# US 11,994,516 B2 · Composition, method and kit for pathology > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,994,516 B2 - Document ID: US11994516B2 - Status: Granted - Kind: B2 - Application number: 16/907,909 - Filed: 2020-06-22 - Published: 2021-03-04 - Granted: 2024-05-28 - Earliest claimed: 2015-02-27 - Applicants: Richard Runge - Inventors: Richard Runge - Web page: https://patentgrep.com/patent/US11994516B2 ## CPC - G01N 33/532: Production of labelled immunochemicals - C07K 16/24: against cytokines, lymphokines or interferons - C07K 16/2896: {against molecules with a "CD"-designation, not provided for elsewhere} - G01N 33/569: for microorganisms, e.g. protozoa, bacteria, viruses - G01N 33/58: involving labelled substances (G01N33/53 takes precedence) - G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q) - C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00) ## Abstract Disclosed herein are embodiments of compositions, methods and kits that describe ancillary reagent constructs for simultaneous immunological and morphological investigation of pathology specimens. The kits include reagents, possibly organized in panels, which give the pathologist additional confidence in making a diagnosis based on the morphology of a cell. Reagents can be used or selected to identify specific antigens or a class of antigens. The reagents further comprise detection agents, which are visible under standard microscopy in the presence of standard stains. The reagents, used on their own or as part of a kit, make possible immunological analysis simultaneously with pathology performed in the presence of standard stains. ## Claims ### Claim 1 A method for conducting simultaneous immunological and morphological investigation comprising the steps of: isolating a pathology specimen from a patient; selecting at least one appropriate ancillary reagent construct with an antibody to an antigen expressed on a cell associated with a biological state of interest, the at least one appropriate ancillary reagent construct being visible at microscale under light microscopy and physically stable in the presence of an appropriate standard stain, wherein the at least one appropriate ancillary reagent construct comprises a detection agent, wherein the detection agent is a particle ranging from 0.5 to 5 microns; counting the number of cells in the pathology specimen; administering an appropriate amount of the at least one appropriate ancillary reagent construct; administering the appropriate standard stain; identifying, via light microscopy, stained cells with morphology consistent with the biological state of interest; and confirming, simultaneously with identification of the stained cells with morphology consistent with the biological state of interest, the biological state of interest based on the absence or presence of the detection agent proximal to the stained cells with morphology consistent with the biological state of interest and not proximal to the stained cells with morphology inconsistent with the biological state of interest. ### Claim 2 (depends on 1) The method of claim 1, wherein: the patient pathology specimen is whole blood; the at least one appropriate ancillary reagent construct is a panel of ancillary reagent constructs having the detection agent conjugated to antibodies against B cell antigens and a panel of ancillary reagent constructs having the detection agent conjugated to antibodies against kappa and lambda light chains; and the biological state is lymphocytosis. ### Claim 3 (depends on 2) The method of claim 2, wherein the B cell antigens are selected from the group consisting of CD 19, CD 20, CD24, CD72, and CD73. ### Claim 4 (depends on 1) The method of claim 1, wherein: the patient pathology specimen is a body fluid; the at least one appropriate ancillary reagent construct is a neoplastic panel of ancillary reagent constructs and a reactive panel of ancillary reagent constructs; and the biological state is cancer. ### Claim 5 (depends on 4) The method of claim 4, wherein the neoplastic panel comprises ancillary reagent constructs having the detection agent conjugated to antibodies to antigens selected from the group consisting of EPCAM, CEA, CD15, Berep4, ecad, and EMA. ### Claim 6 (depends on 4) The method of claim 4, wherein the neoplastic panel is a single ancillary reagent construct having the detection agent conjugated to antibodies to both EPCAM and CEA. ### Claim 7 (depends on 6) The method of claim 6, wherein the ratio of EPCAM to CEA on the ancillary reagent construct is 5 to 2.