Compositions which are:

Used as preparations for dentistry, e.g. for artificial teeth, for filling or for capping teeth, or for taking dental impressions.

Used for cosmetic purposes for treating the skin, hair, nails, teeth or oral cavity with a view to cleaning them, changing their appearance, correcting body odours, protecting them or keeping them in good condition.

Used for medicinal purposes, e.g. drugs, biological compositions, when they are capable of:

Processes:

Subclass A01N covers the preservation of bodies of humans or animals or plants or parts thereof; biocides, e.g. as disinfectants, as pesticides or as herbicides. The distinction between classification in subclass A61K and subclass A01N is probably best envisaged in terms of the purpose. Subject-matter classified in subclass A61K imparts a direct benefit to the organism to which it is administered, e.g. curative. Subject-matter classified in subclass A01N on the other hand has no benefit to the target organism even though there may well be a secondary benefit to another organism, e.g. pesticides in crop protection.

Compounds per se are classified in classes C01, C07 or C08.

Subclass C08K covers the use of substances as compounding ingredients.

Compositions per se containing polymers are classified in subclass C08L.

Microorganisms per se are classified in subclass C12N.

The therapeutic activity of medicinal preparations is further classified in subclass A61P.

The use of cosmetics or similar toiletry preparations is further classified in subclass A61Q.

Looping references between A61L and A61K have been identified. CPC will be updated/corrected once this inconsistency is resolved in IPC. The current classification practice in CPC is as follows: Both A61L and A61K will be considered as informative reference (classification in both subclasses is done when needed).

Attention is drawn to the definitions of the groups of chemical elements following the title of section C.

In this subclass, with the exception of group A61K 8/00, in the absence of an indication to the contrary, classification is made in the last appropriate place.

Attention is drawn to the Notes in class C07, for example, the Notes following the title of the subclass C07D, setting forth the rules for classifying organic compounds in that class, which rules are also applicable, if not otherwise indicated, to the classification of organic compounds of subclass A61K.

A composition, i.e. a mixture of two or more ingredients, is classified in the last of groups A61K 31/00 - A61K 47/00 that provides for at least one of these ingredients.

Any part of a composition which is not identified by classification according to the last appropriate place of an active ingredient, which itself is determined to be novel and non-obvious, must also be classified. The part can be either a single ingredient or a composition in itself.

Any part of a composition which is not identified by the classification according to the last appropriate place, which is considered to represent information of interest for search, may also be classified. This can for example be the case when it is considered of interest to enable searching of compositions using a combination of classification symbols. Such non-obligatory classification should be given as "additional information".

Chemical compositions:

Apparatus, devices and methods per se for the application of the dental compositions are classified in the subclasses corresponding to their general function, e.g. impression cups or impression trays (A61C 9/00 or A61C 9/0006); impression methods (A61C 9/00); computer assisted-sizing (A61C 13/0004).

Chemical compounds/compositions per se without claimed use as dental composition are to be primarily classified in the subclasses corresponding to their chemical features (e.g. C07C, C07D, C08L, C04B, etc.), with a secondary classification in A61K 6/00 if the use in a dental treatment is further claimed.

A61K 6/90 covers dental compositions for taking dental impressions. However analysis and determination, detecting (2D or 3D) by using computer imaging methods are classified G06T 19/00.

Images-producing devices are classified in A61B 90/00 .

Surgical adhesives or cements are classified in A61L 24/00 and ionomer cements, e.g. glass-ionomer cements are classified A61L 24/12.

In the following groups the focus is on the intended use; the subgroups within a class are used to index further characteristics of the composition:

A61K 6/30: for temporarily or permanently fixing teeth

A61K 6/40: as primers

A61K 6/50: for dental root treatment

A61K 6/80: for artificial teeth, for filling or capping teeth

A61K 6/90: for taking dental impressions

The following groups are used as an indexing scheme to classify further features of the chemical composition:

A61K 6/15: characterised by physical properties

A61K 6/60 and A61K 6/70: characterised by the additives

A61K 6/802: use of ceramics

A61K 6/84: use of metals or alloys

A61K 6/849: use of inorganic cements

A61K 6/884: use of natural or synthetic resins

In groups A61K 6/30-A61K 6/58 and A61K 6/887-A61K 6/90 the use of specific polymers is indicated by addition of classification symbols of the subclass C08L, creating the correspondent Combination-set, e.g. compositions for taking dental impressions containing alginates are classified in (A61K 6/90, C08L 5/04).

A61K 6/887:

Polymers obtained by reactions only involving carbon to carbon unsaturated bonds are classified in A61K 6/887 in combination with the C08L subclass identifying the specific monomer; if only the general polymerisation mechanism is characterising, and not a specific monomer, documents are to be classified in A61K 6/887 without combination subclass.

A61K 6/889:

In the special case of glass ionomer cements, documents are to be classified in the groups A61K 6/889 (Polycarboxylate cements).

A glass ionomer cement is a dental cement mixture (CaF₂-Al₂O₃-SiO₂ + polycarboxylate) of low strength and toughness produced by mixing a powder prepared from a calcium aluminosilicate glass and a liquid prepared from an aqueous solution of polycarboxylates.

A61K 6/891:

Polymers obtained otherwise than by reactions only involving carbon to carbon unsaturated bonds are classified in A61K 6/891 in combination with the C08L subclass identifying the specific polymer; if a variety of polymers is mentioned, no particular type of polymer being characterising, documents are to be classified in A61K 6/891 without combination subclass.

In the special cases of polyurethanes (A61K 6/893), polyorganosilicon compounds (A61K 6/896), polysaccharides (A61K 6/898) documents are to be classified also in said groups.

Compositions characterised by physical properties and physical parameters in general. For example, a composition of a semi-crystalline resin and nanocluster with the physical property of being self-supporting. Furthermore the self-supporting structure has sufficient malleability to be reformed into a second shape, preferably at a temperature of about 15°C to 38°C, more preferably at a temperature of about 20°C to 38°C etc.

Documents are classified in A61K 6/15 only if the characterising physical property is other than:

Protective coatings for natural or artificial teeth such as anti-abrasive coatings or remineralization coatings with particles, dye coatings for natural appearance, and temporary acid-resistant coatings during treatment as well as varnishes.

Material used for assessing if the surface of a tooth is regular or not, for instance by determining the surface contact points.

Chemical compositions for temporarily or permanently fixing teeth, palates or the like. For example, dental adhesives and primers for dental adhesives.

Surgical adhesive or cements are classified in A61L 24/00.

If the type of polymer is characterized as an adhesive, the polymer should be classified in combination with the appropriate C08L subclass for specifying the kind of polymer. For example, using hydroxy cellulose as adhesive: Combination-set (A61K 6/35, C08L 1/02). The specific use of stabilising dentures in the mouth are to be classified in A61K 6/35.

Primer compositions used before applying a further material or layer thereon.

A primer is a chemical composition for modifying and pre-treatment of (dental) surfaces, resulting in a preparatory surface modification on materials before further treatment, ensuring better adhesion, but not to be confused with dental adhesives, which are classified in A61K 6/30.

Primers are to be classified in combination with the appropriate C08L subclass for specifying the kind of polymer, e.g. a primer composition based on homopolymers or copolymers of methyl methacrylate: Combination-set (A61K 6/40, C08L 33/12); if the kind of polymer is not characterizing, they are to be classified in the group A61K 6/40.

Chemical compositions for the treatment of the root canal:

Documents are to be classified in the group A61K 6/50 only if the type of dental root treatment is other than:

Cleaning, Disinfecting (A61K 6/52),

Filling, Sealing (A61K 6/54),

Apical treatment (A61K 6/56),

Dental root treatment in combination with dental implants (A61K 6/58).

Chemical compositions for dental treatment characterised by the presence of organic or organo-metallic additives.

According to their function, the additives are to be classified in the subgroups as:

initiators:

dyes (A61K 6/65):

medicaments or drugs (A61K 6/69)

Chemical compositions for dental treatment characterised by the presence of inorganic additives.

According to their function, the additives are to be classified in the subgroups as:

Chemical compositions for artificial teeth, for filling or for capping teeth with respect to e.g. crowns, inlays, onlays, and filling material based on polymeric, metallic, ceramic, cement and composite materials.

Documents are to be classified in the group A61K 6/80 only if no more appropriate class can be found according to the material used:

Specific resins are to be classified in the appropriate class (A61K 6/887 or A61K 6/891, see below) in combination with a C08L class for specifying the kind of polymer; only if the resin used is very general, documents are to be classified in the main group A61K 6/884.

Chemical compositions for taking dental impressions.

The specific chemical compositions for taking dental impressions are to be classified in combination with the appropriate C08L subclass for specifying the kind of polymer, e.g. containing alginates are classified in Combination set (A61K 6/90, C08L 5/04); for general polymer compositions, documents are to be classified in the main group A61K 6/90.

Compositions for making-up the skin e.g. lipsticks, rouge, mascara, foundation or preparations for removing make-up, manicure and pedicure preparations e.g. nail polish and nail coating remover, hair care preparations e.g. Shampoo, preparations for permanent waving or straightening, bleaching, dying or conditioning the hair, preparations for affecting hair growth e.g. treatment of hair loss or for slowing hair grow, Preparations for removing hair e.g. shaving and depilatory preparations, oral care preparations e.g. dentifrices, formulations for perfume preparations, Anti-perspirants or body deodorant, barrier preparations e.g. insect repellents or sunscreens, preparations for care of the skin e.g. whitening, tanning, slimming, anti-aging or cleansing preparations.

Processes of preparing and using the cosmetic or similar toilet preparations.

Use of cosmetics or similar toilet preparations should be further classified in subclass A61Q.

Soap bars (i.e. solid cleansing compositions) are classified in C11D, even though general cleansing compositions which are usually liquid are classified in A61Q and in A61K 8/00.

Compositions which can be used in a therapeutic treatment should be classified in A61K 31/00 - A61K 51/00 and subgroups if they are defined by their ingredients or in A61K 9/00 and subgroups, if they are defined by their physical form.

Ingested compositions like food or dietary supplements having an external cosmetic effect are further classified in A23L. Examples might be dietary supplements to strengthen nails or to act against skin aging, or drops or sweets affecting the oral cavity

In each of groups A61K 8/02 and A61K 8/18, in the absence of an indication of the contrary, classification is made in the last appropriate place.

Each relevant compound (i.e. which belong to the core of the invention (see* in Glossary of terms)) is classified according to the last place rule in one of A61K 8/19 - A61K 8/99.

Only relevant compounds or pertinent physical form, i.e. compounds in the composition or specific form (example: emulsion, foam) linked to the effect aimed, i.e. "core of the invention" (see * in Glossary of terms). To classify a patent document, the claims, the description and the examples have to be checked to assess the core of the invention (see* in Glossary of terms).

-> example I

Only specific compounds, i.e. those present in the exemplified compositions, are classified, not a general concept or a general formula.

-> example II

Attention is drawn to the Notes in class C07, for example the Notes following the title of subclass C07D, setting forth the rules for classifying organic compounds in that class, which rules are also applicable, if not otherwise indicated, to the classification of organic compounds in group A61K 8/00.

Salts or complexes of organic compounds are classified according to the base compounds. If a complex is formed between two or more compounds, classification is made in both places.

Further "properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects" are further classified in A61K 2800/00 and subgroups.

Class combinations

This group is always combined with the subclass A61Q (i.e. principal uses (see** in Glossary of terms)) and can be further classified in A61K 2800/00 and/or A61Q.

The Indexing Codes of this scheme are to be used mainly with classification A61K 8/00 and A61Q and is considered to be obligatory supplementary classification of subject matter already classified in A61K 8/00 and A61Q if applicable.

A61Q is considered as additional information (see** in Glossary of terms), i.e. obligatory supplementary classification of subject matter already classified in A61K 8/00 and A61Q if applicable. This subclass concerns cosmetic uses that are indicated as eventual application(s) for the composition.

->Example III

Reference is further made to annotations in subclasses where it has been considered relevant and helpful.

Example I: "classify only relevant compounds"

A sunscreen composition stabilised with a specific compound will be classified as follow: A61Q 17/04 and under A61K 8/00 for the compound; no class is attributed for the sunscreen agent used in the example, i.e. redundant information. In case where the technical problem of the patent document is linked to a specific compound, the compound is classified!

The same can be observed for compositions containing hair oxidative or direct dyes or skin tanning agent and dealing with an other technical problem, i.e. viscosity, cosmetic properties where the type of cosmetic agent is not pertinent.

Example II: "General formula /specific compound"

A patent document claims the use of an amino acid (group title of A61K 8/44) but the single compound used in the examples is Histidine (i.e. A61K 8/4946) or Cysteine (A61K 8/447). Classes are made only for the concrete compounds explicitly disclosed or present in exemplified compositions in the patent document.

The same is applicable for ingredients described by a general formula (i.e. "Markush formula"), only the concrete compounds are classified, not the common chemical concept.

Example III: principal or additional use(s)

A skin moisturising composition which is further used in a anti-ageing preparation or as lip cream, would be classified in A61Q 19/00, A61Q 19/08 and A61Q 19/001.

If the active is a new sunscreen and an anti-ageing preparation which contains this new compound is exemplified, it should be classified in A61Q 17/04 and A61Q 19/08.

If the active is a compound to condition the hair and a shampoo or a colouring composition (non-permanent hair dyeing containing direct dyes) is exemplified, it should be classified in A61Q 5/12, A61Q 5/02 and A61Q 5/065

Films; injections; cotton-swab applicators (Q-tip); paracrystaline or

multiphases; Oral administration

Compositions characterized by special physical form should be classified in group A61K 8/02 together with the appropriate Indexing Code under A61K 2800/00.

Towelettes; impregnated napkins; impregnated sponges; impregnated

non-woven fabrics.

Packs

Rod-like micelles; globular micelles.

On a phase diagram, a multiple emulsion (classified in A61K 8/066), liquid crystals (classified in A61K 8/0295) and micelles can coexist.

Lyotropic phases; mesophases; mesomorphic phases; lamellar, cubic

(isotropic) or hexagonal phases; nematic, smectic or cholesteric phases;

bilayer lamellar gel network (WO0119343).

Dispersions of a macromolecular compound in colloidal form in a liquid dispersing phase.

Wax microdispersions.

Foamable compositions; self foaming (CO₂ releasing) compositions;

sprays; post-foaming compositions.

Effervescent compositions should be classified in subclass A61K 8/046 together with the appropriate Indexing Code under A61K 2800/00.

Direct emulsions (O/W); inverse emulsions (W/O); Pickering emulsions.

Transparent emulsions; o/w nanogel (US2003012759).

Encapsulated compositions having a particle size bigger than 100

micrometers.

Nanosomes; nanovesicles.

Nanosomes and nanovesicles should be classified in subclass A61K 8/14 together with the appropriate Indexing Code under A61K 2800/00.

Complexes e.g. zinc hyaluronic acid, should be classified in the subclass A61K 8/19 and subgroups according to the inorganic part together with the appropriate classification according to the organic part in A61K 8/30 and subgroups.

Perborates; persalts; H 2O 2.

Persulphates; thiosulphates.

Tripolyphosphates; Fluorophosphates (NaMFP).

Glass beads; sand; talc (Mg silicate); Chrysotile (Mg silicate).

Clays in general (aluminosilicates): Bentonite, hectorite, montmorillonite, kaolin; mica; zeolites.

Quaternary ammonium clays should be classified in subclass A61K 8/26 together with subclass A61K 8/416.

Zinc oxides; Zinc peroxides.

Aluminium-zirconium compounds.

Titanium oxides.

Paraffins, e.g. Permethyl 99A (isododecane) or Isopar E (mixture of C 8-C 9 aliphatic hydrocarbons); Squalane; Patrolatum (Vaseline); Carotenes, e.g. lycopene.

Aldehydes; Ethers.

Salts and anhydrides thereof; Dicarboxylic acids.

Salts and anhydrides thereof; Gluconic acids.

Salts and anhydrides thereof.

Carbonic acid ester, e.g. dialkyl carbonates.

Polyglycerins containing from 2 to 10 repeating units in the same chain.

Imine R=N-H; Oximes R-CH=N-OH; Hydrazones R-CH=N-NH 2; Azines

R-CH=N-N=C; Nitriles R-CN; Isocyanates R-N=C=O; Cyanates R-O-CN;

Amine oxides; Quinoneimines; Azo compounds; imides RR'C=NH.

Alkanolamines; Cyanamides NC=NH 2; Sphingosines.

Urea (H 2N-C(=O)-NH 2 ) is also included in this group

Betaines; Carbamates.

Amidobetaines; Cocoamphoacetates; Aspargine; Glutamine.

Thiocyanates R-S-CN; Sulfamic acids N-SO 3H.

Sulfonamides; Sulfosuccinates; Sultaines, e.g. Cocoamidopropylhydroxysultaine; Taurine; Isethionates.

Thiazole, pyrrole-oxazole, morpholine; Heterocyclic compounds containing having at least two different hetero atoms in the same or

different hetero ring, condensed or not and/or in the same or different ring system.

Heterocyclic compounds containing one or several hetero rings, condensed or not, in the same or different ring system, each hetero ring

having only one nitrogen as the only hetero atom.

Pyrrole; Pyrrolidine; Proline; Heterocyclic compounds containing one or several not condensed hetero rings, in the same or different ring system, each hetero ring having only one nitrogen as the only hetero atom and having five membered hetero rings.

Phthalimides; Pyrrocoline; Isatin; Trytophan; Heterocyclic compounds containing one or several condensed hetero rings, in the same or different ring system, each hetero ring having only one nitrogen as the only hetero atom and having five membered hetero rings.

Piperidine; Pyridine; Acridine; Quinoline; Heterocyclic compounds containing one or several condensed or not hetero rings, in the same or different ring system, each hetero ring having only one nitrogen as the only hetero atom and having six-membered hetero rings.

Heterocyclic compounds containing one or several hetero rings, condensed or not, in the same or different rings systems, each hetero ring having only one nitrogen as the only hetero atom and having sulphur as an exocyclic substituent of the hetero ring.

Pyrazole; Piperazine; Pyridazine; Pyrazine; Heterocyclic compounds containing one or several hetero rings, condensed or not, in the same or different rings systems, and at least one hetero ring having more than one nitrogen as the only hetero atom.

Allantoin (imidazolidinyl urea derivative); Histidine.

Condensed derivatives of the pyrimidine ring; Purines; Orotic acid;

Adenine; Guanine.

Oxetane; sorbitan esters; Heterocyclic compounds containing one or several hetero rings, condensed or not, in the same or different rings systems, each hetero ring having oxygen as the only hetero atom.

Genistein; Heterocyclic compounds containing one or several hetero rings, condensed or not, in the same or different rings systems, each hetero ring having oxygen as the only hetero atom and having six membered hetero rings.

Thiophene; Lipoic acid; Compounds containing one or several hetero rings, condensed or not, in the same or different rings systems, each hetero ring having sulphur as the only hetero atom.

Condensed derivatives; Polysorbates.

Organometallic compounds.

Silanes; Silisesquioxanes; Cyclomethicones, e.g. Hexamethylcyclotrisiloxane, Octamethylcyclotetrasiloxane, Decamethylcyclopentasiloxane; Linear volatile siloxanes; Chlorophyll.

Oligosaccharides up to 5 monomeric units; Aminosugars, e.g. glucosamine; Uronic acids, e.g. glucuronic acid; Erythrulose.

Glucosides; Galactosides.

Alkylmonoglycosides, oligoglycosides and -polyglycosides.

Cytochromes; glycoproteines; antibodies.

Cyclosporins should be classified according to their structures.

Folic acid.

Derivatives of ascorbic acid.

Derivatives of tocopherol.

Synthetized pseudoceramide derivatives which are characterized by structures having both amide or nitrogen bonds and hydroxyl groups as hydrophilic units, as well as two long chains; Alkanolamides from sphingosine and a fatty acid; Glycoceramides.

Organic fluorides and Chlorofluorocarbons (Freons).

Natural rubber; Latex; Melanins; Dendrimers; Supra-molecular polymers.

Polymers of 6 or more saccharide units, e.g. dextran.

(Malto) dextrin.

Locust bean gum; Tara; Ceratonia siliqua.

Unless otherwise specified in this classification, these group and its subgroups cover the polymers as defined in C08L 23/00 - C08L 49/00.

Polydecene.

Sodium polystyrene sulfonate; Polymers obtained from divinylbenzene.

Polymers obtained from polyacrylamidomethylpropane sulphonic acid

(AMPS).

This class is given only if the nitrogen atom or the nitrogen containing heterocycle ring is directly linked to the polymer forming double bond.

Polyvinylsulfonates; Polythiophenes.

This class is given only if the sulphur atom or the sulphur containing heterocycle ring is directly linked to the polymer forming double bond.

Polymers obtained from monomers having conjugated double bonds, e.g. butadiene, isoprene and chloroprene.

Unless otherwise specified in this classification, these group and its subgroups cover the polymers as defined in C08L 59/00 - C08L 87/00;

Polyureas; Polyurilene resin.

Alkoxylated derivatives containing 11 or more oxyalkylene groups in the same chain.

Polyaminoacids formed from one up to three repeating aminoacid units; Polyimides; Polyaminoamides.

Polysiloxanes derivatives containing from 2 to 10 alkoxy or aryloxy groups; Dimethicone PEG-8 benzoate.

Polysiloxanes derivatives containing 11 or more oxyalkylene groups.

Crosspolymers obtained from vinyl dimethicone.

Mixtures of several compounds of different nature and being oils, fats or waxes.

Essential oils.

Mud; Sea water; mineral water.

Humus; Tar; Charcoal; Saponins; Tannins with no specific chemical structure.

No document should be classified in this subgroup. Every document concerning material or animal origin should be classified in A61K 8/981 and subgroups or in A61K 8/987 and subgroups.

Material from fish or insects; Silk; Natural sponges; Pearls from oysters;

Mother-of-pearl (nacre).

Cell cultures; Yeasts; Plankton; Lower fungi; Bacteria; Krill; Lichens;

Undifferentiated plant seed cells.

Fermentated products should be classified according to their origin together with an Indexing Code, e.g. A61K 2800/85.

Pharmaceutical compositions which are characterised by the following galenical aspects:

In addition, the following is also classified:

In A61K "Galenic" form" relates to pharmaceutical (drug delivery) compositions in general. "Galenical" aspects relate to aspects of pharmaceutical technology of pharmaceutical compositions. (i.e. aspects of pharmaceutical compositions other than the active ingredient per se, e.g. physical form, excipients, dosage etc.

It is sufficient to say pill, capsule, particle etc. for classification. The pill or the like does not require further elaboration to warrant classification in A61K 9/00. Any concrete, well-defined pharmaceutical composition disclosed in the examples is considered to be characterized by a physical form. Also classified are independent claims defining galenical aspects of a pharmaceutical composition or a medical use. For example the following forms are considered to be characterized by a physical form:- a suppository, ointment, solution, dispersion, emulsion, aerosol, foam, liposome, powder, granulate, micro/nanosphere, pill, tablet, capsule, micro/nanocapsule, web, sheet, filament, etc. This list is not exhaustive. A borderline case is an animal test where the galenical aspect of the composition is not further defined (e.g. intravenous injection, per os administration), unless it is absolutely clear that the test represents the intended mode of administration.

Galenical aspects of pharmaceutical compositions are usually classified by giving a combination of classes in A61K 9/00 and A61K 47/00. The last place rule does not apply between A61K 9/00 and A61K 47/00 - A61K 47/46. Excipients can be classified in A61K 47/00 or in A61K 9/00, depending on the situation: A61K 47/00 is used to classify excipients in compositions for which A61K 9/00 does not provide information on excipients. No A61K 47/00 is given if A61K 9/00 already provides information on excipients (e.g. tablet excipients are only classified in A61K 9/20...). New excipients per se are (in addition) classified in A61K 47/00.

Conjugates, i.e. compounds comprising a non-active ingredient bound to the active ingredient, are classified in A61K 47/50. Pharmaceutical compositions comprising conjugates may in addition be classified in A61K 9/00.

The active ingredients in pharmaceutical compositions are classified in A61K 31/00 - A61K 45/00, or A61K 48/00 - A61K 51/00.

Bandages for treatment of wounds are classified in A61L. These bandages may comprise active agents, e.g. anti-inflammatory, antibacterial agents to enhance the action of the bandage. Compositions comprising an active agent for wound healing which are neither bandages, nor form bandages (e.g. spray-on bandages) are classified in A61K 9/00. These compositions, e.g. lotions, are classified according to the site of application, A61K 9/0014 and, where relevant, according to the form e.g. A61K 9/06, A61K 9/08 and/or excipients used (A61K 47/00). Bandages for wound treatment should not be confused with transdermal patches, the main function of which is (usually systemic) drug delivery rather than the treatment of wounds. Transdermal patches are classified in A61K 9/7023 and subgroups. Bandages also should not be confused with medicated film (forming) compositions that are not for wound healing; these are classified in A61K 9/7007 (and A61K 9/7015)

Classified are concrete, well-defined pharmaceutical compositions disclosed in the examples. Also classified are independent claims defining galenical aspects of a pharmaceutical composition or a medical use.

All relevant galenical aspects must be classified.

The one dot groups of A61K 9/00 do not follow the last place rule

In principle all examples are classified, also 'standard' examples in documents describing e.g. a new medical use.

However, systematically classifying all excipients in the examples is not necessary, and often undesirable. In any case classified are excipients which are described as being important for the invention, or which the reader can identify as having an important function, e.g. for sustained release. For 'standard' compositions the examiner should choose one or a few excipients to classify. (Note: A 'standard' example is an example that is simple and does not appear to be part of the invention. For instance in a document relating to the new medical use of a (new) chemical compound, often some compositions are given which are 'standard' (if not hypothetical): a tablet with e.g. lactose, microcrystalline cellulose and magnesium stearate, an injection solution with NaCl, etc.

In any case such examples should be classified, whether considered 'standard' or not. In how far all excipients in such compositions are classified is left to the classifier's discretion).

When there are too many examples, they can sometimes be covered by a more general class. However, head groups should not be used for this.

( A "head" group does not have the same meaning as a main group. With "head group" is meant a group which is further subdivided in such a way that classification can always be made in one of the lower groups. For instance A61K 9/2004 is a head group, A61K 9/0012 is a head group, as well as A61K 9/0002. In principle such head groups should be empty.

A61K 9/0002 is the head group for the drug release techniques (see Definition statement). Only its subgroups are used for classification, when relevant. A61K 9/0002 is empty; there is no general sustained release group.

Animal tests to study pharmacokinetic properties of a drug are not classified, unless it is absolutely clear that they represent the intended mode of administration. (Note: What is meant here, are pharmacokinetic tests in animals, e.g. by injection or gavage. Such tests usually say nothing about the final intended dosage forms, but are necessary e.g. for regulatory purposes. The value of their pharmaceutical/galenical information is therefore very low. Exceptions are perhaps inhalation tests in animals, as these are normally only done with drugs intended to be inhaled).

Processes for preparing a composition, even when claimed, are only classified if they appear of interest.

The description and dependent claims are not classified. However, if the document as a whole focuses on one clearly preferred embodiment, this embodiment may be classified, even in the absence of relevant examples or independent claims. The intention here is primarily to avoid that all lists in the dependent claims are fully classified (e.g. all tablet excipients for sustained release, while only one is used in the examples).

If a specific subcombination is claimed, such a subcombination will usually be reflected in the examples, which should in any case be classified. And if this subcombination is not reflected in examples, but clearly forms the invention (following e.g. the description), then it also should be classified. In all other cases, the specific subcombination is probably not inventive, so no need to classify.

In general, information relating to the invention is classified using invention information symbols, while additional information is classified using additional information symbols. This is largely up to the discretion of the examiner. Please note however the following special situations:

Medicinal formulations or compositions per se containing organic therapeutically active ingredients.

Organic active compounds for use in any first or further medical application.

Use of an organic active ingredient for the manufacture of a medicament for the treatment of a pathological condition.

When a compound is only and exclusively defined in the description and claims by means of a functional definition, and no specific examples at all are provided, and it is unclear whether the functionally defined compound would be a compound according to any of A61K 31/00, A61K 33/00, A61K 35/00, A61K 36/00, A61K 38/00 or A61K 39/00, the main group A61K 45/00 is to be assigned.

For mixtures containing one or more active ingredients without chemical characterisation (i.e. only expressed in term of a functional feature, e.g. antihistamines, PDE4 inhibitors, neuroprotectors, serotonin receptor agonists, etc.), the symbol A61K 45/06 is also to be given in addition to the A61K 31/00 subgroup corresponding to the well defined component(s) of the mixture.

In the case of peptidic enzyme inhibitors wherein the chemical structure is well defined and can be classified under an A61K 31/00 subgroup (e.g. apicidin), that A61K 31/00 subgroup is assigned in addition to the appropriate A61K 38/00 symbol. This applies in the rare cases where a compound could be classified in both groups and thus could be retrieved either via the A61K 31/00 classification scheme or the A61K 38/00 classification scheme, bearing in mind that no information should be lost during the classification process.

Cosmetic preparations which can be used for cosmetic as well as therapeutic indications are classified in both A61K 8/00 and A61K 31/00.

Compositions with a therapeutic application in the form of food, beverages or dietary supplements are further classified in A23L.

Organic active compounds containing non-radioactive isotopes, e.g. deuterium, N15 or C13, are to be classified in A61K 31/00 and not in A61K 51/00.

Contrary to IPC , no A61K 31/00 symbol is given for novel compounds, i.e. compounds claimed per se (including polymorphs and highly pure compounds) falling under subclasses C07C - C07J, even when the set of claims further contains claims relating to their medical use. For those compounds, classification is only made in the relevant subclasses C07C - C07J according to the structure. This exception does not apply to novel compounds falling outside C07C - C07J. Thus, novel polymers also claimed for their therapeutic use will be classified under C08 as well as the corresponding symbol under A61K 31/00.

However, when the invention also discloses medicinal preparations containing said novel compounds, falling under C07C - C07J, in admixture with one or more active organic ingredients, then said novel compounds are also classified in the appropriate A61K 31/00 subgroup followed by symbol A61K 2300/00 to create the corresponding Combination-set, e.g. (A61K 31/60, A61K 2300/00), in addition to the C07 classification.

When a document discloses materials or extracts from algae, lichens, fungi or plants as well as the active component which has been isolated from said material or extract, and said active component has a well defined chemical structure falling under A61K 31/00, a class under A61K 36/00 together with the appropriate A61K 31/00 class is given. This applies unless the isolated active compound is a novel compound falling under C07C - C07J.

General rules

What is classified?

How are compounds classified?

When a compound is only and exclusively defined in the application by means of functional definitions, and no specific examples at all are provided, the main group A61K 31/00 will be assigned provided it is clear that the intended compound is an organic compound falling under A61K 31/00. However, should the application refer to said functionally defined compounds as being e.g. inorganic compounds, peptides, proteins, antigens or antibodies, then A61K 31/00 is not to be assigned.

Combinations or mixtures of pharmaceutically active compounds are classified in the appropriate A61K 31/00 subgroup followed by A61K 2300/00 in the corresponding Combination-set for each active ingredient. This also applies to mixtures comprising novel compounds receiving C07 classification. However, the combination of an organic therapeutically active compound with a specified excipient (e.g. crospovidone and mannitol) is not to be considered as a mixture of two therapeutically active ingredients and therefore no Combination-set is to be created. In this case, the assignment of the appropriate symbol in A61K 47/00 for the excipient(s) may be required.

Salts or complexes of organic active compounds are classified according to the corresponding free compounds. However, salts or complexes formed between two or more organic active compounds are classified according to all compounds forming the salts or complexes followed by with A61K 2300/00 to create the corresponding Combination-set (i.e. as a mixture of active organic compounds).

According to the last place rule, salts formed between an organic active compound and heavy metals should be classified in A61K 33/24 - A61K 33/38 and not in subgroups A61K 31/28 - A61K 31/32, A61K 31/555 or A61K 31/714. This does not apply to complexes with heavy metals, as apparent from the A61K 31/00 scheme, wherein the complexes hemin and hematin are classified in A61K 31/555 and cyanocobalamin in A61K 31/714.

If a subgroup title is the name of a specific compound or a group of specific compounds (e.g. A61K 31/203 "Retinoic acid", A61K 31/375 "Ascorbic acid", A61K 31/4415 "Pyridoxine") only exactly the compounds named are classified in this group (not derivatives thereof). For instance A61K 31/203 covers retinoic acid, but not derivatives thereof. However, salts of retinoic acid or ascorbic acid still fall under the respective subgroup for the acid.

On the other hand, when a compound is mentioned in the group title only as an example ("e.g."), such as in A61K 31/5375 "1,4-oxazines, e.g. morpholine", the scope is not limited to this example.

A fusion heteroatom, i.e. a heteroatom which is shared by two (or more) rings in a fused ring system is to be counted for all adjacent rings. Example: indolizine is correctly classified in A61K 31/437.

Unless otherwise specified (e.g. when distinguishing between non-condensed pyridines in A61K 31/44 and non-condensed piperidines in A61K 31/445), a class definition using a ring name encompasses all hydrogenated, (partially) dehydrogenated, oxidized (i.e. carrying a keto-group) and/or substituted derivatives. Examples: A61K 31/404 "Indoles" also covers fully hydrogenated derivatives, e.g. trandalopril

A61K 31/4709 "Non condensed quinolines and containing further heterocyclic rings" covers e.g. clinafloxacin

Unless explicitly defined otherwise, all chemical terms have their universally accepted meaning as understood by a chemist, e.g. as defined in the IUPAC Gold Book.

Further details of the subgroups

A61K 31/137

The term "Arylalkylamines" in A61K 31/137:

are to be classified in A61K 31/137.

However, if the keto-substitution is adjacent to the amino-group to give an amide, e.g. as in guanfacine

,

then the amido group would take precedence, thus the compound is not to be classified in A61K 31/137 nor in A61K 31/155 (guanidine), but in A61K 31/165 according to the last place rule.

for example ketamine and tranylcypromine

are to be classified in A61K 31/135 not in A61K 31/137.

is to be classified in A61K 31/135 not in A61K 31/137.

does not encompass N-aryl,N-alkylamine; for example aprindine

is to be classified in A61K 31/136 not in A61K 31/137.

A61K 31/198

This subgroup also encompasses amino acid derivatives such as e.g. carbidopa, which is seen as an N-amino-substituted amino acid.

A61K 31/33

Heterocyclic compounds having e.g. "sulfur as a ring heteroatom" and "having five-membered rings" (A61K 31/381), means that the sulfur containing ring must be a five-membered one. For example zileuton, which contains a carbocyclic six-membered ring, is to be classified in A61K 31/381 and not in A61K 31/382.

The same applies to all subclasses relating to heterocyclic compounds.

A61K 31/48

Ergoline derivatives include a class of compounds characterized by the ring system

As explicitly mentioned in the scheme, the subclass for the ergoline ring system A61K 31/48 takes precedence over A61K 31/495 "six membered rings with two nitrogen atoms as the only ring heteroatoms" and corresponding subclasses. For example bromocriptine is to be classified in A61K 31/48 and not in A61K 31/495.

A61K 31/485

Morphinan derivatives include a class of compounds characterized by the ring system below (with or without an oxygen bridge)

e.g. butorphanol

;

; dihydrocodeine

A61K 31/49

Chinconane derivatives are characterized by the ring system

A61K 31/495

This subgroup also covers compounds having six-membered rings with four nitrogens as the only ring heteroatoms, i.e. tetrazine and tetrazine-containing compounds. For example temozolomide is to be classified in this subgroup.

A61K 31/515

Barbituric acid derivatives share the structure below

Therefore, primidone is not to be considered a barbituric acid derivative since it is missing a carbonyl group (primidone is to be correctly classified in A61K 31/513).

Moreover, the presence of the core structure of barbituric acid may not be sufficient per se in order to identify a compound as a barbituric acid derivative. In this subgroup, the classifier will not only take into account the extent of modification but also whether the compound shares the same pharmacological effect of barbituric acid, i.e. any of sedative, anaesthetic, anxolytic, hypnotic and anticonvulsant effect.

A61K 31/555

In addition to the examples explicitly referred to in the scheme, other examples e.g. carboplatin, oxaliplatin and sodium stibogluconate are also to be classified here (not in A61K 33/00 nor in A61K 31/282 or A61K 31/29), since they are heterocyclic active compounds forming a complex with a heavy metal.

A61K 31/56 - A61K 31/585

The compounds in these subgroups have the following skeleton

and are further subdivided according to the structure of

estranes

gonanes

androstanes

pregnanes

cholanes

as well as according to the presence or absence of substitutions in position 10, 13, 17 and/or 21.

In subgroups A61K 31/58 and A61K 31/585, the additional ring can be isolated or condensed to the cyclopentanoperhydrophenantrene ring system.

A61K 31/59 - A61K 31/593

The compounds in these subgroups have the following skeleton

the difference between 9,10-secoergostane derivatives and 9,10-secocholestane derivatives being a double bond in the side chain.

ergocalciferol

cholecalciferol

A61K 31/60 - A61K 31/625

These subgroups cover salicylic acid and derivatives thereof.

The presence of the core structure of the 2-hydroxybenzoic acid, i.e.

may not be sufficient per se in order to identify a compound as a salicylic acid derivative. In this subgroup, the classifier will not only take into account the extent of modification but also whether the compound shares the same pharmacological effect of salicylic acid, i.e. any of analgesic, antipyretic and antiinflammatory effect. Derivatives with a substitution on the benzene ring are also included in this group (e.g. diflunisal).

For instance, certain compounds are not to be considered salicylic acid derivative due to the extent of the modification and because they do not possess the pharmacological profile of salicylates, e.g. for example the compounds labetalol (A61K 31/166), cisapride (A61K 31/4468), flecainide (A61K 31/4458), metoclopramide (A61K 31/166) and remoxipride (A61K 31/40).

A61K 31/65

The compounds in this subgroup share the core structure of tetracycline

A61K 31/7105

This subgroup also includes non-modified miRNA and snRNA; shRNA and ribozymes.

A61K 31/713

This subgroup also includes siRNA, pRNA, sd-rxRNA, recombinant nucleic acids, as well as modified miRNA and snRNA.

Antisense nucleotides and non-coding nucleic acids are classified in C12N 15/00.

Medicinal preparations containing inorganic active ingredients either alone or in a mixture with other active ingredients. Organic active compounds forming salts or complexes with heavy metals are also classified in A61K 33/00 according to the last place rule, unless explicit reference to the contrary is made in the A61K 31/00 scheme (see below)

In this group classification is according to the last place priority rule.

In this group no distinction is made between Invention and Additional information.

In other words all information, whether it be invention or additional, is classified in as far as it relates to material which the classifier considers likely to be of importance for future reference. Trivial or general state-of-the-art disclosure is not classified.

Therapeutic use: an A61K 33/00 classification symbol is given only if the inorganic ingredient has a physiological, pharmacological or biological effect.

Combinations/mixtures: Give a classification symbol followed by A61K 2300/00 for each active ingredient in the mixture. For each mixture containing at least one active ingredient without chemical characterisation (e.g. functional feature), A61K 45/06 is additionally to be given.

Medicinal preparations containing various tissues, cells, organisms, materials or reaction products thereof, also with undetermined constitution, as well as their first or further medical use.

An A61K 35/00 symbol is given only if the therapeutic effect is clearly attributed to the "active substance" of the medicinal preparation, and is an essential part of the disclosure.

The main group A61K 35/00 may overlap with many other subclasses or main groups relating to medicinal preparations, or preparations comprising the tissues, cells organisms or materials, where the effect is neither mainly nor only pharmaceutical. The most relevant areas are genetically modified cells, viral or cellular vaccines, and antibodies.

Gene therapy: A61K 48/00. Genetically modified cells: C12N 5/10.

Example of where an A61K 35/17 class is given in regard to lymphocytes: A method of enhancing normal healing in individuals comprising administering to a site in need thereof an effective amount of autologous B cells immediately before, at the time of or immediately after tissue injury.

Documents relating to viruses per se (without medical use) are classified in C12N 7/00; viral proteins per se C07K 14/005; use of virus as a vector C12N 15/86; use of virus or part thereof as vaccine A61K 39/12; therapeutic use of a viral protein A61K 38/16.

Preparations comprising a modified virus are classified in C12N 7/00; the ICO code A61K 35/13 is given if a therapeutic activity (not vaccine) is suggested. If a therapeutic activity (not vaccine) is disclosed for the modified virus, it is also classified in A61K 35/00.

The last place rule does not apply in A61K 35/00. Each component of a pharmaceutical composition (if an active ingredient and not a vaccine) that is falling under the definitions of A61K 35/00 is classified

A classification symbol is given for each active ingredient in the mixture followed by A61K 2300/00 to create the corresponding Combination-set.

For example, a composition comprising lactobacilli and propolis extract will be allocated the symbols A61K 35/74 and A61K 35/644, each followed by the symbol A61K 2300/00.

For each mixture containing at least one ingredient without chemical characterisation (e.g. functional feature), A61K 45/06 is to be given.

Indexing codes used in A61K 35/00:

For additional information purposes:

A61K 35/00 Medicinal preparations comprising living biological materials, e.g. virus, cells, tissue, organs

A61K 2035/11 Medicinal preparations comprising living procariotic cells

A61K 2035/115: Probiotics (used in cases of nutritional compositions with probiotics, where a medical use is not clearly shown but implied, or where the probiotic bacteria are not disclosed and a specific A61K 35/74 class cannot be assigned.

With respect to materials from mammals:

A61K 35/12 Medicinal preparations comprising living eukaryotic cells

A61K 2035/122..for inducing tolerance or suppression of immune responses

A61K 2035/124.. the cells being haematopoietic, bone marrow derived or blood cells

A61K 2035/126.. immunoprotecting barriers, e.g. jackets, diffusion chambers

A61K 2035/128… capsules, e.g. microcapsules

A61K 35/13 Medicinal preparations comprising living viruses

Medicinal preparations containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines, also of undetermined constitution.

A61K 36/00 is given only if a therapeutic effect is clearly attributed to the "active substance" of the medicinal preparation, and is an essential part of the disclosure. In particular:

Medicinal formulations or compositions per se containing therapeutically active material from algae, lichens, fungi or plants

Material from algae, lichens, fungi or plants for use in any first or further medical application

Use of a material from algae, lichens, fungi or plants for the manufacture of a medicament for the treatment of a pathological condition

Purified active components: if the active component has been isolated from material from algae, lichens, fungi or plants and the chemical structure is well-defined and can be classified under A61K 31/00, a class under A61K 36/00 together with the appropriate A61K 31/00 class is given.

Purified proteins, peptides or lectins: documents related to isolated plant peptides or proteins are classified in A61K 38/00. An additional A61K 36/00 class is given if the source of the purified compound can be clearly attributed to a specific material from algae, lichens, fungi or plants.

Claims to a new galenic formulation of a known material for use in therapy are classified in A61K 9/00. An additional A61K 36/00 class is given for the material only in case of a specific material from algae, lichens, fungi or plants. No A61K 36/00 class is given if only unspecific material (for example "plant extracts", "essential oil") is mentioned.

Cosmetic preparations containing material from algae, lichens, fungi or plants are classified in A61K 8/00. An additional A61K 36/00 class is given for the material only in case of a therapeutic effect.

Food containing material from algae, lichens, fungi or plants is classified in A23L 5/00. An additional A61K 36/00 class is given for the material only in case of a therapeutic effect (functional food).

Bacteria: If bacteria are claimed per se, they are classified in C12N 1/00, medicinal preparations with bacteria are classified in A61K 35/74.

Blue algae (Spirulina) are cyanobacteriae and classified in A61K 35/74.

Honey, beeswax, propolis: A61K 35/644

Genetically modified cells: Compositions comprising genetically modified cells are classified in A61K 48/00 (Gene therapy), or C12N 5/10 (Genetically modified cells).

Separation procedures as such, not relating to a medicinal preparation or a therapeutic use, are classified in B01D.

Each specific active component is classified according to its systematic name in A61K 36/00. The last place rule does not apply.

A class within this group is only given for the use of specific compounds, i.e. those present in the claims or exemplified in the description, and therapeutically active agents (which is not always the case, e.g. essential oils used as perfume or taste masking compounds).

Relevant subject-matter that is exemplified, but not claimed, should also be classified. Important aspects of the invention mentioned only in the description deserve a class as well.

Classification should be restricted to the relevant or essential part of the disclosure. For very long lists (10 and more) of material claimed for a therapeutic use, and if it appears from the dependent claims/description/examples that only few plants are preferred/well described, classification should be limited to the compounds tested, or the more significant compounds.

A general concept (e.g. "Compound X for use in treating disease Y, wherein X is a plant, an antibody or a chemical compound" with no specific compounds given) does not get any A61K 36/00 class.

The medicinal preparation can also be in the form of a product by process claim, reflecting a specific extraction process.

If the extraction process is claimed and considered relevant or an essential part of the disclosure, at least one additional Indexing Code in A61K 2236/00 is given.

Combinations/mixtures: a Combination-set is generated having after "," the symbol A61K 2300/00 for each active ingredient in the mixture, for example (A61K 31/60, A61K 2300/00)

For each mixture containing at least one ingredient without chemical characterisation (e.g. functional feature), A61K 45/06 is to be given.

For fermented preparations the Indexing Code A61K 2236/19 is to be added:

A medical preparation with red fermented rice will get A61K 36/899 (rice), A61K 36/062 (Monascus) and A61K 2236/19 (fermentation process)

Pollen (not further specified): A61K 36/00

Wood tar, sap or resin (not further specified): A61K 36/00

Peptides, proteins or their fragments (from dipeptides onwards), or the corresponding nucleic acids encoding these peptides/proteins, when claimed for use in the therapy of humans or animals, i.e. when claimed as therapeutically active components.

In particular:

Medicinal formulations or compositions per se containing therapeutically active peptides or proteins.

Peptides or proteins for use in any first or further medical applications.

Use of a peptide or protein for the manufacture of a medicament for the treatment of a pathological condition.

Proteins or peptides claimed per se, are classified under the proper C07K subgroup; within the same document, further claims to their use in therapy are given the additional information symbol A61K 38/00. An invention information classification should be given in A61K 38/00+ only for documents claiming the further medical use of proteins or peptides without claiming the proteins or peptides per se (Note: The A61K 38/00 scheme is mostly (with exceptions) aligned with the C07K 2/00 - C07K 14/00 schemes, however with less subdivisions. Hence to find the appropriate A61K 38/00 classification subgroup to be given to a protein used in therapy, the procedure consists of checking the place of said protein in the C07K scheme and apply the corresponding place, if correct and justified, in the A61K 38/00 scheme, for the sake of consistency between schemes).

The use of proteins or peptides of known source in therapy, or therapeutic compositions, is classified as additional information in the A61K 35/00 or A61K 36/00 subgroups if the source is considered an important aspect of the invention, as well as in the appropriate A61K 38/00 subgroup for known sequences or A61K 38/02 for unknown sequence. If the source is not known, only a classification in A61K 38/00+ is needed.

When a protein or peptide mixture for use in therapy contains at least one active ingredient without chemical characterisation (e.g. functional feature such as antiphlogistics, anti-cancer agent), invention information classifications should be given in A61K 38/00+ and A61K 45/06.

When a compound is only and exclusively defined in the description and claims by means of a functional definition, no specific examples are provided, and it is unclear whether the functionally defined compound is a compound according to any of A61K 31/00, A61K 33/00, A61K 35/00, A61K 36/00, A61K 38/00 or A61K 39/00, then invention information classification in A61K 45/00 is assigned. For example a general concept (e.g. "Compound X for use in treating disease Y, wherein X is a protein, an antibody or a chemical compound" with no specific compounds given, i.e. the document does not give a single, concrete example of peptidic or proteic compounds) is not classified under A61K 38/00 but under A61K 45/00.

Preparations comprising enzymes are classified under A61K 38/43 - A61K 38/54, followed by a C12Y invention information symbol for the specified enzyme(s). For example, a preparation comprising alpha-galactosidase is classified under A61K 38/47 (i.e. Hydrolases acting on glycosyl compounds) and C12Y 302/01022 (i.e. alpha-galactosidase EC 3.2.1.22).

Claims to "enzyme inhibitors" for use in therapy, without any specific example or without an identified peptidic structure, i.e. "reach-through" claims, are not covered by A61K 38/00 but are classified in C12Q 1/00 or G01N 33/00 as appropriate. At first glance this may appear somewhat of an anomaly however claims of this type are usually a result of a screening process e.g. A compound identified by the method of claim 1 for treatment of disease X. Claim 1 would typically be something like A method for identifying an inhibitor for cholesterol esterase comprising ...etc. As the method for identification of such a compound would be classified in C12Q and no provision is made in A61K 38/00 for classification of compounds without an identified peptidic structure, classification in C12Q alone is deemed sufficient. The same applies to documents classified in G01N for screening purposes. (Note: A "reach-through" claim is defined as a claim attempting to obtain protection for a chemical products' uses, compositions thereof, etc. by defining that product by its functionality in terms of its action e.g. an agonist, antagonist, inhibitor of a biological target such as an enzyme or receptor).

Stabilisation of a specific active protein or peptide with an inert additive (i.e. inactive carrier, targeting agent, potentiator, adjuvant) for use in therapy is classified under the appropriate A61K 38/00 symbol for the therapeutically active protein or peptide and under A61K 47/00. For example, a therapeutic composition comprising growth hormone together with albumin or collagen, the latter being present in the composition for its function as stabiliser of the hormone, will be classified under A61K 38/27 (growth hormone) as well as A61K 47/42 (albumin, collagen) but not under A61K 38/38 (albumin used as therapeutically active agent) nor A61K 38/39 (collagen used as therapeutically active agent).

Proteins or peptides for use in therapy, characterised by the special physical form (i.e. new galenic formulation of a known protein or peptide for use in therapy) may require classification under A61K 9/00. An A61K 38/00 classification is given for the protein or peptide only in case of a specified protein or family of proteins. No A61K 38/00 classification is given as invention information to an exhaustive list of unrelated and unspecific proteins. Instead A61K 38/00 is given as additional information.

For gene therapy, an appropriate A61K 38/00 classification is given for the protein or peptide used in the gene therapy method, together with an A61K 48/00 symbol. The same applies for the use of a nucleic acid encoding a specific protein, or of cells modified to produce a specific protein, for use in gene therapy: an invention information is given both in A61K 38/00+ and A61K 48/00+.

For vaccines comprising peptides or fragments thereof, if the therapeutic effect is clearly and exclusively a vaccine effect, no A61K 38/00 classification is given. The vaccine is classified in A61K 39/00 or one of its subgroups as appropriate.

Each specific active component in a medical use claim is classified according to the last place rule.

Classification within this group is only given for the use of peptides or proteins (i.e. those present in the claims or exemplified in the description) as active agents.

The sole symbol for additional information classification is A61K 38/00, without subdivisions. An invention information classification with the head symbol A61K 38/00 should be avoided.

A fragment of a protein in a medical claim is classified with its parent, if known. If the protein from which the fragment derives is not identified in the document to be classified, the fragment will be classified according to its length. Protein fragments less than 5 amino acids long are additionally classified under A61K 38/043 - A61K 38/07.

A nucleic acid encoding a protein in a medical use claim is classified under the protein it encodes.

In principle all specific compounds mentioned in the claims are classified. However, when there are too many compounds, as in the case of lengthy, exhaustive lists of proteins or peptides claimed for a therapeutic use, classification should be limited to a reasonable number of assignments covering e.g. the compounds tested or exemplified. Any generalisation which would lead to the next hierarchically higher level should be avoided. The therapeutic use of undefined proteins or peptides (no peptidic structure described) is not classified under A61K 38/02 which is for the medical use of compounds of peptidic or proteic nature but of undefined length, e.g. polymers of repeated motifs of aminoacids of undefined length, but nevertheless disclosed in the document.

Enzyme inhibitors in a medical use claim are classified within the A61K 38/005 (enzyme inhibitors) or A61K 38/55 (protease inhibitors) groups only if they are of peptidic structure. A61K 38/005 or A61K 38/55 should be assigned with another, more informative classification symbol: if the inhibitor is directly derived from the enzyme sequence itself, like for example an inhibitory enzyme fragment, it is also classified under the enzyme from which it is derived (A61K 38/43 - A61K 38/54); if the inhibitor is not disclosed in the document as being derived from a known enzyme, for example the inhibitor is synthetically produced and is clearly constituted of a sequence of amino acids (defined or not), it is classified under its length. The concept "enzyme inhibitors" without any specific example or given peptidic structure does not require classification within this group.

For mixtures or combinations: a classification symbol is given for each active ingredient in a medical use claim, followed by A61K 2300/00 (Additional Information Symbol for mixtures) to create the corresponding Combination-set. This applies also if one mixture component is claimed per se.

Fusion peptides in a medical use claim are classified under A61K 38/00 with the symbols of their components.

Important aspects of the invention mentioned only in the description should also be classified.

The use of antigens or antibodies in medicinal preparations for immunization..

Gene therapy: An appropriate A61K 39/00 symbol is given when the in vivo expression of a protein arising from the delivery of a nucleic acid encoding the protein, and the generation of an immune response against the encoded protein results in a prophylactic or therapeutic effect. The same applies for the use of cells modified to produce a specific antigen/antibody, for use in gene therapy. An A61K 48/00 symbol may also be given, if applicable, as specified under the A61K 48/00 section definitions

In CPC, an important limitation for the classification in A61K 39/00 has been introduced, in comparison with the IPC:

The medicinal use of proteinaceous antigens hypothetically useful for vaccination is classified only in C07K 14/00 or C12N 9/00, according to the origin of the protein, with addition of the Indexing Code A61K 39/00.

Guidance for the classification of medicinal preparations containing antibodies (A61K 39/395 and subgroups) as active ingredients is given in a separate definition concerning antibodies (C07K 16/00).

What follows below is the classification strategy for the medicinal use of antigens for which vaccination has been sufficiently disclosed.

Documents relating to the medicinal use of antigens are classified in A61K 39/00, mainly according to the origin of the antigen.

Indexing Codes (A61K 2039/51 - A61K 2039/64) are used for classifying further relevant and sufficiently disclosed aspects of the immunogenic compositions.

Preparations containing archeal antigens for vaccination: A61K 39/0001

Preparations containing fungal antigens for vaccination: A61K 39/0002

Preparations containing invertebrate antigens for vaccination: A61K 39/0003

Preparations containing vertebrate antigens for vaccination:

from A61K 39/0005 - A61K 39/0012

A61K 39/0006 :contraceptive vaccins, vaccins against sex hormones

A61K 39/0007 : preparations containing nervous system antigens or prions

A61K 39/0008 : preparations containing antigens related to auto-immune diseases and preparations to induce self-tolerance

A61K 39/001 : preparations to induce tolerance to non-self, e.g. prior to transplantation

A61K 39/0011 : preparations containing cancer antigens

A61K 39/0012 : preparations containing lipid or lipoprotein antigens

Preparations containing protozoa antigens: from A61K 39/002 - A61K 39/018 according to the origin of the antigen

A61K 39/005 : preparations containing Trypanosoma antigens

A61K 39/008 : preparations containing Leishmania antigens

A61K 39/012 : preparations containing Coccidia antigens

A61K 39/015 : preparations containing Hemosporidia antigens e.g. Plasmodium antigens

A61K 39/018 : preparations containing Babesia antigens e.g. Theileria antigens

Preparations containing bacterial antigens: from A61K 39/02 - A61K 39/118 according to the origin of the antigen

A61K 39/0208 : preparations containing antigens from specific bacteria, which cannot be classified in A61K 39/0216 - A61K 39/118

A61K 39/0216 : preparations containing antigens from Bacteriodetes, e.g. Bacteroides, Ornithobacter, Porphyromonas

A61K 39/0225 : preparations containing antigens from Spirochetes, e.g. Treponema, Leptospira, Borrelia

A61K 39/0233 : preparations containing antigens from Rickettsiales, e.g. Anaplasma

A61K 39/0241 : preparations containing antigens from Mollicutes, e.g. Mycoplasma, Erysipelothrix

A61K 39/025 : preparations containing antigens from Enterobacteriales, e.g. Enterobacter, Yersinia

A61K 39/0258 : preparations containing antigens from Escherichia

A61K 39/0266 : preparations containing antigens from Klebsiella

A61K 39/0275 : preparations containing antigens from Salmonella

A61K 39/0283 : preparations containing antigens from Shigella

A61K 39/04 : preparations containing antigens from Mycobacterium, e.g. Mycobacterium tuberculosis

A61K 39/05 : preparations containing antigens from Actinobacteria (e.g. Actinomyces, Streptomyces, Nocardia, Bifidobacterium,Gardnerella), Corynebacteria, Propionibacteria. Preparations containing antigens from Mycobacterium are classified in A61K 39/04

A61K 39/07 : preparations containing antigens from Bacillus

A61K 39/08 : preparations containing antigens from Clostridium, e.g. Clostridium tetanus

A61K 39/085 : preparations containing antigens from Staphylococcus

A61K 39/09 : preparations containing antigens from Lactobacillales, e.g. Aerococcus, Enterococcus, Lactobacillus, Lactococcus

A61K 39/092 : preparations containing antigens from Streptococcus

A61K 39/095 : preparations containing antigens from Neisseria

A61K 2039/10 : not used

A61K 39/098 : preparations containing antigens from Brucella

A61K 39/099 : preparations containing antigens from Bordetella, e.g. Bordetella pertussis

A61K 39/102 : preparations containing antigens from Pasteurellales, e.g. Actinobacillus, Pasteurella, Haemophilus

A61K 39/104 : preparations containing antigens from Pseudomonadales, e.g. Pseudomonas

A61K 39/1045 : preparations containing antigens from Moraxella

A61K 2039/106 : not used

A61K 39/098 : preparations containing antigens from Delta proteobacteriales, e.g. Lawsonia, from Epsilon proteobacteriales, e.g. campylobacter, Helicobacter

A61K 39/114 : preparations containing antigens from Fusobacterium

A61K 39/116 : preparations containing antigens from more than one bacteria; preparation containing a mixture of bacterial and viral antigens are classified in A61K 39/295

A61K 39/118 : preparations containing antigens from Chlamydiaceae, e.g. Chlamydia trachomatis or Chlamydia psittaci

Preparations containing viral antigens: A61K 39/12 AND C12N 7/00 in combination with an Indexing Code in the C12N 2710/00 - C12N 2796/00 series according to the origin of the viral antigen.

The specific Indexing Codes have the format C12N7xx/xxxx34

The first part (xxx/xxxx)of the code indicates the specific virus from which the antigen has been derived. The first four digits after the "/" represent the taxonomic location of the virus and the last place rule applies.

C12N 2710/00 double stranded DNA virus

C12N 2720/00 double stranded RNA virus

C12N 2730/00 reverse transcribing DNA virus

C12N 2740/00 reverse transcribing RNA virus

C12N 2750/00 single stranded DNA virus

C12N 2760/00 single stranded RNA virus negative-sense

C12N 2770/00 single stranded RNA virus positive-sense

C12N 2780/00 viroids and subviral agents

C12N 2790/00 naked RNA Virus

C12N 2792/00 archaeabacteria virus

C12N 2795/00 bacteriophage

The second part of the Indexing Code(34) indicates the use, namely that the virus or viral component is used as vaccine

Preparations containing multiple antigens of which at least one is a viral antigen: A61K 39/295 AND C12N 7/00 in combination with an Indexing Code in the C12N 2710/00 - C12N 2796/00 series according to the origin of the viral antigen(s).

Preparations containing allergens for vaccination: from A61K 39/35 - A61K 39/36

A61K 39/36 : preparations containing allergens

A61K 39/36 : preparations containing allergens from pollen

Preparations containing antigens from snakes for vaccination: A61K 39/38

Preparations characterized by haptens or antigens bound to a carrier: A61K 39/385

Documents disclosing a new carrier will be classified within A61K 39/385. In addition, specific examples will also be classified according to the nature of the antigen with the addition of an Indexing Code from the A61K 2039/60 series to characterise the carrier.

Documents relating to compositions containing specific antigens bound to a carrier are preferably classified according to the nature of the antigen in groups A61K 39/00 - A61K 39/38 with the addition of an Indexing Code from the A61K 2039/60 series to characterise the carrier and possibly also an Indexing Code from the A61K 2039/62 series to characterise the link between the carrier and the antigen and an Indexing Code from the A61K 2039/64 series to characterise the architecture of the carrier-antigen complex.

Preparations characterized by the immunostimulating additive or adjuvant: A61K 39/39

Documents disclosing a new adjuvant will be classified within A61K 39/39 and the specific examples will also be classified according to the nature of the antigen with the addition of an Indexing Code from the A61K 2039/555 series to characterise the adjuvant.

Documents relating to compositions containing specific antigens in the presence of an immunostimulating additive/adjuvant are classified according to the nature of the antigen in groups A61K 39/00 - A61K 39/38 with the addition of an Indexing Code from the A61K 2039/555 series to characterise the adjuvant.

Preparations containing DNA encoding an antigen for vaccination

Documents disclosing a DNA vaccine will be classified according to the nature of the antigen in groups A61K 39/00 - A61K 39/38 with the addition of the Indexing Code A61K 2039/53.

Preparations containing an antigen for vaccination in combination with another/other active ingredient(s) are classified in the corresponding A61K 39/00 class with the addition of the Indexing Code A61K 2300/00

The following relevant and sufficiently disclosed aspects of the vaccines are further classified using Indexing Codes:

vaccines comprising whole cells, animal cells, bacterial cells or viruses: A61K 2039/51 and subgroups thereof

vaccines characterised by the route of administration: A61K 2039/54 and subgroups thereof

vaccines characterised by the dose, timing or administration schedule: A61K 2039/545

vaccines characterised by the host/recipient: A61K 2039/55 and subgroup A61K 2039/552

vaccines characterised by a specific combination antigen/adjuvant: A61K 2039/555 and subgroups thereof for characterising the adjuvant

vaccines characterised by the type of immune response: A61K 2039/57

vaccines characterised by the carrier linked to the antigen: A61K 2039/60 and subgroups thereof

vaccines characterised by the link between antigen and carrier: A61K 2039/62 and subgroups thereof

vaccines characterised by the architecture of the carrier-antigen complex: A61K 2039/64 and subgroup A61K 2039/645

Isolated cells of the immune system presenting or targeting a specific antigen or a mix of antigens for use in therapy against e.g. cancer, infectious diseases or auto-immune diseases.

The antigen presented/targeted may be a single epitope or a mix of epitopes or antigens.

Antigens may also be undefined like in the case of TILs or LAKs derived lymphocytes which will target several unidentified antigens.

Due to their structure, cells used in cellular immunotherapy may warrant classification of subject-matter in various main groups, beyond the allocation in A61K 39/46 and subgroups.

If the structure of the antibody portion of the construct is an important aspect, then classification in C07K 16/00 and subgroups should be considered. The same applies to the type of protein expressed (TCR, CAR, cytokine…), which can be classified in C07K 14/00 and subgroups.

Genetically modified cells or T lymphocytes for immunotherapy may be classified in C12N 5/0634 - C12N 5/064 with added classification in A61K 39/46 and subgroups, and indexing codes A61K 2239/00 - A61K 2239/59. Documents relating to the in vitro cell culture/expansion methods or to specific types/subtypes of immune cells may also be classified in C12N 5/00 and subgroups.

Cells for cellular immunotherapy may be given symbols in A61K 35/15 (e.g. dendritic cells) and/or A61K 35/17 (e.g. Lymphocytes; B-cells; T-cells; Natural killer cells; Interferon-activated or cytokine-activated lymphocytes) for the cell and A61K 39/00 and subgroups for the therapeutic aspect of the antigen/antibody, as well as in C07K 14/00 (when a novel peptide is claimed and exemplified) and/or C07K 16/00 and subgroups (for further, specific classification of the antibody and/or when the antibody is novel).

Classification in A61K 35/17 should be considered if the effect of the lymphocyte is not due to its antigen specificity (e.g. the administration of B cells to treat tissue injury). A61K 35/15 or A61K 35/17 need not be given by default to immune cells directed to a given antigen (or to a mixture of antigens).

Therapeutic activity can further be classified in subclass A61P, as secondary classification and following the criteria outlined in the definitions of A61P.

In this group, classification of the cell type and of the antigen specificity is compulsory, provided the document contains credible evidence that the effect has been or can be achieved.

Further relevant aspects, like those characterizing the structure of the chimeric antigen receptor [CAR], the target(s) and the route of administration, should also be classified.

The cell type and the type of immune response is to be classified in subgroups A61K 39/461 - A61K 39/4622.

These subgroups relate to immune cells, including antigen-presenting cells or T lymphocytes. Further aspects relate to the type of immune responses, which can be for instance immunosuppressive or immunostimulatory (A61K 39/462 - A61K 39/4622).

Aspects relating to the nature of the receptors or molecules expressed recombinantly by the immune cell are to be classified in subgroups A61K 39/463 - A61K 39/4637. CAR receptors are for instance classified in A61K 39/4631.

The former subgroups should all be used in combination with the subgroups relating to the target antigen(s), which are to be found in subgroups A61K 39/464 - A61K 39/46484.

The additional subgroups A61K 2239/00 - A61K 2239/59 should also be considered for a comprehensive classification of cellular immunotherapy.

These subgroups concern the structure of the chimeric antigen receptor [CAR], as well as the mechanisms enabling the control of the function or activity of the CAR or of the CAR-expressing cells in vivo.

In case of multiple targets, classification in the subgroups A61K 2239/27 - A61K 2239/30 can also be considered.

The route of administration, the schedule and the adjuvant(s) used can be classified in A61K 2239/31 - A61K 2239/39.

Finally, and in view of the wide use of cellular immunotherapy against cancer, specific subgroups for the cancer organ can be found in subgroups A61K 2239/46 - A61K 2239/59. These subgroups can be used in combination with the antigen subgroups to more precisely identify documents relating to some specific cancers.

Combination Sets (C-Sets) classification:

C-Sets syntax rules:

C-Sets examples:

A61K 41/0023: preparations for use in therapy during which wave energy or particle radiation is administered, in order to "activate" the agent, e.g. photodynamic therapy, or for releasing a pharmacologically active agent, e.g. thermosensitive liposomes, photolabile linkers are classified in A61K 41/0023 - A61K 41/0095

A61K 41/0028: disruption (e.g. by heat or ultrasounds), sonophysical or sonochemical activation; e.g. thermosensitive or heat-sensitive liposomes, disruption of calculi with a medicinal preparation and ultrasounds.

A61K 41/0033: sonodynamic cancer therapy with sonochemically active agents/sonosensitizers, having their cytotoxic effects enhanced through application of ultrasounds (ultrasound therapy per se is classified in A61N 7/00).

A61K 41/0038: radiosensitizing, i.e. administration of pharmaceutical agents that enhance the effect of radiotherapy (radiotherapy per se is classified in A61N 5/10).

A61K 41/0042: photocleavage of drugs in vivo (e.g. cleavage of photolabile linkers in vivo by UV radiation for releasing the pharmacologically-active agent from the administered agent); photothrombosis or photoocclusion.

A61K 41/0047: sonopheresis (i.e. ultrasonically-enhanced transdermal delivery), electroporation of a pharmacologically active agent (NB: to be classified in A61K 9/0009 when it is in relation to the galenic form).

A61K 41/0052: thermotherapy; hyperthermia; magnetic induction; induction heating therapy (NB: simple magnetic guidance of drugs in vivo is to be classified in A61K 41/00, and in A61K 47/6941).

A61K 41/0057: photodynamic therapy with a photosensitizer, i.e. agent able to produce reactive oxygen species upon exposure to light or radiation, e.g. UV or visible light; photocleavage of nucleic acids with an agent.

A61K 41/0061: 5-aminolevulinic acid-based PDT (5-ALA-PDT involving porphyrins or precursors of protoporphyrins generated in vivo from 5-ALA).

A61K 41/0066: psoralene-activated UVA photochemotherapy (PUVA-therapy), e.g. for treatment of psoriasis or eczema, extracorporeal photopheresis with psoralens (fucocoumarins).

A61K 41/0071: PDT with porphyrins having 20 carbon atoms and 4 nitrogen atoms forming the ring system (i.e. based on the non-expanded tetrapyrrolic ring system, e.g. bacteriochlorin, chlorin e6, or phthalocyanines).

A61K 41/0076: PDT with expanded (i.e. having more than 20 carbon atoms and/or 4 nitrogen atoms forming the ring system) (metallo)porphyrins, e.g. texaphyrins, sapphyrins, hexaphyrins, pentaphyrins, porphocyanines.

A61K 41/008: two-photon or multi-photon PDT, e.g. with two-photon upconverting dyes or photosensitizers.

A61K 41/0085: mossbauer effect therapy based on mossbauer effect of a material (i.e. re-emission of gamma rays after absorption of gamma rays by the material); selective radiation therapy (i.e. involving re-emission of ionizing radiation upon exposure to a first ionizing radiation).

A61K 41/009: neutron capture therapy, e.g. using uranium or non-boron material.

A61K 41/0095: boron neutron capture therapy (BNCT), e.g. using boronated porphyrins.

A61K 41/10: preparations which are obtained by treating materials with wave energy, e.g. U.V. light, or particle radiation, prior to administration, for decontamination:

A61K 41/13: by ultrasonic waves.

A61K 41/17: by ultraviolet [UV] or infrared [IR], X-rays or gamma rays.

Galenical aspects of pharmaceutical compositions are also classified by giving a combination of classes in A61K 9/00 and A61K 47/00 to and including A61K 47/50.

The active ingredients in pharmaceutical compositions are classified in A61K 31/00 - A61K 48/00.

Preparations for testing in vivo using radioactive substances, or substances for use in therapy labeled with a radioactive isotope, are classified in A61K 51/00.

Preparations for testing in vivo, or for use in an in vivo diagnostic imaging method (e.g., by luminescence, fluorescence, X-ray imaging, ultrasound imaging, echography, MRI) are classified in A61K 49/00 and its subgroups.

Attention is drawn to A61L 2/0029, A61L 2202/21 and/or A61L 2202/22 if the invention lies in the method of sterilization of the medicinal preparation rather than the sterilized medicinal preparation.

In A61K 41/10 and its subgroups, pharmaceutical compositions are classified that are decontaminated prior to use, by applying radiation, or of which one of the constituents is thus decontaminated.

Photosensitizers used in photodynamic therapy (the photosensitizer being considered as the therapeutically active part) and modified by another compound (e.g. polymer or an antibody) to be classified in A61K 41/0071 or A61K 41/0076 and according to the A61K 47/50 subclass of the modifying agent.

Attention is drawn to A61L 2/0029 if the invention lies in the method of sterilization of the medicinal preparation rather than the sterilized medicinal preparation.

Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses by radiation are classified in A61L 2/08 - A61L 2/12.

1) No distinction is made between Invention and Additional information.

2) Therapeutic use: the A61K 45/06 classification symbol should mainly be reserved for mixtures containing at least one active ingredient without chemical characterisation.

It is also used in the case that there are too many exemplified combinations.

A61K 47/00 - A61K 47/46

A61K 47/50

It should be noted that in A61K 47/00 the invention resides in the use of at least one particular compound as a biologically inert additive or excipient, for example to enhance the stability of a pharmaceutical formulation or to enhance the bioavailability of a biologically active ingredient in the body. The invention therefore does not reside in what the active ingredient does but in what at least one of the biologically inert ingredients does. It may be that this inert ingredient is a separate chemical entity from the biologically active ingredient or it may be that the inert ingredient is chemically bound to the biologically active ingredient. Thus any novelty that resides in the said inert compound per se will warrant classification in the appropriate area in class C01 for inorganic compounds or classes C07 or C08 for organic or polymeric compounds respectively.

Galenical aspects of pharmaceutical compositions are classified in A61K 9/00 and in A61K 47/00. The last place rule does not apply between A61K 9/00 and A61K 47/00 - A61K 47/46.

Excipients can be classified in A61K 47/00- A61K 47/46 or in A61K 9/00, depending on the situation: A61K 47/00 is used to classify excipients in compositions for which A61K 9/00 does not provide information on excipients. No A61K 47/00 is given if A61K 9/00 already provides information on excipients (e.g. tablet excipients are only classified in A61K 9/20...). New excipients per se are (in addition) classified in A61K 47/00.

Conjugates, i.e. compounds comprising a non-active ingredient bound to the active ingredient, are classified in A61K 47/50. Pharmaceutical compositions comprising conjugates may in addition be classified in A61K 9/00.

The active ingredients in pharmaceutical compositions are classified in A61K 31/00 - A61K 45/00, or A61K 48/00 - A61K 51/00.

Classified are concrete, well-defined pharmaceutical compositions disclosed in the examples. Also classified are independent claims defining galenical aspects of a pharmaceutical composition or a medical use.

IIn principle all examples are classified, also 'standard' examples in documents describing e.g. a new medical use.

However, systematically classifying all excipients in the examples is not necessary, and often undesirable. In any case classified are excipients which are described as being important for the invention, or which the reader can identify as having an important function, e.g. for sustained release. For 'standard' compositions the examiner should choose one or a few excipients to classify.

Animal tests are not classified, unless it is absolutely clear that they represent the intended mode of administration.

The description and dependent claims are not classified. However, if the document as a whole focuses on one clearly preferred embodiment, this embodiment may be classified, even in the absence of relevant examples or independent claims.

In general, information relating to the invention is classified using invention information symbols, while additional information is classified using additional information symbols. This is largely up to the discretion of the examiner. Please note however the following special situations:

A61K 47/02 covers inorganic compounds but does not cover polymeric inorganic materials, which are covered by A61K 47/30 - macromolecular (organic or inorganic) compounds – e.g., inorganic polyphosphates.

A61K 47/06 covers hydrocarbon materials of both natural and synthetic sources. Natural examples include petrolatum, mineral oil and ozokerite – i.e., there are no functional groups present in such materials, i.e., ester, ketone, hydroxyl or carboxylic groups. A61K 47/06 also covers mixtures of hydrocarbons as well as pure hydrocarbons.

A61K 47/10 covers alcohols such as aliphatic alcohols, phenols or salts thereof; polyalkylene glycols [PEG], [PPG]; poloxamers; PEG/POE alkyl ethers. This subgroup does not cover sugar alcohols (A61K 47/26) or copolymers comprising polyalkylene glycols or poloxamers (A61K 47/34).

A61K 47/34 does not cover polyalkoxylated compounds, which are classified according to the compounds being derivatised. The following list gives examples of such polyalkoxylated compounds together with the relevant group.

A61K 47/44 covers materials that comprise mixtures of chemically distinct components, i.e., more than one of the groups A61K 47/02-A61K 47/42, i.e., carboxylic acids and esters. Materials that comprise such mixtures may include natural or modified oils, fats or waxes such as olive oil, castor oil, montan wax, lignite, shellac, lanolin and beeswax. Materials that comprise only a mixture of different carboxylic acids – i.e., of different carbon chain lengths or a mixture of aromatic and aliphatic carboxylic acids – will be classified in A61K 47/12.

A61K 47/64 covers the situation where peptides, proteins or polyamino acids are chemically bonded directly to drugs or are chemically bonded to the drug via a linker. A61K 47/62 is more appropriate where peptides, proteins or polyamino acids are bound or complexed to special galenical forms of a drug, e.g., a liposome or a nanoparticle modified on its surface by a peptidic modifying agent. In these latter situations, classification in A61K 47/69 would also be appropriate.

If the modifying agent in the conjugate is some kind of inclusion complex, e.g., a cyclodextrin, then classification in A61K 47/69 will be appropriate. If cyclodextrin is used as a simple excipient then classification in A61K 47/40 will be required.

This group does not cover polyalkoxylated compounds, which are classified according to the derivatized compounds. The following list of references provides examples of such polyalkoxylated compounds together with their relevant group.

Medicinal preparations containing conjugates. A conjugate is meant to define a pharmacologically/therapeutically-active agent or drug chemically bound (by covalent bonds or by complexation) to a modifying agent. The classification in this subgroup is based on this modifying agent. The "pharmacologically/therapeutically-active agent" covers a molecule used as the drug and linked to the modifying agent, or a molecule used as the drug and encapsulated/linked to a special physical/galenical form. The modifying agent is for example used to:

In the subgroups of A61K 47/50, the classification is based on the non-active ingredient, i.e. the modifying agent.

However, for the conjugates of an antibody, the pharmacologically/therapeutically-active agent of the conjugate is also classified, in the subgroups of A61K 47/68. The modifying group must be part of a well-defined class of compounds.

The last place priority rule does not apply in group A61K 47/50, i.e. all aspects of the invention are classified. For example, a liposome modified on its external surface by a modifying agent, is classified both in A61K 47/6911 and in the appropriate subgroup of A61K 47/50, e.g. in A61K 47/62 for a peptide/protein, and in the appropriate subgroup of A61K 47/6835 for an antibody.

Targeted drug delivery systems as defined in A61K 47/555, A61K 47/66 and A61K 47/6891 comprise more than one component. For example, in antibody-directed enzyme prodrug therapy [ADEPT], one component carries the enzyme to its target, and the other the prodrug. Although less detailed, the classification of conjugates in which the modifying component is a peptide follows a classification similar to that in the field of new peptides or proteins, i.e. C07K 14/00 and subgroups. Similarly, the classification of conjugates in which the modifying component is an antibody, the classification of the characterising antibody follows a classification similar to that of new antibodies, C07K 16/00 and subgroups, again less detailed. For the specificity of the antibody, the same rules are followed as for the classification in C07K 16/00. For the specificity of the antibody, if the antibody is new, the corresponding class in C07K 16/00 and subgroups is also given.

The active agent is also classified in A61K 47/50 in two situations:

Porphyrins used as photosensitizers in photodynamic therapy, where the photosensitizer is considered as the therapeutically active part, and modified by another compound, e.g. polymer or an antibody, should be classified in A61K 41/0071 or A61K 41/0076 in addition to the appropriate subgroup A61K 47/50 according to the modifying agent.

Nucleic acids can be coding, non-coding, nucleic acid which being therapeutically-active or not, e.g. oligonucleotides, DNA, RNA, siRNA, and nucleic acid aptamers.

Cholesterol

Codrugs of pharmacologically active/therapeutically-active steroids are classified in this group and also in A61K 47/55.

A targeting agent able to target specific cells or receptors in the body (T) being an organic compound, not being a peptide, protein or antibody.

The concept of "pre-targeting" covers the administration of the modifying agent, which is an agent able to target specific cells in the body, and of the pharmacologically or therapeutically active agent, e.g. drug D, in several steps, their "binding" occurring at the in vivo targeted site.

It involves administration in at least two steps, for example, (i) a conjugate T-A corresponding to a targeting agent able to target specific cells or receptors in the body (T) linked to a compound A, and (ii) a conjugate D-M corresponding to the drug linked to a modifying agent M able to target the compound A.

The sequence involves the administration of T-A and then D-M. Between step (i) and step (ii), a further compound able to bind to A and M may also be administered, e.g. during a clearing step.

Classification is made according to the nature of T in the subgroups of A61K 47/555, A61K 47/66, and A61K 47/6891.

In A61K 47/555 and its subgroups, if T is an organic compound, other than a peptide, protein or antibody, classification is also made according to the nature of organic compound T in the appropriate A61K 47/54 subgroup. If T is a peptide, protein or antibody, classification is made in the corresponding A61K 47/66 (peptide or protein) or A61K 47/6891 (antibody) group.

Enzymes being used as group A, and being first targeted to specific cells via administration of the conjugate T-A. Then, the conjugate M-D which being a substrate for A being administered. The enzyme A being able to cleave the conjugate M-D, which can be a prodrug. The drug D being thus released through enzymatic cleavage at particular targeted cells.

Chemical reactions inducing the cleavage of the pharmacologically or therapeutically active agent from the carrier while at the same time producing light.

Special physical or galenic forms modified by covalent attachment or complexation of a protein, peptide or polyamino acid, are classified in A61K 47/62 and additionally in A61K 47/69, if considered relevant. E.g. a liposome modified on its surface by a peptide is classified in A61K 47/6911 and in A61K 47/62, a PLGA nanoparticle modified on its surface by a peptide is classified in A61K 47/6937 and in A61K 47/62.

Conjugates, wherein a peptide or protein being the pharmacologically or therapeutically active agent is linked to another peptide or protein being the modifying agent via chemical methods.

Chemically-produced peptides or protein-peptides or protein conjugates, the peptides or proteins used as modifying agents.

Haptens, e.g. conjugates of morphine or nicotine and KLH inducing an immune response, are classified both in this group and additionally in A61K 47/643.

The concept of "pre-targeting" covers the administration of the modifying agent, i.e. an agent able to target specific cells in the body, and of the pharmacologically or therapeutically active agent (drug D) in several steps, their "binding" occurring at the in vivo targeted site.

It involves administration in at least two steps, for example, (i) a conjugate T-A corresponding to a targeting agent T able to target specific cells or receptors in the body (T) linked to a compound A, and (ii) a conjugate D-M corresponding to the drug D linked to a modifying agent M, able to target the compound A.

T being a peptide or protein, not being an antibody.

The sequence involves the administration of T-A and then D-M. Between step (i) and step (ii), a further compound able to bind to both A and M may also be administered, e.g. during a clearing step.

Classification is made according to the nature of T in subgroups of A61K 47/555, A61K 47/66, and A61K 47/6891.

Enzyme prodrug therapy, e.g. gene directed enzyme drug therapy [GDEPT], VDEPT. An enzyme is used as group A in the sense of this group, being first targeted to specific cells via administration of the conjugate T-A. Then, the conjugate M-D, which is a substrate for A, is administered. The enzyme A is able to cleave the conjugate M-D, which can be a prodrug. The drug D is thus released through enzymatic cleavage at particular targeted cells.

Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates. The modifying part is an antibody or immunoglobulin bearing at least one antigen-binding site.

Antibodies per se are classified in C07K 16/00.

In this group, classification is made according to the nature of the drug, i.e. the pharmacologically or therapeutically active agents in the antibody conjugate. If the nature of the antibody in a specific conjugate is known, it is additionally classified in A61K 47/6835. If the conjugate comprises also a polymer or a polyamino acid, then classification is also made in A61K 47/6883 or A61K 47/6885.

Modifying agents being a well-defined antibody or immunoglobulin bearing at least one antigen-binding site.

According to the nature of the antibody, classification is additionally made in the appropriate groups of A61K 47/6835. The pharmacologically or therapeutically active agent in the antibody conjugate is additionally classified in A61K 47/6803, whenever considered appropriate.

Pre-targeting systems involving an antibody for targeting specific cells. The concept of "pre-targeting" covers the administration of the modifying agent, i.e. an agent able to target specific cells in the body, and of the pharmacologically or therapeutically active agent (drug D) in several steps, their "binding" occurring at the in vivo targeted site.

It involves administration in at least two steps, for example, (i) a conjugate T-A corresponding to a targeting agent able to target specific cells or receptors in the body (T) linked to a compound A (wherein T is an antibody), and (ii) a conjugate D-M corresponding to the drug linked to a modifying agent M, able to target the compound A.

The sequence involves e.g. the administration of T-A and then D-M. Between step (i) and step (ii), a further compound able to bind to A and M may also be administered, e.g. during a clearing step.

Classification is additionally made according to the nature of T in A61K 47/555, A61K 47/66, and A61K 47/6893. Classification is also made according to the nature of the antibody in A61K 47/6835. If M and A form a pair of biotin and (strept)avidin, or derivatives of biotin and (strept)avidin, then classification is also made in A61K 47/6898.

Avidin-biotin systems, wherein at least one avidin- or biotin-conjugated antibody is used in a two- or three-steps pretargeting system, e.g. wherein M and A in form a pair of biotin and (strept)avidin, or derivatives of biotin and (strept)avidin.

Antibody Directed Enzyme Prodrug Therapy [ADEPT]. An enzyme is used as group A and is first targeted to specific cells via administration of the conjugate T-A. Then, the conjugate M-D, which is a substrate for A, is administered. The enzyme A is able to cleave the conjugate M-D, which can be a prodrug. The drug D is thus released through enzymatic cleavage at particular targeted cells.

Conjugates characterized by a special physical or galenical form.

The conjugates correspond either (i) to a pharmacologically or therapeutically active agent complexed/covalently linked to the special physical or galenical form, e.g. on the surface of a polymeric nanoparticle or liposome, or to polymeric chains in the matrix of a polymeric gel, or (ii) to a special physical or galenical form encapsulating the pharmacologically or therapeutically active agent and modified on its surface or matrix by a modifying agent.

In case of (i) above, classification is made according to the nature of the special physical or galenical form in this group. Additionally the compound, to which the pharmacologically or therapeutically active agent is linked, is classified in the relevant subgroups of A61K 47/50 e.g. A61K 47/544 in case of a drug linked to a phospholipid and inserted in the bilayer surface of a liposome.

In case of (ii) above, classification is made according to the nature of the modifying agent. Physical or galenical forms not modified by a modifying agent and/or wherein the pharmacologically or therapeutically active agent is not complexed/covalently linked to said forms, are not classified in A61K 47/50, but in A61K 9/00.

Micelles modified by a polymer because they incorporate a polymer-lipid conjugate are only classified in this group, if the polymer modifying the lipid is unusual. Micelles, which are pegylated because they incorporate a pegylated lipid, are not classified in this group, but in A61K 9/1075.

Liposomes, i.e. bi-layered vesicles, having its surface modified by covalent attachment or complexation of the pharmacologically or therapeutically active agent and/or modifying agent.

Liposomes, which are modified by a polymer because they incorporate a polymer-lipid conjugate are only classified in this group, if the polymer modifying the lipid is unusual. Liposomes, which are PEGylated because they incorporate a PEGylated lipid, are not classified in this group, but in A61K 9/1271.

When the surface of the liposome is functionalised by a modifying agent, classification is also made according to the nature of this modifying agent, e.g. a liposome modified on its surface by a peptide is classified in this group and additionally in A61K 47/605. Liposomes, wherein the pharmacologically or therapeutically active agent is linked to a phospholipid of the liposomal surface, are classified in this group and additionally in A61K 47/544.

Classification is also made according to the nature of the antibody in the appropriate subgroup of A61K 47/6835.

Polymersomes, i.e. a liposome with polymerisable or polymerized bilayer-forming substances.

Liposomes comprising polymers grafted on their surface are not classified in this group, but in A61K 47/6911, if the polymer is unusual, or in A61K 9/1271.

Inorganic particles, e.g. ceramic particles, silica particles, ferrite, synsorb

When the inorganic particle is a magnetic particle, being guided from outside the body with the means of a magnetic field, classification is additionally made in A61K 41/00.

Microcapsules, nanocapsules, microbubbles or nanobubbles, i.e. a hollow or gas-filled microparticle or nanoparticle or sphere, a gas-filled microparticle or nanoparticle for use in therapy

Pharmacologically or therapeutically active agents released from a microcapsule or nanocapsule by acoustic/ultrasound activation are also classified in A61K 41/0028 and A61K 9/0009.

Solid microparticles having no hollow or gas-filled core, wherein its size or diameter is higher or equal to 1 micrometer.

Nanoparticles, e.g. immuno-nanoparticles, wherein its size or diameter is smaller than 1 micrometer.

Classification is also made according to the nature of the antibody with the appropriate subgroup of A61K 47/6835.

Genetic material encoding proteins, the in vivo expression of which results in an in vivo therapeutic effect being attained. Cells can be used as delivery vehicle following ex vivo transfection with a nucleic acid encoding a therapeutic protein, enzyme or peptide if the therapeutic effect is a consequence of the ex vivo transfection step, i.e. arising as a result of the modification carried out. The protein in question may be expressed directly from the delivered nucleic acid sequence, or may, for example, be involved in a recombination process with a mutant, 'defective' gene, protein expression from the 'repaired' gene then ensuing at a time thereafter. The expression of the protein may be to replace / complement a 'defective protein', or may be to provide an entity (such as an enzyme) which is therapeutic (for example in the context of cancer therapy).

Transgenic animals are classified in A01K 67/027.

Proteins and peptides per se, encoded by the genetic material, are classified in the appropriate C07K subgroups, unless the protein is an enzyme. In this case the appropriate subgroup in C12N 9/00 should be used. Then classification of the specific enzyme is also made in C12Y as invention.

If therapy arises only as a consequence of the cells per se being delivered, and not due to the manner in which the cells have been modified ex vivo, classification in the subclass for gene therapy should not be made.

An invention classification symbol should be given in A61K 38/00 for the protein or peptide if the expression results from the nucleic acid delivered via gene therapy.

Enabling subject matter should be classified. More specifically, subject matter that pertains to the technical effect in question which the skilled person would be able to carry out based on the teachings of the application without undue burden, should be classified. Subject matter which is enabling but not clearly a technical contribution over the art should also be classified. Subject matter which is purely hypothetical or theoretical should not be classified. An example is when a particular substance is stated to be suitable for the treatment of a list of diseases but for which no data, even in an in vitro or animal model setting, is made available. On the other hand, subject matter supported by data which may be for example derived only from an in vitro setting but which lends at least partial credibility to an in vivo treatment should be classified.

Contrast agents for use in diagnostic imaging methods performed in vivo, or for detecting in vivo.

An apparatus used for in vivo imaging is classified in A61B.

In the preparation of new organic compounds and their use in X-ray contrast preparations, classification is only made in the relevant subclasses C07C - C07J according to the type of compound.

Galenical aspects of pharmaceutical compositions: if this is an important aspect of the invention, it may also be classified in A61K 9/00 or A61K 47/00 - A61K 47/46.

General contrast agents are e.g. chelating agents for which several imaging methods are exemplified and/or claimed, e.g., an antibody labeled with a chelating group, where the chelating group is used to complex either gadolinium (for MRI) or a heavy metal (for X-ray imaging). This subgroup also includes conjugates of a targeting agent, linked to a chelating group, wherein the application mentions several imaging techniques, without an actual example.

Multifunctional or multimodal agents are preparations, in which the contrast agent is suitable for more than one imaging technique, e.g. agents for dual mode imaging, e.g., containing a moiety for MRI and a fluorescent moiety.

The classification codes of the individual imaging techniques are also given.

Non-human animal models (e.g. transgenic model for heart failure, Alzheimer disease animal model) are only classified in subgroup A61K 49/0008 if they are used in a method for testing/screening agent in vivo and if this testing/screening for therapeutic usefulness in vivo is the invention or part of the invention.

This subgroup is not used for those documents in which the examples are using a well-known animal model to verify if an agent does indeed exert the effect it is supposed to, where the actual invention is the compound or its use.

Diagnostic compositions containing an agent detected in vivo using fluorescence, phosphorescence, (chemo)luminescence or dying/colouring/staining.

If a fluorescent group is complexed or covalently linked to a carrier, classification is also made according to the nature of the carrier in the appropriate A61K 49/005 subgroup.

If the physical or galenical form containing a fluorescent agent is modified by a particular agent, classification is also made according to the nature of this agent in the appropriate A61K 49/005 subgroup.

Classification is also made according to the nature of the fluorescent group in the appropriate subgroup of A61K 49/0019.

If the dye used for staining is fluorescent, classification is also given for the appropriate subgroup of A61K 49/0019.

Quantum dots modified on their surface by an antibody are also classified in A61K 49/0058.

When the formulation aspect is the invention or part of the invention (e.g. liposomal formulations), or when the physical form is the fluorescence-active part (e.g. quantum dots), classification is also made according to the appropriate A61K 49/0063 group.

In the fluorescence subgroups, the compound can be characterised by the fluorescing group, by the carrier/targeting group and/or the physical/galenical form. If the three aspects are present, the three groups must be allocated.

Microemulsion means that the dispersed phase is in the form of globules having a diameter above or equal to 1 micrometer. Nanoemulsion means that the dispersed phase is in the form of globules having a diameter below 1 micrometer.

Micelles comprise a monolayer of surfactant molecules that are aggregated head-to-head and tail-to-tail, thus forming a small spherical particle; micelles can be normal, i.e. the surfactant heads are hydrophilic, or inverse.

When the surface of the liposome encapsulating a fluorescent agent and used in vivo is functionalised by a modifying agent, classification is also made according to the nature of this modifying agent: e.g. a liposome modified on its surface by a peptide is classified in A61K 49/0084 and A61K 49/0056. Liposomes encapsulating a fluorescent agent, used in vivo and modified on their surface by a polymer because they incorporate a polymer-lipid conjugate, are only additionally classified in A61K 49/0054 if the polymer modifying the lipid is unusual. Liposomes encapsulating a fluorescent agent which are pegylated because they incorporate a pegylated lipid are only classified in A61K 49/0084, not in A61K 49/0054.

When the surface of the microparticle encapsulating a fluorescent agent and used in vivo is functionalised by a modifying agent, classification is also made according to the nature of this modifying agent, e.g. a microparticle modified on its surface by a peptide is classified in A61K 49/0091 and A61K 49/0056.