DEUTSCHES PATENT- UND MARKENAMT German Patent and Trade Mark Office Subcl.: C07K Date : 2005 June 21 DE - Proposal — TE 110 Rapporteur Proposal for project TE 110 (existing example No. C-1) Level/Category (ies) CL 1b, 2b3, 2d, 3a, 3b AL 1b, 2b3, 2d, 3a, 3b Documents (Classification is based on GB 2 179 947 A) 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). The milk used in the process is concentrated by ultrafiltration (see claims 9 to 12). 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. 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). I2: Products, lactotransferrins and immunoglobulins obtained by the process of I1 (see claims 15 to 17). I3: Pharmaceutical compositions comprising at least one product of I2 (see claim 18). Additional Information A1: The lactotransferrin obtained by the described process retains its bacteriostatic properties and has therefore a useful therapeutic activity, which is 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 Catchword Index General processes for the preparation C07K of Proteins/Peptides I2 Catchword Index Proteins/Peptides C07K I3 Catchword Index MEDICAL PREPARATION or A61K PHARMACEUTICAL COMPOSITION A1 Note (4) in A61K THERAPEUTIC ACTIVITY of A61P chemical compounds or MEDICAL PREPARATIONS BACTERIOSTATIC Analysis and Selection of Classification Symbols Core Level I1: A process for extraction of proteins is of interest. The use of the catchword “peptide” leads to subclass C07K. In this subclass the last place priority rule is used. Main group C07K 1/00 covers “General processes for the preparation of peptides” and is therefore a correct group. I2: 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 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. I3: 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 I1: A process for extraction of proteins is of interest. The use of the catchword “peptide” leads to subclass C07K. 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 C07C to C07K). The fact that the extraction of the protein is done by “adsorption on ion exchanger” leads to C07K 1/18. For the extraction of the proteins an ultrafiltration step has to be done as well, so that C07K 1/36 is according to the last place rule the right classification for the claimed process. To keep the information that an ultrafiltration step and an ion exchanger are used in this process, C07 1/18 and C07K 1/34 should be mentioned as well. I2: 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). The catchword “peptide” leads to subclass C07K. A chemist or biochemist would recognise that lactotransferrins are peptides with more than 20 amino acids and therefore proper for C07K 14/00. The subdivision of C07K 14/00 is carried out according to the origin of the peptide. The lactotransferrins are extracted from milk and are therefore from animals, which is considred in C07K 14/435. In subgroup C07K 14/79 transferrins and namely lactoferrins are mentioned as special types of peptides from animals or humans, which is therefore a correct IPC place. Immunoglobulins are a special form of peptides and are covered by C07K 16/00. The origin of the immunoglobulins is as well the criteria for the subdivision of C07K 16/00. Immunoglobulins from milk are covered by C07K 16/04. The “pharmaceutical composition” (see claim 18) is an informative part of the I3: 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. Lactotransferrins are peptides with more than 20 amino acids, so that C07K 38/04 is first of all the correct one dot group. According to the classification of the peptides per se in C07K in A61K a specification of the peptides as lactoferrins is possible as well in A61K 38/40. In the Advanced Level the best IPC place to classify a medicinal preparation containing immunglobulins is A61K 39/395. In the description of the document (see GB document, page 2, lines 20 to 22) A1: 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. In A61P 31/04 a further specification as an antibacterial agent is possible. Subject Matter I1 Anaylsis of Analysis of IPC CL Subclass Group IPC (2006) Selection Selection Subclass/group Subcalss C07K Last place priority title rule Subclass/group C07K 1/00 IPC AL C07K 1/36 C07K 1/34 C07K 1/18 I2 I3 A1 C07K Last place priority C07K 14/435, C07K 14/79, title rule C07K 16/04 C07K 16/04 Subclass/group A61K Last place priority A61K 38/16, A61K 38/40, title rule A61K 39/395 A61 K 39/395 Reference in A61K A61P Common rule A61P 31/00 A61P 31/04 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 1/36 (2006.01) C07K 1/34 (2006.01) C07K 1/18 (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