Patent including normal range of gene expression

Press release: Source MDx announced that it has been issued US patent no. 6,960,439, which describes the discovery of "normal," healthy levels of human gene expression and covers the use of such normal ranges to diagnose disease and response to therapy. Specifically, the patent establishes claims for methods of diagnosing a biological condition using two or more genes linked to inflammation or immune response. A wide range of diseases and disorders are associated with inflammatory and immune events, including autoimmune disorders, cancer, immunosuppression, and cardiovascular, eye, infectious, gastrointestinal, metabolic/endocrine and pulmonary diseases. Source MDx's patent represents the first known intellectual property claim on a normal range of gene expression and lays the foundation for the use of RNA-based molecular diagnostics to monitor an individual's health, disease status and response to therapy.

The first claim states:

A method, for evaluating a biological condition of a subject, based on a sample from the subject, the sample providing a source of RNAs, the method comprising:

using amplification for measuring the amount of RNA of at least two constituents from any one of Tables 1 through 12 from the sample of the subject, where a panel of constituents is selected so that measurement of the constituents enables evaluation of the biological condition and wherein the measures of all constituents in the panel form a first profile data set,

using amplification for measuring the amount of RNA of all constituents in said panel wherein the measures of all constituents in the panel are from a relevant population of subjects and form a normative baseline profile data set; and

producing a calibrated profile data set for said panel, wherein each member of the calibrated profile data set is a function of a member of the first profile data set and the corresponding member of the normative baseline profile data set, wherein the measures for each constituent are performed under measurement conditions that are substantially repeatable and the efficiencies of amplification for all constituents are substantially similar and the calibrated profile data set provides a measure of the biological condition of the subject.

Of the correlation issue in Lab Corp. v. Metabolite, note the text:
The index function alternatively be constructed to weigh the expression value of a constituent in the panel generally in accordance with the extent to which its expression level is determined to be correlated with extent of inflammation.

Of the discussion about "normal," there is text:
The consistency between gene expression levels of the two distinct populations is dramatic. Both populations show gene expressions for each of the 48 loci that are not significantly different from each other. This observation suggests that there is a "normal" expression pattern for human inflammatory genes, that a Gene Expression Profile, using the Inflammation Gene Expression Panel of Table 1 (or a subset thereof) characterizes that expression pattern, and that a population-normal expression pattern can be used, for example, to guide medical intervention for any biological condition that results in a change from the normal expression pattern.



The priority chain is complicated:

The present application claims priority from a series of provisional patent applications, by inventors herein, as follows: Ser. No. 60/348,213, filed Nov. 9, 2001; Ser. No. 60/340,881, filed Dec. 7, 2001; Ser. No. 60/369,633, filed Apr. 3, 2002; and Ser. No. 60/376,997, filed Apr. 30, 2002. The present application is also a continuation in part of application Ser. No. 09/821,850, filed Mar. 29, 2001 now U.S. Pat. No. 6,692,916, which in turn is a continuation in part of application Ser. No. 09/605,581, filed Jun. 28, 2000 now abandoned, by the same inventors herein, which application claims priority from provisional application Ser. No. 60/141,542, filed Jun. 28, 1999 and provisional application Ser. No. 60/195,522 filed Apr. 7, 2000.