Nova Patents
IL190885A

Immunogenic compositions and methods of use

Abstract

This record has no abstract on file.

IL190885A, drawing sheet 1
Sheet 1 of 168

Term

No projected expiry on record.

  1. Priority
  2. Filed
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16 claims: 3 independent, 13 dependent

  1. 1
    An immunogenic composition, comprising a multilayer film comprising two or more layers of polyelectrolytes, wherein adjacent layers comprise oppositely charged polyelectrolytes, wherein a first layer polyelectrolye comprises a first antigenic polypeptide comprising one or more surface adsorption regions covalently linked to one or more antigenic determinant regions, wherein the antigenic polypeptide and the one or more surface adsorption regions have the same polarity, wherein the one or more surface adsorption regions comprises one or more amino acid sequence motifs, the one or more amino acid sequence motifs consisting of 5 to 15 amino acids and having a magnitude of net charge per residue of greater than or equal to 0.4, and wherein the one or more antigenic determinant regions comprises 3 to about 250 amino acid residues, wherein the first antigenic polypeptide is not a homopolymer, is at least 15 amino acids long, and has an aqueous solubility at pH 4 to 10 of greater than 50 pg/ml;wherein a second layer comprises a second layer polyelectrolyte comprising a polycationic material or a polyanionic material having a molecular weight of greater than 1,000 and at least 5 charges per molecule, and a charge opposite that of the first layer polypeptide.
  2. 14
    An immunogenic composition for eliciting an immune response in a vertebrate organism, wherein the immunogenic composition comprises, a multilayer film comprising two or more layers of polyelectrolytes, wherein adjacent layers comprise oppositely charged polyelectrolytes, wherein a first layer polyelectrolye comprises an antigenic polypeptide comprising one or more surface adsorption regions covalently linked to one or more antigenic determinant regions, wherein the antigenic polypeptide and the one or more surface adsorption regions have the same polarity, wherein the one or more surface adsorption regions comprises one or more amino acid sequence motifs, the one or more amino acid sequence motifs consisting of 5 to 15 amino acids and having a magnitude of net charge per residue of greater than or equal to 0.4, and wherein the one or more antigenic determinant regions comprises 3 to about 250 amino acid residues, wherein the antigenic polypeptide is not a homopolymer, is at least 15 amino acids long, and has an aqueous solubility at pH 4 to 10 of greater than 50 pg/ml;wherein a second layer comprises a second layer polyelectrolyte comprising a polycationic material or a polyanionic material having a molecular weight of greater than 1,000 and at least 5 charges per molecule, and a charge opposite that of the first layer polypeptide.
  3. 15
    A method of making an immunogenic composition, the method comprising:depositing a first layer polyelectrolyte on a surface of a substrate to form a first layer;wherein, a first layer polyelectrolye comprises a first antigenic polypeptide comprising one or more surface adsorption regions covalently linked to one or more antigenic determinant regions, wherein the antigenic polypeptide and the one or more surface adsorption regions have the same polarity, wherein the one or more surface adsorption regions comprises one or more amino acid sequence motifs, the one or more amino acid sequence motifs consisting of 5 to 15 amino acids and having a magnitude of net charge per residue of greater than or equal to 0.4, and wherein the one or more antigenic determinant regions comprises 3 to about 250 amino acid residues, wherein the first antigenic polypeptide is not a homopolymer, is at least 15 amino acids long, and has an aqueous solubility at pH 4 to 10 of greater than 50 pg/ml;depositing a second layer polyelectrolyte on the first layer polyelectrolyte to form a second layer;wherein a second layer comprises a second layer polyelectrolyte comprising a polycationic material or a polyanionic material having a molecular weight of greater than 1,000 and at least 5 charges per molecule, and a charge opposite that of the first layer polypeptide. Anmelde-Nr: Application No: 06 844 221.9 Demande n°: Blatt Sheet Feullle Datum Date 04.01.2010 Date The examination is being carried out on the following application documents Description, Pages 1-36 as published Sequence listings part of the description, Pages 1-5 as published Claims, Numbers I- 10 filed with entry into the regional phase before the EPO II- 15 filed with telefax on 05-06-2009 Drawings, Sheets 1/4-4/4 as published Amendments The amendments filed with the telefax on 05.06.2009 are in not accordance with Article 123(2) EPC. No clear basis in the original application can be found for the the non-therapeutic method of claim 15, since the passage in paragraph [00102] relates to a therapeutic use only. Patentability Amended claim 15 is directed to a method of eliciting a non-therapeutic immune response in a vertebrate organism. The step of administering encompasses a surgical method (e.g. intravenous or intramuscular administation, see paragraph [00102]), which may not be patentable under Article 53(c) EPC (see also pending decision G1/07). Furthermore, the present method encompasses the use of human beings to raise antibodies, which is contrary to morality, and therefore not acceptable under Article 53(a) EPC. Novelty The present application does not meet the criteria of Article 54 EPC, because the subject - matter of claim 1 is not new. The document D1 discloses (the references in parentheses applying to this document) a multilayer film wherein a first layer comprises polypeptides which have 32 or 48 amino acid residues and which comprise one or more amino acid sequence motifs EPO Form 2906 01.91TRI Anmelde-Nr: Application No: 06 844 221.9 Demanden“: Blatt Sheet Feullle Datum Date 04.01.2010 Date consisting of from 5 to 15, preferably 7, amino acid residues and having a magnitude of a net charge per residue of more than 0.5 at neutral pH (see abstract, figures 1-3, 6 and page pages 294-297). Due to their net charge greater than 0.5, the first peptide of D1 has inherently an aqueous solubility at pH 4 to 10 of greater than 50 pg/ml. The second layer comprises oppositely-charged polyelectrolytes (see page 294). Since the immunogenic composition is defined only in terms of the multilayer film and all the technical features of the claimed multilayer film are disclosed in D1, the subjectmatter of independent claim 1 is not new. The document D2 discloses (the references in parentheses applying to this document) a multilayer film wherein a first layer comprises polypeptides which comprise one or more amino acid sequence motifs consisting of from 5 to 15, preferably 7, amino acid residues and having a magnitude of a net charge per residue of more than 0.5 at neutral pH (see paragraphs [0061 -0065], claim 21, figures 1 and 5). Due to their net charge greater than 0.5, the first peptide of D2 has inherently an aqueous solubility at pH 4 to 10 of greater than 50 pg/ml. The second layer comprises oppositely-charged polyelectrolytes. Since the immunogenic composition is defined only in terms of the multilayer film and all the technical features of the claimed multilayer film are disclosed in D2, the subjectmatter of independent claim 1 is not new. The applicant argues in his letter of 05.06.2009 that the polypeptides of the films of D1 and D2 do not have an antigenic determinant region covalently linked to the known surface absorption region. However, the antigenic determinant region of claim 1 is only defined by the number of amino acid residues of at least three amino acid residues. An antigenic determinant region of three amino acid residues covalently linked to a short surface adsorption region of e.g. five amino acids falls under the scope of the polypeptides of the films of D1 and D2. It is also noted that such polypeptides are capable of eliciting an immune response, see also paragraphs [0035] and [0036] of the present application. Consequently, there seems to be no structural or even a functional difference between an antigenic determinant region on the one hand and a surface adsorption region on the other hand. Clarity Claim 1 is unclear in the sense of Article 84 EPC, because the antigenic polypeptide comprises surface adsorption region(s) and antigenic determinant region(s), wherein the antigenic polypeptide and the surface adsorption region(s) have the same polarity. It is unclear how the antigenic polypeptide and one of its component can have the same polarity. It seems that the phrase should read as wherein the one or more antigenic determinant regions and the one or more surface adsorption regions have the same (net) polarity. Conclusion EPO Form 2906 01.91TRI Anmelde-Nr: Application No: 06 844 221.9 Demande n°: Blatt Sheet Feullle Datum Date 04.01.2010 Date It is not at present apparent which part of the application could serve as a basis for a new, allowable claim. Should the applicant nevertheless regard some particular matter as patentable, an independent claim should be filed taking account of Rule 43(1) EPC. The applicant should also indicate how the subject-matter of the new claim differs from the state of the art and the significance thereof. EPO Form 2906 01.91TRI 05/06 '09 16:35 FAX 441865305111 EPO MUNICH @004 11. The immunogenic composition of claim 1, wherein the multilayer film encapsulates one or more non-peptide bioactive molecule. 12. The immunogenic composition of claim 1, wherein the multilayer film is in the form of a microcapsule. 13. The immunogenic composition of claim 12, wherein the microcapsule comprises a core, and the core comprises an additional bioactive molecule wherein the additional bioactive molecule comprises a drug, a protein, an oligonucleotide, a nucleic acid, a lipid, a phospholipid, a carbohydrate, a polysaccharide, a lipopolysaccharide, or a combination of one or more of the foregoing bioactive molecules. 14. An immunogenic composition for eliciting a therapeutic immune response in a vertebrate organism, wherein the immunogenic composition comprises, a multilayer film comprising two or more layers of polyelectrolytes, wherein adjacent layers comprise oppositely charged polyelectrolytes, wherein a first layer polyelectrolye comprises an antigenic polypeptide comprising one or more surface adsorption regions covalently linked to one or more antigenic determinant regions, wherein the antigenic polypeptide and the one or more surface adsorption regions have the same polarity, wherein the one or more surface adsorption regions comprises one or more amino acid sequence motifs, the one or more amino acid sequence motifs consisting of 5 to 15 amino acids and having a magnitude of net charge per residue of greater than or equal to 0.4, and wherein the one or more antigenic determinant regions comprises 3 to about 250 amino acid residues, wherein the antigenic polypeptide is not a homopolymer, is at least 15 amino acids long, and has an aqueous solubility at pH 4 to 10 of greater than 50 pg/ml;wherein a second layer comprises a second layer polyelectrolyte comprising a polycationic material or a polyanionic material having a molecular weight of greater than 1,000 and at least 5 charges per molecule, and a charge opposite that of the first layer polypeptide. Received at the EPO on Jun 05, 2009 17:31:09. Page 4 of 8 05/06 '09 16:35 FAX 441865305111 -> EPO MUNICH @005 15. A method of eliciting a non-therapeutic immune response in a vertebrate organism, comprising administering into the vertebrate organism an immunogenic composition comprising a multilayer film comprising two or more layers of polyelectrolytes, wherein adjacent layers comprise oppositely charged polyelectrolytes, wherein a first layer polyelectrolye comprises an antigenic polypeptide comprising one or more surface adsorption regions covalently linked to one or more antigenic determinant regions, wherein the antigenic polypeptide and the one or more surface adsorption regions have the same polarity, wherein the one or more surface adsorption regions comprises one or more amino acid sequence motifs, the one or more amino acid sequence motifs consisting of 5 to 15 amino acids and having a magnitude of net charge per residue of greater than or equal to 0.4, and wherein the one or more antigenic determinant regions comprises 3 to about 250 amino acid residues, wherein the antigenic polypeptide is not a homopolymer, is at least 15 amino acids long, and has an aqueous solubility at pH 4 to 10 of greater than 50 pg/ml;wherein a second layer comprises a second layer polyelectrolyte comprising a polycationic material or a polyanionic material having a molecular weight of greater than 1,000 and at least 5 charges per molecule, and a charge opposite that of the first layer polypeptide.
  4. 16
    A method of making an immunogenic composition, the method comprising:depositing a first layer polyelectrolyte on a surface of a substrate to form a first layer;wherein, a first layer polyelectrolye comprises a first antigenic polypeptide comprising one or more surface adsorption regions covalently linked to one or more antigenic determinant regions, wherein the antigenic polypeptide and the one or more surface adsorption regions have the same polarity, wherein the one or more surface adsorption regions, comprises one or more amino acid sequence motifs, the one or more amino acid sequence Received at the EPO on Jun 05, 2009 17:31:09. Page 5 of 8 05/06 16:36 09 י FAX 441865305111 -» EPO MUNICH @006 motifs consisting of 5 to 15 amino acids and having a magnitude of net charge per residue of greater than or equal to 0.4, and wherein the one or more antigenic determinant regions comprises 3 to about 250 amino acid residues, wherein the first antigenic polypeptide is not a homopolymer, is at least 15 amino acids long, and has an aqueous solubility at pH 4 to 10 of greater than 50 μg/ml;depositing a second layer polyelectrolyte on the first layer polyelectrolyte to form a second layer;wherein a second layer comprises a second layer polyelectrolyte comprising a polycationic material or a polyanionic material having a molecular weight of greater than 1,000 and at least 5 charges per molecule, and a charge opposite that of the first layer polypeptide.
Independent claims4