医疗方法的专利保护研究

    It has also been held that a therapeutic treatment of animals did not lose its therapeutic character simply because it had the side effect of increasing meat production from the treated animals. Nor should a treatment be considered as being other than therapeutic simply because it was ancillary to a treatment for a different purpose (contraception).

    A different approach to the question of contraception was followed in Contraceptive method/British Technology Group. In this case the claim was a use claim to the use of a specified compound as a contraceptive by application to the cervix of a female. After agreeing that contraception is not a method of therapy for which patent protection is barred, the Board nevertheless maintained the rejection of the claim on the ground that the acts specified in the claim were of a private nature and so the invention as claimed was incapable of industrial application. The fact that acts of contributory infringement would clearly be of industrial applicability was felt to be irrelevant; some act of direct infringement had to be industrially applicable for patentability.[Page]

    Abstract

    1. Chemical compound composed of thenoyl peroxide with the formula see diagramm : EP0004810,P4,F3 for its use in a method of therapeutic treatment for the human or animal body.

    Claims

    Revendications

     1) Application a titre de médicament, notamment de médica

    ment destine au traitement de l'acné, du peroxyde de

    thénoyle de formule

    2) Compositions pharmaceutiques caractérisées en ce qu'elles

    renferment, a titre de principe actif, le peroxyde de

    thénoyle.

    3) Compositions selon la revendication 2, caractérisées en ce qu'elles renferment de 2 à 20 % de principe actif.

    4) Application à titre de produit cosmetique du peroxyde de thénoyle.

    5) Compositions cosmétiques, caractérisées en ce qu'elles renferment le peroxyde de thénoyle.

    6) Compositions selon la revendication 5, caractérisées en ce qu'elles renferment de 0,2 à 20 do de peroxyde de thénoyle.

    此案中， 当产品被表明有多个特征时，保护权利可以给予多个用途。一个产品在人类或者动物身体上的医疗方法中的第一个用途，和它的美容用途可以因此在一个和相同的专利申请中被主张。产品的美容作用如果同时具备医疗作用并不落入EPC第53条(C)的范围，因此可以专利。

    该案件是：欧洲专利申请号 79 400 198.2，在1979年3月28日提起，1979年10月17日公开。优先权日期为法国1978年3月31日。审查部1982年10月15日拒绝。理由是1981年5月6日提交的几个权利要求：1，7，9，10。

    权利要求1是：Medication characterised in that it is composed of thenoyl peroxide with the formula

    SCO-O-O-CO S

    权利要求7是：Pharmaceutical compositions characterised in that they contain thenoyl peroxide as active principle.

    权利要求9是：Use of thenoyl peroxide as a cosmetic product.

    权利要求10是：Cosmetic compositions, characterised in that they contain thenoyl peroxide.

    拒绝理由是：权利要求1、7违反EPC第54(5)。审查部认为：为了满足该条要求，权利要求必须限定于描述的therapeutic indication。申请人反对，认为：EPC54(5)没有明确限定药物（medication）范围。[Page]

    IV. In its interlocutory communications the Board of Appeal proposed certain changes in the wording of the medical claims, principally to bring them into line with Article 54(5). The new wording was accepted by the appellants. The Board also raised the question of Claim 8's admissibility as it was finally worded, it being identical to Claim 9 of the set of claims refused. Claim 9 had not been contested by the first instance, but appeared to the Board to relate to a method of treatment by therapy (Article 52(4) EPC) since it was intended to treat acne, which is a disease.

    申请人在1984年5月4日请求批准如下权利要求。

    1. Chemical compound composed of thenoyl peroxide with the formula SCO-O-O-CO S for its use in a method of therapeutic treatment for the human or animal body.

    2. Chemical compound according to Claim 1 for its antibacterial use.

    3. Chemical compound according to Claim 1 for its antifungal use.

    4. Chemical compound according to Claim 1 for its comedolytic use.

 5. Chemical compound according to Claim 1 for its use in the treatment of acne.

    6. Pharmaceutical compositions characterised in that they contain, as active principle, thenoyl peroxide, as well as an inert pharmaceutical excipient.

    7. Compositions according to Claim 6, characterised in that they contain from 2 to 20% of active principle.

    8. Use as a cosmetic product of thenoyl peroxide.

    9. Cosmetic compositions, characterised in that they contain thenoyl peroxide.

    10. Compositions according to Claim 9, characterised in that they contain from 0.2 to 20% of thenoyl peroxide.

    判决理由：

    1. The appeal complies with Articles 106 to 108 and Rule 64 EPC and is therefore admissible.

    2. The claims' subject-matter does not extend beyond the content of the application as filed. The use of thenoyl peroxide as an active pharmacological substance and as a medication according to Claims 1 to 5 was disclosed in the application as filed (see page 1, lines 15 to 20; page 3, line 34; page 4, line 2 and Claim 1). Claims 6 and 7 are based on the original Claims 2 and 3 and on page 2, lines 11 to 22, of the description. Claims 8 to 10 are the original Claims 4 to 6.

    3. The applicants have submitted to the specialist world the new teaching that thenoyl peroxide can be used as a therapeutic agent, particularly as a medication for treating acne. Thenoyl peroxide, the active principle claimed, has already been described in the prior art (see Monatshefte, Volume 80 (1949), page 739). However, its use in any method according to Article 52(4) EPC is not part of the state of the art and is considered new under Article 54(5) EPC. [Page]

    4. Benzoyl peroxide, a product similar in structure to thenoyl peroxide, is already used for the treatment of acne in human beings, as has been acknowledged by the applicants (see original description, page 3, lines 1 to 13), citing J. Pharm. Sci,. Volume 66 (1977), page 718. Taking account of the closest prior art, the applicants set themselves the problem of finding not only a better medication than benzoyl peroxide for the treatment of acne, but also a product whose antibacterial, antifungal and comedolytic action permitted therapeutic and cosmetic uses. The applicants found in thenoyl peroxide a solution to this problem as set out in Claims 1 to 10. Having taken into consideration the article in Monatshefte, Volume 80 (1949), page 739, the Board sees no reason to question the novelty of the compositions nor of Claims 1 to 10. As regards inventive step, the Board accepts that the two closest prior art documents do not suggest the therapeutic and cosmetic properties shown by the applicants. The document relating to the treatment of acne in no way prompts the idea of looking for such properties in structurally similar products, not even a product like thenoyl peroxide, which has long been known. Moreover, comparative studies presented in the description are conclusive in showing that the solution proposed matches the problem posed. Consequently, in the absence of any other document pointing in this direction, the Board accepts, as did the Examining Division, that the subject-matter of Claims 1 to 10 involves an inventive step.

    5. The reasons given by the Examining Division for refusing the application relate to Claims 1 and 6 only (corresponding to the refused Claims 1 and 7). It remains to be established for the purposes of the appeal whether the wording of Claims 1 and 6 indicating an extended use is admissible under Article 54(5) EPC.

    5.1 In the decision T 128/82 Pyrrolidine derivatives/HOFFMANN- LA ROCHE (OJ 4/1984, page 164), the Board has already considered the question of a first medical indication. It concluded that where a known compound is for the first time proposed and claimed for use in therapy, the fact that a specific use is disclosed in the specification does not in itself call for a restriction of the purpose-limited product claim to that use.

    5.2 The same conclusion applies to the case in suit. As in the other case, the use as a medication of the product claimed has been disclosed to a large extent from the outset in the description (see page 1, line 15 to page 2, line 26, of the description as filed). Claims 1 to 6 are therefore admissible.

    6. Since the Board itself questioned the admissibility of Claim 8, it remains to be examined whether that claim may be accepted. In this context it also has to be established whether a cosmetic indication is distinct from a medical indication. Such a distinction is clearly set out in the description as filed (see page 2, lines 27 to 30).

    6.1 It is clear from reading the description that the anti- bacterial and comedolytic activities that thenoyl peroxide has been shown to have are essential for the treatment of acne and are used in the application only in relation to a local remedy (description, page 6). However, the application shows that pharmaceutical and cosmetic preparations can have very similar, if not identical, forms (see description as filed, page 2, line 1 to page 3, line 6). Consequently, the cosmetic treatment according to the application may also incidentally involve a medical treatment.

    6.2 However, the pharmacological study of thenoyl peroxide presented in the description includes a study of the comedolytic activity. This comedolytic study concentrates on the ratio between the orifice of comedones and their large diameter before and after applying thenoyl peroxide. It shows their transformation into open comedones, allowing the horny comedo matter to extrude (description as filed, page 5, lines 10 to 13). This operation assists in skin cleansing. The Board regards this activity of thenoyl peroxide as one clearly belonging to the field of non- medical body hygiene rather than that of therapy. The benefits gained by this activity in a cosmetic indication should not therefore be considered as being excluded from patentability under Article 52(4) EPC.

6.3 When considering the exclusions from patentability under Article 52(4) EPC the wording of Claim 8 is important. Having discovered for the first time the surprising properties of a chemical product already known in the state of the art and having shown those properties in various uses, the applicant has the right to have those uses protected. In the present case the uses are presented in the description as two methods: a method of medical treatment and a method of non-medical treatment. Under Article 52(4) a method of medical treatment is not patentable but a product for use in that method certainly is. Claims 1 to 7 have been worded accordingly. The method of non-medical treatment is one falling within the general field of patentable inventions. There can be no objection to the patentability of either use or method claims in general. The Enlarged Board of Appeal has held that it is a matter of preference whether any activity is claimed as a method of carrying out the activity or as the use of a thing for a stated purpose. There is no difference of substance (Gr 05/83, Second medical indication/EISAI, OJ 3/1985, page 64 et seq., points 11 and 12 of the Reasons for the Decision). The applicants have chosen the phrase "use as a cosmetic product of thenoyl peroxide". The Board considers that this form of claim is acceptable in the case in suit. In the Board's opinion the question of industrial application does not arise, since professional use of the invention in a beauty parlour is an industrial application within the meaning of Article 57 EPC.

    6.4 The Board considers it useful to add the following remark concerning the wording of Claim 8: To avoid any possible conflict with the provisions of Article 52(4) EPC in a use or indication claim, it would have been possible to envisage the exclusion of the non-patentable invention within the meaning of that article by means of a disclaimer. In the present case the Board considers use of the term "cosmetic" to be sufficiently precise. Without the necessity of going into the provisions of national law in the various countries, which in any case largely point in the same direction (see point V), the term "cosmetic" is used adjectivally for a non-medical substance intended for use on the skin etc. (cf. Grand dictionnaire encyclopédique Larousse). The standard English- and German-language reference works support that definition.

    7. In the circumstances there is no need to examine the alternative request maintained by the appellant. [Page]

    ORDER

    For these reasons, it is decided that

    1. The decision of the Examining Division of the European Patent Office dated 15 October 1982 is set aside.

    2. The case is referred back to the first instance with the order that a European patent be granted on the basis of the following documents: Description, pages 3 to 6 as filed, page 1 received on 3 October 1983 page 2 received on 4 May 1984 Claims1 to 10 received on 20 April 1985.

    技术申诉委员会的一些判决：关于医疗方法专利性。

    T469/94

    A European patent application was filed relating to a method of reducing the perception of fatigue for a person who has participated in, or is about to participate in, major sport. The method involved administering choline. Choline was known for the treatment of muscular diseases. The Board considered that muscular fatigue was not a disease, but was a natural state for a healthy person. As such, fatigue was not comparable with the pathological state typical of a disease or injury. Thus, the Board considered that such treatment of fatigue was not a therapeutic method and hence not excluded from patentability. Also, the Board considered whether the therapeutic and non-therapeutic effects were distinguishable from each other. The Board decided that the effects were distinguishable since the methods would be applied to different groups of patients. Therefore, the methods were distinguishable from each other.

    Comment:This decision confirms that treatment of healthy humans or animals, for reasons other than prophylactic, are patentable. Also the fact that the treatment can have therapeutic effects is not a bar to patentability where the treatment is not applied to a sick patient.

    T655/92：第二医疗用途权利要求。诊断方法。本案关系到This case relates to a contrast medium for use in a method of in vivo nuclear magnetic resonance (NMR) imaging of a patient. The contrast medium was known as such. Also a first medical use of the contrast medium was known. The applicant therefore filed a claim in the “second medical use” format. The EPO allows so-called “first medical use” claims and “second medical use” claims. A first medical use claim (cf. Art. 54(5)) is a claim to ’substance X for use in medical method Z’. Article 54(5) expressly limits “first medical use” claims to substances or compositions for use in a medical method which is excluded from patentability by virtue of Article 52(4). A second medical use claim is used where there is already a known medical use. The claim is set out as ’the use of substance X in the manufacture of substance Y for use in medical method Z’. The Board considered that the same considerations should apply to such “second medical use” claims. The Board then went on to investigate whether the use of a contrast medium in NMR imaging is indeed subject-matter excluded from patentability as a diagnostic method. The Board came to the conclusion that such a method was a diagnostic method excluded from patentability. The Board therefore allowed the inclusion of “second medical use” claims.

    评论：First and second medical use claims derive their novelty from the specified intended use. It is however important to first establish that a direct claim to their use would be excluded from patentability as a medical or diagnostic method. If this is the case then claims in the first or second medical use format can be included in an application.

    黑白区域少，灰色区域多。

    加拿大公司使用创造性的专利战略，允许投资者保护似乎不可专利的发明。它们还可以获得美国专利来利用美国更自由得美国专利法。美国专利法保护更多更宽的保护。一些领域里，发明人京城不知道专利保护的边界。

    在加拿大，医疗方法阿不能得到专利。然而，这种发明可以北保护，通过制作通用专利权利要求为了使用一个药物或者装置，而且忽略执行医疗程序或者管理药物的步骤。

    这种抓你并不试图包含技术人员的技巧。该技巧是医疗方法的构成部分。一个新药物或者医疗器械的专利也保护它，因为任何医疗使用该药物或者器械将侵犯专利权。在美国，医疗方法专利可以。无论方法是否包含外科，医疗器械，或者管理药物。

    A. The Patents

    The three patents at issue, all of which are assigned to Institut Pasteur, are directed to structural components of and methods of detecting the presence of two types of Human Immunodeficiency Virus ("HIV"), HIV-1 and the less common HIV-2. Infection with either type of HIV leads to Acquired Immune Deficiency Syndrome ("AIDS"), and thus assays that can detect HIV-1 and HIV-2 are crucial to diagnosing, treating, and arresting the spread of AIDS. The '861 patent generally pertains to certain HIV-1 peptides (amino acid sequences which comprise part of the structure of the virus) and methods for detecting the presence of HIV-1. The '391 patent is directed to diagnostic assays for detecting the presence of HIV-2, and the '496 patent claims a number of structural peptides of HIV-2. The issues central to this appeal focus on the interpretation of licensing agreements that govern these patents, not on the claims or any other aspect of the patents themselves.

    5,217,861

    Assignee: Institut Pasteur (FR)

    1. An in vitro diagnostic method for the detection of the presence or absence of antibodies which bind to antigens of human retrovirus indicative of Acquired Immune Deficiency Syndrome (AIDS) or of Lymphadenopathy Associated Syndrome (LAS), which method comprises   contacting isolated p18 protein of said retrovirus with a biological fluid for a time and under conditions sufficient for the protein and antibodies in the biological fluid to form a complex; and   detecting the formation of the complex. [Page]

    2. The method as claimed in claim 1, wherein the detecting step further comprises measuring the formation of said complex.

    3. The method as claimed in claim 1, wherein the biological fluid is human serum.

    4. Structural protein of Human Immunodeficiency Virus (HIV), which is p18 protein of said virus, and said protein is in isolated form.

    5. A labeled polypeptide, wherein   the polypeptide is capable of being immunologically recognized by serum of a patient afflicted with Lymphadenopathy Syndrome (LAS) or Acquired Immune Deficiency Syndrome (AIDS);     the polypeptide is p18 protein of Human Immunodeficiency Virus (HIV) in isolated form; and  said label is an immunoassay label selected from the group consisting of a radioactive label, an enzyme label, and a fluorescent label.

    6. An in vitro diagnostic method for the detection of the presence or absence of antibodies which bind to antigens of human retrovirus indicative of Acquired Immune Deficiency Syndrome (AIDS) or of Lymphadenopathy Associated Syndrome (pre-AIDS), which method comprises  contacting an isolated antigen mixture comprising

     (A) p18 protein of said retrovirus, and

     (B) p25 protein of said retrovirus, with a biological fluid, for a time and under conditions sufficient for the antigen and antibody in the biological fluid to form an antigen-antibody complex; and detecting the formation of the complex.

     7. An isolated mixture of structural proteins of Human Immunodeficiency Virus (HIV), wherein the proteins are p18 and p25 proteins.

     8. An in vitro diagnostic method for the detection of the presence or absence of antibodies which bind to antigens of human retrovirus indicative of Acquired Immune Deficiency Syndrome (AIDS) or of Lymphadenopathy Associated Syndrome (LAS), which method comprises

   contacting p12 protein of said retrovirus with a biological fluid for a time and under conditions sufficient for the protein and antibodies in the biological fluid to form a complex; and detecting the formation of the complex.

    9. Structural protein of Human Immunodeficiency Virus (HIV), which is p12 protein of said virus, and said protein is in isolated form.

    10. A labeled polypeptide, wherein the polypeptide is capable of being immunologically recognized by antibodies in the serum of a patient afflicted with Lymphadenopathy Syndrome (LAS) or Acquired Immune Deficiency Syndrome (AIDS); the polypeptide is p12 protein of Human Immunodeficiency Virus (HIV) in isolated form; and said label is an immunoassay label selected from the group consisting of a radioactive label, an enzyme label, and a fluorescent label. [Page]

    11. A mixture of structural proteins of Human Immunodeficiency Virus (HIV), wherein the proteins are selected from the group consisting of p12, p18, and p25 proteins, and the mixture is in isolated form.

    5,055,391

    Assignee: Institut Pasteur (Paris, FR)

    What is claimed is:

    1. An in vitro diagnostic method for the detection of the presence or absence of human antibodies which bind to antigens of a human retrovirus, which is Human Immunodeficiency Virus Type 2 (HIV-2), indicative of Lymphadenopathy, wherein said antigens comprise protein antigen, glycoprotein antigen, peptide antigen, or a mixture thereof of HIV-2, and wherein said method comprises

    contacting antigens of HIV-2 with a biological fluid for a time and under conditions sufficient for the antigens and antibodies in the biological fluid to form antigen-antibody complexes, and detecting the formation of the complexes.

    2. The method of claim 1, wherein the biological fluid is human serum.

    3. The method of claim 1, wherein the biological fluid is from a patient with pre-AIDS.

    4. The method of claim 1, wherein the human retrovirus is a human retroviral variant of LAV-2 which is cytopathic for human lymphocytes.

    5. The method of claim 1, wherein the biological fluid is simultaneously contacted with a mixture of antigens comprising protein, glycoprotein, and peptides of Lymphadenopathy Associated Virus Type 1 (LAV-1) capable of binding to human antibodies, in an amount sufficient to detect the presence or absence of human antibodies which bind to antigens of LAV-1. [Page]

    6. The method of claim 1, wherein the antigens comprise a lysate of HIV-2 and the antigens are capable of being immunologically recognized by serum of a patient afflicted with Lymphadenapathy Syndrome (LAS), Acquired Immune Deficiency Syndrome (AIDS), or AIDS Related Complex (ARC).

    7. The method of claim 1, wherein the antigens comprise at least one protein or glycoprotein of HIV-2 selected from the group consisting of p16, p26, gp 36, and gp 130-140.

    8. The method of claim 1, wherein the antigens comprise p16 and p26 proteins of HIV-2.

    9. The method of claim 1, wherein the antigens comprise gp 36 glycoprotein of HIV-2.

    10. The method of claim 1, wherein the antigens comprise gp 130-140 glycoprotein of HIV-2.

    11. The method of claim 1, wherein the antigens comprise p26 protein and gp36 glycoprotein of HIV-2.

    12. The method of claim 1, wherein the antigens comprise p26 protein and gp 36 glycoprotein and gp 130-140 glycoprotein of HIV-2.

    13. The method of claim 1, wherein the antigens comprise p16 and p26 proteins and gp 130-140 glycoproteins of HIV-2.

    14. The method of claim 1, wherein the biological fluid is also contacted with antigens indicative of Human Immunodeficiency Virus Type 1 (HIV-1), which are capable of binding to human antibodies, in an amount sufficient to detect the presence or absence of human antibodies which bind to antigens of HIV-1, wherein said antigens comprise protein antigen, glycoprotein antigen, peptide antigen, or a mixture thereof indicative of HIV-1.

    15. The method of claim 14, wherein the antigens of HIV-1 are selected from the group consisting of p18, p25, gp 41-43, gp 110/120, and mixtures thereof, of HIV-1.

  16. The method of claim 14, wherein the antigens of HIV-1 comprise p25 and gp 41 of HIV-1.

    17. The method of claim 14, wherein the antigens are isolated from lysates of HIV-1 and HIV-2 by affinity chromatography and fixed to a water-insoluble support.

    18. The method of claim 1, wherein the antigens are fixed to a water-insoluble support.

    19. The method of claim 1, wherein the antigens are fixed to water-insoluble spheres.

    20. The method of claim 1, wherein the antigens are fixed to water-insoluble agarose spheres.

    21. The method of claim 1, wherein the antigens are fixed to wells of a titration microplate.

    22. The method of claim 1, wherein the antigens do not immunologically cross-react with p19 protein or p24 protein of human T-lymphotropic virus type 1 (HTLV-I) or of human T-Lymphotropic virus type 2 (HTLV-II).

    23. A diagnostic kit for the detection of the presence or absence of human antibodies which bond to antigens of Human Immunodeficiency Virus Type 2 (HIV-2) indicative of lymphadenopathy, wherein said antigens comprise protein antigen, glycoprotein antigen, peptide antigen, or a mixture thereof, and wherein said kit comprises antigens of HIV-2, a reagent to detect antigen-antibody complexes that comprise said antigens, a biological reference material lacking antibodies that immunologically bind with said antigens,a comparison sample comprising antibodies of HIV-2, and wherein said antigens, reagent, and biological reference material are present in an amount sufficient to perform said detection. [Page]

    24. The diagnostic kit of claim 23, wherein said immune complexes are detected by employing immunological labels selected from the group consisting of radioisotopes, enzymes, and fluorescent labels.

    25. The diagnostic kit of claim 23, wherein said kit also contains antigens of Lymphadenopathy Associated Virus Type 1 (LAV-1), wherein said antigens comprise a mixture of protein, glycoprotein, and peptides of Lymphadenopathy Associated Virus Type 1 (LAV-1) capable of binding to human antibodies, in an amount sufficient to detect the presence or absence of human antibodies which bind to antigens of LAV-1.

    26. An in vitro diagnostic method for the detection of the presence or absence of human antibodies which bind to antigens indicative of a human retrovirus, which is Human Immunodeficiency Virus Type 2 (HIV-2), wherein said antigens comprise protein antigen, glycoprotein antigen, peptide antigen, or a mixture thereof indicative of HIV-2, and wherein said method comprises contacting said antigens with a biological fluid for a time and under conditions sufficient for the antigens and antibodies in the biological fluid to form an antigen-antibody complex, wherein said antigens are substantially free of viral particles, and detecting the formation of the complex.

    27. The method of claim 26, wherein the biological fluid is human serum.

    28. The method of claim 26, wherein the antigen is a peptide.

    29. The method of claim 26, wherein the antigen is a glycoprotein.

    30. The method of claim 26, wherein said antigen is labeled with a immunoassay label selected form the group consisting of radioisotopes, enzymes, and fluorescent labels.

    31. The method of claim 26, wherein the human retrovirus is LAV-2.

    32. The method of claim 21, wherein the human retrovirus is a human retroviral variant of LAV-2 which is cytopathic for human lymphocytes.

    33. The method of claim 26, wherein the antigens are derived from a retrovirus having the characteristics of the virus deposited under culture collection accession number C.N.C.M. No. I-502.

    34. The method of claim 26, wherein the antigens are derived from a retrovirus having the characteristics of the virus deposited under culture collection accession number C.N.C.M. No. I-532.

    35. The method of claim 26, wherein the antigens comprise an extract of HIV-2, and the antigens are capable of being immunologically recognized by sera of a patient afflicted with Lymphadenopathy Syndrome (LAS), Acquired Immune Deficiency Syndrome (AIDS), or AIDS Related Complex (ARC).

    36. The method of claim 26, wherein the antigen is an external envelope protein of HIV-2.

    37. The method of claim 26, wherein the antigen is a transmembrane protein.

    38. The method of claim 26, wherein the antigen is a major core protein of HIV-2.

    39. The method of claim 26, wherein the antigen is a core protein of HIV-2, other than a major core protein of HIV-2.

    40. The method of claim 26, wherein the antigens comprise at least one protein or glycoprotein of HIV-2 selected from the group consisting of p16, p26, gp 36, and gp 130-140.

    41. The method of claim 26, wherein the antigens comprise p16 and p26 proteins of HIV-2.

    42. The method of claim 26, wherein the antigens comprise gp 36 glycoprotein of HIV-2.

    43. The method of claim 26, wherein the antigens comprise gp 130-140 glycoprotein of HIV-2.

    44. The method of claim 26, wherein the antigens comprise p26 protein and gp36 glycoprotein of HIV-2.

    45. The method of claim 26, wherein the antigens comprise p26 protein and gp 36 glycoprotein and gp 130-140 glycoprotein of HIV-2.

    46. The method of claim 26, wherein the antigens comprise p16 and p26 proteins and gp 130-140 glycoproteins of HIV-2.

    47. The method of claim 26, wherein the biological fluid is also contacted with antigens indicative of Human Immunodeficiency Virus Type 1 (HIV-1), which are capable of binding to human antibodies, in an amount sufficient to detect the presence or absence of human antibodies which bind to antigens of HIV-1. [Page]

    48. The method of claim 47, wherein the antigens of HIV-1 are selected from the group consisting of p18, p25, gp 41-43, gp 110/120, and mixtures thereof, of HIV-1.