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October 07, 2014

Comments

The piece doesn't mention the patent numbers, but apparently they are US 7323341 and US 8367414. Without wishing to belittle Dr. Jasper's contributions to the use of isotope ratios as a tool for fingerprinting batches of material, I wonder, post-Prometheus/Myriad/Alice, if at least some of the claims of these patents are now suspect under 101. The '341 patent was granted before any of those decisions, and the '414 patent was granted after Prometheus but before the other two. The independent claims of the '341 patent read,

1. A method for objectively identifying a known product, comprising: obtaining isotopic data from elements present in said product; providing a mathematical array that includes the isotopic data, the mathematical array being fixed in a readable form, said readable form with said mathematical array fixed thereon being an identification of said product; wherein the isotopic data does not include data obtained from a taggant; and wherein the product consists essentially of a pharmaceutical product.

8. A method for objectively identifying a known product, comprising: obtaining isotopic data from elements present in said product; providing a mathematical array that includes the isotopic data, the mathematical array being fixed in a readable form, said readable form having said mathematical array fixed thereon being an identification of said product; wherein the isotopic data comprises isotopic data for at least one isotope of an element selected from the group consisting of carbon, hydrogen, nitrogen, oxygen and sulfur; and wherein the product consists essentially of a pharmaceutical product.

The independent claims of the '404 patent read,

1. A method for constructing an isotopic process profile for a first product made using a known synthetic process, comprising: obtaining a first isotopic composition profile for the first product and a second isotopic composition profile for one or more starting material used to make the first product; determining isotopic fractionation values for one or more reaction steps in the known synthetic process; and providing a database that includes a plurality of data selected from the group consisting of (i) the first isotopic composition profile for the first product, (ii) the second isotopic composition profile for one or more starting material used to make the first product, and (iii) isotopic fractionation values for one or more reaction steps in the known synthetic process; wherein the database is an isotopic process profile of the product.

11. A method for determining whether a product of undefined origin was made by a first known synthetic process, comprising: obtaining a first isotopic composition profile for the product; providing fractionation information regarding the first known synthetic process, the starting materials used to make the product, or both; and inferentially determining whether the product of undefined origin was made by the first known synthetic process by comparing the first isotopic composition profile to the information.

29. A method for monitoring process quality of a chemical synthesis process, comprising: defining an acceptable range of isotopic abundance at an intermediate point or an end point in the chemical synthesis process for at least one stable isotope, the acceptable range encompassing isotopic abundance values that exist when the process is proceeding in an acceptable manner; periodically extracting samples from the chemical synthesis process at the intermediate point or the end point; measuring the actual isotopic abundance for the at least one stable isotope in the samples; and comparing the actual isotopic abundance to the acceptable range to determine whether the chemical synthesis process is proceeding in an acceptable manner.

31. A system for monitoring process quality of a chemical synthesis process, comprising: a sample extraction device operable to periodically obtain samples from a process stream for the chemical synthesis process at an intermediate point or an end point in the process; a measuring instrument operable to receive the samples from the extraction device and determine actual isotopic abundance information for one or more isotopes in the samples; and a computer processor operable to store and display the isotopic abundance information.

33. A method for making a new product batch that has a unique isotopic composition profile different than a previously-made product batch with the same molecular content, comprising adjusting at least one aspect of the manufacturing process for the product in a manner selected from the group consisting of (i) selecting a starting material having a different isotopic composition profile, (ii) identifying a chemical reaction in the process that has an isotope effect, and halting the reaction at a different stage short of completion, (iii) identifying a chemical reaction in the process that has an isotope effect, and making the limiting reagent one that is not used to derive the isotopic composition profile of the product, (iv) altering the amount of the limiting reagent that is available for reaction, and (v) mixing into the product an excipient having a different isotopic composition profile.

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