclass/group covers:

All methods which use the detection of reporter genes or the activity of specific promoters for screening and nucleic acid analysis.

References relevant to classification in this group
This subclass/group does not cover:

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

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

Special rules of classification within this group

Annex 1.

involving virus or bacteriphage
Definition statement
This subclass/group 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 relevant to classification in this group
This subclass/group does not cover:

Virus antigen in a vaccine

Virus

Immunoassay/protein based Biospecific binding assay for viruses

Special rules of classification within this group

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

{Specific hybridization probes}
Definition statement
This subclass/group covers:

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

Special rules of classification within this group

Annex 1 and 2.

{for retroviruses}
Definition statement
This subclass/group 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 within this group

Annex 1 and 2.

{Viruses associated with AIDS}
Definition statement
This subclass/group 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 within this group

Annex 1 and 2.

{for herpetoviridae, e.g. herpes simplex, varicella zoster}
Definition statement
This subclass/group 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 within this group

Annex 1 and 2.

{for hepatitis}
Definition statement
This subclass/group 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 within this group

Annex 1 and 2.

{non-A, non-B Hepatitis, excluding hepatitis D}
Definition statement
This subclass/group 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 within this group

Annex 1 and 2.

{for papilloma}
Definition statement
This subclass/group 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 within this group

Annex 1 and 2.

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

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

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Last Modified: 10/11/2013