DEUTSCHES PATENT- UND MARKENAMT German Patent and Trade Mark Office Subcl.: C07K Date : 2005-01-10 DE - Proposal — TE 110 Rapporteur Proposal for project TE 110 (existing example No. C-1) Level/Category (ies) CL AL 1b, 2b3, 2d, 3a, 1b, 2b3, 2d, 3a, 3b Documents (Classification is based on underlined document) GB 2 179 947 A DE 3 623 474 A1 FR 2 584 727 A Short Version of the Disclosure The extraction of proteins from milk is described. The starting material in this process is raw milk from which the casein and the fatty substances have been substantially removed. Such milk or lactoserum concentrated by ultrafiltration is used to obtain proteins capable of fixing iron, like lactotransferrins and/ or immunoglobulins. These proteins are obtained in a single adsorption-elution stage on an ion exchanger, under particularly mild conditions. The process comprises therefore adsorbing the proteins on a cationic resin, followed by elution whereby adsorption and elution is carried out at substantially the same pH in the range from 5 to 8,5. Representative Prior Art FR 2 505 615 - extraction of proteins capable of fixing iron like lactotransferrins and immunoglobulins from casein free milk or concentrated lactoserum. For the extraction the proteins are adsorbed on a solid support like silicon dioxide in weak basic environment at a pH greater than 7,5 and eluated in an acidic environment at a pH below 4. Invention Information I1: A process for the extraction of proteins from milk free of casein and fatty substances is described. The extraction is done on an ion exchanger, in which the adsorption and elution of proteins is carried out at substantially the same pH (see claim 1). 106750294 1/4 I2: The milk used in the process is concentrated by ultrafiltration (see claims 9 to 12). I3: For the extraction a preferably weak cationic resin is used (see claims 5 and 6) and a pH of from 5 to 8,5 is chosen (see claims 7 and 8). The elution is being effected by modifying the ionic strength, e.g. by means of sodium chloride (see claim 3 and description, page 1, line 57 to 64). The different ionic strengths are chosen so as to enable separation of the desired proteins. I4: After elution the desired proteins are submitted to the action of a complexing agent to increase their capacity for fixing iron (see claim 4 and description, page 2, line 10 to 14). I5: Products, lactotransferrins and immunoglobulins obtained by the process of I1 to I4 (see claims 15 to 17). I6: Pharmaceutical compositions comprising at least one product of I5 (see claim 18). Additional Information A1: The lactotransferrin obtained by the described process retains its bacteriostatic properties and has therefore a useful therapeutic acitivity, which is an important information even in regard to the claimed pharmaceutical compositions (see GB 2 179 947, description, page 2, line 18 to 22 and claim 18). Identification of Potential Subclasses Subject Matter Tool Query IPC Places I1 to I4 Catchword Index General processes for the preparation of Proteins/Peptides C07K I5 Catchword Index Proteins/Peptides C07K I6 Catchword Index MEDICAL PREPARATION or A61K PHARMACEUTICAL COMPOSITION A1 Note in A61K THERAPEUTIC ACTIVITY of A61P chemical compounds or MEDICAL PREPARATIONS BACTERIOSTATIC Analysis and Selection of Classification Symbols Core Level I1 to I4: The process for extraction of proteins is of interest. The use of the catchword “peptide” leads to subclass C07K. In this subclass the last priority rule is used. Main group C07K 1/00 covers “General processes for the preparation of peptides” and is therefore a correct group. I5: The extracted lactotransferrins and immunoglobulins represent important information for the inventive step and are claimed, so these substances have to be classified (see claims 16 and 17). C07K has a main group C07K 14/00 which is directed to peptides having more than 20 amino acids. With subgroup C07K 14/435 it is possible to specify the extracted 106750294 2/4 lactoproteins as proteins from an animal. Therefore C07K 14/435 is a correct subgroup. Furthermore C07K 16/00 defines immunoglobulins. By using subclass C07K 16/04 it is possible to specify the immunoglobulins as immunoglobulins from milk. Therefore C07K 16/04 is as well a correct group. I6: The “pharmaceutical composition” (see claim 18) is an informative part of the invention because of the bacteriostatic properties of the lactotransferrins (see GB document, page 2, lines 20 to 22). In this case the use of the catchword “pharmaceutical preparation” as a synonym for “pharmaceutical composition” leads to subclass A61K. Medicinal preparations containing peptides are covered by A61K 38/00. In regard to the last appropriate place according to Note (2) after the title of A61K subgroup A61K 38/16 is a correct IPC place to classify pharmaceutical compositions containing proteins like lactotransferrins. The last appropriate place rule leads in addition to A61K 39/395 to classify a drug containing immunoglobulins. A1: In the description of the document (see GB document, page 2, lines 20 to 22) it is mentioned that the isolated lactotransferrins have bacteriostatic properties. Note (4) under the title of A61K refers to subclass A61P where therapeutic activity of medicinal preparations is classified. Substances which show bacteriostatic properties are called “Antibiotics” and this catchword leads to subgroup A61P 31/00, which is the correct group. Advanced Level The arguments under “Core level” above apply here. However the advanced level has finer subdivisions in C07K, A61K and A61P. I1 to I4: In accordance with Note (3) following the title of class C07 the process for the extraction of proteins from milk is classified under C07K 1/00 (the last place rule according to Note (2) following the title of class C07 is only applicable to “compounds”, but in class C07 classification is made as well in the last appropriate subclass of subclasses C07B to C07K). In regard to the fact that the extraction of the protein is done by “adsorption on ion exchanger” the process is classified in C07K 1/18. For the extraction of the proteins an ultrafiltration step has to be done as well, which makes a classification in C07K 1/36 obligatory. I5: Under subgrpoup C07K 14/435 of the Advanced Level a further subdivision of peptides from animals or humans is given. In subgroup C07K 14/79 transferrins and namely lactotransferrins are mentioned as special types of peptides, which is therefore a correct IPC place. In accordance with the Core Level C07K 16/04 is as well in the Advanced level the precise classification for the immunoglobulins of claim 17. I6: When in the Core Level the pharmaceutical compositions of claim 18 can be characterised only as a medicinal preparation containing peptides having more than 20 amino acids, in the Advanced Level subgroup A61K 38/40 defines the pharmaceutical composition of claim 18 as a medicinal preparation containing lactortransferrins as active substances. As well in the Advanced Level exists no better IPC place than A61K 39/395 to classify a medicinal preparation containing immunglobulins. A1: Starting from maingroup A61P 31/00 which was identified in the Core level as the appropriate IPC place for the bacteriostatic activity of the lactoferrins, in the Advanced level subgroup A61P 31/04 for “Antibacterial agents” is the correct group. 106750294 3/4 Subject Matter Anaylsis of Subclass Selection Subcalss Analysis of Group Selection IPC CL IPC (2006) IPC AL I1 to I4 Subclass/group title Subclass/group title Subclass/group title Reference in A61K C07K Last place priority rule Last place priority rule Last place priority rule Common rule C07K 1/00 C07K 1/18 C07K 1/36 C07K 14/79, 16/04 A61K 38/40, 39/395 A61P 31/04 I5 I6 A1 C07K A61K A61P C07K 14/435, 16/04 A61K 38/16, 39/395 A61P 31/00 Complete Classification The complete core and advanced level classification for this document based on the above analysis is as follows: Core Level Int.Cl.(2006) C07K 1/00 C07K 14/435 C07K 16/04 A61K 38/16 A61K 39/395 A61P 31/00 Advanced Level C07K 1/18 (2006.01) C07K 1/36 (2006.01) C07K 14/79 (2006.01) C07K 16/04 (2006.01) A61K 38/40 (2006.01) A61K 39/395 (2006.01) A61P 31/04 (2006.01) Andrea Münzberg 106750294 4/4