US PATENT CLASS 436
Class Notes


Current as of: June, 1999
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436 /   HD   CHEMISTRY: ANALYTICAL AND IMMUNOLOGICAL TESTING



DEFINITION

Classification: 436/

This is the generic class for:

A. Processes which involve a chemical reaction for determining qualitatively or quantitatively the presence of a chemical element, compound or complex in a composition or a chemical compound, or an element or radical in a compound.

B. Process for analysis which involve an in vitro antigen-antibody, immunological or protein binding interaction other than those involving a living antigen, or enzyme label.

C. Processes of analysis or study of the chemical properties of a sample; the physiological effect of a sample; or chemical determination of a physical property of a sample.

D. Compositions and their mere methods of use of thermoparticulating compositions.

E. Chemical test standards for A, B, and C.

F. Analytical compositions for A, B or C subject to the caveat lin Lines With Other Classes, Other Search Notes, "A. Class 252 Compositions Search," below.

G. Combinations of tests or measurements with methods of regulating a chemical reaction not otherwise provided for in a chemical synthesis class or otherwise.

(1) Note. For an elaboration of the distinction between subclasses 1-146 and subclasses 147-181 which provide for methods of examining the results of a significant chemical interaction see Lines With Other Classes, "Classification Guidelines For This Class," below. LINES WITH OTHER CLASSES

CLASSIFICATION GUIDELINES FOR THIS CLASS

A. Compositions: Standards and Analytical Compositions used to prepare a sample for chemical testing or to standardize a

test procedure are classifiable in subclasses 8-19. Subclasses 8-19 will also provide for the process of use of such standards to calibrate a test procedure but will not provide for a comprehensive chemical test process including calibrating and analytical testing of an unknown. Compositions used for qualitative or quantitative chemical testing are classifiable with their process of use.

Class 516 provides for compositions otherwise seemingly proper for Class 436 when the compositions are subject matter relating to: colloid systems (such as sols*, emulsions, dispersions, foams, aerosols, smokes, gels, or pastes) or wetting agents (such as leveling, penetrating, or spreading); subcombination compositions of colloid systems containing at least an agent specialized and designed for or peculiar to use in making or stabilizing colloid systems; compositions and subcombination compositions specialized and designed for or peculiar to use in breaking (resolving) or inhibiting colloid systems; processes of making the compositions or systems of the class; processes of breaking (resolving) or inhibiting colloid systems.

B. Testing Processes: Methods of chemical testing or analysis are classifiable on the basis of the specie tested for if such specie is claimed or solely disclosed. Subclasses 147 - 181 provide for processes not limited by claim or sole disclosure to the concepts of subclasses 1-146. If placement in subclasses 147 - 181 appears proper, two cautions should be observed. First, the claim or claims in question should be scrutinized for the presence of a significant chemical interaction which is not merely the application of measuring technique otherwise classifiable in another class. Second, due to long-standing conflicts and nonuniform practice in the determination of significant chemistry, classification in subclasses 147 - 181 indicates that at least a cursory search should be made of the class providing for the appropriate technique absent significant chemistry.

A method of testing for a disease or condition if by claim or disclosure is a test for a particular chemical specie and classification is proper in the subclass providing for that specie.

A test for an extract or factor is properly classifiable in the subclass providing for the major chemical constituents as determined by the disclosure or a standard reference work.

A process directed to the analysis of a complex is classified on the basis of the first appearing member of the complex.

A process testing a flue gas, off gas, combustible gas, or other gaseous composition for a particular claimed or solely disclosed species should be classified with that species. A broad analysis claim should be classified in subclasses 147 - 181.

A broadly recited anion or cation test is classifiable in subclasses 147-181. A test to determine the utility or suitability if a sample for some use or some generalized property (e.g., toxicity, etc.) is properly classifiable in subclasses 2+.

C. Presumptive Identity: In the absence of a clear showing to the contrary the following will control classification. Terms are followed by their Presumed Classification

Term : "acidic" or "basic" component Presumed classified as: inorganic acid or base

Term : ginsing extract Presumed classified as: saponin

Term : hydrocarbon Presumed classified as: compound of hydrogen and carbon only

Term : isotopes Presumed classified as: nonisotopic form

Term : marahuana Presumed classified as: tetrahydrocannabinol

Term : octane test Presumed classified as: hydrocarbon

Term : organo Presumed classified as: hydrocarbon derivative

Term : "organic compound" Presumed classified as: by technique in 147 - 183

GENERAL NOTE

The mere presence of a chemical reaction is not generally sufficient to place a patent in this class. This class provides for the qualitative and quantitative analysis of chemical compounds, complexes and elements which at some point involve a chemical interaction. In other words, the subject matter of this class involves an investigation of what chemical specie is present and/or how much of the specie is present or investigates some chemical property of a sample. The technique used to detect the result of chemical interaction need not be chemical but may involve a physical, optical or electrical measurement. No attempt should be made to apply or generalize the lines of any given class to any other given class in regard to this class. In any instance where the line notes use the word significant or nominal this is especially true and the limits of such terms can only be determined on a case by case basis in view of an examination of the patents in the involved class. See References to Other Classes, below, for the lines between this class (436) and related classes. OTHER SEARCH NOTES

A. Class 252 Compositions Search.

This class was created by incorporation of chemical standards and chemical testing compositions from Class 252, subclass 408.1. The superior subclasses in 252 other than subclass 1 were not screened to remove all chemical test compositions or standards properly classifiable therein. Thus, when considering the proper search and classification of a chemical testing composition Class 252 should always be consulted. Upon conclusion that 252 does not provide for the subject composition, the composition is properly classifiable in this class.

B. Class 424 in vivo/ in vitro line.

Class 436, subclasses 500+ incorporate patents to in vitro antigen-antibody, immunological, or protein binding tests formerly classified in Class 424, subclass 1.5 (which no longer exists) and subclasses 2+. Class 424 continues to provide for in vivo antigen-antibody, immunological, or protein binding tests when the final testing or diagnosis step occurs in or on the living body. A document which includes the in vivo production of an in vitro test material or reagent, such as the in vivo production or treatment of an antigen or antibody used in an immunoassay, will be provided for the Class 436 (see especially subclasses 543-548).

C. Analysis in combination with other chemical processes.

This class includes tests or measurements of any type claimed in association with a chemical reaction when the reaction is not part of a process elsewhere classifiable. Measurements and tests when claimed in association with e.g., condition responsive control, etc., chemical processes provided for in other classes, e.g., 208, 260, 435 etc., are classified in the class providing for the chemical process.

D. Immobilized peptides, namely proteins, enzymes and immunologically active species

Immobilized peptides, namely proteins, enzymes and immunologically active species are classified in Classes 260, 435 and 436 respectively. In the instance where the claims are directed to a generic immobilization process with or without species claims to the particular peptides the order of superiority of placement is 435, 436, and 260 (including the resin series). Class 424 will take a composition which may contain any of the immobilized species above as a composition for the treatment of the living body and will control placement.

E. Composition class superiority.

The rules for determining Class placement of the Original Reference (OR) for claimed chemical compositions are set forth in the Class Definition of Class 252 in the section LINES WITH OTHER CLASSES AND WITHIN THIS CLASS, subsection COMPOSITION CLASS SUPERIORITY, which includes a hierarchical ORDER OF SUPERIORITY FOR COMPOSITION CLASSES.

REFERENCES TO OTHER CLASSES

SEE OR SEARCH CLASS

71, Chemistry: Fertilizers, provides for a process of soil analysis combined with the application of Class 71 composition in response to the analysis.

436, Chemistry: Analytical and Immunological Testing, provides for a process of qualitative or quantitative chemical analysis of a soil sample.

73, Measuring and Testing, is the generic class for making a measurement or test of any kind not provided for in other classes. Class 73 is also the generic class for sampling processes and apparatus not otherwise provided for (Class 73 provides in Note (3) of the Class Definition an extensive listing of classes for measuring and testing, per se, and a sampling).

436, Chemistry: Analytical and Immunological Testing, provides for processes of analysis which involve a chemical reaction and a qualitative or quantitative measurement or test and such processes including sampling or sample preparation (For a more precise indication of the line between this class and Class 73 the line and search notes indexed in section IV should be consulted).

116, Signals and Indicators, provides for a signal or indicator wherein the signal or indicator is given by a chemical reaction, e.g., change in color, smoke, odor etc. Class 116 provides for a temperature indicator which has a single temperature indication.

436, Chemistry: Analytical and Immunological Testing, provides for a method of qualitative or quantitative chemical analysis.

128, Surgery, provides for methods including the use of claimed specific structure adapted to be placed on or in the living body and further includes diagnostic or therapeutic methods and apparatus when the only disclosed utility is for diagnosis or treatment of a living body.

436, Chemistry: Analytical and Immunological Testing, provides for methods of qualitative or quantitative chemical testing including (1) the in vitro testing of a body fluid which may be diagnostic of a body condition as well as (2) methods wherein the disclosed utility of a chemical test is both diagnostic and nondiagnostic.

156, Adhesive Bonding and Miscellaneous Chemical Manufacture, provides for processes of chemical manufacture not otherwise provided for and for a process of chemical testing when combined with such process. Class 156 particularly provides for a process of measuring and testing when combined with a process of etching or laminating.

436, Chemistry: Analytical and Immunological Testing, provides for a process of qualitative or quantitative chemical analysis of a crystalline material, etching solution or laminate material.

162, Paper Making and Fiber Liberation, provides for a process of fiber liberation including a step of chemical testing of the fiber or testing fluid as well as providing for chemical testing in combination with a paper making operation.

436, Chemistry: Analytical and Immunological Testing, provides for a qualitative or quantitative chemical test of fibers, paper or processing fluids therefor when not claimed in combination with a process of fiber liberation or paper making.

166, Wells, for a chemical test in combination with a process of using, making or treating a well where such process incorporates more than a nominal step in a claim reciting drilling or treating a well or recovering a fluid therefrom. The headnotes of Class 166 provide comprehensive listing of the disposition of well related testing art.

436, Chemistry: Analytical and Immunological Testing, provides for processes of chemical analysis of samples derived from wells which may include a step of inserting and recovering an absorbent material or a nominal step of drilling or treating a well or recovering a fluid therefrom.

175, Boring or Penetrating the Earth, provides for a process for boring into the earth combined with a measurement or test where more than a mere step of boring is claimed.

436, Chemistry: Analytical and Immunological Testing, provides for a process of chemical testing combined with a nominal step of earth boring.

210, Liquid Purification or Separation, provides for a process of chromatos:graphic separation for separation of the constituents of mixture.

436, Chemistry: Analytical and Immunological Testing, provides for a process including gas or liquid chromatography with a colorimetric test of the colored bands or bands from the chromatography column where a chemically reactive reagent is necessary to develop the color for the colorimetric test.

250, Radiant Energy, provides for a method of using, generating, controlling or detecting radiant energy or a subcombination thereof when not otherwise provided for. This includes use of X-rays to determine chemical composition or crystal structure as well as use of a mass spectrometer. 436, Chemistry: Analytical and Immunological Testing, provides for a qualitative or quantitative chemical test including a step involving the generation, use or detection of radiant energy. The mere use of a fluorescent material is not considered to be chemical, at least in regard to Class 250.

252, Compositions, provides for a chemical testing composition when claimed in combination with a composition specifically provided for in Class 252 and for physical testing, analysis, indicating or warning agents or for physical standards, tracer or identification compositions.

436, Chemistry: Analytical and Immunological Testing, provides for compositions used in a process of chemical analysis including tracers, identifying compositions, diluents, buffers, standards, compositions which simulate or calibrate a test as well as chemical reactants and immunochemical compositions for in vitro testing (See the note on creation of this class for a more complete analysis of the relation of compositions of this class with other classes).

264, Plastic and Nonmetallic Article Shaping or Treating: Processes, provides for a step of chemically testing or inspecting some variable condition in a shaped article, molding material, mold or shaping surface as part of a process included in Class 264.

436, Chemistry: Analytical and Immunological Testing, provides for a chemical test or analysis of a shaped article absent a claim to a process of producing the shaped article.

324, Electricity, Measuring and Testing, is the residual home for measuring and testing electrical properties or the measuring testing or sensing of nonelectric properties (e.g., moisture, pH etc.) by electric means including a chemical reaction by name only. The presence of any detail to the chemical reaction is beyond Class 324. In general, a 324 process may result in the identification of a chemical specie by NMR, ESR, conductivity, impedance, or other electrical property but only absent a significant chemical reaction in which case Class 436 will provide for the combination.

436, Chemistry: Analytical and Immunological Testing, will provide for electrical measuring, testing or sensing when claimed in combination with significant chemical reaction. Significant is taken to mean the inclusion of any detail of a chemical reaction in the claimed process.

340, Communications: Electrical, provides for electrical indicating and measuring systems which include the use of a catalytic or semiconductor gas detector.

436, Chemistry: Analytical and Immunological Testing, will provide for the use of a catalytic or semiconductor gas detector when claimed as part of a process involving a

significant chemical reaction as part of a qualitative or quantitative chemical analysis.

356, Optics: Measuring and Testing, provides for methods and apparatus for determining the optical or nonoptical properties of materials or articles by noting the effect produced by the materials or articles or light associated therewith. Light analysis includes spectroscopy, interference, polarization, shade or color and photometers. The material properties involve crystal or gem examination, blood analysis, optical pyrometers, oil testing, document verification, refraction testing, light transmission or absorption, light reflection, and inspection for flaws or imperfections in materials.

436, Chemistry: Analytical and Immunological Testing, will provide for a process of optical examination which involves a chemical reaction either prior to the optical examination or as a chemically reactive reagent or indicator necessary to develop color or produce an optically detectable result. 364, Electrical Computers and Data Processing Systems, provides for a process or nominally recited chemical analysis combined with a significant data processing or computer or calculating method.

436, Chemistry: Analytical and Immunological Testing, will provide for the combination of a claimed chemical reaction as part of an analytical process when combined with a step involving data processing or computational manipulation.

424, Drug, Bio-Affecting and Body Treating Compositions, provides for an in vivo test which may include a chemical reaction. Class 424 provides for: compositions (A) for preventing, alleviating, treating, or curing abnormal and pathological conditions of the living body, for maintaining, increasing, decreasing, limiting, or destroying a physiologic body function, for diagnosing a physiological condition or state by an in vivo test, for controlling or protecting an environment or living body by attracting, disabling, inhibiting, killing, modifying, repelling, or retarding an animal or micro-organism, (B) for deodorizing, protecting, adorning, or grooming a body, (C) for fermentates and extracts for use in A or B and not elsewhere provided for, and (D) such compositions defined in terms of specific structure; methods of making the above compositions; methods of using the class defined compositions for purposes in A and B; and methods of using compounds, per se, for purposes in A and B.

436, Chemistry: Analytical and Immunological Testing, provides for in vitro qualitative or quantitative chemical analysis including the use of an vitro antigen-antibody interaction as well as for production of an immunological test material by treatment of a live animal.

426, Food or Edible Material: Processes, Compositions, and

Products, provides for processes of performing a test or measurement on an edible combined with an additional operation for treating, preparing, or perfecting an edible, with the exception of an additional operation which is solely involved in perfecting the test or measurement.

436, Chemistry: Analytical and Immunological Testing, provides for processes of performing a test or measurement on an edible involving a chemical reaction.

435, Chemistry: Molecular Biology and Microbiology, provides for a test or measurement involving a microorganism or enzyme which functions catalytically as well as antigen antibody tests involving a living microorganism or enzyme label.

436, Chemistry: Analytical and Immunological Testing, provides for a measurement or test in which an enzyme reacts chemically, i.e., noncatalytically and antigen-antibody tests for the identification of chemical species that do not involve a living antigen or enzyme.

(1) Note. The burden of showing an enzyme is functioning noncatalytically is on Class 436, i.e., the presumption, as between Class 435 and Class 436, is that an enzyme in a testing composition functions catalytically until rebutted.

GLOSSARY:

ANTIBODY A protein of the globulin in type that is formed in an animal organism in response to the administration of an antigen and that is capable of combining specifically with that antigen. Abbr Ab. See also immunoglobulin.

ANTIGEN

A substance, frequently a protein that can stimulate an animal organism to produce antibodies and that can combine specifically with the antibodies thus produced; called also complete antigen as distinct from a hapten. Abbr Ag.

ANTIGEN - ANTIBODY COMPLEX

The generally insoluble molecular aggregate that is formed by the specific interaction of antigens and antibodies. It is also referred to as the immune complex.

HAPTEN

A substance that can react selectively with antibodies of the appropriate specificity but stimulates the production of these antibodies in an animal only when it is coupled to a carrier.

IMMUNOADSORBENT

An insoluble material that is used for the purification of antibodies by adsorbing them from a serum; a gel for trapping antibodies, or an inert solid to which either antigens or haptens have been covalently linked are two examples.

IMMUNOASSAY

An assay that utilizes antigen antibody reactions for the determination of chemical substances. IMMUNOELECTROPHORESIS

A technique for identifying antigens in complex mixtures by first separating the antigens in one dimension by means of gel electrophoresis, and then allowing them to react with antibodies by means of two dimensional double diffusion through the gel; a pattern of precipitin arcs is thereby produced. Abbr IE.

IMMUNOGLOBULIN

1. A protein of animal origin that has a known antibody activity. 2. A protein that is closely related to an antibody by its chemical structure and by its antigenic specificity.